(142 days)
No
The description focuses on the mechanical design of a nasal mask and its use as an accessory for CPAP/bi-level therapy, with no mention of AI or ML capabilities.
No.
The Comfort Twin Nasal Mask is described as an accessory to a non-continuous ventilator, and its function is to deliver positive pressure ventilation. While it plays a role in a therapeutic process (CPAP/bi-level therapy), the mask itself is a delivery interface, not the therapeutic device that generates the pressure or performs the therapy. The document clearly states it is an "accessory."
No
The Comfort Twin Nasal Mask is an accessory to a ventilator, intended for delivering positive pressure ventilation. It does not perform any diagnostic function.
No
The device is a physical nasal mask, which is a hardware component, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The Comfort Twin Nasal Mask is a respiratory accessory used to deliver positive pressure ventilation to the lungs. It is a physical interface between a patient and a ventilator.
- Lack of Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical/physical in facilitating airflow.
The description clearly indicates its use in delivering therapy directly to the patient's respiratory system, not in analyzing samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.
Product codes
BZD
Device Description
The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a single patient use accessory for use with CPAP or bi-level devices.
The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose (patient's face covering the nose)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
hospital, clinic and home environments.
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)
The new device was validated using bench data. All performance characteristics performed within specification and comparable to the cited device predicates. This testing has confirmed that the Comfort Twin Nasal Mask performs equivalently to the cited device predicates.
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
TAB 5
Comfort Twin Nasal Mask
SEP - 3 2009
510(K) SUMMARY
Date of Submission
9 April 2009
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 724-387-7490 f
Classification Reference
21 CFR 868 5905
Product Code
BZD - Non-Continuous ventilator (IPPB)
Nasal Mask Common/Usual Name
Proprietary Name
Respironics Comfort Twin Nasal Mask
Predicate Device(s)
Respironics Reusable II Contour Nasal Mask (K991648) Resmed Mirage Activa (K032916)
Reason for submission new device
Substantial Equivalence
The Comfort Twin Nasal Mask has the following similarities to the previously cleared predicate device:
- O Same intended use.
- Same operating principle.
Same technology
Same manufacturing process.
1
The Respironics Reusable II Contour Nasal Mask was cleared in K991648. The Resmed Mirage Activa was cleared in K032916. To update the design of the Reusable II, an inter sealing cushion was added to this device design. This cushion within a cushion design has been reviewed and cleared by the agency in K032916. The new device was validated using bench data. All performance characteristics performed within specification and comparable to the cited device predicates. This testing has confirmed that the Comfort Twin Nasal Mask performs equivalently to the cited device predicates.
Intended Use
The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.
Device Description
The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a single patient use accessory for use with CPAP or bi-level devices.
The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.
(End of Tab.)
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Zita A. Yurko Director of Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
SEP - 3 2009
Re: K091066
Trade/Device Name: Comfort Twin Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 21, 2009 Received: August 24, 2009
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 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); 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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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,
for
Susan Runner, D.D.S., M.A. Acting Division 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): _ |