The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home environment or multi-patient, multi-use in the hospital/institutional environment.

Device Description

The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a multi-patient, multi- use accessory for use with CPAP or bi-level devices. The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

AI/ML Overview

The provided text describes the 510(k) summary for the "Comfort Twin Nasal Mask - Multi-Patient, Multi-Use". It focuses on establishing substantial equivalence to predicate devices and detailing the device's design and intended use, rather than presenting a study with specific quantitative acceptance criteria or detailed performance metrics against those criteria.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use: Device is an accessory to a non-continuous ventilator for adult patients prescribed CPAP or bi-level therapy. Intended for single-patient reuse (home) or multi-patient, multi-use (hospital/institutional).	The Comfort Twin Nasal Mask shares the "Same intended use" as the predicate device.
Operating Principle: Same operating principle as predicate.	The Comfort Twin Nasal Mask shares the "Same operating principle" as the predicate device.
Technology: Same technology as predicate.	The Comfort Twin Nasal Mask shares the "Same technology" as the predicate device.
Manufacturing Process: Same manufacturing process as predicate.	The Comfort Twin Nasal Mask shares the "Same manufacturing process" as the predicate device.
Performance with cleaning/disinfection (Cidex): Exposure to specified cleaning and disinfection agent (Cidex) does not degrade performance.	"The results of this testing confirm that exposure to the specified cleaning and disinfection agent (Cidex) does not degrade the performance of the Comfort Twin Nasal Mask."
Mask Efficacy Testing (Cleaning Method): Cleaning method specified in the cleaning and disinfection guide is effective.	All mask materials in contact with Cidex "have been tested by an independent laboratory to confirm efficacy of the cleaning method".

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any of the performance tests.
Data Provenance: Not specified, but the testing was internal ("Performance testing has been carried out to verify the safety & effectiveness...") and for mask efficacy testing, "tested by an independent laboratory". It does not mention country of origin or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" here refers to physical performance characteristics and cleaning efficacy, not interpretations made by experts in a diagnostic context.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process is described for physical performance and cleaning efficacy tests.

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 device is a medical accessory (nasal mask), not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an algorithmic device. Performance testing focused on the physical device's characteristics and its ability to withstand cleaning.

7. The type of ground truth used:

For performance with cleaning/disinfection: The "ground truth" would be established by objective measurements of material integrity and device function after exposure to Cidex, likely against pre-defined engineering specifications.
For mask efficacy testing (cleaning method): The "ground truth" would be the demonstrated removal or inactivation of specified microorganisms or contaminants, measured by an independent laboratory.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

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

Not applicable.

Summary

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Tab 5 - 510(k) summary ·

TAB 5

510(K) SUMMARY

Date of Submission

18 June 2009

SEP 1 0 2009

Official Contact

Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Zita.yurko@respironics.com

724-387-4120 t 724-882-4120 c 724-387-7490 f

21 CFR 868.5895

Nasal Mask

Classification Reference

Product Code

BZD - Non-Continuous ventilator (IPPB)

Common/Usual Name

Proprietary Name

Respironics Comfort Twin Nasal Mask

Predicate Device(s)

Respironics Reusable II Contour Nasal Mask (K991648) Resmed Mirage Activa (K032916)

Reason for submission

New device. Includes multi-patient, multi-use claim

Substantial Equivalence

The Comfort Twin Nasal Mask has the following similarities to the previously cleared predicate device:

Same intended use. 디
Same operating principle.
Same technology.
Same manufacturing process.

6691843

Comfort Twin Nasal Mask - MPU

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Comfort Twin Nasal Mask - MPU

The Respironics Reusable II Contour Nasal Mask was cleared in K991648. The Resmed Mirage Activa was cleared in K032916. To update the design of the Reusable II, an inter sealing cushion was added to this device design. This cushion within a cushion design has been reviewed and cleared by the agency in K032916. The new device was validated using bench data. All performance characteristics performed within specification and comparable to the cited device predicates. This testing has confirmed that the Comfort Twin Nasal Mask performs equivalently to the cited device predicates.

Intended Use

Device Description

The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

Performance Data

Performance testing has been carried out to verify the safety & effectiveness of the Comfort Twin Nasal Mask with all cushion sizes. The results of this testing confirm that exposure to the specified cleaning and disinfection agent (Cidex) does not degrade the performance of the Comfort win Nasal Mask. Test data is provided in Tab 18 of this submission.

Mask Efficacy Testing

All mask materials that come in contact with the specified cleaning and disinfection agent (Cidex) have been tested by an independent laboratory to confirm efficacy of the cleaning method specified in the Comfort Twin Nasal Mask Cleaning & Disinfection guide. The details are specified in Tab 14 of this submission.

(End.of Tab.)

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is black and the background is white. The text is centered horizontally.

SEP 1 0 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Zita A. Yurko Director of Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K091843
Trade/Device Name: Comfort Twin Nasal Mask – Multi-Patient, Multi-Use Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 18, 2009

Received: June 22, 2009

Dear Ms. Yurko:

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.

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 - Ms. Yurko

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nh for

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

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Indications for Use

510(k) Number (if known): Jr ( 4/3

Comfort Twin Nasal Mask - Multi-patient, multi-use Device Name:

The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for singlepatient reuse in the home environment or multi-patient, multi-use in the hospital/institutional environment.

Prescription Use X Over-The-Counter Use Prescription Ose ____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Schultheis
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091843

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).