(60 days)
K884046/A
Not Found
No
The summary describes a system for electroacoustic analysis of hearing aids using digital signal processing and standard measurement techniques, with no mention of AI or ML.
No
The device is used to calibrate and assess the electroacoustic characteristics of hearing aids, not to directly treat a patient's medical condition. It's an analysis system for another device.
No
The device is described as a "hearing aid analysis system" used to "calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid." It evaluates the performance of a hearing aid, not the medical condition of a patient.
No
The device description explicitly details physical hardware components including a test chamber, speakers, microphones, a display/control unit, printer, and various connectors. While it mentions digital signal processing, it is clearly a system with significant hardware components.
Based on the provided information, the Audioscan® Verifit™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid". This is a technical assessment of a medical device (a hearing aid), not a diagnostic test performed on a biological sample from a patient.
- Device Description: The description details a system for testing hearing aids, including a test chamber, speakers, microphones, and signal processing. It does not mention any components or processes related to analyzing biological samples.
- Anatomical Site: While the device is used in conjunction with a patient's ear canal during real-ear measurements, the device itself is analyzing the performance of the hearing aid, not the patient's biological state.
- Performance Studies and Metrics: The performance studies and key metrics focus on the accuracy and conformance of the device in measuring the characteristics of hearing aids (e.g., measurement accuracy, harmonic distortion accuracy, battery drain accuracy). These are technical performance metrics, not diagnostic performance metrics like sensitivity, specificity, or AUC which are typical for IVDs.
In summary, the Audioscan® Verifit™ is a device used to evaluate the performance of hearing aids, which are medical devices. It does not perform diagnostic testing on biological samples from a patient, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.
Product codes
ETW
Device Description
Audioscan® Verifit™ Model VF-1 is a hearing-aid calibrator & analysis system. It functions as a hearing aid analysis system used to calibrate and assess electroacoustic frequency and sound intensity characteristics. Key features and specifications of the Audioscan® Verifit™ Model VF-1 include:
- Overall dimensions: Rear main unit 14.5" x 16" x 6.5", Test chamber 14" x 14.4" x 4"
- Weight: 16 lbs
- Display type: fluorescent backlit active color, 12.1" diagonal with 800 x 600 (SVGA) pixels (resolution)
- Printer type: thermal line printer Operating at 200 dots per inch resolution and a paper width of 3" (80 mm)
- Connectors: 1 - mouse (PS2-6 pin), 1 - QWERTY keyboard (PS2-6pin), 1 - external monitor (15HD), 1 - parallel printer (25D), 1 - RS232 serial (9D), 1 - ethernet (RJ45), 2 - USB, 2 - external speakers (RCA), 2 - external speakers (1/4" mono), 2 - real-ear mics. (3.5 mm st), 1 - RECO transducer (3.5 mm st), 1 - monitor headset (3.5 mm st), 1 - test chamber ref. mic. (3.5 mm st), 1 - coupler microphone (3.5 mm st), 1 - battery substitute (3.5 mm st)
- Headphone monitor amplifier: 1 watt into 16 ohms
- Power amplifiers: 2 - 5 watts each
- Stimulus channels: 2
- Measurement channels: 2
HEARING AID TEST CHAMBER:
- Working space: 8" x 5" x 1.5" (approx.)
- Speakers: 2 - 2" x 3" Independent
- Induction coils: 1 - Telephone Magnetic Field Simulator (TMFS ANSI S3.22 - 1996), 1 - 20 cm diameter test loop
- Battery simulator: per ANSI S3.22 - 1996
- Frequency range: 200 to 8000 Hz
- Test stimuli: tone, broad-band noise, recorded speech
- Test stimulus levels: 40 to 90 dB SPL in 5 dB steps
- Test stimulus levels (inductive): 31.6 mA/m per ANSI S3.22 - 1996
- Test stimulus distortion:
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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Edi E
sion incorporated
41 Byron Avenue, Dorchester, Ontario NOL 1G0 Tel: (519) 268-3313 Fax: (519) 268-3256
SEP 2 1 2001
SECTION E - 510(K) SUMMARY OF SAFETY & EFFECTIVENESS
Audioscan® Verifit™ Model VF-1
| Classification Name: | Hearing-Aid Calibrator & Analysis System |
|---|---|
| Common/Usual Name: | Hearing Aid Analyzer |
| Proprietary Name: | Audioscan ® Verifit™ Model VF-1 |
| Establishment Registration: | 8022229 |
| Medical Specialty: | Panel 77, Ear, Nose, & Throat |
| Product Code: | ETW |
| Regulation Number: | 21 CFR 874.3310 |
| Device Classification: | II |
| Contact Person: | William A Cole, President |
Indications for Use:
The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.
Performance Standards Conformance:
-
- The VF-1 meets or exceeds the equipment requirements of the following standards: American National Standards Institute, Methods of Measurement of Real-Far Performance Characteristics of Hearing Aids, (ANSI S3.46-1997), American National Standards Institute, New York, 1997, and, American National Standards Institute, Specification of Hearing Ald Characteristics, (ANSI S3.22-1996), American National Standards Institute, New York, 1996.
-
- The VF-1 meets or exceeds the applicable requirements of the following standards for safety: IEC 60601-1, EN60601-1, UL-2601 and UL 544.
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Etymonic Design Incorporated Applied Microelectronics
- The VF-1 meets or exceeds the Food and Drug Administration radiation safety 3. performance standards prescribed in the Code of Federal Regulations, Title 21, Chapter I. Subchapter J.
Substantial Equivalence:
Determination of substantial equivalence of the Audioscan® Verifit™ VF-1 instrument to the currently marketed Audioscan® Real Ear Measurement System RMS00, 510(k) No. K884046/A, February 13, 1989, is based on the following safety and effectiveness information:
- The Audioscan® Verifit™ device is manufactured and delivered completely . assembled to the health care professional using materials and techniques widely used by other manufacturers of devices as with the predicate device.
- Patient safety is preserved in both the Audioscan® Verifit™ and predicate . devices. There is no direct electrical connection to the patient. The silicone probe microphone assembly that has contact with the patient's ear canal during the testing of the hearing aid, has no exposed metal parts and is classed as an F-Type Applied Part in UL2601-1. Thus, there is no possibility of electrical conductance.
- Regarding physical configurations, the system is integrated with the hearing test ● chamber physically part of the display/control unit in the predicate device, whereas the Audioscan® Verifit™ hearing aid test chamber is physically separated from the display/control unit.
- Software algorithms are essentially equivalent for both the Audioscan® Verifit™ t and predicate devices.
- To establish the safety and effectiveness of the software that controls the . instrument, the development, verification, validation, and testing procedures are in accordance with FDA guidances for devices containing software 12, Quality Assurance procedures are adhered to and test results demonstrate that both system specifications and function requirements are met.
1 Guidance Principles of Software Validation, Draft Guidance Version 1.1, June 9, 1997, Center for Devices and Radiological Health, Food and Drug Administration
2 ODE Guidance for the Content of Premarket Submission for Medical Devices Containing Software, May 29, 1998, Center for Devices and Radiological Health, Food and Drug Administration
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Etymonic Design Incorporated Applied Microelectronics
41 Byron Avenue, Dorchester, Ontario NoL. 1G0 Tel: (519) 268-3313 Fax: (519) 268-3256
- The maximum sound level output of the Audioscan® Verifit™ speakers, if used . as intended, remains below +90 dB SPL throughout the frequency range of 200 to This demonstrates that the Audioscan® Verifit™ unit emits sounds 8000 Hz. well within OSHA permissible exposure limits of 8 hours at 90 dB, The maximum sound level output of the predicate device speakers is 85 dB SPL if used as intended.
- The signal processing and analysis differ between the Audioscan® Verifit™ and . the predicate device. Signals are processed and analyzed by digitally controlled analog amplifiers, attenuators and filters in the predicate device. In the Audioscan® Verifit™, with the exception of the microphone preamplifiers and output amplifiers, all signal processing and analysis is carried out digitally.
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vmon n Incorporated
41 Byron Avenue, Dorchester, Ontanio NOL 1G0
| CHARACTERISTIC | MODEL RM500 | VERIFIT™ MODEL
VF-1 |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GENERAL | | |
| Overall dimensions | 15.5" x 13.2" x 6.2" | Rear main unit 14.5" x 16" x 6.5"
Test chamber 14" x 14.4" x 4" |
| Weight | 15 lbs | 16 lbs |
| Display type | fluorescent backlit blue on
white | fluorescent backlit active color |
| Display size | 6.4" diagonal | 12.1" diagonal |
| Display pixels (resolution) | 320 x 200 (VGA) | 800 x 600 (SVGA) |
| Printer type | thermal line printer | SAME |
| Printer resolution | 200 dots per inch | SAME |
| Paper width | 3" (80 mm) | SAME |
| Connectors | 1 - external monitor (15HD)
1-RS232 (9D)
1 - external speaker (RCA)
1 - real-ear/coupler mic. (RJ11) | 1 - mouse (PS2-6 pin)
1 - QWERTY keyboard (PS2-6pin)
1 - external monitor (15HD)
1 - parallel printer (25D)
1 - RS232 serial (9D)
1 - ethernet (RJ45)
2 - USB
2 - external speakers (RCA)
2 - external speakers (1/4" mono))
2 - real-ear mics. (3.5 mm st)
1 - RECO transducer (3.5 mm st)
1 - monitor headset (3.5 mm st)
1 - test chamber ref. mic. (3.5 mm st)
1 - coupler microphone (3.5 mm st)
1 - battery substitute (3.5 mm st) |
| Headphone monitor amplifier | 1 watt into 16 ohms | SAME |
| Power amplifiers | 1 - 1.7 watts | 2 - 5 watts each |
| Stimulus channels | 1 | 2 |
| Measurement channels | 2 | SAME |
| HEARING AID TEST CHAMBER | | |
| Working space | 5.5" x 3.5" x 2" | 8" x 5" x 1.5" (approx.) |
| Speakers | 1 - 3.5" diameter | 2 - 2" x 3" Independent |
| Induction coils | 1 - Telephone Magnetic Field
Simulator (TMFS ANSI S3.22 -
1996)
1 - 20 cm diameter test loop | SAME |
| Battery simulator | per ANSI S3.22 - 1996 | SAME |
| Frequency range | 200 to 8000 Hz | SAME |
| Test stimuli | tone | tone, broad-band noise, recorded
speech |
| CHARACTERISTIC | MODEL RM500 | VERIFIT™ MODEL
VF-1 |
| Test stimulus levels | 40 to 90 dB SPL in 5 dB steps | SAME |
| Test stimulus levels (inductive) | 31.6 mA/m per ANSI S3.22 -1996 | SAME |
| Test stimulus distortion | Real-Ear Unaided
Response
Real-Ear Aided Response
Real-Ear Occluded
Response
Real-Ear Insertion Gain | SAME |
| Other tests available | > Real-ear harmonic
distortion
Real-ear spectral analysis
manual measurement of
output, gain and distortion | SAME |
| Prescriptive fitting methods available | > National Acoustics Labs
Revised
Pogo II
Berger
Libby
Desired Sensation Level | SAME |
Specification Comparison Table
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.
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Image /page/5/Picture/0 description: The image shows the logo for Etymonic Design Incorporated, Applied Microelectronics. The logo consists of the letters "edi" in a stylized font on the left, followed by the company name in a more standard font on the right. The words "Applied Microelectronics" are written in a smaller font below the company name.
41 Byron Avenue, Dorchester, Ontario NOL 1G0 Tel: (519) 288-3313 Fax: (519) 268-3256
NOTES:
The couplers used in the RM500 hearing aid test chamber are also used in the Verifit™ VF-1. 1)
- The probe tubes used with the RM500 real-ear microphone assembly are also used with the VF-1.
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Image /page/6/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 a stylized symbol that resembles three abstract human figures or waves.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2001
William A. Cole, President Etymonic Design Incorporated 41 Byron Avenue Dorchester, Ontario N0L 1G0
Re: K012306
Trade Name: Audioscan Verifit™ Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing Aid Calibrator and Analysis System Regulatory Class: Class II Product Code: ETW Dated: July 20, 2001 Received: July 23, 2001
Dear Mr. Cole
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - William A. Cole, President
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Etymonic Design Incorporated Applied Microelectronics
41 Byron Avenue, Dorchester, Ontario N0L 1G0 Fax: (519) 268-3256 Tel: (519) 268-3313
SECTION D - INDICATIONS FOR USE STATEMENT
er/ 3 - 4/24/96
Applicant: Etymonic Design Incorporated
510(k) Number (if known):
Device Name: Audioscan® Verifit™
Indications For Use
The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic referenc device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.
Ama H. Kane Ph.D. 9/17/01
Division Sign-Off
Division Sign-Off) Division of Ophthalmic Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)