(142 days)
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.
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.
The provided text describes a 510(k) summary for the Comfort Twin Nasal Mask, which is a new device. The acceptance criteria and the study proving the device meets them are discussed in the context of demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance within specification comparable to cited device predicates. | "All performance characteristics performed within specification and comparable to the cited device predicates." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "The new device was validated using bench data." This indicates that the testing was performed in a laboratory setting. The specific sample size for the test set is not provided. The provenance of the data is bench data, implying controlled experimental conditions rather than human or animal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. Since the validation was performed using "bench data," there was no need for human experts to establish ground truth in the way it would be required for clinical image analysis or diagnostic studies. The ground truth would be defined by the technical specifications and measurements of the device components and its interaction with test equipment.
4. Adjudication Method for the Test Set:
Not applicable. As the validation was based on "bench data," an adjudication method for reconciling expert opinions is not relevant. The "adjudication" would involve comparing measurements against predefined technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study focused on demonstrating substantial equivalence through bench data, comparing the performance characteristics of the new device to predicate devices. There is no mention of human readers or AI assistance in this context.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
Yes, in spirit, but not in the context of an algorithm. The study essentially evaluates the "standalone" performance of the physical device itself (the Comfort Twin Nasal Mask) in a controlled bench setting, without human intervention or interpretation that would typically be associated with an algorithm. It's an engineering performance evaluation, not an AI algorithm evaluation.
7. Type of Ground Truth Used:
The ground truth used was technical specifications and performance characteristics of the predicate devices (Respironics Reusable II Contour Nasal Mask and Resmed Mirage Activa), against which the new device's "bench data" was compared. The statement "All performance characteristics performed within specification and comparable to the cited device predicates" implies that the predicate devices' established performance benchmarks served as the ground truth for comparison.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device (nasal mask), not an AI algorithm that requires a training set. The concept of a "training set" is not relevant to this type of product submission.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As a physical device, there is no training set in the context of machine learning.
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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.
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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.)
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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.
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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
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Indications for Use
510(k) Number (if known): _ |< 0 9 / 0 66
Device Name: _________________________________________________________________________________________________________________________________________________________________
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.
Over-The-Counter Use Prescription Use × 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)
Ashull5
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091066
§ 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).