(118 days)
Not Found
No
The device description and summary of performance studies focus on the physical components and function of a CPAP/Bilevel mask, with no mention of AI or ML technologies.
No.
The device is a mask that interfaces with therapeutic devices (CPAP or Bilevel ventilators) to deliver pressurized gases, but it does not directly provide therapeutic treatment itself.
No
The device is a non-invasive patient interface (mask) used for delivering CPAP or Bilevel ventilator treatment, which are therapeutic interventions, not diagnostic ones. Its "Intended Use" states it's for individuals "who have been diagnosed by a physician," indicating it's used after a diagnosis has been made.
No
The device description clearly outlines a physical medical device (a full face mask) with hardware components like headgear straps, a quick release clip, a non-rebreathing valve, a swivel adaptor, exhalation vents, a contoured base, a soft facial seal, and a foam cushion. There is no mention of software as the primary or sole component.
Based on the provided text, the Flexifit™ HC432 Full Face Mask is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for delivering CPAP or Bilevel ventilator treatment. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a non-invasive patient interface for delivering pressurized gases. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or screening.
Therefore, the Flexifit™ HC432 Full Face Mask is a medical device used for respiratory therapy, not an IVD.
N/A
Intended Use / Indications for Use
The Flexifit™ HC432 Full Face Mask is designed for adult patients requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting. The mask may be reprocessed and reused by healthcare facilities to allow multi-patient use. The mask may be reprocessed up to 20 times.
The Flexifit™ HC432 Full Face Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel 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 Flexifit™ HC432 Full Face Mask is a non invasive patient interface that covers the patient's mouth and nose. The mask is held on the face with headgear straps and a quick release clip. It connects to a single breathing tube by a non-rebreathing valve and a swivel adaptor, to receive pressurized gases. The non-rebreathing valve is designed to prevent carbon dioxide build up in the mask in the event of cessation of airflow from the breathing circuit. On the body, or base, of the mask are exhalation vents (bias holes) located above the bridge of the nose that allows exhaled gases to be continually flushed and removed to room air. The base is contoured and has a soft facial seal, which is fitted with a foam cushion 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
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 Flexifit™ HC432 Full Face Mask was compared to the predicate Flexifit™ Series HC431 Full Face Mask for performance and biocompatibility. These tests demonstrate substantial equivalence of the Flexifit™ HC432 Full Face 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.
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
K061236
HC432J
HC432 Full Face Mask 510(k) Submission
SECTION 5 - 510K Summary
AUG 2 9 2006
Image /page/0/Picture/5 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line, with the ampersand symbol between them. The word "HEALTHCARE" is on the second line, directly below the first line.
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 www.fphcare.com Website:
| Contact person | Reena Daken |
|---|---|
| Date prepared | 27 April 2006 |
| Trade name | Flexifit™ HC432 Full Face Mask |
| Common name | Full Face Mask |
| Classification | |
| name | Non continuous ventilator IPPB |
| (21 CFR § 868.5905, product code BZD) | |
| Predicate | |
| devices | K040506 Fisher & Paykel Healthcare Flexifit HC431 Face Mask |
| K033087 Fisher & Paykel Healthcare Oracle Oral Mask (predicate | |
| for material biocompatibility) |
1
5.1 Description
The Flexifit™ HC432 Full Face Mask is a non invasive patient interface that covers the patient's mouth and nose. The mask is held on the face with headgear straps and a quick release clip. It connects to a single breathing tube by a non-rebreathing valve and a swivel adaptor, to receive pressurized gases. The non-rebreathing valve is designed to prevent carbon dioxide build up in the mask in the event of cessation of airflow from the breathing circuit. On the body, or base, of the mask are exhalation vents (bias holes) located above the bridge of the nose that allows exhaled gases to be continually flushed and removed to room air. The base is contoured and has a soft facial seal, which is fitted with a foam cushion for comfort and to reduce leakage.
5.2 Intended Use
The Flexifit™ HC432 Full Face Mask is designed for adult patients requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting. The mask may be reprocessed and reused by healthcare facilities to allow multi-patient use. The mask may be reprocessed up to 20 times.
5.3 Technological Characteristics Comparison
The Flexifit™ HC432 Full Face Mask is very similar to the predicate Flexifit™ Series HC431 Full Face Mask. It uses the same base shape and seal, headgear, quick release clip and also contains a non-rebreathing valve. Both masks are for non continuous ventilation. The Flexifit™ HC432 Full Face Mask differs with the use of the exhalation vent containing holes, rather than the slots of the predicate mask, and the holes are positioned above the nasal bridge whereas the slots on the predicate mask are above and below the mouth. It also differs in using a foam cushion. The predicate mask does not use a foam cushion. The foam cushion is designed to provide comfort and better sealing, hence minimising air leaks.
5.4 Non-clinical Tests
Testing of the Flexifit™ HC432 Full Face Mask was compared to the predicate Flexifit™ Series HC431 Full Face Mask for performance and biocompatibility. These tests demonstrate substantial equivalence of the Flexifit™ HC432 Full Face 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 Flexifit™ HC432 Full Face Mask is substantially equivalent to the predicate Flexifit+" Series HC431 Full Face Mask. The Flexifit™ HC432 Full Face Mask is proven to be safe and effective for CPAP and Bilevel 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 features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
Public Health Service
AUG 2 9 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Reena Daken Regulatory Affairs Engineer-OSA Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, NEW ZEALAND
Re: K061236
Trade/Device Name: Flexifit™ HC432 Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 26, 2006 Received: July 31, 2006
Dear Ms. Daken:
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 vour 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. Daken
:
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Carl
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
Enclosure
4
SECTION 4 - Indications for Use Statement
510(k) Number KO 6 1a36
Device Name
Flexifit™ HC432 Full Face Mask
Indications for Use:
The Flexifit™ HC432 Full Face Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel 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)
Mumhnd
on Sign-Off) on of Anesthesiology, General Hospital, tion Control, Dental Devices
Number. K061236