ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530

K012207 · Tiara Medical Systems, Inc. · BZD · Jul 23, 2001 · Anesthesiology

Device Facts

• Record ID: K012207
• Device Name: ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
• Applicant: Tiara Medical Systems, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 23, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH2O for the treatment of adult obstructive sleep apnea.

Device Story

Advantage™ Nasal Mask interfaces between positive airway pressure (CPAP) device and patient airway; delivers prescribed pressure to treat obstructive sleep apnea. Used in home or hospital settings by adult patients. Device functions as passive conduit for airflow; no active electronic components or sensors. Healthcare provider prescribes therapy; patient wears mask during sleep. Benefits include effective delivery of CPAP therapy to maintain airway patency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nasal mask for CPAP interface. Passive device; no energy source. Designed for single-patient use. Materials and dimensions consistent with standard respiratory interface devices. No software or electronic components.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea requiring positive airway pressure therapy (≥3 cmH2O). Intended for single-patient use in home or hospital/institutional 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.

Submission Summary (Full Text)

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Public Health Service

JUL 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Geoffrey Sleeper Tiara Medical System, Inc. 14414 Detroit Avenue, Suite 205 Lakewood, OH 44107

Re: K012207

Advantage™ Nasal Mask Regulation Number: 868.5905 Regulatory Class: II (two) Product Code: 73 BZD Dated: July 12, 2001 Received: July 16, 2001

Dear Mr. Sleeper:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Page 2 - Mr. Geoffrey Sleeper

have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Dee Tellh
L. James E. Diller, III

ames E. Dillard I Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 3 - Indications for Use Enclosure

510(k) Number: 《ΟΙΖΖΟ 7

Device Name: Tiara Medical Systems Advantage™ Nasal Mask

## Intended Use / Indications for Use:

The Tiara Medical Systems Advantage™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH2O for the treatment of adult obstructive sleep apnea.

## Environment of Use / Patient Population:

The mask is intended for single patient use and re-use in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012207

Prescription Use
(per 21 CFR 801.109) ✓

OR

Over the Counter Use Optional Format 1-2-96