(69 days)
Nidek's HANDY NM-l00 is a hand-held non-mydriatic fundus camera which captures images of the retina electronically.
Nidek's HANDY NM-l00 is a hand-held non-mydriatic fundus camera which captures images of the retina electronically.
The provided text is an FDA 510(k) clearance letter for the Nidek Handy NM-100 Fundus Camera. It explicitly states that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require new performance studies to prove safety and effectiveness.
Therefore, this document does not contain information regarding acceptance criteria or a study proving the device meets those criteria, as a new study was not required.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or effect sizes.
- Information on standalone performance.
- The type of ground truth used (as no new performance study was conducted).
- Sample size for a training set.
- How ground truth for a training set was established.
The FDA's determination of substantial equivalence (K973218) for the Nidek Handy NM-100 Fundus Camera is based on its similarity to existing devices, specifically stating: "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... "
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
Mr. Ken Kato Vice President Nidek, Inc. 47651 Westinghouse Drive Fremont, CA 94539
Re: K973218 Trade Name: Nidek Handy NM-100 Fundus Camera Regulatory Class: II Product Code: 86 HKI Dated: August 25, 1997 Received: August 27, 1997
Dear Mr. Kato:
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.
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Page 2 - Mr. Kato
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 (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,
A. Roepke Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:__Nidek Handy NM-100
Indications For Use:
Nidek's HANDY NM-l00 is a hand-held non-mydriatic fundus camera which captures images of the retina electronically.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AmWilliams
(Division Sign-Off)
Division of Ophthalmic Devices
2073218
Prescription Use
(Per 21 CFR 801.109)
OR
510(k) Number
Over-The-Counter Use
..
(Optional Format 1-2-96)
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.