(61 days)
To provide power to operate various accessories to cut hard tissue, bone, soft tissue.
Not Found
I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) clearance letter for a "Med'ext 1000 Surgical Drill," indicating it has been deemed substantially equivalent to a predicate device. However, it does not include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established for either test or training sets.
- The sample size for the training set.
The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed performance study report.
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Thomas J. Mickel, Ph.D. Executive Vice President Med"ext Inc. .... .. .. 5490 Dexter Way West Palm Beach, Florida 33407
AUG 20 1997
Re: K972308 Trade Name: Med"ext 1000 Surgical Drill Regulatory Class: I Product Code: GEY Dated: June 18, 1997 Received: June 20, 1997
Dear Dr. Mickel:
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 (OS) 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 - Thomas J. Mickel, Ph.D.
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 vour 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) 594-4595. 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,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use Statement
510 (k) Number (if known):
Device Name: .................................................................................................................................................................
Indications for Use:
..............................................................................................................................................................................
. (
To provide power to operate various accessories to cut hard tissue, bone, soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OQE)
bcolleto
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K972308
Prescription Use
(Per 21CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.