AMPLAID A311 SERIES

{0}------------------------------------------------ K983712 JAN | 2 | 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 October 17, 1998 ## 510(k) Summary of Safety and Effectiveness - Identification of the Device: 1. Proprietary-Trade Name: "Amplaid A311 Series™ "(AM 11, A311) Classification Name: Audiometer 77EWO Common/Usual Name: Clinical Audiometer - Equivalent legally marketed devices This product is similar in design and function 2. to the Amplaid 309 Clinical Audiometer (K880059), Amplaid 308 Clinical Audiometer (K891988), and Amplaid A460 (K971747) - Indications for Use (intended use) The Amplaid A311 Series is a clinical diagnostic 3. 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. - Description of the Device: The Amplaid A311 Series is a two channel clinical 4. 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, Multifrequency, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., and Tone Decay. The A311 Series comes in two models, both using the same internal circuit board: The AM11 which uses a personal computer as the user interface (communicates via RS232), and the A311, with uses a dedicated front panel keyboard with an LCD display. - Safety and Effectiveness, comparison to predicate device. The results of bench ર and user testing indicates that the new device is as safe and effective as the predicate devices. {1}------------------------------------------------ ## 6. Substantial Equivalence Chart | Characteristic | Predicate device:<br>The Amplaid 309<br>K880059 | New device:<br>"Amplaid AM11TM" | New device:<br>"Amplaid A311TM" | |------------------------------------------|---------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------| | Intended Use: | Clinical diagnostic<br>audiometric applications | (Same) | (Same) | | Physical characteristics: | | | | | Size/weight | 17.3" W x 19.3" D x 7"<br>H, 28 lbs. | 12" W x 9.5" D x 2.75"<br>H, 3 kg =6.6 lbs. | 12.9" W x 15.7" D x<br>6.9" H, 6.8 kg =15 lbs | | Energy Source: | 115/230 Vac, ± 10%,<br>50-60 Hz | (Same) | (Same) | | User Interface | LCD/Dedicated<br>Keyboard | Via attached personal<br>computer | LCD/Dedicated<br>Keyboard | | Hardcopy<br>Output: | Possible via computer<br>interface | Via attached personal<br>computer. | Via attached personal<br>computer. (Future<br>software release) | | Standards and Safety<br>characteristics: | | | | | Audiometric: | ISO 389-1975, ANSI<br>S3.6-1969, ANSI S3.13-<br>1972, IEC 645 | ISO 389-1989, ANSI<br>S3.6-1989, IEC 60645 | ISO 389-1989, ANSI<br>S3.6-1989, IEC 60645 | | Electrical<br>safety: | UL-544, IEC 601 | UL 2601, IEC 60601-1 | UL 2601, IEC 60601-1 | ## 7. Conclusion After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid A311 Series™" 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. {2}------------------------------------------------ Re: Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 12 1999 Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, IL 60015 K983712 Amplaid A311 Series Clinical Audiometers (AM11 and A311) Dated: October 17, 1998 Received: October 21, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO : 12.1 12.1 Dear Mr. Kamm: We have reviewed vour 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 (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 requlatory 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 Image /page/2/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. {3}------------------------------------------------ ## j) Indications for Use 510(k) Number = 9 Device Name: Amplaid A311 Series Clinical Audiometers (AH // +A31/ Indications for Use: The Amplaid A311 Series is a two channel 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. Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number Prescription Use_ V OR Over the Counter Use (Per 21 CFR 801.109)