(96 days)
No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is also "Not Found".
No.
The device is an interface (mask) for applying CPAP or BiPAP therapy, not the therapeutic device itself.
No
The device is described as an interface for applying CPAP or BiPAP therapy, which are forms of treatment, not diagnostic procedures. Its function is to deliver air/pressure, not to diagnose a medical condition.
No
The device description clearly outlines physical components like a faceplate, cushion seal, valve, and headgear hooks, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an interface for applying CPAP or BiPAP therapy to patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a mask and its components for delivering air pressure, not for analyzing biological samples.
- 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 health status.
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. This device's function is to facilitate a therapeutic treatment (CPAP/BiPAP), not to perform a diagnostic test.
N/A
Intended Use / Indications for 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.
The Performax Total Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients. For multi-patient reuse in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs/30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP System. An exhalation port is built into this mask so that a separate exhalation port is not required. This mask is latex free and Di(2-ethylexyl)phthalate free.
Product codes
BZD
Device Description
The Respironics Performax Total Face 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 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. Similar to the device predicate, Total Face Mask, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
adult patients, patients (>66 lbs/30 kg)
Intended User / Care Setting
Home or hospital/institutional environment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Traditional 510(k)
Tab 5-510(k) summary
TAB 5
510(K) SUMMARY
| Labels | Values |
|---|---|
| Date of Submission | 12 September 2007 |
| Official Contact | Zita A. Yurko |
| Director, Regulatory Affairs | |
| Respironics, Inc. | |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Zita.yurko@respironics.com | |
| 724-387-4120 t | |
| 724-882-4120 с | |
| 724-387-4216 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 |
Respironics Performax Total Face Mask
DEC 1 9 2007
Reason for submission modified device
Substantial Equivalence
Predicate Device(s)
The Respironics Performax Total Face Mask has the following similarities to the previously cleared predicate device:
Respironics Total Face Mask (K992969) - BZD
- 0 Same intended use.
- Same operating principle.
- Same technology.
- Same manufacturing process.
1
This premarket notification submission demonstrates that the Performax Total Face Mask is substantially equivalent to the design of the Respironics Total Face Mask (K992969). Design modifications have been made to the Total Face Mask for this submission. These modifications are described here in. Based on the testing performed, none of the design modification affect the safety or effectiveness of the device.
The following changes have been made:
- . The change in the face plate design to contour the face
- The change in the sealing cushion design
- The change in the entrainment valve design to replace the flapper with magnet design with a r silicone flapper design
- . The addition of the claim for multi-patient use to be included.
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 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 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. Similar to the device predicate, Total Face Mask, 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.)
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 lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Ms. Zita Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K072592
Trade/Device Name: Respironics Performax Total Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 21, 2007 Received: November 23, 2007
Dear Ms. Yurko:
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. Yurko
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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
Indications for Use
510(k) Number (if known):
Device Name: ____ Respironics Performax Total Face Mask
The Performax Total Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients. For multi-patient reuse in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs/30 kg) for whom CPAP or BiPAP therapy has been prescribed using a Respironics CPAP or BiPAP System. An exhalation port is built into this mask so that a separate exhalation port is not required. This mask is latex free and Di(2-ethylexyl)phthalate free.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miy 7 hlm