(87 days)
The Zest™ Petite Nasal Mask is intended to be used by individuals greater than 66lbs (30kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The Zest™ Petite Nasal Mask is intended for Single Patient Use in the home and Multiple Patient Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The Zest™ Petite 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 describes a 510(K) summary for the Zest™ Petite Nasal Mask. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a detailed study to prove that a device meets specific performance metrics in the way a clinical trial or a validation study for an AI/ML device would.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, sample size for training set, how ground truth for training set was established) are not applicable in this context. The 510(k) submission for the Zest™ Petite Nasal Mask primarily relies on non-clinical testing and comparison to predicate devices, not on a study with human readers or AI algorithms.
Here's a breakdown of the information that can be extracted from the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a medical device in a 510(k) submission like this are generally aligned with demonstrating substantial equivalence to a predicate device. This means the new device must perform comparably to the predicate device in relevant non-clinical tests. The text indicates the device met these criteria through testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate Fisher & Paykel Healthcare Zest™ Nasal Mask (K083832) | "Testing of the Zest™ Petite Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask for performance... These tests demonstrate substantial equivalence..." |
| Biocompatibility comparable to predicate Fisher & Paykel Healthcare Zest™ Nasal Mask (K083832) and Flexifit HC432 Full Face Mask (K061236) | "...and for biocompatibility. These tests demonstrate substantial equivalence... The comparison of features, performance, and biocompatibility are identical to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask (K083832) and the HC432 Full Face Mask (K061236) for biocompatibility." |
| Intended use for individuals > 66lbs (30kg) requiring CPAP or Bi-Level Ventilator treatment | "The comparison of intended use 66lbs (30kg) is identical to the predicate Respironics ComfortGel Blue Nasal Mask (K092835) and is identical to the Fisher & Paykel Healthcare Zest™ Nasal Mask (K083832) in terms of Single Patient Use in the home and Multiple Patient Use in the hospital or other clinical setting." |
| Safe and Effective for CPAP and Bilevel ventilation therapy | "The Zest™ Petite Nasal Mask is proven to be safe and effective for CPAP and Bilevel ventilation therapy." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The text mentions "Testing of the Zest™ Petite Nasal Mask was compared to the predicate..." but does not detail the number of units tested.
- Data Provenance: The testing was non-clinical (laboratory/bench testing) and performed by Fisher & Paykel Healthcare. The country of origin for the data (where the tests were conducted) is not explicitly stated but is likely New Zealand, given the company's location. The testing is prospective in the sense that it was conducted specifically for this submission, but it's not a clinical trial on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device submission relies on non-clinical performance and biocompatibility testing, not expert-adjudicated "ground truth" in the context of diagnostic accuracy or similar metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, no expert adjudication was involved.
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 physical medical device (nasal mask), not an AI/ML diagnostic tool.
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.)
- The "ground truth" in this context is the performance and biocompatibility characteristics of the predicate devices and industrial standards for such masks, against which the new device was compared. The testing involved measuring physical properties and material responses (e.g., performance, biocompatibility).
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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SECTION 5 - 510K Summary
MAR 2 4 2011
K103786 aykel sherです 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 0148 Website: www.fphcare.com
| Contact person | Tina Mason |
|---|---|
| Date Prepared | 14th December 2010 |
| Trade Name | Zest™ Petite Nasal Mask |
| Common Name | Nasal Mask |
| ClassificationName | Non continuous ventilator IPPB(21 CFR § 868.5905, product code BZD) |
| PredicateDevices | K083832 Fisher & Paykel Healthcare Zest Nasal Mask |
| K092835 Respironics ComfortGel Blue Nasal Mask | |
| K061236 Fisher & Paykel Healthcare Flexifit HC432 Full FaceMask (predicate for material biocompatibility) |
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5.1 Description
The Zest™ Petite 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.
5.2 Intended Use
The Zest™ Petite Nasal Mask is intended to be used by individuals greater than 66lbs (30kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The Zest™ Petite Nasal Mask is intended for Single Patient Use in the home and Multiple Patient Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
5.3 Technological Characteristics Comparison
The Zest™ Petite Nasal Mask is very similar to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask. Both masks are for non continuous ventilation, and deliver CPAP gasses through the nose. The main difference is that the Zest Petite Nasal Mask is a smaller size than the Zest Nasal Mask. The overall dimensions of the Zest Petite Nasal Mask are smaller and the silicone seal is smaller. All the technology, features and specifications are identical. The only difference is that it will fit patients with smaller faces.
5.4 Non-clinical Tests
Testing of the Zest™ Petite Nasal Mask was compared to the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask for performance and for biocompatibility. These tests demonstrate substantial equivalence of the Zest™ Petite Nasal Mask to the predicate mask. Copies of test reports are included in Appendix B.
5.5 Conclusion
The comparison of features, performance, and biocompatibility are identical the predicate Fisher & Paykel Healthcare Zest™ Nasal Mask (K083832) and the HC432 Full Face Mask (K061236) for biocompatibility.
The comparison of intended use 661bs (30kg) is identical to the predicate Respironics ComfortGel Blue Nasal Mask (K092835) and is identical to the Fisher & Paykel Healthcare Zest™ Nasal Mask (K083832) in terms of Single Patient Use in the home and Multiple Patient Use in the hospital or other clinical setting.
The Zest™ Petite Nasal Mask is proven to be safe and effective for CPAP and Bilevel ventilation therapy.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three wavy lines representing the three branches of government.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tina Mason Regulatory Affairs Engineer Fisher & Paykel Healthcare, Limited 15 Maurice Paykel Place East Tamaki, Auckland NEW ZEALAND 2013
MAR 2 4 2011
Re: K103786
Trade/Device Name: Zest™ Petite Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 20, 2010 Received: December 27, 2010
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 practive, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, forvever, 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. 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 regulering. 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 53) -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 vours.
hh for
Anthony 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 Zest™ Petite Nasal Mask
Indications for Use:
The Zest™ Petite Nasal Mask is intended to be used by individuals greater than 66lbs (30kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The Zest™ Petite Nasal Mask is intended for Single Patient Use in the home and Multiple Patient 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)
L. Schulltho
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
§10(k) Number: 4103786
§ 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).