(316 days)
Not Found
No
The description focuses on the mechanical components and physical design of a CPAP mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an interface for continuous positive airway pressure (CPAP) or bi-level therapy, which are treatments for sleep apnea and other respiratory conditions. These therapies are therapeutic interventions.
No
The device is a mask for CPAP or bi-level therapy, which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines physical components like a frame, cushion, elbow, and headgear, 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 is to provide an interface for CPAP or bi-level therapy, which is a treatment for respiratory conditions. This involves delivering air pressure to the patient's airway.
- Device Description: The description details a physical mask, frame, cushion, elbow, and headgear designed to fit on a patient's face and connect to a therapy device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The device interacts directly with the patient's airway.
IVD devices are specifically designed for testing biological samples in vitro (in a lab setting). This device is a therapeutic device used in vivo (on a living patient).
N/A
Intended Use / Indications for Use
The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.
Product codes
BZD
Device Description
The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.
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 greater than 66lbs/30kg
Intended User / Care Setting
single-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)
Clinical tests were not required to demonstrate the safety and effectiveness of the Revolution Full Face Mask. Product functionality has been adequately assessed by nonclinical tests.
Non-Clinical Tests: Performance testing was performed before and after cleaning and disinfection treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- Intentional Leak
- Total Mask Leak
- Deadspace Volume
- Pressure Drop
- Anti- Asphyxia Feature Open to Atmosphere Pressure
- Anti- Asphyxia Feature Closed to Atmosphere Pressure
- CO2 Rebreathing
- Cleaning and Disinfection Efficacy
- Storage
The Revolution Full Face Mask has been designed to meet the requirements of the following standards:
- ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories
- ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 14971 Medical devices – Application of risk management to medical devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human face in profile, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Respironics, Inc. Colleen Witt Manager, Regulatory Affairs, Patient Interface 1001 Murry Ridge Lane Murrysville, PA 15668
Re: K140580
Trade/Device Name: Revolution Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 18, 2014 Received: December 19, 2014
Dear Mrs. Witt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
K140580
Device Name Revolution Full Face Mask
Indications for Use (Describe)
The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 PP
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Section 6: 510(k) Summary
| Date of Submission | 3/3/14 |
|---|---|
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 387-4870 | |
| (724) 387-3999 (fax) | |
| Official Contact | Colleen Witt |
| Regulatory Affairs Manager, Patient Interface | |
| Establishment | |
| Registration # | 2518422 |
| Proprietary Name | Respironics Revolution Full Face Mask |
| Common/Usual Name | Mask Accessory to a Non-Continuous Ventilator |
| Classification Panel | Anesthesiology Devices |
| Classification | |
| Reference | 21 CFR 868.5905 |
| Classification Name / | |
| Product Code | BZD - Ventilator, non-continuous (respirator) |
| Predicate Device(s) | Respironics Revolution Full Face Mask (K082866) |
| Respironics Comfort Gel Full Face Mask (K073600) |
Device Description
The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower
5
Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.
Indications for Use
The Revolution Full Face Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.
Similarities and Differences of the Subject Device Compared to the Predicate Devices
The Revolution Full Face Mask (subject device) has the following similarities in the technological characteristics to the previously cleared devices (Revolution Full Face Mask K082866 and Comfort Gel Full K073600):
- . Same intended use
- . Same operating principle
- . Similar technology
- . Same elbow, and swivel materials used
- Similar device design and physical properties
- Same scientific concepts that form the basis for the device ..
The Revolution Full Face Mask (subject device) has the following differences in the technological characteristics to the previously cleared device (Revolution Full Face Mask K082866 and ComfortGel Full K073600):
- . Additional material that has been added to the current cushion material that comes into contact with the face.
These differences do not raise new questions of safety and effectiveness.
Clinical Tests
Clinical tests were not required to demonstrate the safety and effectiveness of the Revolution Full Face Mask. Product functionality has been adequately assessed by nonclinical tests.
©2014 Respironics Inc.
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Section 6: 510(k) Summary
Non-Clinical Tests
Performance testing was performed before and after cleaning and disinfection treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- . Intentional Leak
- . Total Mask Leak
- Deadspace Volume .
- . Pressure Drop
- . Anti- Asphyxia Feature Open to Atmosphere Pressure
- . Anti- Asphyxia Feature Closed to Atmosphere Pressure
- CO2 Rebreathing .
- . Cleaning and Disinfection Efficacy
- . Storage
The Revolution Full Face Mask has been designed to meet the requirements of the following standards:
- . ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories
- . ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 14971 Medical devices – Application of risk management to medical devices
Conclusion
The performance and technological characteristics of the modified Revolution Full Face Mask are substantially equivalent to those of the Revolution Full Face Mask (K082866). The differences described above do not raise new questions of safety and effectiveness.
©2014 Respironics Inc.