de novo

Med Device Monday – De Novo Clearance of The Miris Human Milk Analyzer

Breast milk is often considered a “superfood” for babies; it contains the appropriate vitamins, minerals, and nutrients to support a baby’s growth and development (not to mention hormones and enzymes that promote maturation and digestion, and antibodies that help the baby resist infection!). It’s no wonder why breast milk is often referred to as “nature’s first health plan.”

Yet for infants born preterm (before 37 weeks gestation), or with certain health conditions, breast milk may not contain sufficient protein or provide enough energy. For these infants with increased nutritional needs, knowing the macronutrient content of the breast milk being provided could give vital information to the health care team and parents, allowing them to make informed decisions on how to fortify the breast milk based on the individual needs of the infant.

In December 2018, the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer (HMA) to Miris AB of Sweden. The Miris HMA uses an infrared spectroscopy system to analyze samples of human milk, and provides a quantitative measurement of fat, protein and total carbohydrate content, as well as calculations of the total solids and energy content contained in the milk. The prescription device is intended for use by trained health care personnel at clinical laboratories, providing healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

FDA reviewed the Miris HMA test through the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with its granting, FDA established a list of special controls to provide for the accuracy and reliability of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. As discussed in our previous blogs about the De Novo pathway, this action also creates a new regulatory classification; meaning subsequent devices of the same type and intended use may go through FDA’s 510(k) process.

Already on sale in over 25 countries worldwide, the Miris HMA is now available to analyze breast milk and guide the individual nutrition of preterm babies in the U.S. The new device supports Miris’ mission, “to make individual nutrition, based on human milk, available globally to improve neonatal health.” We’re excited to see a new device on the market that has the potential to help one of the most vulnerable patient populations. Go babies!


Additional Reading:

1.      FDA Press Release

2.      De Novo Letter for The Miris Human Milk Analyzer

3.      NIH: Do breastfed infants need other nutrition?

4.      CDC: Breastfeeding

5.      Miris Website

Med Device Monday: ClearMate - Effective Carbon Monoxide Poisoning Treatment granted via De Novo Pathway

Have you heard the saying, “canary in a coal mine”? Well, the saying started because canaries were actually used in coal mines (until 1986!?) to detect dangerous levels of the gas carbon monoxide. With a faster metabolism, canaries show the effects of poisoning by the colorless, odorless gas before the carbon monoxide levels become critical for workers. While many homes and businesses now have electronic carbon monoxide detectors (canaries everywhere rejoice!), inadvertent carbon monoxide exposure and poisoning is still a major issue worldwide.

According to the Centers for Disease Control and Prevention, carbon monoxide poisoning is the most common type of poisoning in many countries, and is responsible for over 20,000 emergency room visits per year in the US. Carbon monoxide gas is produced primarily by motor vehicles and poorly maintained and/or poorly ventilated heating systems, gas stoves, or gas-powered generators. It is particularly dangerous due to its ability to outcompete oxygen for its spot on hemoglobin, the protein in red blood cells that typically carries oxygen from the lungs to the rest of the body. The affinity between hemoglobin and carbon monoxide is approximately 230 times stronger than that between hemoglobin and oxygen.

As a result of exposure to carbon monoxide, an individual may suffer symptoms including headache, dizziness, weakness, upset stomach, vomiting, chest pain and confusion. Exposure to high levels of carbon monoxide can cause death in minutes. The standard treatment for carbon monoxide poisoning is to have the patient breathe 100 percent oxygen through a mask. In severe cases, a hyperbaric chamber may be used, which delivers oxygen under higher than normal pressure. However, according to Dr. Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA's Center for Devices and Radiological Health, “hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire US. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time.”

On March 14th, 2019, the FDA granted marketing authorization of ClearMate to Thornhill Research, Inc. ClearMate, which is intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning, is designed to quickly remove carbon monoxide from the body by increasing a patient’s respiration rate. The device consists of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask, and hoses. By delivering both 100 percent oxygen to the patient, as well as a mixture of oxygen and carbon dioxide, the patient breathes faster. More rapid breathing accelerates the rate at which the carbon monoxide leaves the patient’s body, allowing a normal amount of oxygen to attach to hemoglobin and be carried to where it is needed throughout the body. In clinical studies, using ClearMate resulted in faster elimination of carbon monoxide than treatment with 100 percent oxygen alone (although not faster than hyperbaric oxygen therapy).

Per the Thornhill Medical website:

“The compact, 6 Kg, ClearMate™ is totally pneumatic – no electricity, batteries or computers are needed for it to work. ClearMate™ was designed for rescue vehicles, hospital emergency departments, factories, schools, and any other facilities where the earliest possible treatment of CO [carbon monoxide] poisoning will save lives. Whenever carbon monoxide poisoning may have occurred, ClearMate™ can be used on the scene by anyone with minimal training, and with no risk of side effects.”

ClearMate was reviewed under the FDA’s De Novo premarket pathway, the regulatory pathway for low-to-moderate-risk devices of a new type. Approval through the De Novo pathway establishes a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

So while canaries can let out a sigh of relief, so can patients who might need this device. Previous to the De Novo, ClearMate achieved CE Marking, and was also approved for sale in Canada, Australia, China, Korea and Taiwan. Now that this device is available in the US, Americans who might experience carbon monoxide poisoning have a better chance of survival…and that’s all something we can breathe easier about!


Additional Reading:

  1. FDA Classification Order for ClearMate

  2. FDA Press Release for ClearMate

  3. More information on the ClearMate Device

  4. More information about carbon monoxide poisoning


Med Device Monday: INNOVO – Therapy Device to Treat Stress Urinary Incontinence granted via the De Novo Pathway

Image from http://www.atlantictherapeutics.com/

Image from http://www.atlantictherapeutics.com/

Urinary incontinence is a very common, often ignored health issue. Stress incontinence is the most common type of urinary incontinence, and describes accidental leaks that occur when coughing, sneezing, laughing, jumping or doing heavy lifting. These simple movements, or stressors, put pressure on the bladder. Unfortunately, when the pelvic floor muscles are weak, this pressure can lead to a messy and potentially embarrassing leak. In women, stress urinary incontinence (SUI) can happen at any age, however it is most common during pregnancy, after childbirth, and during stages of menopause.

In November of last year, FDA granted a De Novo automatic reclassification to Atlantic Therapeutics’ INNOVO therapy device to treat stress urinary incontinence in women. INNOVO is a wearable device that may be prescribed as a front-line therapy to those suffering stress urinary incontinence, or as a second line therapy to those that previously failed physical therapy (in the form of supervised or unsupervised pelvic floor exercises, also known as Kegel exercises).

So, what exactly is a pelvic floor?

The term pelvic floor describes the group of muscles that span the bottom of the pelvis and support the pelvic organs. The pelvic organs in men (yes, men also have a pelvic floor) are the bladder and bowel, and in women they are the bladder, bowel and uterus. Weak pelvic floor muscles can lead to incontinence, pain, and prolapse, or the slipping down or forward of a pelvic organ. Honestly, we can’t think of anything good that comes from a weak pelvic floor.

According to the manufacturers, using a hand-held controller that is attached to a two-part garment, the INNOVO therapy device sends targeted impulses via conductive pads (attached to your upper thigh and buttocks) to activate the muscles of the pelvic floor. It is a technology that has been designed to optimally strengthen your pelvic floor with 180 contractions per session, allowing the device to do your pelvic floor exercises for you.

The device has demonstrated promising results. 87.2% of patients were dry or almost dry of after a 12-week treatment period, with 93% of patients experiencing improvement in as little as four weeks using the device five days a week for 30 minutes. One potential benefit of the device is that it is a transcutaneous electrical stimulator that offers a non-invasive choice to treat stress urinary incontinence. Elizabeth LaGro, Vice President of The Simon Foundation for Continence said it well, “INNOVO offers a new frontline therapeutic option for the millions of American women living with stress urinary incontinence, and in a significant group could delay or prevent the need for higher risk surgery or medical intervention.”

And finally, in addition to talking about a novel device coming soon to the US market, this week’s Medical Device Monday gives us the opportunity to again mention the De Novo pathway. In December, now outgoing FDA Commissioner Dr. Scott Gottlieb provided a high level description of the pathway; “the De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health”. In practice, the De Novo pathway is used for the review of novel, low to moderate risk devices for which there are ways to provide reasonable assurance of the device’s safety and effectiveness, but for which there is no existing predicate to use in the determination of substantial equivalence. So now, after years on the European market, women in the US will soon have access to INNOVO. We hope to see more US moms on trampolines in the near future!

Additional Reading:

1.      FDA Classification order

2.      Atlantic Therapeutics website

3.      Video explaining how INNOVO works

4.      Press release

5.      More info on SUI

Med Device Monday: ThermoNeuroModulation Device to Treat Migraines

It’s Medical Device Monday! As excited as we are here at AcKnowledge RS about Mondays, it is known by many as #MigraineMonday on social media. Well, today we have some exciting news for sufferers: a stimulator by Scion NeuroStim LLC called the ThermoNeuroModulation (TNM) Device. Although it is currently for prescription use only, it is still a step forward for those who experience migraines.

IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

Over 39 million Americans suffer from migraines; 2-3 million of those 38 million suffer from chronic migraines. During a migraine, a person may experience a variety of symptoms including vertigo, pain, sensitivity to light, or nausea. Some people suffer from vestibular migraines that cause repeated bouts of dizziness and may or may not include headache. Vestibular migraines can also lead to issues with balance, extreme motion sensitivity, vomiting, and feeling disoriented.  

Migraine treatments for traditional migraines are relatively limited; you can take pain-relieving medications or preventive medications, depending on the severity and frequency of your migraines. Pain-relieving medications can range from ibuprofen to opioids. Preventive medications include cardiovascular drugs, antidepressants, Botox, and even anti-seizure drugs. Both approaches clearly involve the use of pharmaceuticals, and unfortunately may not alleviate pain or prevent migraines from happening again.

The TNM Device is a non-drug solution for migraines that was granted through the de novo process in April 2017. Per the device description in the FDA de novo Classification Request:

“The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.”

The device is a non-invasive, home-use, DC-powered device that uses an over-the-ear headset with metallic earpieces that protrude into the external ear canals. While the user reclines and relaxes during treatment, the earpieces change temperature from 16-42°C. The controlled thermal fluctuations interact with the user’s vestibular system, causing changes that are used to treat their migraine headaches. The control unit with touchscreen display allows the patient to manage the treatment.

The TNM Device was studied in a multi-center, triple-blind, placebo-controlled, randomized study. Half of the patients were treated with the device while the other half received a placebo device. After three months of treatment, patients experienced a 21% decrease in total headache pain scores and the duration of migraine days decreased from 7 to 4.

The de novo pathway provided a mechanism for devices such as the TNM Device to undergo FDA review even though there are no other devices like it on the market. We hope that this device can help those who suffer from migraines. After all, don’t we all want a migraine-free Monday/week/life?

Are you interested in the de novo pathway? Check out our original blog post and update about if the de novo pathway is right for your device!

Additional reading:





Med Device Monday: BONEBRIDGE by Med-El

Hearing loss is the third most common health problem in the U.S after heart disease and arthritis. It is estimated that about 48 million Americans have some form of hearing loss, often caused by illness, genetics, or other ear-damaging elements that come with a modern lifestyle (e.g. sporting events, airplanes, concerts, and working with heavy machinery). FDA recently granted a de novo request for the BONEBRIDGE device, manufactured by Austrian company, Med-El. BONEBRIDGE is an active bone conduction implant system, and is designed for individuals 12 years and older who have conductive hearing loss, mixed hearing loss, or single-sided deafness.

To understand who should use this device, we need to understand a little more about the types of hearing loss. Hearing loss can be categorized into 4 categories:

  • Conductive: Any problem in the outer or middle ear that prevents sound from being conducted properly.

  • Sensorineural: Hearing loss that results from missing or damaged sensory cells (hair cells) in the cochlea and is usually permanent.

  • Mixed: As the name suggests— is a combination of conductive and sensorineural hearing loss, indicating damage in both the outer or middle ear, and the inner ear.

  • Neural: Neural hearing loss results from the lack of or damage to the auditory nerve, which is a bundle of fibers that carries auditory sensory information from the cochlea to the brain.


Traditional cochlear implants help patients who have sensorineural hearing loss as they replace the functional components of the inner ear (read more about cochlear implants on our blog from May 2016)! Alternatively, BONEBRIDGE is indicated for conductive or mixed hearing loss, which means sound cannot take the natural route through the outer and middle ear to the inner ear. This makes it difficult for the hearing loss sufferer to hear soft sounds and can also lead to the muffling of louder sounds.

Image from www.medel.com/us/bonebridge

Image from www.medel.com/us/bonebridge


BONEBRIDGE transmits sound waves via bone conduction directly to the inner ear, where they are processed as natural sound. The device consists of two components: an externally worn audio processor (called SAMBA), and a surgically-inserted bone conduction implant (called the BCI 601) which lies directly beneath the skin. The audio processor is held directly above the implant using magnetic forces.

Now, let’s get into the specifics of how this device works! Initially, the microphones of the audio processor pick up the sound waves. Then, the audio processor converts those sound waves into electrical signals, which are then transmitted through the skin to the implant. The implant, which is fixed in the temporal bone, converts these electrical signals into mechanical vibrations which are transmitted to the skull. The bone then conducts these vibrations to the inner ear. Signal transmission to the inner ear via bone conduction bypasses the outer and the middle ear, solving the complication of sound’s inability to pass through the natural route that comes with conductive and mixed hearing loss. The inner ear then processes these mechanical vibrations in a way that is similar to the way natural hearing is processed, and transmits nerve signals to the auditory nerve in the brain.

The audio processor is equipped with adaptive directional microphones, which adapts to different environments and individual usage. One of the really cool things about the audio processor (not that the device isn’t already super cool) is that it automatically identifies and minimizes noise interference in situations where there is loud background noise, which can become overwhelming to people who aren’t used to those background noises. The audio processor also comes with a remote control that has wireless connectivity capabilities. Using this remote control, the users can select different programs that have various settings depending on the user’s current environment or activity.

FDA classified BONEBRIDGE under product code PFO as a Class II device with special controls. These special controls include:

1.       Clinical performance testing

2.       Non-clinical performance testing (includes impact testing, mechanical Integrity testing, etc.)

3.       Biocompatibility testing

4.       Sterility of the patient-contacting components of the device

5.       Shelf life of the device

6.       Wireless compatibility, electromagnetic compatibility, and electrical safety

7.       Software verification, validation, and hazard analysis

8.       Labeling

 

We’re so excited to see medical technology like this enter the US market!

Additional Reading:

1.       FDA Classification Order

2.       Video explaining how the BONEBRIDGE works

3.       More info about BONEBRIDGE

4.       More info about the de novo process HERE and HERE