AMPLAID A315 AND A319

K983915 · Amplifon S.P.A. · EWO · Jan 29, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K983915
• Device Name: AMPLAID A315 AND A319
• Applicant: Amplifon S.P.A.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Amplaid Models A315 and A319 are two channel clinical diagnostic audiometers 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 A315 and A319 are two-channel clinical diagnostic audiometers; used by audiologists in clinical settings for hearing loss diagnosis. Devices perform pure tone, speech, high frequency, multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., tone decay, and M.L.D. tests. Inputs are patient responses to auditory stimuli; outputs are diagnostic audiometric data. A319 includes built-in thermal printer; both support external printers or PC-based output via ASA software. Clinical decision-making is supported by providing comprehensive diagnostic data for evaluating cochlear, retrocochlear, central, and non-organic hearing loss.

Clinical Evidence

Bench and user testing performed. No clinical trials conducted. Testing confirmed device performance meets established audiometric standards (ISO 389-1989, ANSI S3.6-1989, IEC 645-1, -2, -4) and electrical safety requirements (UL-2601, IEC 60601).

Technological Characteristics

Two-channel clinical diagnostic audiometer. Energy source: 115/230 Vac, 50-60 Hz. Standards: ISO 389-1989, ANSI S3.6-1989, IEC 645-1, -2, -4. Electrical safety: UL-2601, IEC 60601. Output: Built-in 640-point thermal printer (A319) or external printer via Centronics interface; PC connectivity via ASA software.

Indications for Use

Indicated for adult and pediatric patients for the measurement and diagnosis of various types of hearing losses by a qualified/trained audiologist.

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 460 (K971747)

Submission Summary (Full Text)

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K98 3915

JAN 29 1999

EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-02-57472.482 Fax ++39-02-57409427 Contact: Giovanni Rollier, President

November 1, 1998

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: "Amplaid A315 and A319TM" Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Audiometer
- 2. Equivalent legally marketed devices This product is similar in design and function to the Amplaid 460 (K971747)
- 3. Indications for Use (intended use) The Amplaid A315 and A319 Series are clinical diagnostic audiometers 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.
- 4. Description of the Device: The Amplaid A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. They provide testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
- 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 devices.

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| Characteristic | Predicate device: The<br>Amplaid 460 (K971747) | New device: "Amplaid<br>A315 and A319TM" |
|------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Clinical audiometric applications | (Same) |
| Physical characteristics: | | |
| Size/weight | 17.3" W x 19.3" D x 7" H,<br>28 lbs. | 18.9" W x 15.7" D x 7.8" H, 8 kg<br>=17.6 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | (Same) |
| Hardcopy Output: | Built in via 640 point thermal<br>printer | External printer via parallel<br>Centronics interface. Built in via<br>640 point thermal printer (Model<br>A319), or via PC using ASA<br>software. |
| Standards and Safety<br>characteristics: | | |
| Audiometric: | ISO 389-1989, ANSI S3.6-1989,<br>IEC 645-1,-2, -4 | (Same) |
| Electrical safety: | UL-544, IEC 601 | UL-2601, IEC 60601 |

## 6. Substantial Equivalence Chart

## 7. Conclusion

After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid A315, A319 Series™" audiometers are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate Device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 29 1999

Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, IL 60015

Re:

K983915

Amplaid A315 and A319 Audiometers Dated: November 1, 1998 Received: November 4, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

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 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). 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 requirements, 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 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 notfication"(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/dsma/dsmamain.html".

**Sincerely yours,**

Capt. Daniel G. Schultz, M.D. Acting 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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j. Indications for Use

510(k) Number K98 Kg83915

Device Name: Amplaid A315, A319 Series Clinical Audiometers

Indications for Use: The Amplaid Models A315 and A319 are two channel clinical diagnostic audiometers 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

Prescription Use V

OR Over the Counter Use (Per 21 CFR 801.109)