(65 days)
Surgin's Prizm Blades are designed as replacement blades for the Nidek Model MK2000 keratome.
Not Found
This document, a 510(k) clearance letter from the FDA for the Prizm Keratome Blade, does not contain information about acceptance criteria or a study proving device performance against such criteria.
The letter explicitly states: "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 ... You may, therefore, market the device, subject to the general controls provisions of the Act."
The 510(k) pathway for medical device clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove performance against specific acceptance criteria.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Mr. Don W. Haar Q.A. / Regulatory Manager Surgin, Inc. 14762 Bentley Circle Tustin, CA 92680
Re: K013337
Trade/Device Name: Prizm Keratome Blade (Nidek Model MK 2000) Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: October 9, 2001 Received: October 9, 2001
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 stared in also encreater) to ical 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally premaired nothication. The PDA midning of bacomman or 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 If you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Fall 807.10 for mirrato atagonomics and advertising of Compliance at (301) 594-4017. Tidnitionally 16. questions . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general intormation on your respend on Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Surgin, Inc
DEC 1 3 2001
14762 Bentley Circle Tustin, CA 92680 Tel: 714 832 6300
INDICATIONS FOR USE STATEMENT
510(k) Number (1 known): K013337
Device Name: Prizm Keratomo Blade
Indications For Use:
Surgin's Prizm Blades are designed as replacement blades for the Nidek Model MK2000 keratome.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K013337 |
| 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.