← Product Code [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD) · K061236 # FLEXIFIT HC432 FULL FACE MASK (K061236) _Fisher & Paykel Healthcare, Ltd. · BZD · Aug 29, 2006 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K061236 ## Device Facts - **Applicant:** Fisher & Paykel Healthcare, Ltd. - **Product Code:** [BZD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD.md) - **Decision Date:** Aug 29, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5905 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## 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. ## Device Story Non-invasive full face mask; covers mouth and nose; interfaces with CPAP or Bilevel ventilator systems. Receives pressurized gases via single breathing tube; includes non-rebreathing valve to prevent CO2 buildup during airflow cessation; features exhalation vents (bias holes) above nasal bridge for continuous flushing of exhaled gases. Secured to face via headgear straps and quick-release clip; includes foam cushion for facial seal and comfort. Used in home, hospital, or clinical settings; operated by patients or healthcare providers. Reprocessable for multi-patient use (up to 20 times). Output is delivery of pressurized respiratory therapy; facilitates patient compliance through improved seal and comfort. ## Clinical Evidence Bench testing only. Performance and biocompatibility testing compared the subject device to the predicate HC431 mask to demonstrate substantial equivalence. ## Technological Characteristics Non-invasive full face mask; foam cushion seal; non-rebreathing valve; exhalation vents (bias holes); headgear with quick-release clip. Materials biocompatibility validated against predicate. Designed for non-continuous ventilation (CPAP/Bilevel). Reprocessable (up to 20 cycles). ## Regulatory 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. ## Predicate Devices - Fisher & Paykel Healthcare Flexifit HC431 Face Mask ([K040506](/device/K040506.md)) - Fisher & Paykel Healthcare Oracle Oral Mask ([K033087](/device/K033087.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K061236](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BZD/K061236) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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