AMPLAID A724 AND A728

{0}------------------------------------------------ K912370 SEP 2 0 1999 EXHIBIT 2 Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-02-57472482 Fax ++39-02-57409427 Contact: Giovanni Rollier, President July 13, 1999 # 510(k) Summary of Safety and Effectiveness - 1. Identification of the Device: Proprietary-Trade Name: Amplaid A724 and A728 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 770 Admittance Meter (K903066) - 3. Indications for Use (intended use) The Amplaid A724 A728 are Programmable Admittance Meters 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 A724 and A728 ADMITTANCE METERS perform plane 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. {1}------------------------------------------------ | Characteristic | Predicate device: | New device: | |------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Amplaid 770 Per K903066 | Amplaid A724 -A728 | | Intended Use: | Clinical auditory impedance<br>testing applications | (Same) | | Technical characteristics | | | | Physical characteristics: | | | | Computer interface | RS232 Transmit only | RS232 Bi-directional | | Display | Built-in liquid crystal | (Same) | | Control interface | Built-in keyboard | (Same) | | Size/weight | 17.3" W x 19.3" D x 7" H,<br>28 lbs. | 19.6"w x 16"d x 8"h<br>18.8 lbs. | | Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | (Same) | | Hardcopy Output: | Built-in Thermal printer | (Same) | | Standards and Safety<br>characteristics: | | | | Audiometric: | ANSI 3.6, 1969, ISO 1975 for<br>contralateral, 2 cm3 cavity for<br>ipsilateral, IEC 61027 | (Same or better) Standards<br>updated and added:<br>IEC 61027 (1993); Instruments<br>for the measurement of aural<br>acoustic impedance/admittance<br>ANSI S3.39(1987): Specifications<br>for Instruments to Measure Aural<br>Acoustic Impedance and<br>Admittance (Aural Acoustic<br>Immittance);<br>IEC 60645-1: Audiometers - Part<br>1: Pure-tone audiometers<br>ANSI S3.6 (1996): Specification<br>for audiometers;<br>EN ISO 389 (1995): Acoustics -<br>Standard reference zero for the<br>calibration of pure-tone air<br>conduction audiometers | | Electrical safety: | UL-544, IEC 601 | Safety: EN 60601-1 Class I Type<br>BF (1990); EN 60601-1/A1<br>(1993);<br>EN 60601-1/A2 (1995); EN<br>60601-1/A13 (1996)<br>EMC: EN 60601-1-2 (1993) | # 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 A724 and A728 are 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines above three wavy lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 0 1999 Mr. Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield IL 60015 USA Re: K992370 Trade Name: Amplaid A724 and A728 Clinical Automatic Programmable Admittance Meters Regulatory Class: II Product Code: 77 ETY Dated: July 13, 1999 Received: July 15, 1999 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, 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 . {3}------------------------------------------------ # Page 2 - Mr. Daniel Kamm, P.E. This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Alvarez Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### j) Indications for Use 510(k) Number K9923 70 Device Name: Amplaid A724 and A728 Clinical Automatic Programmable Admittance Meters Indications for Use: The Amplaid A724 and A728 are Programmable Admittance Meters which can - 1. 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. - 2. Perform Acoustic reflex test. - 3. Determine acoustic reflex threshold - 4. Perform reflex decay test. They 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) Ray J. Lankester OR Prescription Use / Over the Counter Use (Per 21 CFR 801.109) . "