(75 days)
The ComfortLite Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy for the treatment of Obstructive Sleep Apnea. The mask is for use in the home or hospital/institutional environment on adults.
The ComfortLite Nasal Mask is a nasal interface for application of non-invasive CPAP or bi-level therapy. The mask consists of a nasal interface with a built-in exhalation device, interface adjustment mechanisms, and 6" of standard 22 mm tubing connected to a crown swivel (elbow) for connection to the CPAP or Bi-level device. The mask is supported by a baseball-cap type headgear to allow a seal with the patient's nostrils via the nasal interface.
The mask is available with three types of nasal interface: simple cushion, direct seal cushion, and nasal pillow. The nasal interface may be adjusted vertically by an extension tube twist mechanism and horizontally by an angle selector. In addition, a thin, bendable support stabilizer arm is located on the outer body of the direct seal cushion and nasal pillow to allow for more fine adjustment of these nasal interfaces. The mask has a built-in exhalation device, thus no separate exhalation device is needed.
The mask directs standard 6 ft. 22 mm tubing, provided with a CPAP or Bi-level device, over the user's head.
The provided text describes a 510(k) premarket notification for the ComfortLite Nasal Mask, where the manufacturer states that "Design verification tests were performed on the ComfortLite Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, the document does not provide specific details about the acceptance criteria or the actual results of these tests. It only makes a general statement that the device met them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about the study that proves the device meets specific acceptance criteria based on the provided text.
The document focuses on demonstrating substantial equivalence to predicate devices and describing the device itself. It does not contain the detailed reporting of design verification test results or the underlying study methodology that would typically include the information requested.
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FEB 1 5 2006
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string appears to be "K053352". The characters are written in a bold, somewhat rough style, giving the impression of being quickly written or perhaps a bit worn. The contrast is high, with dark characters against a light background.
ComfortLite Nasal Mask
Date of Submission
1 December 2005
Official Contact / Address of Manufacturing facility
Zita A. Yurko Manager, Regulatory Affairs Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
Phone: 724-387-4120 Fax: 724-387-4216 Zita. Yurko@Respironics.com
- ComfortLite Nasal Mask Proprietary Name
- Common/Usual Name Nasal Mask
- Ventilator, Non-Continuous (Respirator) Device Classification Name
Class II
BZD
Anesthesiology
- Classification Reference 21 CFR 868.5905
- Classification
- Appropriate Classification Panel
- Product Code
- Predicate Devices
- Respironics Nasal Interface Model 7910 (K974453)
- Reason for submission Modified design
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- D Same operating principle.
- Q Same technology.
- □ Same manufacturing process.
Design verification tests were performed on the ComfortLite Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
Intended Use
The ComfortLite Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy for the treatment of Obstructive Sleep Apnea. The mask is for use in the home or hospital/institutional environment on adults.
Device Description
The ComfortLite Nasal Mask is a nasal interface for application of non-invasive CPAP or bi-level therapy. The mask consists of a nasal interface with a built-in exhalation device, interface adjustment mechanisms, and 6" of standard 22 mm tubing connected to a crown swivel (elbow) for connection to the CPAP or Bi-level device. The mask is supported by a baseball-cap type headgear to allow a seal with the patient's nostrils via the nasal interface.
The mask is available with three types of nasal interface: simple cushion, direct seal cushion, and nasal pillow. The nasal interface may be adjusted vertically by an extension tube twist mechanism and horizontally by an angle selector. In addition, a thin, bendable support stabilizer arm is located on the outer body of the direct seal cushion and nasal pillow to allow for more fine adjustment of these nasal interfaces. The mask has a built-in exhalation device, thus no separate exhalation device is needed.
The mask directs standard 6 ft. 22 mm tubing, provided with a CPAP or Bi-level device, over the user's head.
(End of Tab.)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2006
RESPIRONICS, INC. C/O Ms. Zita A. Yurko Respironics, Incorporated Sleen and Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K053352
Trade/Device Name: ComfortLite Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: February 3, 2006 Received: February 10, 2006
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 mendments, 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 (1 wr t), ice 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 - Zita A. Yurko
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s Issualles of a substantar ique complies with other requirements
mean that FDA has made a determination that your device the flearly agancies mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regarents, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practice and ifsing (21 CFR Part 807), labeling (21 CFR Part 87) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) This letter will anow you to ocean made .
premarket notification. The FDA finding of substantial equivalence of your device to a premarket notification. The PDF missis 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 Par: 301), If you desire specific advice for your do roll of the more of the regulation in the regulation prease contact the Other or Ochipital ( ( ( ( ) ) ( ( may obtain other general information on your responsibilities under the Act from the may ovant other general Manufacturers, International and Consumer Assistance at its toll-free Driber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
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
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____ComfortLite Nasal Mask
Indications for Use:
The ComfortLite Nasal Mask is intended to provide an interface for application of Respironics CPAP or bi-level therapy for the treatment of Obstructive Sleep Apnea. The mask is for use in the home or hospital/institutional environment on adults.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cuyubom
of mainer General Hospital
§ 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).