(95 days)
Not Found
No
The description focuses on the physical components and intended use of a face mask for noninvasive ventilation, with no mention of AI or ML technologies.
No
The device is described as a patient interface mask for noninvasive ventilation, intended to be an accessory to ventilators for the treatment of respiratory conditions. It does not directly provide a therapeutic effect itself but facilitates the therapy delivered by a ventilator.
No
The device is a mask intended to provide a patient interface for noninvasive ventilation, specifically for applying CPAP or positive pressure ventilation. It is a therapy delivery device, not a diagnostic one.
No
The device description clearly outlines physical components made of polycarbonate and silicon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the mask is a patient interface for noninvasive ventilation. This involves delivering air or oxygen to the patient's respiratory system.
- Device Description: The description details the physical components of the mask and its connection to a patient circuit.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples from the body, not to directly interact with the body for therapeutic purposes like ventilation.
N/A
Intended Use / Indications for Use
The Performax SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea.
The mask is for multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
Product codes
CBK, BZD
Device Description
The Respironics Performax SE Total Face Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. Like the device predicate, Image 3SE full face mask (K023135), the interface to the patient circuit is a polycarbonate standard elbow. The design of the standard elbow (SE) is the same as the SE used on the Image 3SE Full Face mask. The mask when used with the standard elbow has one integrated exhalation feature, which includes one port on the faceplate. Similar to the device predicate, Total Face Mask (K992969), 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 SE 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
patients weighing > 30 kg
Intended User / Care Setting
hospital/institutional environment only.
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
§ 868.5895 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).
0
Traditional 510(k) Tab 5 – 510(k) summary
Respironics Performax SE Total Face Mask
TAB 5
| 510(K) SUMMARY | |
|---|---|
| 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 c | |
| 724-387-4216 f | |
| DEC 1 8 2007 | |
| Classification Reference | 21 CFR 868.5895; 21CFR 858.5905 |
| Product Code | CBK - Continuous Ventilator; BZD - non-continuous ventilator |
| Common/Usual Name | Ventilator, continuous, facility use; ventilator, non-continuous (respirator) |
| Proprietary Name | Respironics Performax SE Total Face Mask |
| Predicate Device(s) | Respironics Total Face Mask (K992969) - BZD |
| Image 3 SE Face Mask (K023135) - CBK | |
| Reason for submission | new device |
Substantial Equivalence
The Respironics Performax SE Total Face Mask has the following similarities to the previously cleared predicate device:
- Same intended use.
- Same operating principle. ப
- Same technology. D
- Same manufacturing process. ා
1
This premarket notification submission demonstrates that the Performax SE Total Face Mask is substantially equivalent to 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:
- 프 The change in the face plate design to contour the face
- I The change in the sealing cushion design
- r The addition of a standard elbow without exhalation similar to the standard elbow used on the Image 3 SE. This design is intended for use with a ventilator that has an integral safety valve.
- ı The addition of the claim for multi-patient use to be included.
Intended Use
The Performax SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea.
The mask is for multi-patient reuse on patients weighing > 30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
Device Description
The Respironics Performax SE Total Face Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. Like the device predicate, Image 3SE full face mask (K023135), the interface to the patient circuit is a polycarbonate standard elbow. The design of the standard elbow (SE) is the same as the SE used on the Image 3SE Full Face mask. The mask when used with the standard elbow has one integrated exhalation feature, which includes one port on the faceplate. Similar to the device predicate, Total Face Mask (K992969), the mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.
2
The Respironics Performax SE 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.)
: : :
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it.
DEC 1 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K072588
Trade/Device Name: Respironics Performax SE Total Face Mask Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK 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.
4
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 (OS) 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,
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
5
Indications for Use
510(k) Number (if known): ________________
:
Device Name: Respironics Performax SE Total Face Mask_________________________________________________________________________________________________________________
The Performax SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea.
The mask is for multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
Prescription Use ____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aut J. Wate