(81 days)
Phacoemulsification of cataracts in the human eye.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document is a 510(k) clearance letter from the FDA to Circuit Tree Medical, Inc. for "The Wave Digital Phaco System." It states that the device is substantially equivalent to legally marketed predicate devices for the indication of "Phacoemulsification of cataracts in the human eye."
This type of FDA letter confirms market clearance but does not typically include detailed study results, performance metrics, or information on how ground truth was established, which are usually found in the 510(k) summary or the full submission.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1998
Circuit Tree Medical, Inc. Maurice Imonti c/o Imonti and Associates 25707 Compass Way San Juan Capistrano, CA 92675
Re: K981989 Trade Name: The Wave Digital Phaco System Regulatory Class: II Product Code: 86 HQC Dated: June 2, 1998 Received: June 5, 1998
Dear Mr. Imonti:
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. Maurice Imonti
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): K981989
Device Name: The WAVE Digital Phaco System
Hndications For Use: Phacoemulsification of cataracts in the human eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alegn L. Hoang, Scientific Reviewer
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981989
Prescription Use_X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.