(15 days)
The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Not Found
The provided text is a 510(k) summary for a medical device (Titanium Hip Tool™ Locking Plate), indicating its administrative information, intended use, and substantial equivalence to a predicate device. It is a regulatory document and does not contain details about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in a scientific study or clinical report.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance for test sets
- Number and qualifications of experts for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study details (effect size)
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is focused on demonstrating regulatory compliance based on substantial equivalence rather than presenting detailed performance study data.
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Special 510(k): Device Modification
Titanium Hip Tool™ Locking Pla
510(k) SUMMARY
ADMINISTRATIVE INFORMATION
AUG 2 1 2007
| Manufacturer Name: | Orthopedic Sciences, Inc.3020 Old Ranch Parkway, Suite 325Los Angeles, CA 90045 |
|---|---|
| Official Contact: | James K. Brannon. M.D. President/CEOTelephone (562) 799-5550 Fax (562) 799-5533 |
DEVICE NAME
| Classification Name: | Plate, fixation, bone |
|---|---|
| Trade/Proprietary Name: | Titanium Hip ToolTM Locking Plate |
| Common Name: | Bone plate |
PREDICATE DEVICE INFORMATION
The predicate device for this modification is the TS Bone Hip Tool™ Implant, a component of the TS Bone Hip Tool™ Bone Graft Stabilization System, cleared by FDA under K063709.
INTENDED USE
The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2007
Orthopedic Sciences, Inc. % James K. Brannon, M.D. President/CEO 3020 Old Ranch Parkway, Suite 325 Seal Beach, California 90740
Rc: K072175
Trade/Device Name: Titanium Hip Tool™ Locking Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 2, 2007 Received: August 6, 2007
Dear Dr. Brannon:
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
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Page 2 - James K. Brannon, M.D.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index:html.
Sincerely vours,
Barbara Beeckman
Mark N. Melkerson Director 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: K072175
Device Name: Titanium Hip Tool™ Locking Plate
Indications for Use:
The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Carbare Buehler | |
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Division Sign-Onanision of General, Records and Neurological Devices
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510(k) Number
§ 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.