The Zest™ Nasal Mask is intended for single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment in the home, hospital or other clinical setting.

Device Description

The Zest™ Nasal Mask 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 receive pressurized gases. On the mask base are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The silicone seal is contoured for comfort and to reduce leakage.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Zest™ Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria and a detailed study design. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this type of regulatory submission and is not present in the provided document.

The document primarily relies on non-clinical comparative testing to establish substantial equivalence.

Here's a breakdown of the information that can be extracted or inferred from the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., leakage rate, pressure drop limits). Instead, the acceptance criterion for regulatory approval is "substantial equivalence" to the predicate device. This is demonstrated through comparative testing rather than meeting pre-defined numerical thresholds for new performance.
Reported Device Performance: The document states that "Testing of the Zest™ Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance... These tests demonstrate substantial equivalence of the Zest™ Nasal Mask to the predicate mask." The specifics of the performance results are summarized as demonstrating equivalence, but no raw data or numerical outcomes are provided in this summary.

Criterion	Acceptance Goal	Reported Device Performance
Performance (e.g., sealing, gas delivery)	Substantial Equivalence to Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask	Demonstrated substantial equivalence through non-clinical comparative tests.
Biocompatibility	Substantial Equivalence to Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask	Demonstrated substantial equivalence through non-clinical comparative tests.
Intended Use	Same intended use as predicate device for CPAP/Bi-level ventilator treatment (single patient adult use)	Confirmed to have the same intended use.
Technological Characteristics	Similar to predicate, with justified differences	Described as "very similar," with main differences in sealing method, headgear, and size. These differences were assessed not to raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable/Not provided. The "test set" in this context refers to non-clinical comparative testing (e.g., bench tests, materials testing), not a clinical study involving human subjects or a large dataset in the way AI/ML models are evaluated. The document references "test reports included in Appendix B," but the details of these tests (e.g., number of masks tested, number of cycles) are not in the provided summary.
Data Provenance: Not applicable/Not provided. As it's non-clinical testing, there's no data provenance in terms of country of origin for patient data. The testing would have been conducted by the manufacturer or a contracted lab. It's retrospective in the sense that the test results are reviewed after completion.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. For non-clinical validation of medical devices like a nasal mask, "ground truth" is typically established by engineering specifications, international standards, or physical measurements, not expert clinician consensus on a dataset.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no human interpretation or adjudication of test results in the way it's done for diagnostic AI algorithms. Test results are compared against engineering/performance specifications or directly against the predicate device's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is not relevant for the regulatory clearance of a physical medical device like a nasal mask. MRMC studies are typically used for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret cases.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No. The device is a physical nasal mask, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used

Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
- Engineering Specifications: Adherence to design specifications and relevant industry standards (e.g., for airflow, pressure integrity, dead space).
- Predicate Device Performance: Direct comparison of the Zest™ Nasal Mask's measured performance characteristics against those of the K063036 Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask.
- Biocompatibility Standards: Compliance with recognized standards for material safety, likely demonstrated by reference to the K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask, which was also found to be substantially equivalent for biocompatibility.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the mask is based on engineering principles and potentially anthropometric data, not machine learning from a "training set."

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of the Study:

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) was a series of non-clinical comparative tests.

Purpose: To demonstrate that the Zest™ Nasal Mask is substantially equivalent in terms of safety and effectiveness to its predicate devices.
Comparison for Performance: The Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask (K063036).
Comparison for Biocompatibility: The Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask (K061236).
Methodology: The document states "Testing... was compared to the predicate... for performance and... for biocompatibility." This implies bench testing and material analyses were conducted, and the results were evaluated against the predicate's known characteristics. The specifics are in "Appendix B" which is not provided.
Conclusion: The manufacturer concluded, and the FDA agreed, that "The comparison of features, performance, and intended use demonstrate that the Zest™ Nasal Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the HC432 Full Face Mask for biocompatibility."

Summary

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080209

HEALTHCARE

Paykel

SECTION 5 - 510K Summary

SEP 1 2 2008

15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0196 Website: www.fphcare.com

Contact person	Tina Mason
Date Prepared	25th January 2008
Trade Name	Zest™ Nasal Mask
Common Name	Nasal Mask
ClassificationName	Non continuous ventilator IPPB(21 CFR § 868.5905, product code BZD)
PredicateDevices	K063036 Fisher & Paykel Healthcare Opus HC482 Direct NasalMask
	K061236 Fisher & Paykel Healthcare Flexifit HC432 Full FaceMask (predicate for material biocompatibility)

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5.1 Description

5.2 Intended Use

5.3 Technological Characteristics Comparison

The Zest™ Nasal Mask is very similar to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask. Both masks are for non continuous ventilation, and deliver CPAP gasses through the nose. The main difference is the way the seal is achieved, the Zest Nasal Mask seals around the nose and on the upper lip, where the Opus HC482 Direct Nasal Mask seals on the entrance of the nostrils. Other differences are that the Zest Nasal Mask has 4 headgear attachment points (as opposed to 2 in the Opus). The Zest Nasal Mask has only one size, where the Opus HC482 has 3 sizes (the Zest Nasal Mask is designed to fit a large proportion on the patient population with only one size) and the Zest Nasal Mask has a larger dead space due the wav it achieves a seal on the face.

5.4 Non-clinical Tests

Testing of the Zest™ Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the HC432 Full Face Mask for biocompatibility. These tests demonstrate substantial equivalence of the Zest™ Nasal Mask to the predicate mask. Copies of test reports are included in Appendix B.

5.5 Conclusion

The comparison of features, performance, and intended use demonstrate that the Zest™ Nasal Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the HC432 Full Face Mask for biocompatibility. The Zest™ Nasal Mask is proven to be safe and effective for CPAP and Bi-level ventilation therapy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

Ms. Tina Mason Regulatory Affairs Engineer Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland NEW ZEALAND

Re: K080209

Trade/Device Name: Zest™ Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 28, 2008 Received: July 30, 2008

Dear Ms. Mason:

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 such 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. Mason

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Tikamuli-Lindu-y forey

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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SECTION 4 - Indications for Use Statement

510(k) Number

Zest™ Nasal Mask Device Name

Indications for Use:

Prescription Use > (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)

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

510(k) Number: K06205

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).