(56 days)
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
- Fixation of soft tissue to bone such as anterior cruciate reconstruction
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "Biopro Memory Staple," indicating that the device has been found substantially equivalent to a predicate device.
The letter discusses:
- The trade/device name and regulation information.
- The substantial equivalence determination by the FDA.
- General controls and potential additional controls applicable to the device.
- Requirements for marketing the device.
- Contact information for further inquiries.
- Indications for Use for the Biopro Memory Staple.
There is no mention of:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- A study design, methodology, or results demonstrating performance against any criteria.
- Details regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the text provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
BioPro % Mr. David Mrak Director of Product Development 17 Seventeenth Street Port Huron, Michigan 48060
Re: K061798
Trade/Device Name: Biopro Memory Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: June 21, 2006 Received: June 26, 2006
Dear Mr. Mrak:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. David Mrak ﮨﮯ ﮨﯿ
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saibare Buekus
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Biopro Memory Staple
Indications For Use:
-
Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
-
Fixation of soft tissue to bone such as anterior cruciate reconstruction
Prescription Use xxxxx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aubene Strickland Johnson
(Division Sign-Off) (Wivision big-----------------------------------------------------------------------------------------------------------------------------------------------------------------Division of the Provices
510(k) Number K061798
Page 1 of 1
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.