(24 days)
The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 20mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use.
The provided text is related to a 510(k) submission for a medical device called the "Latarjet Cortical Screw Set." This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for low-to-moderate risk medical devices.
The information you are requesting about "acceptance criteria and the study that proves the device meets the acceptance criteria" (specifically for AI/algorithm performance) is not applicable to this submission.
Here's why, based on the provided text:
- Device Type: The Latarjet Cortical Screw Set is a physical implantable device (bone fixation screw) used in orthopedic surgery. It is not an AI/algorithm-based diagnostic or treatment device.
- Regulatory Pathway: The submission is a 510(k) Pre-market Notification, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance (e.g., mechanical testing, biocompatibility) to show it's as safe and effective as existing devices. It does not involve clinical studies to demonstrate the performance of an AI algorithm against specific acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
- Lack of AI/Algorithm Information: There is no mention of any AI component, software, diagnostic algorithm, or any form of "AI assistance" in the entire document. The device is purely mechanical.
Therefore, I cannot extract the information requested as it pertains to AI/algorithm performance studies, as such studies were not conducted or described for this specific device.
The study referenced in the document is a "validation" to verify that the device's "performance is the same" as the predicate device based on its technological characteristics. This would typically involve engineering tests (e.g., mechanical strength, fatigue, torque, biocompatibility) rather than clinical performance metrics in humans or AI performance metrics.
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KU0763 (1/1)
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided: APR 1 1 2011
- Submitter George J. Hattub 1. (a) MedicSense, USA Address: 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer T.A.G. Medical Products D. N. Ashrat Address: Kibbutz Gaaton 25130, Israel Mfg. Phone: Tel .: 972-3-647-4840 Contact Person: Dan Moor Date: March 14, 2011 2. Device & Classification Bone Fixation Screw, class II device (product code HWC). Latarjet Cortical Screw Set Name: Predicate Device: The Latariet Cortical Screw Set K083096 & K091694 3. 4. Description: The Latarjet Cortical Screw Set consists of an implantable fixation screw which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 20mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use. The Latariet Cortical Screw Set is intended to provide the orthopedic 5. Intended Use: surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries. With respect to its indication for use, the Latarjet Cortical Screw Set is 6. Comparison of substantially equivalent to its predicate device in that it intended for the Technological same clinical purpose. With respect to technology, the design is similar as Characteristics: confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products believes that its device is safe and effective because it performs the same function in the same manner.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
T.A.G. Medical Products Corporation, Ltd. % MediSense, USA Mr. George J. Hattub 291 Hillside Avenue Somerset, Massachusetts 02726
APR 1 1 291
Re: K110763
Trade/Device Name: Latarjet Cortical Screw Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 16, 2011 Received: March 18, 2011
Dear Mr. Hattub:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 -- Mr. George J. Hattub
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); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KI10763(1/1)
Indications for Use
510(k) Number (if known):
Device Name: Latarjet Cortical Screw Set
Indications For Use: The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.
Prescription Use × (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)
:
Ar M. Meikerson
(Division Sign-Of) Division of Surgical, Orthopeane, and Restorative Devices
Page 1 of 1
510(k) Number K110763
§ 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.