(110 days)
The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea
Not Found
The provided text is a 510(k) premarket notification approval letter for the Surgin AccuBlade™ Microkeratome Blade, which primarily focuses on regulatory approval based on substantial equivalence to existing devices. It does not contain information about specific acceptance criteria for device performance, the details of a study that proves the device meets those criteria, or any of the other requested information regarding sample sizes, ground truth establishment, or clinical study methodologies.
Therefore, I cannot provide the requested table and study details from the given text. The document is a regulatory approval notice, not a clinical study report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2000
Mr. Don W. Haar Surgin Surgical Inc. 14762 Bentley Circle Tustin, Ca 92780
K994015 Re:
Trade Name: Surgin AccuBlade™ Microkeratome Blade (ACS Model MK 8507 and Hansatome Model MK 8508)
Regulatory Class: I Product Code: 86 HNO Regulation: 886.4370 Dated: February 24, 2000 Received: February 24, 2000
Dear Mr. Haar:
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. Don W. Haar
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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Page 1 of 1
K994015 510(k) Number (if Known):_
AccuBladc Device Name:__
Indications For Use:
The Surgin Inc. AccuBlade(ACS Model MK8507 and Hansatome Model MK8508) are designed as replacement blades for the Chiron Vision Corp. Model ACS Keratomo and Chiron Hansatome microkeratome for lamellar resection of the cornea
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUF ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daryl Kaufmer
Division Sign-Off) Division of Ophthalmic Devices 199401. 510(k) Number.
. . .
(Optional Format 3-10-98)
§ 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.