IMASK, MODELS 100, 200 AND 300

K051559 · Vital Signs Colorado, Inc. · BZD · Jul 8, 2005 · Anesthesiology

Device Facts

• Record ID: K051559
• Device Name: IMASK, MODELS 100, 200 AND 300
• Applicant: Vital Signs Colorado, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used with positive airway pressure devices operating at or above 4cmH2O for the treatment of adult obstructive sleep apnea. 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.

Device Story

iMask™ Nasal CPAP Mask is a patient interface for delivery of positive airway pressure therapy. Device connects to CPAP/ventilator tubing to deliver pressurized air to patient's nose. Used in clinical or home settings for treatment of obstructive sleep apnea. Designed for single-patient use or multi-patient use following high-level disinfection by clinical institutions. Provides physical seal to facilitate therapeutic pressure delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal CPAP mask interface; designed for use with positive airway pressure devices operating at ≥4cmH2O. Compatible with high-level disinfection protocols for multi-patient clinical use.

Indications for Use

Indicated for adult patients with obstructive sleep apnea requiring positive airway pressure therapy (≥4cmH2O).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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: | <i>iMask</i> ^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 |

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