The Hsiner NIPPV masks provide a patient interface for application of noninvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure. These masks are intended for use with spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure suitable for nominvasive pressure support ventilation treatment in the hospital/institutional environment (including but not limited to moderate.or severe dyspnea; elevated respiratory rates, labored breathing; or paradoxical breathing).

Device Description

Hsiner's NIPPV Masks are intended to provide a patient interface between a conventional mechanical ventilator system and the patient for applications of non-invasive ventilation. The comection to the ventilator utilizes standard 22mm conical connections complying with ISO 5356-1. The interface with the patient's facial contours utilizes a soft, pliable seal that ensures that a good seal is achieved to deliver the pressurized gasses with minimal unintentional leakage, Unintentional gas leak around the face is minimized by the mask base to improve the closeness of fit to the skin. Soft, clastic headgear insures a tight comfortable fit against the face.

The Esiner NIPPY Masks are modifications to their CPAP/VPAP Masks (K063268). These masks differ from the CPAP/VPAP mask only in that the vents and anti-asphyxiation valves have been removed.

AI/ML Overview

The provided document is a 510(k) summary for A Hsiner Company NIPPV Masks. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample size for test/training set, number of experts, adjudication method, MRMC study, how ground truth was established, effect size with/without AI assistance) is not applicable or cannot be extracted from this document as no clinical test was performed.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA guidance & standards)	Reported Device Performance (Hsiner NIPPV Masks vs. Predicate Devices)
Resistance to flow	Negligible difference between all masks (Hsiner NIPPV, Hsiner CPAP/VPAP, Fisher Paykel RT041).
Exhaust flow	Negligible differences at low pressure settings. Hsiner's NIPPV and CPAP/VPAP masks showed higher flows at higher pressure levels than the Fisher Paykel RT041.
CO2 Rebreathing	Negligible differences for Hsiner NIPPV and Fisher Paykel masks. Hsiner's CPAP/VPAP showed slightly lower EtCO2 levels.
Fraction of Inspired Oxygen (FIO2)	Slightly higher overall FIO2 percentages for Fisher Paykel masks. All FIO2 values significantly lower with added 20 LPM leaks. Decreasing therapeutic pressure resulted in higher FIO2. Increasing supplemental O2 flow rates resulted in significant increases in FIO2.
Swivel leakage	Notably higher for Hsiner NIPPV masks compared to the Fisher Paykel RT041 Mask.

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

No clinical test was performed for this device. The performance evaluation focused on bench testing the device and comparing its physical properties and in-vitro performance to predicate devices and established standards.

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)

Not applicable. No expert ground truth was established for a clinical test set as no clinical test was performed.

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

Not applicable. No adjudication method was used as no clinical test was performed.

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. This document describes a medical device (NIPPV masks), not an AI algorithm. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the performance evaluation, "ground truth" was established by standardized laboratory measurements following protocols described in FDA's July 1995 guidance document "Draft Reviewer Guidance for Ventilators," ASTM 1100-90, and ISO 17510-2 (2007). These standards define acceptable ranges or methods for measuring parameters like resistance to flow, exhaust flow, CO2 rebreathing, FIO2, and swivel leakage.

8. The sample size for the training set

Not applicable. No training set was used as this is a physical medical device, not a machine learning model.

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

Not applicable. No training set was used.

Summary

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E1 - K102120 Summary_052511

AUG 1 2 2011

Hsiner Company NIPPV Masks 510(k) Submission

510(k) Summary ਸੰ

Date: 03 November 2010

In accordance with 21 CFR section 807.92 Ilsincr is submitting the following 510(k) summary.

8.1. Submitter Information

Fisiner Company, LTD No. 13. Tyan Shin St., Taya Hsiang Taiching Itsien, Taiwan, ROC

Phone: +886-4-25664306 FAX: +

Registration No .: 3003862188 Owner/Operator No .: 9053474

8.2. Name of Device

Proprietary Name: NIPPV Masks Common Name: Non-invasive Ventilation Mask Classification Name: Ventilator. Continuous, Facility Use

Product Code: CBK Regulation Number: 868.5895 Device Class: 2

8.3. Description of the device

The Esiner NIPPY Masks are modifications to their CPAP/VPAP Masks (K063268). These masks differ from the CPAP/VPAP mask only in that the vents and anti-asphyxiation valves have been removed.

8.4. Substantially equivalent to:

Hsiner`s CPAP/VPAP Masks (K063268) .
. Fisher Paykel RT04] Hospital Full Face Mask Non Vented (K083122)

8.5. Intended Use of the Device

The Usiner NIPPY masks provide a patient interface for application of nominvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure. These masks are intended for use with spontaneous breathing adult patients (> 30 kg) to administer CPAP or positive pressure ventilation for treatment of respiratory failure,

Revised 11/25/11

Page 51 of 101

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Hsiner Company NIPPY Masks 510(k) Submission

respiratory insufficiency, or obstructive sleep apnea who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment.

I lsince's Nasal Mask is intended for patients that have trouble tolerating their full face versions

8.6. Clinical-Performance Evaluations

No clinical test was performed for this device

Comparison to Predicate Devices 8.7.

8.7.1. Design, Materials and Intended Use

The Hsiner NIPPV masks are equivalent in design; materials and performance to the Fisher Paykel's RT41 NIV face mask (K083122) and Hsiner's CPAP/VPAP mask. The I Isiner and Fisher Paykel devices operate on the same principles and have the same intended use.

Performance Evaluation 8.8.

The performance test protocols for Usiner's NIPPV Masks follow those section of FDA's July 1995 guidance document "Draft Reviewer Guidance for Ventilators" applicable to masks used with ventilators and include testing from both ASTM 1100-90 "Standard Specification for Ventilators Intended for Use in Critical Care" and ISO) 17510-2 (2007): "Sleep apnea breathing therapy---- Part 2: Masks and application accessories."

Resistance to flow showed negligible difference between all masks. .
Exhaust flow showed negligible differences at low pressure settings with Flsiner's NIPPV . and CPA/VPAP masks showing higher flows at higher pressure levels than the Fisher Parkel RT041,
CO2 Rebreathing showed negligible differences for the Hsiner NIPPV and Fisher Paykel . masks. As would be expected Ilsiner's CPAP/VPAP showed slightly lower E(CO2 levels.
. Fraction of Inspired Oxygen (FIO2) showed slightly higher over all FIO2 percentages for the Fisher Paykel masks. All FIO2 values were significantly lower with added 20 LPM leaks compared to identical configurations without leak. As expected decreasing therapeutic pressure results in higher F1(), percentages. Increasing supplemental (), flow rates resulted in significant increases in FIO2.
Swivel leakage was notably higher for Hsiner NIPPV masks compared to the Fisher . Paykel RT041 Mask.

8.8.1. Conclusion:

Performance evaluation concludes that there are negligible differences resistance and exhaust flow. The Hsiner masks show slightly better EtCO2 and slightly lower FIO2 values than the Fisher Paykel masks.

Revised 05/25/11

Page 52 of 101

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three curved lines that resemble an abstract representation of a human figure or a bird in flight.

Food and Drug Administration 10903 New Flampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hsiner Company, Limited % Mr. Tom Shanks MD Ventures 29201 Via Norte Temecula. California 92591

AUG 1 2 2011

Re: Ki02120

Trade/Device Name: Hsiner NIPPV Masks Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 30. 2011 Received: August 11, 2011

Dear Mr. Shanks:

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. 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.

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Page 2 - Mr. Tom Shanks

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 liederal 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable. the electronic product radiation control provisions (Sections 331-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

ph for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

cc: DMC - 2 copies ODE Division/Branch ARDB - Sugato De 8/12/11-EFW

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C1 - K102120_Indications for Use_052511

Flsiner Company NIPPV Masks 510(k) Submission

Indications for Use

510(k) Number

IIsiner NIPPV Masks Device Name:

Indications for Use:

Prescription Use X (Pari 21 CFR 801 Sabpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart (2)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of

Nayan Patel for L. Schulthais
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

CTC (k) Number

Modified: 05/22/2011

Page 23 of 101

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).