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.

AI/ML Overview

This is a 510(k) summary for a medical device called ULTepap, an intranasal device intended to treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.

Based on the provided information, I can answer your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with specific thresholds for performance. Instead, it describes non-clinical tests conducted to demonstrate the device's substantial equivalence to predicate devices. The reported device performance is presented as a comparison to these predicate devices.

Attribute/Test	Acceptance Criteria (Implied/Compared to Predicate)	Reported Device Performance
Back pressure comparison	Be in the same range as two predicate devices	Creates back pressure in the same range as two predicate devices (Provent and Bongo)
Air flow cartridge fatigue	Maintain material integrity after cleaning	Tested while evaluating the impact of cleaning on material integrity
Comfort evaluation study	(Implicitly, be comfortable for patients)	(Study conducted, specific outcomes not detailed in this summary)
Accelerated Aging Test	Establish acceptable shelf life claims	To determine acceptable shelf life claims
Inhalation resistance testing	(Implicitly, demonstrate low resistance)	(Test conducted, specific outcomes not detailed in this summary)
Cleaning validation	(Implicitly, demonstrate effective cleaning)	(Test conducted, specific outcomes not detailed in this summary)
Vibration/drop testing	(Implicitly, demonstrate durability)	(Test conducted)
Environmental Testing	(Implicitly, perform in expected environments)	(Test conducted)
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity)	Meet ISO 10993 standards	Tests completed per ISO 10993 standards; materials certified identical to reference device K034053

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing. It does not provide details on sample sizes for any of the non-clinical tests (e.g., how many devices were subjected to airflow cartridge fatigue or comfort evaluation).

For clinical testing, the document explicitly states: "No clinical testing was performed in association with this submission." Therefore, there is no clinical test set, sample size, or data provenance to report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since "No clinical testing was performed," there was no clinical ground truth established by experts for a test set. The document does not describe the use of experts in establishing ground truth for the non-clinical tests mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as "No clinical testing was performed" and no clinical test set was used to assess the device's performance against a ground truth established by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The ULTepap™ is a physical medical device (an intranasal device for OSA treatment) and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The ULTepap™ is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" was based on established engineering and materials science standards (e.g., ISO 10993 for biocompatibility) and comparisons to existing predicate devices (e.g., for back pressure range). Since no clinical trials were conducted, no clinical ground truth (expert consensus, pathology, outcomes data) was used in this submission.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth.

Summary

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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

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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

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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.

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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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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

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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 -

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™ Intranasaldevice	Provent® (K102404)	Bongo (K180619)
Indications forUse	ULTepap™ is indicated foruse in the treatment of mildto moderate ObstructiveSleep Apnea (OSA) inadults > 66 lbs.	Provent® Sleep apneaTherapy is indicated forthe treatment ofobstructive sleep apnea(OSA)	The Bongo Rx is indicated for usein the treatment of mild tomoderate obstructive sleep apnea(OSA) in adults > 66 lbs.
Principles ofOperation -Physicalconfiguration	Soft silicon rubber bodythat contains a pair of bi-resistance airflowcartridges, with flanges toattach headgear and withintegrated nasal pillows tointerface with the nares	A pair of adhesives-backed thin patchescontaining flap valvesthat adhere to theunderside of the nares	A pair of connected silicon rubberinserts that are attached to flapvalves, with flanges to attachheadgear. The inserts interfaceinside the nares

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Features - Howthe devices aresecured to thepatient	The assembly is held inplace by a conventionalCPAP headgear	Held in place by meansof the adhesive	The nasal inserts may be used withor without conventional headgear,depending on patient preference
Features -Duration of use	Usable device for amaximum of three months	One-night use only	Usable device for a maximum ofthree months
Materials	BODY & SHELL - LiquidSilicone rubber (LSR) LIM6040CYLINDER –Polycarbonate resin Type:PC PolyGrade:ML-1020RADHESIVE – RTV 108Acetoxy Sealant	*A pair of adhesivebacked thin patchescontaining flap valvesthat adhere to theunderside of the naresMaterial not known.	*INSERTS & FLAP VALVES –Not knownFLAP CASES –Not known
Positive Pressurerange	$4.2 -20.3$ cmH2O	$5.7 -21.2$ cmH2O	$1.1 – 4.5$ cmH2O
Patient Population	adults > 66 lbs.	Adults	adults > 66 lbs.
Environment ofuse	Home or sleep lab use atnight while sleeping	Home or sleep lab use atnight while sleeping	Home or sleep lab use at nightwhile sleeping
Use Type	Single Patient, reusable	Single patient, one nightonly	Single Patient, reusable
Sealing method	CPAP headgear that holdsthe nasal pillows against thenares	Adhesive that sticks thevalves	Optional CPAP headgear thathelps keep the nasal pillows in thenares
Features	Multiple sizes, singleresistance	One size, singleresistance	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

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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.

Regulation Number and Section

§ 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.”