(89 days)
The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Disk Whisk System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics as a device already legally marketed, or it has different technological characteristics but does not raise different questions of safety and effectiveness. The FDA's 510(k) process is a premarket notification, not a premarket approval process that involves detailed clinical efficacy studies like those required for Class III devices.
Therefore, I cannot provide the requested information based on the provided text.
Here's why:
- No Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) or thresholds that the Disk Whisk System needs to meet.
- No Study Details: The letter refers to a "510(k) notification of intent to market," which typically includes a comparison to predicate devices, but does not detail any clinical study or performance testing study that would establish and prove acceptance criteria.
- No Performance Data: There are no reported device performance figures.
- No Information on Sample Size, Ground Truth, Experts, Adjudication, or Training: Since no study is described, these details are absent.
The provided text focuses solely on the regulatory clearance process (510(k)) and the device's indications for use: "The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone."
To answer your questions, one would need access to the actual 510(k) submission document or related performance data, which is not included in this FDA clearance letter.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human face in profile, composed of three curved lines. The face is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image. The word "DEPARTMENT" starts at the 9 o'clock position and continues clockwise.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rick D. Roberts President and CEO Disk Whisk, Inc. 600 South Rancho Lane, Suite 113 Las Vegas, Nevada 89106
JUL - 8 1997 Re : K971342 Disk Whisk System Requlatory Class: I Product Code: HWE Dated: April 7, 1997 Received: April 10, 1997
Dear Mr. Roberts:
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, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially guivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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
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Page 2 - Mr. Rick D. Roberts
comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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.
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) 594-4595. 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,
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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9713i42
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Indications For Use: The product is indicated for use in endoscopic and nonendoscopic orthopedic procedures, to assist in the removal of fibrous disk material in the spine and for the decortication of bone.
cello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971342
Prescription Use
(Per 21 CFR 801.109)
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III - 9
§ 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.