(29 days)
The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.
The Respironics Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592). The Performax Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. An integrated entrainment valve is provided for exhalation. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K992969. The mask when used with the integrated entrainment valve has two integrated exhalation features, which includes the one port on the faceplate and an exhalation site on the elbow. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.
The Respironics Performax Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.
This document is a 510(k) summary for the "Respironics Performax Total Face Mask," which is a ventilator, non-continuous (respirator) under product code BZD. The submission is a "Special 510(k) Attachment 4" because it is a modification to add autoclaving as an approved method of disinfection.
Here's an analysis of the provided text, broken down by your requested categories:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the submission focuses on demonstrating substantial equivalence to a predicate device (Respironics Performax Total Face Mask, K072592) after a modification: the addition of autoclaving as an approved method of disinfection.
The text does not provide specific, quantifiable acceptance criteria (e.g., "airflow resistance shall not exceed X Pa/cm3/s") or detailed performance data (e.g., "after X autoclave cycles, the mask maintained Y seal integrity"). Instead, it states a high-level conclusion.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Maintain Safety and Effectiveness after Autoclaving (Implied) | "Based on the testing performed, the additional cleaning and disinfection method has no effect on the safety or effectiveness of the device." "The Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592)." (implies original performance maintained) |
| Continue to provide an interface for CPAP/BiPAP therapy (Implied) | The intended use remains the same: "The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients." |
| Retain multi-patient reuse capability (Implied) | The intended use remains the same: "The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment." |
| Maintain operating principle (Explicit Statement) | "Same operating principle." |
| Maintain technology (Explicit Statement) | "Same technology." |
| Maintain manufacturing process (Explicit Statement) | "Same manufacturing process." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing. It also does not mention the data provenance (country of origin, retrospective or prospective). The statement "Based on the testing performed" implies that testing was conducted, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The type of submission (a 510(k) for a physical device modification) typically relies on engineering and sterility testing rather than expert-derived ground truth based on interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are primarily relevant to studies involving human interpretation (e.g., diagnostic image reading), where disagreements need to be resolved. This document, describing a physical device modification and its substantial equivalence determination, does not involve such adjudication methods.
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
An MRMC study is not applicable to this type of device modification. This submission is for a physical medical device (a mask) and its disinfection method, not an AI-powered diagnostic or assistive tool. Therefore, there is no mention of an MRMC study or any effect size related to human readers' improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a physical medical device. There is no algorithm involved, and therefore no standalone performance study in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device modification, the "ground truth" would be established through a combination of:
- Engineering testing: To confirm the mask's physical integrity, seal effectiveness, pressure performance, and material properties after autoclaving.
- Sterility/biocompatibility testing: To demonstrate that the autoclaving process effectively disinfects the device and that the materials remain biocompatible.
- Previous clearance data (K072592): The original performax mask (K072592) served as the "ground truth" for the baseline design, safety, and effectiveness. The current submission's "ground truth" is that the modified device's performance after autoclaving remains equivalent to this established baseline.
The document does not explicitly state these ground truth types but they are implied by the nature of the device and the submission (e.g., "no effect on the safety or effectiveness").
8. The sample size for the training set
This information is not applicable as there is no AI/machine learning model being trained in this submission.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI/machine learning model being trained in this submission.
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K09127
Special 510(k) Attachment 4 - 510(k) summary
Respironics Performax Total Face Mask
| Date of Submission | 29 April 2009 |
|---|---|
| Official Contact | MAY 29 2009Andrew P. ZeltwangerManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668Andrew.Zeltwanger@respironics.com724-387-7442 t724-448-0543 c724-387-7490 f |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Ventilator, Non-Continuous (respirator) |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Proprietary Name | Respironics Performax Total Face Mask |
| Predicate Device(s) | Respironics Performax Total Face Mask (K072592) - BZD |
| Reason for submission | Modification to add autoclaving |
Substantial Equivalence
The Respironics Performax Total Face Mask has the following similarities to the previously cleared predicate device:
- ロ: Same intended use.
- Same operating principle. ට
- Same technology. 0
- Same manufacturing process.
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This premarket notification submission demonstrates that the Performax Total Face Mask is substantially equivalent to the design of the Respironics Performax Total Face Mask (K072592). The Performax Total Face Mask has been modified to add a new method of disinfection for multi-patient use in the hospital or institution. These modifications are described herein. Based on the testing performed, the additional cleaning and disinfection method has no effect on the safety or effectiveness of the device.
The following changes have been made:
- The addition of autoclaving as an approved method of disinfection
- The modification to the Swivel torque specification
Intended Use
The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.
Device Description
The Respironics Performax Total Face Mask has the exact same design as the previously cleared Performax Total Face Mask (K072592). The Performax Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. An integrated entrainment valve is provided for exhalation. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K992969. The mask when used with the integrated entrainment valve has two integrated exhalation features, which includes the one port on the faceplate and an exhalation site on the elbow. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.
The Respironics Performax Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.
(End of Tab.)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2009
Mr. Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics, Incorporated Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K091271
Trade/Device Name: Respironics Performax Total Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 29, 2009 Received: April 30, 2009
Dear Mr. Zeltwanger:
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 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.
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Page 2 - Mr. Zeltwanger
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 Runge
Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _KCN 27 |
Device Name: ____Respironics Performax Total Face Mask
The Performax Total Face Mask is intended to provide an interface for application of CPAP or BiPAP therapy to patients. The mask is for multi-patient reuse on adult patients in the home or hospital/institutional environment.
Prescription Use ____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schett
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K091271
§ 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).