(68 days)
For use in fragmentation and aspiration of the human lens
Frag Commander™ Phacofragmentation Device
This document, a 510(k) clearance letter, does not contain any information about acceptance criteria or a study proving device performance.
The letter from the FDA to Scieran Technologies for the "Frag Commander" device (K973749) indicates that the device has been found substantially equivalent to a legally marketed predicate device. This substantial equivalence determination means that the FDA believes the new device is as safe and effective as a device already on the market.
However, the letter only certifies the regulatory clearance and does not provide details about:
- Acceptance Criteria: What specific performance metrics were required for the device.
- Study Data: Any clinical or non-clinical study results demonstrating the device meets performance thresholds.
- Sample Sizes, Ground Truth, Expert Qualifications, Adjudication, MRMC studies, Standalone performance, or Training set details.
These types of details would typically be found in the 510(k) submission itself, which is not provided in the input. The provided text is solely the FDA's decision letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 1997
Rod Ross President Scieran Technologies 27071 Cabot Rd., Suite 127 Laguna Niguel, Ca 92653
Re: K973749 Trade Name: Frag Commander Regulatory Class: II Product Code: 86 HQC Dated: September 30, 1997 Received: October 1, 1997
Dear Mr. Ross:
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. Rod Ross
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 Roerl lorentthal
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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K973749 510(k) Number (if known):
Frag Commander™ Phacofragmentation Device Device Name: Indication For Use:
For use in fragmentation and aspiration of the human lens
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Dessis L. McCarthy
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number
Prescription Use Per 21 CFR 801.109
Over-The-Counter Use_
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.