AMPLAID 460

K971747 · Amplifon S.P.A. · EWO · Aug 5, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971747
• Device Name: AMPLAID 460
• Applicant: Amplifon S.P.A.
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Aug 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Amplaid 460 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 460 is a two-channel clinical diagnostic audiometer; used in clinical settings by audiologists. Device performs audiometric tests including 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). Inputs are patient responses to auditory stimuli; device processes these to evaluate cochlear, retrocochlear, central dysfunction, and non-organic hearing loss. Output is diagnostic data used by clinicians to assess hearing loss and guide clinical decision-making.

Clinical Evidence

Bench and user testing performed; no clinical trial data provided.

Technological Characteristics

Two-channel clinical diagnostic audiometer. Supports pure tone, speech, high frequency, multifrequency, Bekesy, S.I.S.I., A.B.L.B., D.L.I., M.L.B., tone decay, and M.L.D. testing. Class II device (21 CFR 874.1050).

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 309 Clinical Audiometer (K880059)

Submission Summary (Full Text)

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K971747

AUG - 5 1997

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

April 30, 1997

## 510(k) Summary of Safety and Effectiveness

- Identification of the Device: -Proprietary-Trade Name: Amplaid 460 Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Diagnostic Audiometer
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- Equivalent legally marketed devices This product is similar in design and function 2 to the Amplaid 309 Clinical Audiometer (K880059)
- 3. Indications for Use (intended use) The Amplaid 460 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.
- 4. Description of the Device: The Amplaid 460 is a two 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, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 1997

Amplifon S.P.A. Daniel Kamm Regulatory Engineer c/o Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K971747

Amplaid 460 Research and Clinical Audiometer Dated: April 30, 1997 Received: May 12, 1997 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 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, 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 III (Premarket Approval), it may be subject (c 1 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 OS 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

hTliau Yi

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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j) Indications for Use

K471747 510(k) Number

Device Name: Amplaid 460 Research and Clinical Audiometer

Indications for Use: The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is which can personn an ualified/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)

Prescription Use OR Over the Counter Use **__**
(Per 21 CFR 801.109)

Ra-Pally

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971747