(160 days)
Not Found
No
The device description and performance studies focus on a mechanical intranasal appliance and its effect on AHI, with no mention of AI or ML technologies.
Yes
The device is indicated for use in the "treatment of mild to moderate obstructive sleep apnea (OSA)," which clearly defines it as having a therapeutic purpose.
No
The device is indicated for treatment of obstructive sleep apnea, not for diagnosis.
No
The device description clearly states it is an "intranasal appliance" consisting of "valve assemblies coupled with nasal inserts" and "soft nasal inserts," indicating a physical, hardware-based device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description of the Bongo device clearly states it is an "intranasal appliance" used for the "treatment of mild to moderate obstructive sleep apnea (OSA)." It works by physically directing expiratory flow and increasing intranasal pressure.
- Mechanism of Action: The device's mechanism of action is mechanical and physical, not based on analyzing biological samples.
- No Mention of Biological Samples: The entire description and intended use do not mention the collection or analysis of any biological samples.
The Bongo is a therapeutic device used to treat a condition, not a diagnostic device used to identify or monitor a condition through the analysis of biological samples.
N/A
Intended Use / Indications for Use
Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.
Product codes (comma separated list FDA assigned to the subject device)
OHP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intranasal
Indicated Patient Age Range
adults >66 lbs.
Intended User / Care Setting
Home use, hospitals, and sleep laboratories
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)
Non-clinical Testing:
- Biocompatibility of Patient Contacting Materials: ISO 10993-1, Surface Contact / External Communicating, Permanent duration of use. Materials have been tested per ISO 10993-1 and have been used in legally marketed devices with equivalent patient contact and duration of use. Type of patient contact considered as Surface Contact / mucosal and Externally Communicating / Tissue and permanent duration of use.
- Performance Compared to the Predicate: Comparative testing evaluating the Bongo vs. the predicate ProVent (K102404) for:
- Inhalation Resistance: Comparative inhalation resistance testing was performed evaluating the subject device and the predicate device at various flow rates.
- Expiration Flow rate: Comparative exhalation flow testing was performed evaluating the subject device and the predicate device at various pressures.
- Additional Non-clinical Testing: Age / Shelf-life, Cleaning, Drop test, Environmental conditions, Valve cycling. Results support that the Bongo meets its performance specifications and is not affected by aging or cleaning.
Clinical Testing:
- Study Type: A prospective, non-randomized, open label, single-center clinical study.
- Sample Size: Ten (N=10) patients completed the study.
- Key Results: Seven patients responded 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.
- For the patients (N=10):
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean AHI Reduction: 15.7 to 7.1
Median AHI Reduction: 15.4 to 7.0
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ventus ProVent (K102404)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Date Prepared: | August 10, 2018 |
|---|---|
| InnoMed Healthscience, Inc. | |
| 1701 W. Hillsboro Blvd. | |
| Suite 303 | |
| Deerfield Beach, FL 33442 | |
| Official Contact: | Javier Collazo |
| General Manager and Vice President | |
| Tel - 954.773.9656 | |
| Proprietary or Trade Name: | Bongo |
| Common/Usual Name: | Expiratory resistance valve, intranasal, for obstructive sleep apnea |
| Classification Name: | 21CFR 872.5570 |
| ProCode - OHP | |
| Class 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 obstructive
sleep 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 |
4
K180619
510(k) Summary Page 2 of 4
| Attributes | Proposed Bongo | Predicate
Ventus ProVent (K102404) | Comments |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indications for Use | For use in the treatment of mild to moderate
obstructive sleep apnea (OSA). | For use in the treatment of obstructive sleep
apnea (OSA). | Similar |
| Patient Population | Adults (>66 lbs. / 30 kg.) | Not specified | Similar |
| Environment of Use | Home
Hospitals
Sleep Laboratories | Not specified | Similar |
| Duration of Use | Single patient, multi-use
Used on a daily basis | Single patient, disposable
Used on a daily basis | Bongo can be cleaned
and reused |
| Prescriptive | Yes | Yes | Identical |
| Technology / Mode of Operation | | | |
| Creation of expiratory positive
airway pressure | During exhalation the valves close, directing
air through small ports, increasing resistance.
This resistance creates EPAP (Expiratory
Positive Airway Pressure), which props open
the airway until you inhale again. | During exhalation the valves close, directing
air through small ports, increasing resistance.
This resistance creates EPAP (Expiratory
Positive Airway Pressure), which props open
the 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 was
performed evaluating the subject device and the
predicate device at various flow rates. | Comparative inhalation resistance testing was
performed evaluating the subject device and
the predicate device at various flow rates. | Similar inhalation
resistance |
| Exhalation Flow (ml/sec)
@ a given pressure | Comparative exhalation flow testing was
performed evaluating the subject device and the
predicate device at various pressures. | Comparative exhalation flow testing was
performed evaluating the subject device and the
predicate device at various pressures. | Similar
exhalation flow |
| Classification of Patient Contacting
Materials for Biocompatibility | ISO 10993-1
Surface Contact / External Communicating
Permanent duration of use | ISO 10993-1
Surface Contact / External Communicating
Permanent duration of use | Similar |
| Attributes | Proposed Bongo | Predicate
Ventus ProVent (K102404) | Comments |
| Additional Non-clinical Testing | Age / Shelf-life
Cleaning
Drop test
Environmental conditions
Valve cycling | Not specified in 510(k) summary | Subject device meets
its performance
specifications |
| Clinical Testing | Subjects were evaluated under PSG and the
results demonstrate that AHI was reduced with
Bongo. | Available clinical data showed a reduction in
AHI with the device. | Similar |
5
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). ●
6
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.