(56 days)
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity:
- Slight
X 2. Mild
X 3. Moderate
X 4. Severe - Profound
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
3. Reverse Slope
X 4. Flat
X 5. Other Steeply sloping
Other
X 1. Low tolerance To Loudness
2.
3.
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
Argosy Dynameq Series Models: HS, CCA,Cameo, Passport, Passport Deluxe, Shado, Eclipse, CCAS, CCAS Deluxe, and CCA-Mini Canal
The provided text is a 510(k) clearance letter from the FDA for a series of hearing aids. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter primarily focuses on the device's substantial equivalence to previously marketed devices and general regulatory compliance. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets or data provenance.
- Information on experts used for ground truth or adjudication methods.
- Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies.
- Results from standalone algorithm performance studies.
- Details regarding the type of ground truth used.
- Information on the training set size or how its ground truth was established.
The document only states the general indications for use of the hearing aids, primarily for amplifying sound for individuals with impaired hearing across various severity and configuration categories of hearing loss. It also mentions a general caution about potential electromagnetic interference but does not present any study data related to this or any other performance aspect of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dennis J. Davis President Argosy® Electronics, Inc. 10300 West 70th Street Eden Prairie, MN 55344
JUL - 3 1997
Re: K971699 Argosy Dynameq Series Models: HS, CCA, CAMEO, PASSPORT, PASSPORT DELUXE, SHADO, ECLIPSE, CCAS, CCAS DELUXE and CCA-MINI CANAL Air Conduction Hearing Aids Dated: May 8, 1997 Received: May 8, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Davis:
We have reviewed your Section 510(k) notification of intent to market the device 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 requirement, 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 vour 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 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.
While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital celleliar telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporarily ineffective for the wearer. Because electromagnetic interference may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to medify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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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/dsmamain.html".
Sincerely yours,
holliam 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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09/05/96_ THU 15:46 FAX 301 480 4224
ート - 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
CDRH DRAERD
| 510(k) Number (if known): | K971699 | Page of |
|---|---|---|
| Device Name: | Argosy Dynameq Series Models: HS, CCA,Cameo, Passport, Passport Deluxe, Shado, Eclipse, CCAS, CCAS Deluxe, and CCA-Mini Canal | |
| Indications For Use: |
A. General Indications:
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| 1. Slight | X 1. High Frequency - Precipitously Sloping | X 1. Low tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | 3. Reverse Slope | 3. |
| X 4. Severe | X 4. Flat | |
| 5. Profound | X 5. Other Steeply sloping |
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence pf CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
and Radiological Devices
510(k) Number________________________________________________________________________________________________________________________________________
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.