(239 days)
No
The device description focuses on mechanical components and airflow dynamics, with no mention of AI/ML terms or data-driven performance metrics.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults". Treatment is a characteristic of a therapeutic device.
No
The device description clearly states its purpose is for treatment ("indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea") and the mechanism of action involves creating therapeutic positive pressure on exhalation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components made of silicon rubber, airflow cartridges, flanges, and nasal pillows. It also mentions headgear. This indicates a hardware-based device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of mild to moderate Obstructive Sleep Apnea (OSA). IVDs are used for the diagnosis or monitoring of diseases or conditions using samples from the human body (like blood, urine, tissue).
- Device Description: The device description details a mechanical device that creates positive pressure to treat OSA. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components of IVD devices.
Therefore, the ULTepap™ is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66bs.
Product codes
OHP
Device Description
The ULTepap™ is a single patient, reusable device intended to treat mild to moderate OSA. It is comprised of a soft silicon rubber body that contains a pair of bi-resistance airflow cartridges, has flanges to attach headgear, and has nasal pillows to interface with the nares. The device is held in place on the patients face by means of a common CPAP mask headgear which is provided in the packaging. The device creates a therapeutic level of positive pressure on exhalation by means of the airflow cartridges that allow air to enter the patient's upper airway without resistance on inhalation and created resistance to airflow on exhalation. The airflow cartridges are comprised of a cylinder and a flexible thin-walled shell which are aligned with the nasal pillows to allow unimpeded inspiration and partially restricted expiration to create the appropriate level of therapeutic back pressure. The thin-walled shells collapse on inspiration and re-inflate on expiration and create a restricted area for expiration by inflating and sealing the inner diameter of the cylinder, forcing expiration through a series of channels molded in the cylinder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nares (nasal pillows interface with the nares)
Indicated Patient Age Range
Adults > 66 lbs.
Intended User / Care Setting
Home or sleep lab use at night while sleeping
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were performed on device that underwent full manufacturing:
- Back pressure comparison demonstrating the ULTepap™ creates back pressure in the same range as two predicate devices.
- Air flow cartridge fatigue while testing the cleaning impact on material integrity.
- Comfort evaluation study.
- Accelerated Aging Test to determine acceptable shelf life claims.
- Inhalation resistance testing
- Cleaning validation
- Vibration/drop testing
- Environmental Testing
No clinical testing was performed in association with this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2020
Bryggs Medical, LLC Geoffrey Sleeper President 34910 Commerce Way Avon, Ohio 44011
Re: K191728
Trade/Device Name: ULTepap Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: OHP Dated: January 23, 2020 Received: January 24, 2020
Dear Geoffrey Sleeper:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Rvan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name ULTepap ™
Indications for Use (Describe)
ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66bs.
in millio for annon manus ann a sensa manus and sono di via divis divis divisione n Carlott
Type of Use (Select one or both, as applicable) 🇿PrescriptIon Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Submission Owner and Correspondent 5.1
Submission Owner
BRYGGS Medical, LLC 34910 Commerce Way Suite 2 Avon, OH 44011 Phone: 440-937-8181 Fax: 440-695-0913
Submission Correspondent
Geoffrey Sleeper BRYGGS Medical, LLC 34910 Commerce Way Suite 2 Avon, OH 44011 Phone: 216-870-6990 Email: geoffrey.sleeper@gmail.com
5.2 Date Summary Prepared
June 26, 2019
5.3 Device Trade Name
ULTepap™
5.4 Device Common Name
ULTepap™
5.5 Device Classification Name
Expiratory resistance valve, intranasal for obstructive sleep apnea; OHP; Classification at 21 CFR 872.5570; Class II
5.6 Legally Marketed Device To Which The Device Is Substantially Equivalent
4
The ULTepap™ is substantially equivalent to Ventus Medical's Provent cleared under K102404 on December 2, 2010 and InnoMed Healthscience's Bongo cleared under K180619 on August 16, 2018. BRYGGS is also introducing reference devices for the purpose of making some technological comparisons. Reference devices similar to the ULTepap™ are the SNAPP Sleep Apnea Therapy cleared under K034053 on June 24, 2004 and the P-B Adam Circuit Nasal Pillows cleared under K900164 on January 26, 1990.
Description of The Device 5.7 -
The ULTepap™ is a single patient, reusable device intended to treat mild to moderate OSA. It is comprised of a soft silicon rubber body that contains a pair of bi-resistance airflow cartridges, has flanges to attach headgear, and has nasal pillows to interface with the nares. The device is held in place on the patients face by means of a common CPAP mask headgear which is provided in the packaging. The device creates a therapeutic level of positive pressure on exhalation by means of the airflow cartridges that allow air to enter the patient's upper airway without resistance on inhalation and created resistance to airflow on exhalation. The airflow cartridges are comprised of a cylinder and a flexible thin-walled shell which are aligned with the nasal pillows to allow unimpeded inspiration and partially restricted expiration to create the appropriate level of therapeutic back pressure. The thin-walled shells collapse on inspiration and re-inflate on expiration and create a restricted area for expiration by inflating and sealing the inner diameter of the cylinder, forcing expiration through a series of channels molded in the cylinder.
Intended Use of the Device 5.8
The ULTepap™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults > 66 lbs.
Technological Characteristics 5.9
●
The proposed ULTepap™ has similar technical characteristics to the predicate Ventus Corp Provent Sleep Apnea Therapy device, cleared under K102404, and the Innomed Healthscience, Inc. Bongo, cleared under K180619. A comparison of technological characteristics is presented in Table 5. 1.
| Attribute | Proposed Device: | Primary Predicate Device: | Secondary Predicate Device: |
|---|---|---|---|
| ULTepap™ Intranasal | |||
| device | Provent® (K102404) | Bongo (K180619) | |
| Indications for | |||
| Use | ULTepap™ is indicated for | ||
| use in the treatment of mild | |||
| to moderate Obstructive | |||
| Sleep Apnea (OSA) in | |||
| adults > 66 lbs. | Provent® Sleep apnea | ||
| Therapy is indicated for | |||
| the treatment of | |||
| obstructive sleep apnea | |||
| (OSA) | The Bongo Rx is indicated for use | ||
| in the treatment of mild to | |||
| moderate obstructive sleep apnea | |||
| (OSA) in adults > 66 lbs. | |||
| Principles of | |||
| Operation - | |||
| Physical | |||
| configuration | Soft silicon rubber body | ||
| that contains a pair of bi- | |||
| resistance airflow | |||
| cartridges, with flanges to | |||
| attach headgear and with | |||
| integrated nasal pillows to | |||
| interface with the nares | A pair of adhesives- | ||
| backed thin patches | |||
| containing flap valves | |||
| that adhere to the | |||
| underside of the nares | A pair of connected silicon rubber | ||
| inserts that are attached to flap | |||
| valves, with flanges to attach | |||
| headgear. The inserts interface | |||
| inside the nares |
5
| Features - How
the devices are
secured to the
patient | The assembly is held in
place by a conventional
CPAP headgear | Held in place by means
of the adhesive | The nasal inserts may be used with
or without conventional headgear,
depending on patient preference |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Features -
Duration of use | Usable device for a
maximum of three months | One-night use only | Usable device for a maximum of
three months |
| Materials | BODY & SHELL - Liquid
Silicone rubber (LSR) LIM
6040
CYLINDER –
Polycarbonate resin Type:
PC Poly
Grade:ML-1020R
ADHESIVE – RTV 108
Acetoxy Sealant | *A pair of adhesive
backed thin patches
containing flap valves
that adhere to the
underside of the nares
Material not known. | *INSERTS & FLAP VALVES –
Not known
FLAP CASES –
Not known |
| Positive Pressure
range | $4.2 -20.3$ cmH2O | $5.7 -21.2$ cmH2O | $1.1 – 4.5$ cmH2O |
| Patient Population | adults > 66 lbs. | Adults | adults > 66 lbs. |
| Environment of
use | Home or sleep lab use at
night while sleeping | Home or sleep lab use at
night while sleeping | Home or sleep lab use at night
while sleeping |
| Use Type | Single Patient, reusable | Single patient, one night
only | Single Patient, reusable |
| Sealing method | CPAP headgear that holds
the nasal pillows against the
nares | Adhesive that sticks the
valves | Optional CPAP headgear that
helps keep the nasal pillows in the
nares |
| Features | Multiple sizes, single
resistance | One size, single
resistance | Multiple sizes, single resistance |
5.10 Non-Clinical Testing
The following non-clinical tests were performed on device that underwent full manufacturing:
- Back pressure comparison demonstrating the ULTepap™ creates back pressure in the same range as two predicate devices.
- Air flow cartridge fatigue while testing the cleaning impact on material integrity.
- Comfort evaluation study.
- · Accelerated Aging Test to determine acceptable shelf life claims.
- Inhalation resistance testing
- Cleaning validation
- Vibration/drop testing
- Environmental Testing
Biocompatibility 5.11
6
The following biocompatibility tests were completed:
- · In-Vitro Cytotoxicity Study by Elution Method (ISO 10993-5:2009(E)
- · Skin Sensitization Maximization Test (ISO 10993-10:2010(E))
- · Intracutaneous Reactivity Test (ISO 10993-10:2010(E)
- The materials used in the proposed device are certified by the vendor to be identical in formulation and processing to the reference device, K034053
Clinical Testing 5.12
No clinical testing was performed in association with this submission.
Conclusions 5.13
The results of the comparison of design, materials, intended use, and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices.