AMPLAID 171S

K972862 · Amplifon S.P.A. · EWO · Oct 31, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972862
• Device Name: AMPLAID 171S
• Applicant: Amplifon S.P.A.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Oct 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Amplaid 171S is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Device Story

Amplaid 171S is a one-channel clinical diagnostic audiometer; used in clinical settings by audiologists. Device performs audiometric tests including pure tone and speech testing; evaluates cochlear, retrocochlear, central dysfunction, and non-organic hearing loss. Input consists of audiometric test parameters; output provides diagnostic data for hearing loss assessment. Device facilitates clinical decision-making regarding patient auditory health. Compact form factor (6.6 lbs) compared to predicate; supports hardcopy output via computer interface.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technical specifications, performance standards, and user testing against the predicate device.

Technological Characteristics

One-channel clinical diagnostic audiometer. Energy source: 115/230 Vac, 50-60 Hz. Dimensions: 11 3/8" W x 12" D x 4 3/4" H; Weight: 6.6 lbs. Standards: ISO 389-1989, ANSI S3.6-1989, IEC 645-1, -2, -4. Electrical safety: UL-544, IEC 601. Connectivity: Computer interface for hardcopy output.

Indications for Use

Indicated for use by qualified/trained audiologists on adult and pediatric subjects for the measurement and diagnosis of various types of hearing losses.

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

• Amplaid 308 Clinical Audiometer (K891988)

Submission Summary (Full Text)

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5972862

## 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

OCT 31 1007

August 1, 1997

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: Amplaid 171S Classification Name: Audiometer 77EWO Ocentro .. L. Name: Clinical Dingnostic Aveller
ﺎ .

- 2. Equivalent legally marketed devices This product is similar in design and function to the Amplaid 308 Clinical Audiometer (K891988)
- 3. Indications for Use (intended use) The Amplaid 171S is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audio!ogist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
- 4. Description of the Device: The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, and speech,
- 5 Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate 'evia e

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| Characteristic<br> | Predicate device:<br>Amplaid 308<br>Clinical diagnostic audiometric<br>applications | New device:<br>Amplaid 171S<br>(Same) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Physical characteristics:<br>Size/weight | 17.3" W x 19.3" D x 7" H.<br>28 lbs. | 11 3/8" W x 12"D x 4 3/4" H<br>6.6 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | (Same) |
| Hardcopy Output: | Possible via computer interface | (Same) |
| Standards and Safety<br>characteristics:<br>Audiometric: | ISO 389-1975, ANSI S3.6-1969,<br>ANSI S3.13-1972, IEC 645 | ISO 389-1989, ANSI S3.6-1989,<br>IEC 645-1,-2, -4 (Same,<br>standards have been updated) |
| Electrical safety: | UL-544, IEC 601 | (Same) |

# 6. Substantial Equivalence Chart

#### Conclusion 7.

7. After analyzing both bench and effective as the predicate device, has few
that the Amplaid 171S is as safe and effective as the predicate device, has few that the Amplaid 1715 is as sale and chective as the productions for use, thus rendering it
technological differences, and has no new indications for use, thus rendering it technological differenter, and the predicate Device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 1997

Daniel Kamm, P.E c/o Kamm & Associates PO Box 7007 Deerfield, IL 60015 USA Re: K972862.

Amplaid 171S Clinical Audiometer Dated: August 1, 1997 Received: August 4, 1997 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Kamm:

We have reviewed your Section 5100x) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intentions 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, 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 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 devices under 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 question 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

hĩ liau Yu

Lillian Yin, Ph.D. Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### i) Indications for Use

510(k) Number 11973862

Device Name: Amplaid 171S Clinical Audiometer

Indications for Use: The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is which our perform an audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.

Concurrence of CDRH, Office of Device Evaluation (JDz)

Prescription Use

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ਾਲ

Over the Counter Use (Per 21 CFR 801.109)

Jamil A. Segran

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic 510(k) Number J