(175 days)
The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.
Bladeworks Microkeratome Blade
This letter is a 510(k) clearance letter from the FDA for a medical device (Bladeworks Microkeratome Blade). It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or study design.
- Information on experts, ground truth establishment, or adjudication methods.
- Mention of any multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance studies.
- The type of ground truth used in such studies.
- Sample size for a training set or how its ground truth was established, as these are typically relevant for AI/ML device studies, which this device pre-dates.
The letter focuses on regulatory clearance, not on a detailed scientific study. Its main purpose is to confirm substantial equivalence and allow the device to be marketed.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2000
Mr. Gary S Mocnik Regulatory Consultant Bladeworks Inc. 107 South Covington Street Hillsboro, TX 76445
Re: K993225 Trade Name: Bladeworks Microkeratome Blade Regulatory Class: I Regulation: 886.4370 Product Code: 86 HNO Dated: September 20, 1999 Received: September 29, 1999
Dear Mr. Mocnik:
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. Gary S Mocnik
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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510(k) Number (if known):
Dovicc Namc: Bladeworks Microkeratome Blade
Indication For Use:
The Bladeworks BW 9000 Microkeratorne Blade, in conjunction with the Chiron ACS microkeratome, and the Bladeworks BW 1011 Microkeratome Blade, in conjunction with the Chiron Hansatome microkerutome, is used to perform lamellar keratoplasty procedures.
(ITLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
Prescription Usc 1, l'cr 21 CFR 801.109
OK
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
HXB Nicholas
510(k) Numb
§ 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.