(45 days)
The SCMD-1000 blades are to be used with the SCMD Microkeratome.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the SCMD-1000 device does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This document is a notification of substantial equivalence and does not detail the technical performance or validation studies of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
! 1998 MAY
Mr. Jack W. Howard Official Correspondent Howard Instruments, Inc. 4749 Appletree Ln. Tuscaloosa, AL 35405
Re: K980985 Trade Name: SCMD-1000 Regulatory Class: I Product Code: 86 HNO Dated: March 16, 1998 Received: March 17, 1998
Dear Mr. Howard:
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. Jack W. Howard
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. Ralph 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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K980985 510(k) Number (if known): _
Device Name. SCMD-1000
i '
Indications For Use:
The SCMD-1000 blades are to be used with the SCMD Microkeratome.
Daryl Kaufman
(Division Sign-Off)
Division of Ophthalmic Devices 980987 510(k) Number.
Jack Howard
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrance of CDRH, Office of Device Evaluation (ODE)
X Prescription Use _ (Per 21 CFR 801.109)
OR
Over the Counter Use -
(Optional Format 1-2-96)
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.