(90 days)
The Fisher & Paykel Healthcare Acute Care Single Use Face Mask is a nasal-oral patient interface for use as an accessory to ventilators providing noninvasive bi-level and constant positive airway pressure ventilation. The ventilator must have adequate alarms and safety systems for ventilator failure. The mask is for single patient use with spontaneously breathing patients with respiratory insufficiency or respiratory failure, who are suitable for noninvasive pressure support ventilation in the hospital/institutional environments only.
The Acute Care Face Mask is a nasal-oral non invasive patient interface. The mask is held on the face with headgear straps and a quick release clip. It connects to a single breathing tube by a double swivel adaptor, to receive pressurized gases. On the body, or base, of the mask is an exhalation vent 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 for comfort and to reduce leakage. Oxygen and pressure ports in the base can be used for pressure monitoring and supplemental oxygen tube connection.
The provided text describes a 510(k) summary for the Fisher & Paykel Healthcare Acute Care Face Mask. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing the acceptance criteria and a rigorous study for device performance in the way requested for an AI/software-as-a-medical-device (SaMD) context.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable to this type of traditional medical device submission.
Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance demonstrated to be substantially equivalent to predicate device (Flexifit mask). | Testing showed substantial equivalence to the Flexifit mask for performance. |
| Biocompatibility demonstrated to be substantially equivalent to predicate device (Flexifit mask). | Testing showed substantial equivalence to the Flexifit mask for biocompatibility. |
| Suitable for use with ventilators having alarms and safety systems for ventilator failure. | Device is for use with ventilators that have alarms and safety systems for ventilator failure. |
| Facilitate non-invasive ventilation (CPAP or bi-level). | Device is a nasal-oral non-invasive patient interface for respiratory support. |
| Allow continuous flushing and removal of exhaled gases. | Exhalation vent allows exhaled gases to be continually flushed and removed. |
| Comfortable and reduce leakage. | Contoured base and soft facial seal for comfort and to reduce leakage. |
| Allow for pressure monitoring and supplemental oxygen. | Oxygen and pressure ports in the base can be used for pressure monitoring and supplemental oxygen. |
Explanation of "Acceptance Criteria"
For this type of device, explicit numerical "acceptance criteria" are not detailed in the same way they would be for an AI algorithm. Instead, the primary acceptance criterion for regulatory approval (510(k)) is demonstrating substantial equivalence to an already legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "reported device performance" is essentially that it met this overarching criterion through comparative testing.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "testing" but does not quantify the number of masks or subjects involved in these tests.
- Data Provenance: Not specified. The type of testing (e.g., bench, animal, human) is not detailed, nor is the country of origin of any test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a physical medical device (face mask), not an AI/SaMD requiring expert-labeled ground truth for algorithm training or validation in the typical sense. Performance was likely assessed through engineering tests and potentially clinical observation without a formal "ground truth" establishment by experts.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
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 face mask, not an AI-based diagnostic or assistive technology. No human reader improvement with AI assistance is relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical face mask, not an algorithm.
7. The Type of Ground Truth Used
- For a device like this, "ground truth" would relate to measurable physical properties and user acceptability.
- Performance: Likely assessed through objective measures such as airflow resistance, dead space, CO2 washout, leak rates, and compatibility with ventilators according to relevant standards. The "ground truth" would be the measured values meeting engineering specifications and being comparable to the predicate device.
- Biocompatibility: Assessed through standard biocompatibility tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 series. The "ground truth" would be the pass/fail results against specified limits.
- User Comfort/Fit (Implied): While not explicitly detailed, comfort and fit are mentioned. This would be subjective user feedback, compared against the predicate.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
{0}------------------------------------------------
Ko
510(k) Summary 5
6 2006 APR
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 a horizontal line underneath. The word "HEALTHCARE" is on the second line.
Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure
Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person | Brett Whiston |
|---|---|
| Date prepared | 21 December 2005 |
| Trade name | Acute Care Face Mask |
| Common name | Face Mask |
| Classification name | Ventilator, Continuous, Minimal ventilatory support, Facility use(accessory to)(21 CFR § 868.5895, product code MNT) |
| Predicate device | K040506 Fisher & Paykel Healthcare Flexifit HC431 Face MaskK023135 Respironics Image3 SE Disposable Face Mask |
{1}------------------------------------------------
5.1 Description
The Acute Care Face Mask is a nasal-oral non invasive patient interface. The mask is held on the face with headgear straps and a quick release clip. It connects to a single breathing tube by a double swivel adaptor, to receive pressurized gases. On the body, or base, of the mask is an exhalation vent 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 for comfort and to reduce leakage. Oxygen and pressure ports in the base can be used for pressure monitoring and supplemental oxygen tube connection.
5.2 Intended use
Adult patients requiring respiratory support and suitable for noninvasive ventilation have the option of a full face mask as the patient interface. The ventilator is providing positive pressure support by CPAP or bi-level techniques and has alarms and safety systems for ventilator failure. The mask is single patient use to be used on acute care patients who are in the hospital/institutional environment.
Technological characteristics comparison 5.3
The Acute Care Face Mask is very similar to the Flexifit mask. It uses the same base shape and seal, headgear, quick release clip and also contains an exhalation vent. Both are for non continuous ventilation. The Acute Care mask differs with the use of the exhalation vent containing holes, rather than the slots of the Flexifit mask, and the holes are positioned above the nasal bridge whereas the slots are above and below the mouth. It also differs in not using a non rebreathing valve unlike the Flexifit mask that includes one.
The absence of a non rebreathing valve or anti asphyxiation valve is possible when the mask is indicated for use with ventilators that have alarms and safety systems for ventilator failure, as with the Image3 SE mask. The Image3 SE is cleared for continuous ventilator use but like the Acute Care mask encounters the same situation if the ventilator fails.
5.4 Non-clinical tests
Testing of the Acute Care mask was compared to the Flexifit mask for performance and biocompatibility. These tests show that the Acute Care mask has substantial equivalence to the Flexifit mask.
5.5 Conclusion
The Acute Care Face Mask is substantially equivalent to the Flexifit and Image3 SE masks. The comparison of features, performance, and intended use demonstrate that the Acute Care mask is at least as safe and effective for non invasive ventilation
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes entwined around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
Mr. Brett Whiston Fisher & Paykel Healthcare, Limited P.O. Box 14-348, Panmure Auckland, New Zealand 1701
Re: K060044
Trade/Device Name: Fisher & Paykel Healthcare Acute Care Full Face Mask Regulation Number: 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: MNT Dated: December 21, 2005 Received: January 6, 2006
Dear Mr. Whiston:
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.
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
{3}------------------------------------------------
Page 2 - Mr. Brett Whiston
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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}------------------------------------------------
510(k) Number
Device Name
Fisher & Paykel Healthcare Acute Care Full Face Mask
The Fisher & Paykel Healthcare Acute Care Single Use Face Mask is a nasal-oral patient interface for use as an accessory to ventilators providing noninvasive bi-level and constant mositive airway pressure ventilation. The ventilator must have adequate alarms and safety posters for ventilator failure. The mask is for single patient use with spontaneously breathing Systems 101 ventualer ranah respiratory insufficiency or respiratory failure, who are suitable for noninvasive pressure support ventilation in the hospital/institutional environments only.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
gy, General Hospieri, Tital Sevices
Page 1 of 1
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).