(25 days)
This device is intended to be used with positive airway pressure devices operating at or above 4cmH 2 O for the treatment of adult obstructive sleep apnea.
iMask TM Nasal CPAP Mask
This document is a 510(k) clearance letter for a medical device called the "iMask Nasal CPAP Mask". It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance process and confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not detail specific performance testing results or study methodologies.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus-like symbol consists of three curved lines that converge at the bottom.
JUL - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Dielmann Vice President, RA/QA Vital Signs Colorado, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112
Re: K051559
Trade/Device Name: iMask™ Nasal CPAP Mask Regulation Number: 21 CFR 868. 5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 7, 2005 Received: June 15, 2005
Dear Mr. Dielmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your ea your entermined 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 the Fouchar F USA). You may, therefore, market the device, subject to the general approvisions 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 Nr.), it may be back of Federal Regulations, Title 2 i, Parts 800 to 898. In your device can or routlish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Dielmann
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 mean that I DA nas made a acteriand regulations administered by other Federal agencies. of the Act of ally I ederal backed and squirements, including, but not limited to: registration 1 od inust comply with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), laceling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality sjockers (Sections (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 began finding of substantial equivalence of your device to a premarket notification. - The PDF 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), If you desire specific at no for pliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general and Consumer Assistance at its toll-free Diviber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chu Lin, Ph.D.
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: | K |
|---|---|
| Device Name: | iMask TM Nasal CPAP Mask |
| Indications For Use: | This device is intended to be used with positive airway pressure devices operating at or above 4cmH 2 O for the treatment of adult obstructive sleep apnea. |
| Environment of Use: | The mask is intended for single patient use, or multiple patient use with proper high level disinfection. The mask may be reprocessed per the high level disinfection procedure, by clinical institutions only. |
| Prescription Use (per 21 CFR 801 Subpart D) | X AND/OR Over-The-Counter Use ________ |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number. | K051559 |
SECTION 8 Page 1 of 1
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§ 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).