(83 days)
Not Found
No
The description focuses on the mechanical components and function of a nasal mask for CPAP/Bi-level therapy, with no mention of AI or ML.
Yes
The device is described as "intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment," which are medical treatments for respiratory conditions.
No.
The device is a nasal mask used for CPAP or Bi-level ventilator treatment, which suggests it is a therapeutic device for delivering pressurized gases, not for diagnosing medical conditions.
No
The device description clearly describes a physical respiratory mask with components like a silicone seal, headgear straps, swivel adaptor, and exhalation vents. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering CPAP or Bi-level ventilator treatment to individuals diagnosed with requiring such treatment. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The description clearly states it's a respiratory mask used to deliver pressurized gases. It's a physical device for breathing support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances in these samples to diagnose a condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to facilitate breathing, which is a treatment, not a diagnostic process.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K080209 Fisher & Paykel Healthcare Zest Nasal Mask, K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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 |
| Classification | |
| Name | Non continuous ventilator IPPB |
| (21 CFR § 868.5905, product code BZD) | |
| Predicate | |
| Devices | K080209 Fisher & Paykel Healthcare Zest Nasal Mask |
| K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask |
1
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).
2
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.
3
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
4
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