TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050

K051583 · Tiara Medical Systems, Inc. · BZD · Nov 4, 2005 · Anesthesiology

Device Facts

• Record ID: K051583
• Device Name: TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
• Applicant: Tiara Medical Systems, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tiara Medical Systems SNAPP-X is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP-X is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP-X is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed

Device Story

SNAPP-X is a nasal cannula interface for CPAP therapy; delivers positive airway pressure to patient nostrils via soft, resilient silicone inserts. Device connects to standard CPAP air delivery hoses using a 22 mm polycarbonate Wye adapter/swivel. Features molded vent slots on the underside of the nasal insert body for exhalation, eliminating need for separate exhalation ports. Held in place by adjustable headgear. Used in home or hospital/institutional settings by patients prescribed CPAP therapy. Provides a seal to direct airflow; benefits patient by facilitating obstructive sleep apnea treatment. Cleaned with mild detergent and water; no disassembly required.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: latex-free silicone (nasal inserts, air delivery tubes), polycarbonate (Wye adapter/swivel). Interface: standard 22 mm fitting. Form factor: nasal cannula with adjustable headgear. Features: integrated molded vent slots for exhalation. Non-powered, passive accessory.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea requiring continuous positive airway pressure (CPAP) therapy at or above 3 cmH2O.

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 SNAPP Soft Nasal Accessory for Positive Pressure (K034053)
• Resmed Mirage Swift (K042403)

Submission Summary (Full Text)

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Tiara Medical Systems, Inc.

Special 510(k) Notification: Tiara SNAPP-X

K05/583

NOV - 4 2005

## Attachment 1 - 510(k) Summarv

| 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: | June, 2005 |
| Device Trade Name: | SNAPPTM-X Soft Nasal Accessory for Positive Pressure |
| Device Common Name: | Nasal Mask |
| Classification Name: | Ventilator, Noncontinuous (Respirator), 73BZD |
| Predicate devices: | TMS SNAPPTM Soft Nasal Accessory for Positive Pressure, Resmed Mirage Swi |
| Reason for submission: | Not previously marketed in the USA |

### Device Description and Materials:

The Tiara Medical Systems SNAPP™ -X Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild detergent such as Ivory® dishwasher liquid and water. The cleaning process does not require disassembly.

The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils.

The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use.

The SNAPP-X Headgear is available in multiple sizes to fit a broad range of facial structures, and attaches to the SNAPP-X via slots molded into the nasal insert body.

#### Intended Use:

The Tiara Medical Systems SNAPP is intended to be used with continuous positive anway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP is intended for single patient use and can be used in the home or in a hospitallinstitutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

#### Substantial Equivalence/ Device Technological Characteristics and Comparison to Predicate Device(s):

The Tiara Medical Systems SNAPP™-X Soft Nasal Accessory for Positive Pressure is substantially equivalent to the Tiara Medical Systems SNAPP™, K034053, and the Resmed Swift, K042403.

Among the information and data presented in the 510(k) submission to support the substantial equivalency of the Tiara Medical Systems SNAPP™ X Soft Nasal Accessory for Positive Pressure to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the Tiara Medical Systems SNAPP™-X Soft Nasal Accessory for Positive Pressure and the specified predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its wings.

Public Health Service

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051583

Trade/Device Name: TMS SNAPP™-X Soft Nasal Accessory for Positive Pressure Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 7, 2005 Received: October 11, 2005

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 vour 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 vours.

Siule H. Murphy, MD for Chun Shin, 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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# Attachment 3 - Indications for Use Enclosure

510(k) Number:

Device Name: TMS SNAPP™-X Soft Nasal Accessory for Positive Pressure

Intended Use / Indications for Use:

The Tiara Medical Systems SNAPP-X is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP-X is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP-X is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed

Prescription Use

AND/OR

Over-the-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cum Solom

1.210n Sign-Off) Cition of Anesthesiology, General Hospital,

Intection Control, Dental Devices 051582

Number: A051