AMPLAID MK22

K972959 · Amplifon S.P.A. · GWF · Feb 6, 1998 · Neurology

Device Facts

• Record ID: K972959
• Device Name: AMPLAID MK22
• Applicant: Amplifon S.P.A.
• Product Code: GWF · Neurology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

Electronystagmography (for identification of middle ear conditions), Electroneurography (for facial nerve and blink reflex), Visual evoked potentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.

Device Story

Amplaid MK22 is a multi-channel electrodiagnostic system; acquires physiological signals via two channels; coupled to microcomputer for signal averaging, storage, and display. Features integrated stimulators for auditory, visual, and electrical (somatosensory) modalities. Used in clinical settings by trained professionals. System includes built-in thermal printer and supports external laser printers. Output allows clinicians to analyze evoked potentials for diagnostic purposes; aids in identifying middle ear conditions, facial nerve/blink reflex status, and neurological function. Compact design (22.2 lbs) compared to predecessor.

Clinical Evidence

Bench testing and user testing performed. No clinical trial data provided. Results indicate the device is as safe and effective as the predicate.

Technological Characteristics

Two-channel signal acquisition system; microcomputer-controlled stimulators (auditory, visual, electrical); 9-inch monochrome CRT display (640x400); built-in thermal printer; 95-250 VAC power supply. Electrical safety complies with UL-544 and IEC 601 (Type BF).

Indications for Use

Indicated for patients requiring electrodiagnostic testing, including electronystagmography for middle ear conditions, electroneurography for facial nerve and blink reflex assessment, and visual, auditory, or somatosensory evoked potential testing.

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)

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

K972959

FEB - 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 M. Rollier, President

August 8, 1997

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: 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 Classification Names/Product Codes: 84GWL(Signal Amplifier), 84GWK(signal conditioner), 84GWF(electrical stimulator), 84GWE(photic stimulator), 84GWJ(auditory stimulator).
- 2. Equivalent legally marketed devices This product is similar in design and function to the Amplaid USA, Inc. Evoked Potentials System MK15 (K861014)
- 3. Indications for Use (intended uses) Electronystagmography (for identification of middle ear conditions), Electroneurography (for facial nerve and blink reflex), Visual evoked potentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.
- 4. Description of the Device: The Amplaid MK22 Multi-channel system for electrodiagnosis consists of a two 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 electrical. A thermal printer is built in, and laser printer connection is supported.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.

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

## Substantial Equivalence Chart 6.

| Characteristic | Predicate device:<br>Amplaid MK15 | New device:<br>Amplaid MK22 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended Uses: | Electronystagmography<br>Electroneurography<br>Visual evoked potentials,<br>Auditory evoked potentials,<br>Electrical (somatosensory)<br>evoked potentials | (Same) |
| Physical characteristics: | | |
| Number of channels | 2 or 4 | 1 or 2 |
| Size/weight | 20.8" W x 18.9" D x 13.4 H,<br>44 lbs. | 10" W x 14" D x 14" H<br>22.2 lbs |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | 95-250 VAC, 50-60 Hz 100 VA |
| Display | CRT monochrome (green), 9" | CRT, monochrome (green), 9"<br>640 x 400 (Same) |
| Hardcopy Output: | Built in via 640 point thermal<br>printer or laser printer<br>connection | (Same) |
| Standards and Safety<br>characteristics: | | |
| Electrical safety: | UL-544, IEC 601, Type BF | (Same) |

## 7. Conclusion

7. Alter analyzing outh belief and assire and effective as the predicate device, has few that the Amplaid MRZ2 is as bare and case and has no new indications for use, thus rendering it substantially equivalent to the predicate Device.

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

Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Amplifon S.P.A. C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015

Re: K972959 Trade Name: Amplaid MK22 Regulatory Class: II Product Code: GWF Dated: November 17, 1997 Received: November 18, 1997

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Fithe 215, -----Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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

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

Page 2 - Mr. Kamm

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.D.

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

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

## j) Indications for Use

510(k) Number K972959

Device Name: Amplaid MK22

Indications for Use: The Amplaid MK22 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:

- 5. Electronystagmography
- 6. Visual evoked potentials,
- 7. Auditory evoked potentials, and
- 8. Electrical (somatosensory) evoked potentials.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K972959 |

Prescription Use **✓** OR Over the Counter Use

(Per 21 CFR 801.109)