SMART COUPLER, MODEL M015401

K073384 · Intelligent Hearing Systems · GWJ · Feb 28, 2008 · Neurology

Device Facts

• Record ID: K073384
• Device Name: SMART COUPLER, MODEL M015401
• Applicant: Intelligent Hearing Systems
• Product Code: GWJ · Neurology
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device. The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting. The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medicalgrade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.

Device Story

Smart Coupler is a passive, non-invasive, disposable accessory for auditory evaluation; provides coupling interface between patient ear and auditory stimulator. Available in three models: circumaural, supra-aural, and intra-aural. Attaches to skin via medical-grade biocompatible adhesive hydrogel. Used by trained personnel in clinical settings (hospitals, nurseries, audiologist/physician offices). Device does not produce or consume energy; conveys acoustic energy from external stimulator to patient. Benefits include secure, biocompatible interface for diagnostic testing.

Clinical Evidence

Bench testing only. Performance testing of prototypes to specifications conducted; results met expectations. Biocompatibility testing (cytotoxicity, skin irritation, skin sensitization) performed per ISO 10993.

Technological Characteristics

Passive, non-electrical, non-thermal sound-delivery accessory. Materials: flexible elastomeric material and medical-grade adhesive hydrogel. Models: circumaural, supra-aural, intra-aural. Biocompatibility: ISO 10993 compliant. Single-patient use, non-sterile.

Indications for Use

Indicated for patients of all ages undergoing auditory evaluation studies, including audiometry, auditory evoked potential, and otoacoustic emissions testing.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• VIASYS Healthcare Comfort Cup & Ear Tip Accessories (K031713)

Submission Summary (Full Text)

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

KO73384

## 510(k) Summary (per 21 CFR 807.92)

ಿದ್ದಾರೆ. ಇದರ ಪ್ರ

、

| Submitter: | Intelligent Hearing Systems<br>6860 SW 81st Street<br>Miami, FL 33143 |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact : | Edward Miskiel, Ph.D.<br>Telephone: [phone]<br>Facsimile: [phone] |
| Date Summary Prepared: | November 29, 2007 |
| Device Identification:<br>Common Name:<br>Proprietary Name: | Acoustic Coupler<br>Smart Coupler |
| Predicate Device: | VIASYS Healthcare Comfort Cup & Ear Tip Accessories<br>(K031713) |
| Device Description: | The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.<br><br>The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient. |
| Intended Use: | The Smart Coupler is intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. This is the same intended use as that of the predicate device. |

| Parameter for<br>Comparison | Predicate Device | Similarity or Difference to<br>Predicate Device |
|-----------------------------|----------------------------------|-------------------------------------------------|
| Target Population | Newborns and all ages (assumed). | Same. |
| Where Used | Clinical setting. | Same. |
| Anatomical Sites | Head and external ear. | Same. |
| Sterility | Not supplied sterile. | Same. |

Comparison Summary of Technological Characteristics:

:

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

| Parameter for<br>Comparison | Predicate Device | Similarity or Difference to<br>Predicate Device |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Unknown. | All material in contact with the<br>patient successfully passed the<br>biocompatibility testing criteria<br>specified in the ISO 10993 standard<br>for short-term skin contact<br>(cytotoxicity, skin irritation, & skin<br>sensitization). |
| Design | 2 models available:<br>• Circumaural<br>• Intra-aural | 3 models available:<br>• Circumaural<br>• Intra-aural<br>• Supra-aural |
| Materials | Foam, flexible elastomeric material,<br>and adhesive material to adhere to<br>skin surface. | Same (expect no foam). |
| Human Factors | Simple, easy-to-follow instructions. | Same. |
| Standards | None known. | Same. |
| Energy Used and/or<br>Delivered | Device is passive and does not<br>consume or produce any energy.<br>Only acoustic energy from a different<br>source is conveyed. | Same. |
| Chemical Safety | No chemicals are involved in the use<br>of this device. | Same. |
| Mechanical Safety | No mechanical parts. | Same. |
| Electrical Safety | Device is not electrical in nature. | Same. |
| Thermal Safety | Device is not thermal in nature. | Same. |

## Substantial Equivalence:

This submission includes the results of performance testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the testing.

## Conclusions:

Based on the information presented in this submission, the Smart Coupler device is as safe and effective as and is substantially equivalent to the identified predicate device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2008

Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. 6860 S.W. 81st Street Miami, FL 33143

Re: K073384

Trade/Device Name: Smart Coupler Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 14, 2008 Received: February 15, 2008

Dear Dr. Miskiel:

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}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Maling B. Eglitis, ud

Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

073384

Page 3 -

## Indications for Use

510(k) Number (if known): K073384

Device Name: Smart Coupler

The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.

The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.

The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medicalgrade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.

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)

Daniel C Clapp

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number KD73384

Page 1 of /