The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Device Description

The F&P Simplus™ Full Face Mask is a non-invasive patient interface. The mask includes a silicone seal which covers the nose and mouth of a patient and is held in place by adjustable headgear straps. The mask connects to a single breathing tube via a swivel adaptor to receive pressurized gases. The gases delivered to the patient may be humidified and/or oxygen enriched. The exhaust holes on the mask housing allow exhaled air to be flushed out while the system is in operation. An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.

AI/ML Overview

The provided text describes the F&P Simplus™ Full Face Mask, a non-invasive patient interface for CPAP or Bi-Level Ventilator treatment. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical study or AI algorithm validation would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This means the device met existing standards and showed performance comparable to already approved masks, rather than proving novel performance against a new set of acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Performance: Substantial equivalence to predicate K040506 Flexifit™ Series HC431 Full Face Mask for general performance.	Testing demonstrates substantial equivalence to predicate K040506 Flexifit™ Series HC431 Full Face Mask.
Material Biocompatibility: Substantial equivalence to predicate K121597 Eson Nasal Mask for biocompatibility.	Testing demonstrates substantial equivalence to predicate K121597 Eson Nasal Mask.
Adherence to Standards: Compliance with ISO 17510-2:2007 (Sleep Apnea Breathing Therapy - Part 2: Masks and Applications Accessories).	The device "has been tested to" ISO 17510-2:2007.
Adherence to Standards: Compliance with ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process).	The device "has been tested to" ISO 10993-1:2009.

Explanation of "Acceptance Criteria" here: The "acceptance criteria" are implied by the regulatory requirement to demonstrate substantial equivalence to legally marketed predicate devices and to comply with relevant consensus standards. The "reported device performance" is the conclusion that this equivalence and compliance have been met.

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

Not applicable / Not specified in this document. The document refers to "test reports" in Appendix A, but the content of these reports (including sample sizes and data provenance) is not provided in the summary. For devices like full face masks, "testing" often involves bench testing (e.g., pressure-flow characteristics, dead space, exhalation port performance) and biocompatibility testing on materials, rather than a clinical "test set" of patients with associated provenance.

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

Not applicable. This type of information is relevant for studies validating AI algorithms or subjective diagnostic devices. For a physical medical device like a mask, "ground truth" often refers to objective measurements and adherence to engineering specifications and international standards, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

Not applicable. See point 3.

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:

No. This document describes a physical medical device (a mask), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

No. This is not an AI algorithm. The device is a physical mask for CPAP/Bi-Level ventilation.

7. The type of ground truth used:

For performance, the "ground truth" is implied to be adherence to the performance characteristics of the predicate device (K040506 Flexifit™ Series HC431 Full Face Mask) and compliance with the technical requirements and safety limits defined in ISO 17510-2:2007.
For biocompatibility, the "ground truth" is adherence to the material safety and biocompatibility standards demonstrated by the predicate device (K121597 Eson Nasal Mask) and compliance with ISO 10993-1:2009.
The document implies that "test reports" (in Appendix A, not provided) contain the detailed data supporting these conclusions, likely involving objective measurements and laboratory analyses.

8. The sample size for the training set:

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

Summary

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Section 5 - 510(k) Summary

JUN 0 5 2013

CARDER COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLA-444400AND ALLAnd And And And Andred American
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.LEBERESAdvisorial*****.

15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0148 Website: www.fphcare.com

Date Prepared	7 February 2013
Contact Person	Sue Cho
Contact Details	Address: 15 Maurice Paykel Place, East Tamaki
	PO Box 14 348, Panmure
	Auckland, New Zealand
	Telephone: +64 9 574 0100
	Fax: +64 9 574 0148
Trade Name	F&P Simplus™ Full Face Mask
Common Name	Full Face Mask
Classification Name	Non continuous ventilator IPPB(21 CFR § 868.5905, product code BZD)
Predicate Devices	K040506 Flexifit™ Series HC431 Full Face Mask, Fisher &Paykel Healthcare - for performance
	K121597 Eson Nasal Mask, Fisher & Paykel Healthcare - formaterial biocompatibility

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Device Description 5.1

An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.

5.2 Intended Use

5.3 Technological Characteristics Comparison

The F&P Simplus™ Full Face Mask has the following similarities to the previously cleared Fisher & Paykel Healthcare Flexifit™ Series HC431 Full Face Mask:

Similar intended use. -
-Both masks deliver CPAP gases through the nose and mouth.

The key differences between the two masks are that the F&P Simplus™ Full Face Mask:

-Has a permanently attached ball elbow rather than a detachable swivel elbow.
Is smaller in size with under lip design as opposed to the under chin design. -
-Has a modified non-rebreathing valve design.
Has a modified headgear clip design. -
-Has a modified design and location of exhaust holes.

5.4 Non-Clinical Tests

Testing of the F&P Simplus™ Full Face Mask was compared to the predicate K040506 Flexifit™ Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility. These tests demonstrate substantial equivalence of the F&P Simplus™ Full Face Mask to the two aforementioned predicate masks. Copies of test reports are included in Appendix A.

The F&P Simplus™ Full Face Mask has been tested to the following standards:

. ISO 17510-2:2007 Sleep Apnea Breathing Therapy - Part 2: Masks and Applications Accessories
ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing Within a Risk Management Process

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Conclusion ર.5

The comparison of features, performance, and intended use demonstrate that the F&P Simplus™ Full Face Mask is substantially equivalent to the predicate K040506 Flexifit Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

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

June 5, 2013

Fisher & Paykel Healthcare, Limited Ms. Sue Cho 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, New Zealand 2013

Re: K130328

Trade/Device Name: F&P Simplus™ Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6. 2013 Received: March 7, 2013

Dear Ms. Cho:

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. Iisting 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 - Ms. Cho

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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

K130328

510(k) Number:

Device Name:

F&P Simplus™ Full Face Mask

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

1=HIF+S

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of Anesthesloiogy, General Hospital Division of Ancolnosters

510(k) Number

Anva

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).