(83 days)
The Zest™ 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 Zest™ 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.
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.
The provided text is a 510(k) summary for a medical device called the Zest™ Nasal Mask. This document is related to regulatory approval based on demonstrating substantial equivalence to existing devices, not a study evaluating acceptance criteria of a novel AI (Artificial Intelligence) or advanced medical device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/algorithm performance is not applicable to this type of regulatory submission.
The document states that the Zest™ Nasal Mask is identical to a predicate device (K080209 Fisher & Paykel Healthcare Zest™ Nask Mask) in terms of features, performance, and biocompatibility. Its intended use (Single Patient Adult Use and Multiple Patient Adult Use) is also identical to another predicate device (K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask).
Essentially, the "acceptance criteria" here is demonstrating that the new device is the same as an already approved device for relevant characteristics and intended use. There is no independent "study" with performance metrics in the way one would evaluate an AI system.
Here's how to interpret the available information concerning your request:
1. Table of Acceptance Criteria and Reported Device Performance
This concept doesn't directly apply as the submission is for substantial equivalence. The "acceptance criteria" is that the device is identical to the predicate.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: Identical to Predicate Device K080209 (F&P Healthcare Zest™ Nasal Mask) | Confirmed to be identical in features, performance, and biocompatibility to K080209. |
| Intended Use: Identical to Predicate Device K063036 (F&P Healthcare HC482 Direct Nasal Mask) | Confirmed to be identical to K063036 for Single Patient Adult Use and Multiple Patient Adult Use (in home/clinical settings with proper disinfection). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. A "test set" in the context of an AI/algorithm evaluation doesn't exist for this submission. The device is being compared to an existing device, not undergoing a performance test against a dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There's no ground truth establishment in the context of an AI/algorithm test set here. The comparison is against established predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method defined.
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 is a submission for a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. No algorithm is involved.
7. The Type of Ground Truth Used
The "ground truth" for this submission is the features, performance, biocompatibility, and intended use of the legally marketed predicate devices. The new device is considered acceptable if it is substantially equivalent to these established devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
In summary, the provided document is a regulatory submission for a physical medical device based on substantial equivalence to predicate devices, not an evaluation of an AI or algorithm's performance. Therefore, the questions tailored for AI/algorithm performance studies are not relevant to this specific document.
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SECTION 6 - 510K Summary
KOS 3832
MAR 1 6 2009
Fisher & Paykel HEALTHCARE
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 www.fphcare.com Website:
| Contact person | Tina Mason |
|---|---|
| Date Prepared | 18th December 2008 |
| Trade Name | Zest™ Nasal Mask |
| Common Name | Nasal Mask |
| ClassificationName | Non continuous ventilator IPPB(21 CFR § 868.5905, product code BZD) |
| PredicateDevices | K080209 Fisher & Paykel Healthcare Zest Nasal Mask |
| K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask |
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6.1 Description
ldentical to Predicate Device: K080209 Fisher & Paykel Healthcare Zest™ Nask Mask
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.
6.2 Intended Use
The Zest™ 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 Zest™ 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.
6.3 Technological Characteristics Comparison
ldentical to Predicate Device: K080209 Fisher & Paykel Healthcare Zest™ Nasal Mask
6.4 Non-clinical Tests
ldentical to Predicate Device: K080209 Fisher & Paykel Healthcare Zest™ Nasal Mask
6.5 Conclusion
The comparison of features, performance, and biocompatibility are identical the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask (K080209).
The comparison of intended use Single Patient Adult Use and Multiple Patient Adult Use is identical to the predicate Fisher & Paykel Healthcare HC482 Direct Nasal Mask (K063036).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2009
Ms. Tina Mason Regulatory Affairs Engineer-OSA Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, NEW ZEALAND
Re: K083832
Trade/Device Name: Zest™ Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6, 2009 Received: March 9, 2009
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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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 yours.
Susan Rane.
Ginette Y. Michaud, M.D. Acting 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 5 - Indications for Use Statement
K083832 510(k) Number
Device Name
Zest™ Nasal Mask
Indications for Use:
The Zest™ 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 Zest™ 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.
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)
Susan Piase
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antool, Dental Devices
510(k) Number: K05-2832
§ 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).