TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040

K034053 · Tiara Medical Systems, Inc. · BZD · Jun 24, 2004 · Anesthesiology

Device Facts

• Record ID: K034053
• Device Name: TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040
• Applicant: Tiara Medical Systems, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tiara Medical Systems SNAPP 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 is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

Device Story

Nasal cannula interface for CPAP therapy; delivers positive airway pressure to nostrils. Components: latex-free silicone nasal inserts, polycarbonate Wye adapter/swivel, adjustable headgear. Connects to standard 22mm air delivery hose. Integrated vent slots in nasal insert body direct exhalation away from patient. Used in home or hospital settings by adult patients. Physician prescribes CPAP; patient wears device to maintain airway patency during sleep. Benefits: treats obstructive sleep apnea via non-invasive pressure delivery.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Nasal cannula interface; materials: latex-free silicone (inserts/tubes), polycarbonate (adapter/swivel). Standard 22mm connection. Integrated vent slots for exhalation. Non-powered, passive device. Single-patient use.

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

• Tiara Medical Systems Advantage Series (K012207)
• Breathing Technologies Nasal Aire (K990659)
• Innomed Technologies Nasal Aire II (K022465)
• Sensormedics Lyra Nasal Mask (K031883)

Submission Summary (Full Text)

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# JUN 2 4 2004

Additional Requested Information, K034053

Section 510(k) Notification, Amended Submission ATTACH 2A TMS SNAPP

Tiara Medical Systems, Inc. 14414 Detroit Ave., Ste. 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 2003 |
| Device Trade Name: | SNAPP Soft Nasal Accessory for Positive Pressure |
| Device Common Name: | Nasal Mask |
| Classification Name: | Ventilator, Noncontinuous (Respirator), 73BZD |
| Predicate devices: | Tiara Medical Systems Advantage Series, K012207<br>Breathing Technologies Nasal Aire, K990659,<br>Innomed Technologies Nasal Aire II TM, K022465,<br>Sensormedics Lyra Nasal Mask, K031883, |
| Reason for submission: | Not previously marketed in the USA |

### Device Description and Materials:

The Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive anway pressure devices such as CPAP (Continuous Possure). 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 soap 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 Headgear is available in three sizes to fit a broad range of facial structures, and attaches to the SNAPP via slots molded into the nasal insert body.

#### Intended Use:

The Tiara Medical Systems SNAPP 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 is intended for single patient use and can be used in the home or in a hospital/institutional 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 Soft Nasal Accessory for Positive Pressure is substantially equivalent to the Tiara Medical Systems Advantage Series, K012207, the Breathing Technologies Nasal Aire, K990659, the Innomed Technologies Nasal Aire II ™, K022465, and the Sensormedics Lyra Nasal Mask, K031883.

Among the information and data presented in the 510(k) submission to substantial equivalency of the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, 4) materials, 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 Soft Nasal Accessory for Positive Pressure and the specified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms, or a bird in flight. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2004

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

Re: K034053

Trade Name: Snapp Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 30, 2004 Received: May 4, 2004

Dear Mr. Sleeper:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally while to for commerce pror to May 20, 1978, the econdance with the provisions of the Federal Food, Drug, devices that have been reclaismed in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 If your device is classified (see above) ans. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations ED may be subject to sach additional controller Lines and to 898. In addition, FDA may be found in the Gode of Peacharding your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA s issualled of a backers. In the requirements of the Act
that FDA has made a determination that your device complies with other requirements of the that FDA has made a decemmation administered by other Federal agencies. You must of any Federal statutes and regulations damindies, but not limited to: registration and listing (21 comply with an the Act 3 requirements, morading, and manufacturing practice requirements as set

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Page 2 – Mr. Geoffrey Sleeper

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by steams (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (section (section ) our device as described in your Section 510(k) This icher will anow you to organ maing of substantial equivalence of your device to a legally prematication: "The Presults 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 If you desire specific at 120 101 594-4646. Also, please note the regulation entitled, eoniaet the office of Comp to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Ques

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

# INDICATIONS FOR USE

|510(k)] Number: K034053

Device Name: Tiara Medical Systems SNAPP (Soft Nasal Accessory for Positive Pressure

Indications For Use:

The Tiara Medical Systems SNAPP is intended to be used with continuous positive The The The Medical Upselling at or above 3 cmH20 for the treatment of all way pressure de rioss (OFFIC), epis is intended for single patient use and can be used in oused or in a hospital/institutional environment. The SNAPP is to be used on adult the nother of in a nosplaamstinuous positive airway pressure has been prescribed.

> Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (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)

Cienfuegos

Infection Control. Dental

510(k) Number