TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840

K043382 · Tiara Medical Systems, Inc. · BZD · Jan 19, 2005 · Anesthesiology

Device Facts

• Record ID: K043382
• Device Name: TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
• Applicant: Tiara Medical Systems, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tiara Medical Systems FULL ADVANTAGE™ Full Face Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) for the treatment of adult obstructive sleep apnea. 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.

Device Story

Full Advantage is a full-face mask covering nose and mouth; provides seal for positive airway pressure delivery. Components include molded polycarbonate shell, silicone cushion, adjustable headgear, and forehead pad. Connects to air delivery hose via 22mm polycarbonate elbow/swivel/valve assembly. Integrated vent ports provide continuous air leak to prevent CO2 rebreathing and allow exhalation. Includes anti-asphyxia valve for safety during pressure failure or hose obstruction. Used in home or hospital/institutional settings by adult patients prescribed CPAP therapy. Healthcare providers prescribe the device; patients operate it by securing headgear and connecting to a positive pressure source. Output is the delivery of pressurized air to the patient's airway; facilitates treatment of obstructive sleep apnea.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: polycarbonate shell, silicone cushion/forehead pad, polyethylene clip. Connectivity: standard 22mm hose interface. Features: integrated vent ports for CO2 washout, anti-asphyxia valve. Form factor: full-face mask with adjustable headgear. Non-powered, passive device.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea requiring positive airway pressure therapy (CPAP).

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

• TMS Advantage II (K031935)
• Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Mask (K020759)
• Respironics Spectrum 2 Reusable Full-Face Mask (K002465)

Submission Summary (Full Text)

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Additional Information, K043382 Section 510(k) Notification, Amended Submission TMS Full Advantage ATTACH 2

Tiara Medical Systems, Inc. 14414 Detroit Ave., Stc. 205 Lakewood, OH 44107

# Attachment 2 - 510(k) Summary

| Submitter Name: | Tiara Medical Systems, Inc. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address : | 14414 Detroit Ave. Ste. 205 Lakewood, OH 44107 |
| Contact Person: | Geoffrey Sleeper |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | December, 2004 |
| Device Trade Name: | Full Advantage |
| Device Common Name: | Nasal Mask |
| Classification Name: | Ventilator, Noncontinuous (Respirator), 73BZD |
| Predicate devices: | TMS Advantage II, K031935, Hans Rudolph 7600 Series Reusable Full<br>-Face CPAP/NIPPV Mask, K020759, Respironics Spectrum 2 Reusable<br>Full-Face Mask, K002465 |
| Reason for submission: | This device has not been previously marketed in the USA. |

Reason for submission: Device Description:

The Tiara Medical Systems Full Advantage™ Nasal Mask is an externally placed mask covering the mouth and nose of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.

The Tiara Medical Systems Full Advantage™ Full Face Mask is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process requires limited disassembly.

The mask consists of a molded multiple sized polycarbonate shell with a soft, resilient silicone skincontacting cushion seal which conforms to the patient's facial features. A silicone forehead pad attaches to a polycarbonate frame and is adjustable to suit patient comfort.

The mask connects to a conventional air delivery hose between the mask and the positive airway pressure source via a standard 22 mm polycarbonate elbow/swivel/valve assembly. The

elbow/swivel/valve assembly attaches to the front of the mask with a polyethylene split "c" clip. The built in vent ports are located on the elbow/swivel/valve assembly to provide a continuous air leak to prevent rebreathing of deadspace CO2, direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent ports also allow the patient to exhale normally and do not interfere with the other performance requirements of the vent ports may be visually checked for obstruction prior to use. The elbow/swivel/valve assembly also includes a built in Anti-Asphyxia Valve which allows the patient to continue to breathe fresh air in the event of positive air pressure device failure or output deterioration, or delivery hose kinking/obstruction. Intended Use:

The Tiara Medical Systems FULL 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. The mask is intended for single patient use and reuse in the home or hospitallional environment. The mask is to be used on adult patients (>30kq) for whom positive airway pressure therapy has been prescribed.

## Substantial Equivalence/ Device Technological Characteristics

## and Comparison to Predicate Device(s):

The technological characteristics of the Tiara Medical Systems Full Advantage™ Full Face Mask are equivalent to the predicate devices listed above.

Tests performed on the Tiara Medical Systems Full Advantage™ Full Face Mask demonstrate substantial equivalence to tne predicate devices listed above.

#### Conclusion:

The Tiara Medical Systems Full Advantage™ Full Face Mask is substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem is a stylized representation of an eagle, with three parallel lines forming the body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2005

Mr. Geoffrey Sleeper Vice President Tiara Medical Systems, Incorporated 14414 Detroit Avenue Suite 205 Lakewood, Ohio 44107

Re: K043382

Trade/Device Name: Tiara Medical Systems FULL ADVANTAGETM Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 8, 2004 Received: December 9, 2004

Dear Mr. Sleeper:

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. Sleeper

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/industry/support/index.html.

Sincerely yours,

Charles

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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Tiara Medical Systems, Inc. 14414 Detroit Ave., Ste. 205 Lakewood, OH 44107

Traditional Section 510(k) Notification: TMS Full Advantage™ Full Face Mask

# Attachment 1 -- Statement of Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Tiara Medical Systems FULL ADVANTAGE™ Full Face Mask

## Intended Use / Indications for Use:

The Tiara Medical Systems FULL ADVANTAGE™ Full Face Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) 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.

Prescription Use ×× (per 21 CFR 801.109) OR

Over the Counter Use Optional Format 1-2-96

Cun Smeom

(Division Sign-Off) Olvision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)