The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device directs expiratory flow through small vent ports which increases intranasal pressure similar to the expiratory portion of the breathing cycle during use of the predicate device. The Bongo consists of valve assemblies coupled with nasal inserts. The Bongo has soft nasal inserts to form a seal within the nasal openings. The nasal inserts are offered in various sizes.

AI/ML Overview

The Bongo intranasal appliance is intended for the treatment of mild to moderate obstructive sleep apnea (OSA) in adults weighing over 66 lbs.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a formal "acceptance criteria" table with specific pass/fail thresholds for clinical performance. However, it does describe the performance observed in the clinical study and compares it to the predicate device. Based on the "Clinical Testing" section, the implicit clinical acceptance criterion is a reduction in AHI.

Acceptance Criteria (Implicit)	Reported Device Performance (Bongo)	Comparison to Predicate (Ventus ProVent K102404)
Reduction in Apnea-Hypopnea Index (AHI)	Mean diagnostic AHI: 15.7	Reductions were substantially equivalent.
	Mean AHI with Bongo: 7.1
	Median diagnostic AHI: 15.4
	Median AHI with Bongo: 7.0
No serious adverse events	No serious adverse events occurred.	(Not explicitly compared for predicate)
Inhalation Resistance (comparable to predicate)	Met criteria in comparative testing.	Similar inhalation resistance.
Exhalation Flow Rate (comparable to predicate)	Met criteria in comparative testing.	Similar exhalation flow.
Biocompatibility (ISO 10993-1)	Materials tested per ISO 10993-1.	Similar.
Performance after aging, environmental changes, cleaning, drop test	Device meets performance specifications.	Subject device meets its performance specifications.

2. Sample Size and Data Provenance

Test Set Sample Size: N=10 patients who completed the clinical study.
Data Provenance: The document states "A prospective, non-randomized, open label, single-center clinical study was performed." The country of origin is not explicitly mentioned, but the FDA submission suggests it adheres to US regulatory standards. It is a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the "number of experts" or their specific "qualifications" used to establish the ground truth for the clinical study. However, the ground truth (AHI) was likely determined by sleep specialists or trained sleep technologists interpreting Polysomnography (PSG) results, as is standard clinical practice for OSA diagnosis and monitoring.

4. Adjudication Method

The document does not detail any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth of the test set. The clinical study's outcome measures (AHI reduction from PSG) would typically involve interpretation by a single qualified professional per sleep study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The clinical study described is for the device's performance in reducing AHI and does not involve comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an intranasal appliance, not an AI algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance described is of the physical device worn by patients.

7. Type of Ground Truth Used

The primary ground truth used for the clinical study was Polysomnography (PSG) data, specifically the Apnea-Hypopnea Index (AHI) measurements. This is a recognized objective measure for the diagnosis and severity of obstructive sleep apnea.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. The clinical study described involves patients testing the physical device, not an algorithm being trained.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an algorithm training set, this question is not applicable. The clinical study's ground truth for the "test set" (N=10 patients) was established through PSG recordings.

Summary

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August 16, 2018

InnoMed Healthscience, Inc. % Paul Dryden Consultant InnoMed Healthscience, Inc. c/o ProMedic, LLC 131 Bay Point Dr. NE Saint Petersburg, FL 33704

Re: K180619 Trade/Device Name: Bongo 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: July 16, 2018 Received: July 17, 2018

Dear Paul Dryden:

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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours.

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180619

Device Name Bongo

Indications for Use (Describe)

Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared:	August 10, 2018
	InnoMed Healthscience, Inc.1701 W. Hillsboro Blvd.Suite 303Deerfield Beach, FL 33442
Official Contact:	Javier CollazoGeneral Manager and Vice PresidentTel - 954.773.9656
Proprietary or Trade Name:	Bongo
Common/Usual Name:	Expiratory resistance valve, intranasal, for obstructive sleep apnea
Classification Name:	21CFR 872.5570ProCode - OHPClass II
Predicate Device:	Ventus ProVent (K102404)

Device Description: The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device directs expiratory flow through small vent ports which increases intranasal pressure similar to the expiratory portion of the breathing cycle during use of the predicate device. The Bongo consists of valve assemblies coupled with nasal inserts. The Bongo has soft nasal inserts to form a seal within the nasal openings. The nasal inserts are offered in various sizes.

Indications for Use:	Bongo is indicated for use in the treatment of mild to moderate obstructivesleep apnea (OSA) in adults >66 lbs.
Patient Population:	For adults (>66 lbs.) with mild to moderate OSA.
Environments of Use:	Home use, hospitals, and sleep laboratories

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K180619

510(k) Summary Page 2 of 4

Attributes	Proposed Bongo	PredicateVentus ProVent (K102404)	Comments
Indications for Use	For use in the treatment of mild to moderateobstructive sleep apnea (OSA).	For use in the treatment of obstructive sleepapnea (OSA).	Similar
Patient Population	Adults (>66 lbs. / 30 kg.)	Not specified	Similar
Environment of Use	HomeHospitalsSleep Laboratories	Not specified	Similar
Duration of Use	Single patient, multi-useUsed on a daily basis	Single patient, disposableUsed on a daily basis	Bongo can be cleanedand reused
Prescriptive	Yes	Yes	Identical
Technology / Mode of Operation
Creation of expiratory positiveairway pressure	During exhalation the valves close, directingair through small ports, increasing resistance.This resistance creates EPAP (ExpiratoryPositive Airway Pressure), which props openthe airway until you inhale again.	During exhalation the valves close, directingair through small ports, increasing resistance.This resistance creates EPAP (ExpiratoryPositive Airway Pressure), which props openthe airway until you inhale again.	Identical
Sealing method	Soft nasal inserts	Adhesive seals around the nostril openings	Similar
Features
Multiple sizes of nasal inserts	Yes	Not required	Similar
One expiratory flow / resistance	Yes	Yes	Similar
Single Patient	Yes, but may be cleaned and reused	Yes, but is single use disposable	Similar
Technical Specifications / Performance Testing
Inhalation Resistance	Comparative inhalation resistance testing wasperformed evaluating the subject device and thepredicate device at various flow rates.	Comparative inhalation resistance testing wasperformed evaluating the subject device andthe predicate device at various flow rates.	Similar inhalationresistance
Exhalation Flow (ml/sec)@ a given pressure	Comparative exhalation flow testing wasperformed evaluating the subject device and thepredicate device at various pressures.	Comparative exhalation flow testing wasperformed evaluating the subject device and thepredicate device at various pressures.	Similarexhalation flow
Classification of Patient ContactingMaterials for Biocompatibility	ISO 10993-1Surface Contact / External CommunicatingPermanent duration of use	ISO 10993-1Surface Contact / External CommunicatingPermanent duration of use	Similar
Attributes	Proposed Bongo	PredicateVentus ProVent (K102404)	Comments
Additional Non-clinical Testing	Age / Shelf-lifeCleaningDrop testEnvironmental conditionsValve cycling	Not specified in 510(k) summary	Subject device meetsits performancespecifications
Clinical Testing	Subjects were evaluated under PSG and theresults demonstrate that AHI was reduced withBongo.	Available clinical data showed a reduction inAHI with the device.	Similar

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K180619

510(k) Summary Page 3 of 4

The Bongo intranasal appliance is viewed as substantially equivalent to the predicate device because:

Indications -

The Bongo is intended to be used in the treatment of mild to moderate OSA. ●
The predicate ProVent (K102404) is intended to be used in the treatment OSA, therefore the indications for use are considered . substantially equivalent.

Patient Population -

The Bongo and the predicate ProVent (K102404) are both intended for adults (>66 Ibs.). ●
Therefore, the patient population is considered substantially equivalent.

Technology and Principle of Operation -

The Principle of Operation is to create expiratory positive airway pressure (EPAP). ●
The proposed Bongo and the predicate ProVent (K102404) employ similar technology, i.e., use of flap valves which open during . inhalation and close during exhalation to create the EPAP.
The principle of operation is considered substantially equivalent. .
The Bongo and the predicate ProVent (K102404) both have nasal into the nasal into the nasal openings. The Bongo . utilizes soft nasal inserts, which are offered in various sizes, to form a seal within the nasal openings. The predicate ProVent (K102404), which is offered in one size, utilizes adhesive to seal around the nasal openings.

Environment of Use -

The devices are intended for use in the home, hospitals, and sleep laboratories. ●
Substantially equivalent to predicate ProVent (K102404). ●

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Non-clinical Testing -

Biocompatibility of Patient Contacting Materials -

The materials have been tested per ISO 10993-1 and they have been used in legally marketed . devices which have equivalent patient contact and duration of use.
. ISO 10993-1 would consider the type of patient contact as Surface Contact / mucosal and Externally Communicating / Tissue and permanent duration of use.

Performance Compared to the Predicate

Comparative testing was performed evaluating the Bongo vs. the predicate ProVent (K102404) for the key performance specifications which could demonstrate substantial equivalence. These test included:

. Inhalation Resistance
. Expiration Flow rate

A summary of the testing was presented in the above table.

The results of the comparative performance testing demonstrated that the Bongo is substantially ● equivalent to the predicate ProVent (K102404).
In addition to these comparative tests we also performed testing to demonstrate that the Bongo meets its performance specifications after being subjected to aging, environmental temperature changes, cleaning, and being dropped.
. The results support that the Bongo meets it performance specifications and is not affected by aging or cleaning.

Clinical Testing -

A prospective, non-randomized, open label, single-center clinical study was performed.

The clinical study had ten (N=10) patients who completed the study, with seven patients responding with AHI reduction using the Bongo. For the patients (N=10):

The mean diagnostic AHI was 15.7 and the mean AHI for the final PSG with Bongo was 7.1. ●
. The median diagnostic AHI was 15.4 and the median AHI for the final PSG with Bongo was 7.0.

The results demonstrated that AHI was significantly reduced with the Bongo compared to the baseline diagnostic. There were no serious adverse events.

Discussion:

In comparing available clinical data for the predicate and subject device reduced AHI with the device compared without the device. The reductions were substantially equivalent.

Substantial Equivalence Conclusion:

The sponsor has demonstrated through performance testing, design and features, non-clinical, and clinical testing that the proposed device does not raise different risks of safety and effectiveness compared to the predicate and are substantially equivalent.

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.”