(116 days)
Kirschner Wire - ankle fracture fixation femoral shaft fracture hand fracture scaphold fracturc skeletal tractlon wrist fracture patellar fracture
Steinman Pin - ankle arthrodesis tiblotibular syndesmosis fixallorı femoral shaft fracture acromloclavicular Jolnt repair skeletal traction
Stainless Stool Fixation Pins
I apologize, but the provided text is a 510(k) clearance letter from the FDA for medical devices (Bone Screws, Kirschner Wire, and Steinman Pin). This document confirms that the devices are substantially equivalent to previously marketed devices. However, this type of regulatory correspondence does NOT contain information about acceptance criteria for device performance or the specifics of a study proving the device meets those criteria.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the preclinical and clinical study reports submitted as part of the 510(k) premarket notification, which are not included in this letter.
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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JI IN 1000
:
Ms. Shimona Petroff Vice President Bregma International Trading Company Limited 214-111 Research Drive, Innovation Place Saskatoon, Saskatchewan Canada S7N 3R2
Re: K990351 Bone Screws Trade Name: Regulatory Class: II Product Code: HWC K990353 Kirschner Wire and Steinman Pin Trade Name: Regulatory Class: II Product Codes: JDW and HTY Dated: March 31, 1999 March 31, 1999 Received:
Dear Ms. Petroff:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent 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 comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Ms. Shimona Petroff
concerning your devices 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 requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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 M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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CDRH DRAERD
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Page 1 of 2
S 10(k) Number (if known): ___K990153
THU 09:20 FAX 201 180 1224
Device Name: Stainless Stool Fixation Pins
Indioations For Use:
Kirschner Wirc -
- ankle fracture fixation femoral shaft fracture hand fracture scaphold fracturc skeletal tractlon wrist fracture patellar fracture
Steinman Pin -
ankle arthrodesis tiblotibular syndesmosis fixallorı femoral shaft fracture acromloclavicular Jolnt repair skeletal traction
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801, 109)
OR
Over-The-Counter I Ise.
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990353
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.