(57 days)
To obtain accurate imprint of an individual on ear Canal.
Not Found
This is a 510(k) summary document from the FDA, which focuses on regulatory clearance for a device (Hyunjae Corporation Nusil Earmold Impression Material) as substantially equivalent to a predicate device. It does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the document primarily addresses:
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed devices.
- Regulatory Class: The device is classified as Class I (21 CFR 874.3300/Procode: 77 ESD).
- Indications For Use: "To obtain accurate imprint of an individual on ear Canal."
- General Controls: Mentions general controls provisions of the Act (annual registration, listing, GMP, labeling, etc.).
The information requested in your numbered list (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is part of a performance study report or clinical trial summary, which is not provided in this 510(k) clearance letter. This type of FDA letter typically refers to the fact that the applicant submitted data to support substantial equivalence, but it does not detail the performance study results, acceptance criteria, or ground truth methodology.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I I 1997
Daniel Cho President HYUNJAE CORPORATION 8 South End Plaza New Milford, CT 06776
Re: K973927 Hyuniae Corporation Nusil Earmold Impression Material Dated: October 5, 1997 Received: October 15, 1997 Regulatory Class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Cho:
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 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 your device in the Federal Register. Please note; this response to your premarket notification does not affect any obligation 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 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 (2) CFR Part 801 and additionally 809-10.for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
W. Lillian Yin, Ph.D.
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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CDRH DRAERD
ത്രവുമ
Page__________________________________________________________________________________________________________________________________________________________________________
510(1) Number (if known): K973927
Device Name: Hyunjae Corporation NuSil Ear mold
Impression material
Indications For Use:
To obtain accurate imprint of
an individual on ear Canal.
(PL) ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE! JED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973927
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.