AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

K031713 · Viasys Healthcare, Inc. · EWO · Aug 12, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031713
• Device Name: AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
• Applicant: Viasys Healthcare, Inc.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Aug 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2

Intended Use

The Comfort Cup and Ear Tip accessories are for use with non-Grason Stadler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.

Device Story

Comfort Cup and Ear Tip are passive, single-patient-use disposable accessories; function as patient-applied parts for auditory evaluation. Devices connect to audiometer, OAE, or ABR systems via sound-conducting tubes. Comfort Cup couples auditory stimulus to the ear; Ear Tip couples stimulus to the ear canal. Used by clinicians to facilitate testing; enables compatibility of existing auditory diagnostic equipment with non-GSI systems. Benefits include standardized coupling for accurate auditory stimulus delivery during diagnostic procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Passive coupling accessories; single-patient-use disposable; sound-conducting tube interface; no energy source; no software.

Indications for Use

Indicated for patients undergoing auditory evaluation studies using non-Grason Stadler (GSI) audiometer, otoacoustic emission (OAE), or auditory brainstem response (ABR) devices.

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Predicate Devices

• Audioscreener OAE + ABR (K024205)
• GSI 70 AudioPath Screener (K974237)
• GSI 60 DPOAE System (K934658)
• GSI 37 Auto Tymp (K911095)
• GSI 17 Screening Audiometer (K902540)

Submission Summary (Full Text)

{0}------------------------------------------------

## K031713

# VIASYS Healthcare NeuroCare Group

## Summary of Safety and Effectiveness

| Company Name: | VIASYS Healthcare<br>NeuroCare Group<br>5225 Verona Road, Building 2<br>Madison, WI 53711 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:<br>Phone:<br>Fax: | Glen Hermanson, Manager of Standards and Compliance<br>608 441-2065<br>608 441-2007 |
| Summary Date: | August 7, 2003 |
| Trade Name: | Audiometer, Otoacoustic Emission and Auditory Brainstem Response<br>Comfort Cup and Ear Tip Accessories |
| Common Name: | Audiometer, Evoked Response Auditory Stimulator Accessory |
| Classification Name: | 21 CFR 874.1050, Audiometer, Class II (510(k) exempt),<br>Product Code: EWO<br>21 CFR 882.1900, Evoked Response Auditory Stimulator, Class II, |

Product Code: GWJ.

Predicate Device:

| 510(k) | Manufacturer | Product Code | Class | Trade Name |
|---------|---------------------------------------------------------------|--------------|-------|--------------------------------|
| K024205 | Everest Biomedical<br>Instruments Company<br>Chesterfield, MO | EWO | II | Audioscreener OAE + ABR |
| K974237 | Grason-Stadler Inc. | EWO | II | GSI 70 AudioPath Screener |
| K934658 | Grason-Stadler Inc. | ETW | II | GSI 60 DPOAE System |
| K911095 | Grason-Stadler Inc. | ETY | II | GSI 37 Auto Tymp |
| K902540 | Grason-Stadler Inc. | EWO | II | GSI 17 Screening<br>Audiometer |

#### 1.0 Description of Device

The audiometer, otoacoustic emission (OAE) and auditory brainstem response (ABR) accessories addressed in this pre-market notification are Comfort Cup and Eartip.

{1}------------------------------------------------

# VIASYS Healthcare NeuroCare Group

These devices are used to couple auditory stimulus into the ear or ear canal to support audiometer, OAE and ABR testing. Both devices connect to the audiometer, OAE and ABR devices through a sound conducting tube. The sound from the audiometer, OAE and ABR devices are conducted through the sound conducting tube to the ear in the application of the Comfort Cup or to the ear canal in the applications of the Eartip. The Comfort Cup and Eartip accessories are single patient use disposables.

#### 2.0 Intended Use

The indication for use of the audiometer, OAE and ABR accessories are: The Comfort Cup and Ear Tip accessories are for use with non-Grason Staler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.

#### 3.0 Technological

The Comfort Cup and Eartip accessories are passive devices to support coupling of auditory stimulus to the ear and ear canal.

#### 4.0 Conclusions

The intended use and technology of the Comfort Cup and Eartip accessories as audiometer, otoacoustic emission and auditory brainstem response accessories is the same as the accessories reviewed in Everest Medical and Grason-Stadler premarket notifications. The only difference is the use of these accessories with non-Grason-Stadler devices. This change does not raise new questions of safety or effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 1 1 2003

VIASYS HealthCare NeuroCare Group c/o Gary Syring, Principal Consultant Ouality & Regulatory Assocociates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K031713

Trade/Device Name: Comfort Cup and Eartip Accessories, for use with Non-GSI Audiometer, Otoacoustic Emission and Auditory Brainstem Response Devices Regulation Number: 21 CFR 874.1050; 21 CFR 882.1900 Regulation Name: Audiometer; Evoked response auditory stimulator Regulatory Class: Class II (exempt); Class II Product Code: EWO: GWI Dated: May 29, 2003 Received: June 5, 2003

Dear Mr. Syring:

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.

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.

{3}------------------------------------------------

### Page 2 - Gary Syring, Principal Consultant

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,

A. Paizi Korenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

510(k) Number (if known):

Device Name: Audiometer, Otoacoustic Emission and Auditory Brainstem Response Comfort Cup and Ear Tip Accessories

Indications For Use:

The Comfort Cup and Ear Tip accessories are for use with non-Grason Stadler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.

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

NEEDED)

Lon ENTR Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)