AMPLAID MK12

K971740 · Amplifon S.P.A. · GWF · Mar 16, 1998 · Neurology

Device Facts

• Record ID: K971740
• Device Name: AMPLAID MK12
• Applicant: Amplifon S.P.A.
• Product Code: GWF · Neurology
• Decision Date: Mar 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

Electronystagmography (for identification of middle ear conditions), Visual evoked notentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.

Device Story

Amplaid MK12 is a multi-channel electrodiagnostic system; acquires physiological signals via two or four channels; utilizes microcomputer for signal averaging, storage, and display; includes microcomputer-controlled stimulators for auditory, visual, and electrical modalities. Used in clinical settings by healthcare professionals. System integrates thermal printer for hardcopy output and supports laser printer connection. Output assists clinicians in diagnosing neurological or sensory conditions by analyzing evoked potential responses. Benefits include standardized, automated signal acquisition and processing for diagnostic assessment.

Clinical Evidence

Bench and user testing performed. No clinical trial data provided. Testing confirmed the device meets safety and performance requirements comparable to the predicate.

Technological Characteristics

Multi-channel signal acquisition system (2 or 4 channels); microcomputer-controlled stimulators (auditory, visual, electrical); 640-point thermal printer; laser printer interface. Electrical safety complies with UL-544 and IEC 601. Power: 115/230 Vac, 50-60 Hz. Form factor: 21.25"H x 19.7"D x 7.9"H, 28.6 lbs.

Indications for Use

Indicated for patients requiring electrodiagnostic testing, specifically electronystagmography for middle ear condition identification, visual evoked potentials, auditory evoked potentials, and electrical (somatosensory) evoked potentials.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

• Amplaid USA, Inc. Evoked Potentials System MK15 (K861014)

Submission Summary (Full Text)

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K971740

MAR 1 6 1998

### EXHIBIT 2

Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-2-57472.482 Fax ++39-2-57409427 Contact: Giovanni Rollier, President

## March 12, 1997

# 510(k) Summary of Safety and Effectiveness

#### Identification of the Device: 1.

Proprietary-Trade Name: Amplaid MK22 Common/Usual Name: Evoked potential electrodiagnostic system Classification Names/ Device class: The electrodiagnostic system is a combination of devices which are Class II per regulations 882.1835, 882.1845, 882.1870. 882.1890. and 882.1900

Equivalent legally marketed devices This product is similar in design and 2. function to the Amplaid USA. Inc. Evoked Potentials System MK15 (K861014)

3. Indications for Use (intended use) Electronystagmography (for identification of middle ear conditions), Visual evoked notentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.

4. Description of the Device: The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and clectrical. A thermal printer is built in, and laser printer connection is supported.

Safety and Effectiveness, comparison to predicate device. The results of hench న్. and user testing indicates that the new device is as safe and effective as the predicate devices.

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### Substantial Equivalence Chart હ.

| Characteristic | Predicate device: The<br>Amplaid MK15 | New device: "Amplaid<br>MK12TM" |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use: | Electronystagmography,<br>Visual Evoked Potentials,<br>Auditory Evoked Potentials,<br>Electrical (Somatosensory)<br>Evoked Potentials | (Same) |
| Physical characteristics: | | |
| Size/weight | 20.8"W x 18.9"D x 13.4"H,<br>44 Ibs. | 21.25"H x 19.7"D x 7.9"H<br>28.6 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60<br>Hz. | (Same) |
| Hardcopy Output: | Possible via computer<br>interface | Built in via 640 point<br>thermal printer or laser<br>printer connection |
| Standards and Safety<br>characteristics: | | |
| Electrical safety: | UL-544, IEC 601 | (Same) |

### 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid MK12™" is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate Device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Kamm ·c/o Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

K971740 Re: Amplaid MK12 Trade Name: Regulatory Class: II GWF Product Code: March 2, 1998 Dated: March 4, 1998 Received:

Dear Mr. Kamm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

MAR 1 6 1998

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Page 2 - Mr. Kamm

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# j) Indications for Use

510(k) Number K971740

Device Name: Amplaid MK12

Indications for Use: The Amplaid MK12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:

- Electronystagmography ﻨﺴ
- 2. Visual evoked potentials,
- 3. Auditory evoked potentials, and
- 4. Electrical (somatosensory) evoked potentials.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div> <img alt="signature" src="signature"/> </div> (Division Sign-Off) |
|-----------------------------------------|-------------------------------------------------------------------------|
| Division of General Restorative Devices | |
| 510(k) Number | K971740 |

| Prescription Use | <div> <img alt="prescription_use_check" src="prescription_use_check"/> </div> | OR | Over the Counter Use |
|------------------|-------------------------------------------------------------------------------|----|----------------------|
| | | | (Per 21 CFR 801.109) |