The F&P Eson Nasal 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 Eson Nasal 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 Eson™ is a respiratory mask which is non-invasive. The silicone seal is positioned over the nose and it seals on the area around the nose and the upper lip. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor to received pressurized gases. On the elbow are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The F&P Eson™ Nasal Mask has a diffuser system that is designed to diffuse air that is expelled from the mask. This reduces the draft. The diffuser does not significantly change the amount of air flowing from the mask, therefore the mask can be used with or without the diffuser system. The air may also be humidified and/or oxygen enriched. 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 document describes a 510(k) submission for the F&P Eson™ Nasal Mask. This submission focuses on demonstrating substantial equivalence to a predicate device (Fisher & Paykel Healthcare Zest™ Nasal Mask) rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's an analysis based on your request, highlighting what information is available and what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (What was measured/compared?)	Reported Device Performance (What did the F&P Eson™ do?)
Performance (general)	Substantially equivalent to predicate device (Zest™ Nasal Mask)
Biocompatibility	Substantially equivalent to predicate device (Zest™ Nasal Mask)
Intended Use	Matches predicate device (CPAP or Bi-Level Ventilator treatment, single-patient adult home use, multiple-patient adult hospital/clinical use)
Design Differences (e.g., RollFit Seal, ball elbow, diffuser, headgear, headgear clips)	Described as design features, but not explicitly stated as performance metrics with acceptance criteria. The document claims they reduce draft, increase movement range, increase stability, etc., but without quantifiable performance against a specific standard or predicate.

Missing Information: The document does not provide specific quantifiable acceptance criteria (e.g., "leak rate less than X L/min," "pressure drop less than Y cmH2O"). Instead, it relies on a qualitative claim of "substantial equivalence" to the predicate device for performance and biocompatibility.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "testing" and "test reports" (in Appendix B, which is not provided), implying non-clinical, bench-top testing rather than human subject testing with a "test set" in the context of clinical performance.
Data Provenance: Not explicitly stated for specific test data. The manufacturer is based in Auckland, New Zealand. The tests were "compared to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask," which implies the testing was done by or for the manufacturer.
Retrospective or Prospective: Not applicable as it pertains to non-clinical testing.

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. This type of information is relevant for studies involving human interpretation or diagnosis. The provided documentation focuses on non-clinical engineering and biocompatibility comparisons.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 is a medical device (nasal mask) and not an AI/imaging diagnostic device. Therefore, MRMC studies are not relevant to this submission.

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 non-clinical performance: The "ground truth" was established by comparing the F&P Eson™ Nasal Mask's characteristics and performance to the predicate device (Fisher & Paykel Healthcare Zest™ Nasal Mask). This means the predicate device's established performance was used as the benchmark for "substantial equivalence."
For biocompatibility: The "ground truth" would be established against recognized biocompatibility standards and comparison to the predicate device's known biocompatibility.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not Applicable. See point 8.

Summary of Device Performance and Study:

The "study" described in the 510(k) summary is a set of non-clinical tests comparing the F&P Eson™ Nasal Mask to its predicate device, the Fisher & Paykel Healthcare Zest™ Nasal Mask, for performance and biocompatibility. The conclusion states that these tests "demonstrate substantial equivalence." The actual test reports containing specific data are referenced as being in "Appendix B," which is not provided here.

The document does not detail specific, measurable acceptance criteria that the device had to meet independently. Instead, the primary "acceptance criterion" for this 510(k) submission was to demonstrate that the F&P Eson™ Nasal Mask is substantially equivalent to the predicate device in terms of safety, effectiveness, technological characteristics, and intended use.

Summary

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Section 5 - 510(k) Summary K-121597

Image /page/0/Picture/3 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font. The word "HEALTHCARE" is on the second line in a similar font, but smaller and underlined.

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 .

ОСТ

Contact Person	James Thompson
Date Prepared	29 May 2012
Trade Name	F&P Eson™ Nasal Mask
Common Name	Nasal Mask
Classification Name	Non continuous ventilator IPPB(21 CFR § 868.5905, product code BZD)
Predicate Devices	K083832 Fisher & Paykel Healthcare Zest Nasal Mask

2 2012

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5.1 Description

An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring (previously covered by K003894 Fisher & Paykel Healthcare Limited Oracle Oral Mask).

5.2 Intended Use

5.3 Technological Characteristics Comparison

The F&P Eson™ Nasal Mask is very similar to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask. Both masks are intended for non-continuous ventilation via CPAP and Bi-Level therapy, and deliver CPAP gasses through the nose.

The main difference is the F&P Eson™ has a self-adjusting rolling bridge, marketed as the RollFit Seal, for relieving pressure on the bridge of the nose and strategically thickened and thinned sections for overall structure, support and cushioning, whereas the Zest™ relies on the foam for structure, support and cushioning. Other differences with the F&P Eson™ include:

A permanently attached ball elbow rather than a detachable swivel elbow used by the . Zest™ for increase movement range.
A diffuser system that is designed to diffuse air that is expelled from the mask. This . reduces the draft. The diffuser does not significantly change the amount of air flowing from the mask, therefore the mask can be used with or without the diffuser system
Headgear similar to Zest™ but with the addition of the crown straps which is . designed to go over the top of the head for increased stability. This adds two more adjustment points (six in total for F&P Eson™) as opposed to four for Zest™. Marketed as Ergofit Headgear
The use of the headgear as forehead cushions for the F&P Eson™, rather than . silicone forehead pads used by the Zest™ for less parts.
. Headgear clips are incorporated in the lower headgear straps for F&P Eson™ for ease of use.

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5.4 Non-Clinical Tests

Testing of the F&P Eson™ Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask for performance and biocompatibility. These tests demonstrate substantial equivalence of the F&P Eson™ Nasal Mask to the predicate mask. Copies of test reports are included in Appendix B.

Conclusion 5.5

The comparison of features, performance, and intended use demonstrate that the F&P. Eson™ Nasal Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask for performance and biocompatibility. The F&P Eson™ Nasal Mask has been demonstrated to be safe and effective for CPAP and Bi-Level ventilation therapy.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a stylized representation of human figures.

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

2 2012

OCT

Fisher & Paykel Healthcare, Limited
Mr. James Thompson
Regulatory Affairs Manager - OSA
15 Maurice Paykel Place, East Tamaki
P.O. Box 14 348, Panmure
Auckland, New Zealand

Re: K121597

Trade/Device Name: F&P Eson™ Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 12, 2012 Received: September 17, 2012

Dear Mr. Thompson:

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. Thompson

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/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,

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

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Section 4 - Indications For Use Statement

510(k) Number:

Device Name:

F&P Eson™ Nasal Mask

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schuler

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K121597

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).