AMPLAID AM50

{0}------------------------------------------------ K974235 EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-2-57472482 Fax ++39-2-57409427 Contact: Giovanni Rollier, President FEB | 0 1998 November 7, 1997 ## 510(k) Summary of Safety and Effectiveness - 1. Identification of the Device: Proprietary-Trade Name: Amplaid AM50 Classification Name: Auditory Impedance Tester 77ETY Common/Usual Name: Clinical Admittance Meter - 2. Equivalent legally marketed devices This product is similar in design and function to the Amplaid 709 Admittance Meter (K802097) and the 770 Admittance Meter (K903066) - 3. Indications for Use (intended use) The Amplaid AM50 is a Programmable Admittance Meter which can: - Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, . perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. - Perform Acoustic reflex test. ● - Determine acoustic reflex threshold . - . Perform reflex decay test. 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 AM50 ADMITTANCE METER performs plan and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements. - 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 device. The same circuit technology is used in both devices. The only change is packaging and control software, whereby all keyboard, display, and control functions have been moved to the attached (via RS232) personal computer. {1}------------------------------------------------ | Characteristic | Predicate device: | New device: | |------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------| | | Amplaid 770 | Amplaid AM50 | | Intended Use: | Clinical auditory impedance<br>testing applications | (Same) | | Technical characteristics | Per K903066 | (Same) | | Physical characteristics: | | | | Computer interface | RS232 Transmit only | RS232 Bi-directional | | Display | Built-in liquid crystal | Via attached computer | | Control interface | Built-in keyboard | Via attached computer or<br>dedicated keyboard. | | | | | | Size/weight | 17.3" W x 19.3" D x 7" H, | 11.4" W x 12"D x 4" H | | | 28 lbs. | 4.4 lbs. | | Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | (Same) | | Hardcopy Output: | Built-in Thermal printer | Via attached computer | | Standards and Safety<br>characteristics: | | | | Audiometric: | ANSI 1969, ISO 1975 for<br>contralateral, 2 $cm³$ cavity for<br>ipsilateral, IEC 61027 | (Same) | | Electrical safety: | UL-544, IEC 601 | (Same) | # 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 AM50 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}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH, HUMAN" around the top left of the circle. The right side of the seal contains a symbol that looks like three stylized human profiles stacked on top of each other. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### Amplifon S.p.A. c/o Kamm & Associates Daniel Kamm. P.E., Regulatory Engineer P. O. Box 7007 Deerfield, Illinois 60015 K974235 Re: Amplaid AM50 Clinical Automatic Programmable Admittance Meter Dated: November 7, 1997 Received: November 12, 1997 Regulatory class: II Procode: 77 ETY. 21 CFR 874.1090 FEB | 0 |998 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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendnents, or to devices that have been reclassified in accordance with the provisions of the FederallPood, y Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the West general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing off a practice, labeling, and prohibitions against misbranding and adulteration. 11:48 11 If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Revolutions Sittle 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Pracice requirement, as set forth in the Quality System Regulation (OS) 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 of 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 does not affect any obligation i 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 t substantial equivalence of your device to a legally marketed predication 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 yilgo diagnostic devices), please contact the Office of Compliance at (301) 594-613. 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 premaiter 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/dsmamain.html". Sincerely vours. h.Nliau Yhi 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 {3}------------------------------------------------ ### i) Indications for Use 510(k) Number 5 974 2 3 5 Device Name: Amplaid AM50 Clinical Automatic Programmable Admittance Meter Indications for Use: The Amplaid AM50 is a Programmable Admittance Meter which can - Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, 1. perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. - Perform Acoustic reflex test. 2. - 3. Determine acoustic reflex threshold - 4. Perform reflex decay test. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance. Concurrence of CDRH, Office of Device Evaluation (ODE) David h. Seppanen OR (Division Sign-Off) ivision of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number Prescription Use V Over the Counter Use (Per 21 CFR 801.109)