IMASK TM

K041309 · Vital Signs, Inc. · BZD · Jun 30, 2004 · Anesthesiology

Device Facts

• Record ID: K041309
• Device Name: IMASK TM
• Applicant: Vital Signs, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• 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.

Device Story

Nasal CPAP mask; interfaces patient with positive airway pressure device. Input: pressurized air from CPAP machine. Output: delivery of air to patient airway. Used in home, hospital, or sleep lab; operated by patient or clinician. Features 15mm swivel elbow, 3-point headstrap, and vent for CO2 clearance. Provides comfortable seal via soft facial cushion; lightweight design. Facilitates treatment of obstructive sleep apnea by maintaining airway patency.

Clinical Evidence

Bench testing only. Device demonstrated compliance with ASTM F1054-87, ISO 5356-1, and ISO 17510-2:2003 standards. Biocompatibility testing (cytotoxicity, sensitization, and irritation/intracutaneous reactivity) confirmed materials meet USP Class VI standards. Mask leakage testing confirmed minimum 12 lpm at 4 cm H2O to prevent CO2 rebreathing.

Technological Characteristics

Materials: Polyurethane housing, polycarbonate/acetal copolymer elbow, soft facial cushion, wire insert. Standards: USP Class VI biocompatibility, ASTM F1054-87, ISO 5356-1, ISO 17510-2:2003. Features: 15mm swivel elbow, 3-point headstrap, integrated vent. Non-sterile, polybag packaging. No latex.

Indications for Use

Indicated for adult patients with obstructive sleep apnea requiring positive airway pressure therapy at or above 4cmH2O. For use in home, hospital, or sleep lab settings.

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.

Predicate Devices

• SleepNet Corporation IQ™ Mask (K993269)

Submission Summary (Full Text)

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JUN 3 0 2004

K041309

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS May 13, 2004

Marquest Medical Products, Inc. 11039 East Lansing Circle Englewood, CO 80112 (A division of Vital Signs, Inc.)

Tel – [phone] ext. 412 Fax - [phone]

| Official Contact: | Tom Dielmann, Vice President of RA/QA |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or<br>Trade Name: | iMask ™ (K041309) |
| Common/Usual Name: | Nasal CPAP Mask |
| Classification Name: | 73 BZD - Ventilator, Non-Continuous<br>(Respirator)<br>Subsection 868.5905 |
| Intended Device: | CPAP Nasal Mask |
| Predicate Device: | SleepNet Corporation IQ™ Mask - K993269 |
| Device Description: | A nasal CPAP mask that is used with positive airway<br>pressure equipment recommended by a physician, sleep<br>technician, or respiratory therapist. |
| Indicated Use: | This device is intended to be used with positive airway<br>pressure devices operating at or above 4cmH2O for the<br>treatment of adult obstructive sleep apnea. |
| Targeted Population: | Adult population using a continuous positive airway<br>pressure device. |
| Environment of Use: | Home, hospital, or sleep lab. |

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## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (continued)

| Attribute | Marquest/VSI iMask™ | SleepNet IQ™ Mask<br>K993269 |
|----------------------------------------------------------------------------|---------------------|------------------------------|
| Use<br>Intended for use in<br>respiratory therapy | Yes | Yes |
| Intended to be used with<br>any CPAP device | Yes | Yes |
| Indicated for single patient use<br>In home, hospital, or sleep lab | Yes | Yes |
| Indicated for use with<br>adult cases | Yes | Yes |
| Design/Performance<br>Comfortable face cushion | Yes | Yes |
| 15mm swivel elbow connection | Yes | Yes |
| 3-point headstrap connection | Yes | Yes |
| Adequate venting to minimize<br>rebreathing CO2 | Yes | Yes |
| Vent design to minimize noise | Yes | Yes |
| No latex materials | Yes | Yes |
| No sharp edges | Yes | Yes |
| Mask is lightweight | Yes - 64 grams | Yes - 60 grams |
| Polybag packaging<br>(clean non-sterile) | Yes | Yes |
| Attribute | Marquest/VSI iMask™ | SleepNet IQ™ Mask |
| Materials<br>Polyurethane Housing | Yes | Yes |
| Polycarbonate & Acetal Copolymer<br>15mm Swivel Elbow | Yes | Yes |
| Wire Insert Molded Into Mask<br>Housing | Yes | Yes |
| Soft Facial Contact Cushion | Yes | Yes |
| Polycarbonate 3-Point Headstrap<br>Bracket | Yes | Yes |
| Airway & direct contact component<br>materials meet USP Class VI standards | Yes | Yes |
| Performance Testing<br>Meets ASTM F1054-87 &<br>ISO 5356-1 Standards | Yes | Yes |
| Meets ISO 17510-2:2003 Standard | Yes | Yes |
| Minimum 12 lpm @ 4 cm H2O<br>Mask Leakage To Prevent CO<br>Rebreathing | Yes | Yes |

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### 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (continued)

### Differences

The only difference between the iMask™ and the predicate device is the face cushion material. The iMask™ cushion material was submitted for required biocompatability testing (cytotoxicity, sensitization, and irritation/intracutaneous reactivity). The mask materials have passed the USP Class VI tests (see attachment).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three curved lines representing its wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 3 0 2004

Vital Signs, Incorporated C/O Mr. Thomas Dielmann Vice President, Quality and Regulatory Affairs Marquest Medical Products, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112

Re: K041309

Trade/Device Name: iMask TM Nasal CPAP Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: May 14, 2004 Received: May 17, 2004

Dear Mr. Dielmann:

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 such 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 - 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 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Ohr 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

K041309 510(k) Number:

iMask ™Nasal CPAP Mask Device Name:

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

Prescription Use __ X -(per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 510(k) Number