(228 days)
Not Found
No
The device description and performance studies focus on the physical components and function of a nasal mask, with no mention of AI or ML.
Yes
The device is intended for individuals requiring CPAP or Bi-level ventilator treatment, which are therapeutic interventions.
No
The device is a nasal mask used for CPAP or Bi-level ventilator treatment, not for diagnosing medical conditions. Its function is to deliver pressurized gases, not to conduct diagnostic tests or analyses.
No
The device description clearly describes a physical respiratory mask with hardware components like a silicone seal, headgear straps, and a swivel adaptor. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for delivering pressurized gases for CPAP or Bi-level ventilator treatment. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The description details a respiratory mask that seals around the nose and connects to a breathing tube. This is a physical device used for delivering air, not for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Zest™ Nasal Mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
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.
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
Nose, upper lip
Indicated Patient Age Range
adult
Intended User / Care Setting
Home, hospital or other clinical setting.
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)
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.
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.
K063036 Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask, K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face 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
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 |
| Classification | |
| Name | Non continuous ventilator IPPB |
| (21 CFR § 868.5905, product code BZD) | |
| Predicate | |
| Devices | K063036 Fisher & Paykel Healthcare Opus HC482 Direct Nasal |
| Mask | |
| K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face | |
| Mask (predicate for material biocompatibility) |
1
5.1 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.
5.2 Intended Use
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.
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.
2
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.
3
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
4
SECTION 4 - Indications for Use Statement
510(k) Number
Zest™ Nasal Mask Device Name
Indications for Use:
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.
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