(123 days)
No
The device description focuses on the physical components of a CPAP mask and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is an interface that delivers CPAP or bi-level therapy, but it is not the therapeutic device itself. The therapy is provided by a separate device that connects to the mask.
No
The device is a full face mask designed to provide an interface for the application of CPAP or bi-level therapy, which are treatments for conditions like sleep apnea. It does not perform any diagnostic function.
No
The device description clearly outlines physical components such as a faceplate, silicone cushion seal, exhalation vents, entrainment valve elbow, and headgear straps, 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 bi-level 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 or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is a core characteristic of IVD devices.
- No Diagnostic Output: The device's function is to deliver therapy, not to produce a diagnostic result or measurement.
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 does not fit that description.
N/A
Intended Use / Indications for Use
The Revolution Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is intended for single patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Product codes
BZD
Device Description
The RevolutionFull Face Mask consists of a Hyrel faceplate that holds multiple sizes of a removable and replaceable silicone cushion seal for the face. The mask cushion has eight integrated exhalation vents, four on either side of the cushion. The location of the exhalation vents on the silicone mask cushion is unchanged from K023068. A separate exhalation device is not required for the integrated exhalation vent design. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The functionality and performance of the entrainment valve with fresh air inlets is unchanged from K073600, based on performance test data. The mask frame contains slots for attachment of the headgear straps, lower headgear band and chin support band. The mask is available in three sizes - small, medium and large.
The Respironics RevolutionFull Face Mask is intended for use with a patient circuit that is used to connect a therapy 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
Not Found
Indicated Patient Age Range
patients (>66lbs/30kg)
Intended User / Care Setting
multi-patient reuse in the 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)
Respironics ComfortGel Full Face Mask (K073600), MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068)
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
Respironics RevolutionFull Face Mask
3
Respironics RevolutionFull Face Mask
K082866 page 1 of
TAB 5
510(K) SUMMARY
| Date of Submission | 25 September 2008 |
|---|---|
| Official Contact | Andrew Zeltwanger |
| Manager, Regulatory Affairs | |
| Respironics, Inc. | |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| andrew.zeltwanger@respironics.com | |
| 724-387-7442 t | |
| 724-448-0543 c | |
| 724-387-7490 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 RevolutionFull Face Mask |
| Predicate Device(s) | Respironics ComfortGel Full Face Mask (K073600) – BZD |
| MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068) - BZD | |
| Reason for submission | New device |
Substantial Equivalence
The Respironics RevolutionFull Face Mask has the following similarities to the previously cleared predicate device:
- Same intended use. 0
- Same operating principle. 0
- Same technology. ロ
- Same manufacturing process. 0
1
This premarket notification submission demonstrates that the Respironics RevolutionFull Face Mask is substantially equivalent to the Respironics ComfortGel Full Face Mask (K073600) and the MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068). Design modifications have been made to the predicate masks for this submission. These modifications are described herein. Based on the testing performed, none of the design modification affects the safety or effectiveness of the device.
The following changes have been made:
-
- The exhalation vent location was changed from the entrainment valve to the mask cushion.
-
- The number of exhalation vents was changed from two to eight.
-
- The traditional polycarbonate mask faceplate was changed to a Hytrel frame.
-
- The pressure pick-off port was removed.
-
The tubing quick release design that allows the accessory swivel to be released along with the mask tubing was changed to a swivel design, without release tabs, which can be directly pulled from the end of the entrainment valve.
-
The traditional four-point headgear design was changed to top, back and side headgear straps with a lower headgear band and a chin support band.
-
Change from a ball & socket "quick release" clip.
-
- Change in dead space volume, due to mask design.
-
- Change to the Occluded End Tidal CO2 due to larger dead space resulting from mask design.
-
- Change to the dimensional specifications of the faceplate and cushion including the change to the size and shape of the mask frame (faceplate) and cushion and to the weight of the mask.
-
- Elimination of the forehead arm, stability selector and forehead pad to open the users field of vision.
-
- The change to the mask materials.
Intended Use
The RevolutionFull Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient reuse in the home or hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
2
Device Description
The RevolutionFull Face Mask consists of a Hyrel faceplate that holds multiple sizes of a removable and replaceable silicone cushion seal for the face. The mask cushion has eight integrated exhalation vents, four on either side of the cushion. The location of the exhalation vents on the silicone mask cushion is unchanged from K023068. A separate exhalation device is not required for the integrated exhalation vent design. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The functionality and performance of the entrainment valve with fresh air inlets is unchanged from K073600, based on performance test data. The mask frame contains slots for attachment of the headgear straps, lower headgear band and chin support band. The mask is available in three sizes - small, medium and large.
The Respironics RevolutionFull Face Mask is intended for use with a patient circuit that is used to connect a therapy 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending upwards.
JAN 3 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics Incorporated. Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K082866
Trade/Device Name: Revolution Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 12, 2009 Received: January 14, 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 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 - 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
ું છે.
Ginette Y. Michaud, M.D. Acting 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): K082866
Device Name: Revolution Full Face Mask
The Revolution Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is intended for single patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
Prescription 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082866