OPTI-AMP DC-POWERED

K052060 · Intelligent Hearing Systems · GWL · Aug 31, 2005 · Neurology

Device Facts

• Record ID: K052060
• Device Name: OPTI-AMP DC-POWERED
• Applicant: Intelligent Hearing Systems
• Product Code: GWL · Neurology
• Decision Date: Aug 31, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the Opti-Amp DC-Powered device is to acquire evoked potentials. This is the same intended use as that of the original IHS Opti-Amp, which was previously cleared as 510(k) number K914876.

Device Story

Opti-Amp DC-Powered is a bio-amplifier system consisting of a transmitter and receiver; designed to acquire evoked potentials from patient skin surface via electrodes. Device functions as a physiological signal amplifier. Primary modification from predicate involves power source: subject device utilizes medical-grade power supply with high-isolation voltage DC-DC converter, whereas predicate utilized internal DC batteries. Used by trained personnel in clinical settings (hospitals, nurseries, audiologist offices) to facilitate diagnostic signal acquisition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bio-amplifier system; transmitter and receiver configuration. Power source: medical-grade power supply with high-isolation voltage DC-DC converter. Intended for surface electrode signal acquisition. No software or algorithm details provided.

Indications for Use

Indicated for use as a physiological signal amplifier to acquire bio-electric surface signals via electrodes on the outer skin surface. Intended for use by trained personnel in hospitals, nurseries, clinics, or audiologist offices.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• Opti-Amp (K914876)

Submission Summary (Full Text)

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052060

AUG 3 1 2005

Image /page/0/Picture/2 description: The image shows the logo for Intelligent Hearing Systems. The words "Intelligent Hearing" are in large, bold, black letters. Below that, the word "SYSTEMS" is spelled out with each letter in a black square.

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## 510(k) Summary

| Prepared By: | Intelligent Hearing Systems<br>7356 SW 48th Street<br>Miami, FL 33155 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| FAX: | [phone] |
| Contact Person: | Edward Miskiel |
| Date Summary prepared: | July 26, 2005 |
| Name of the Device: | Opti-Amp DC-Powered |
| Common Name: | Evoked Potential Amplifier |
| Classification Name: | Physiological Signal Amplifier (per CFR 882.1835) |
| Predicate Device: | Opti-Amp (K914876) |
| Device Description: | Opti-Amp DC-Powered is a bio-amplifier testing device (made<br>up of a transmitter and receiver) that is capable of acquiring<br>evoked potentials. |
| Intended Use: | The intended use of the Opti-Amp DC-Powered device is to<br>acquire evoked potentials. This is the same intended use as<br>that of the original IHS Opti-Amp, which was previously cleared<br>as 510(k) number K914876. |
| Technological Characteristics: | The Opti-Amp DC-Powered device is similar to the predicate<br>device in its intended use and methodologies. The intended use<br>of the device has not changed as a result of modifications to the<br>general or electrical specifications of the device.<br>The Opti-Amp DC-Powered device technologically differs from i<br>the predicate device in that the power supplied to the Opti-Amp<br>DC-Powered Transmitter device is provided by a medical grade<br>power supply with additional protection provided by a high<br>isolation voltage DC-DC converter. The power supplied to the<br>predicate device's transmitter is provided by commercially<br>available dc batteries (housed internally). |

## INTELLIGENT HEARING SYSTEMS

| 7356 S.W. 48th Street • Miami, Florida 33155 • Telephone: [phone] • FAX: [phone]<br>Email Address: [e-mail] • www.ihsys.com | Page C |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------|
|---------------------------------------------------------------------------------------------------------------------------------------------|--------|

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

AUG 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intellegent Hearing Systems c/o Edward Miskiel, PhD President & CEO 7356 S. W. 48th Street Miami, Florida 33155

Re: K052060

Trade/Device Name: OPTI-AMP DC-Powered Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: Class II Product Code: GWL Dated: July 26, 2005 Received: July 29, 2005

## Dear Dr. Miskiel

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security the device is substantially equivalent (for the indications
referenced above and have determined the devices devices marketed in interstate referenced above and have detellinities the devices marketed in interstate for use stated in the enclosure) to the enactment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the organision of the Federal Foo commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance when approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval approvisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general concerstions of t You may, therefore, market the device, subject on the general vegistration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the Act mender requirement.
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), (PMA), ( If your device is classified (see and controls. Existing major regulations affecting your device
it may be subject to such additional controls. Existing major regulation, it may be subject to such additional Controls: Existing Migor regalo to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. can be found in the Code of I cacraf Regulations, and device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualited on a substitution with other requirements of the Act
that FDA has made a determination that your device adderal anders . You must that FDA has made a decemination inal your are real by other Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listing or any Federal statutes and regulations and united to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: requirements as se comply with all the Act S requirements, menading practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god manufacturing practice the electronic CFR Part 807); labeling (21 CFR Fall on (21 CFR Patt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and 1f applicable, forth in the quality systems (QS) regalation (21 CFR 1000)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

Everett T. Beers PhD

for David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure: Indications for Use

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KOS 2060 510(k) Number (if known):

Device Name: Opti-Amp DC-Powered

Indications for Use:

The intended use of the Opti-Amp DC-Powered is as a physiological signal amplifier. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

The anatomical site of contact is the patient's outer skin surface with electrodes placed to acquire a bio-electric surface signal.

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="font-size: 2em;">✓</span> </div> |
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OR

| Over-the-Counter Use | |
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Srinivas Mandava

510(k) Numb

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