(63 days)
Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.
Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation and rotational control for fractures of the proximal humerus and distal tibia. The plates feature a low profile limited contact dynamic compression plate (LC-DCP®) design and dynamic compression unit (DCU) screw holes. The blade portion of the plate is cannulated to accept a 2.0 mm guide wire. The plates are available in various sizes to accommodate varying patient anatomy.
This document is a 510(k) premarket notification for the Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates (LC-ABP). It establishes substantial equivalence to predicate devices but does not contain acceptance criteria or a study demonstrating the device meets such criteria.
The provided text is related to regulatory approval for a medical device (bone fixation plates), specifically a 510(k) submission to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data with specific acceptance criteria and detailed performance metrics.
Therefore, most of the requested information cannot be extracted from this document. The document primarily identifies the device, its intended use, classification, and predicates, and confirms its substantial equivalence for marketing.
Here's a breakdown of why the requested information is absent:
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A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or detailed performance data from a clinical or non-clinical study. Its purpose is regulatory clearance based on substantial equivalence, not performance benchmarking against specific criteria.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, clinical data, or information regarding data provenance is included in this 510(k) summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): As there is no clinical test set described, there is no information on experts or ground truth establishment.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic image interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a surgical implant.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical studies or ground truth establishment are described.
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The sample size for the training set: Not applicable as this is a medical device approval document, not a report on an AI model's development.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance letter and summary for a Class II medical device, focused on substantial equivalence. It does not contain the detailed clinical study data, acceptance criteria, or performance metrics typical of a clinical trial report or an evaluation of a diagnostic AI system.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. To the right of the word is a registered trademark symbol.
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'k', followed by the numbers '992837'. The numbers are written in a simple, slightly slanted style, and the image has a clean, white background.
OCT 2 5 1999
3.0 Summary of Safety and Effectiveness Information
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Angela Silvestri |
|---|---|
| DEVICE NAME: | Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates |
| CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component metallic bone fixationappliances and accessories. |
| PREDICATE DEVICE: | Synthes Small T-PlateAce DePuy Symmetry Proximal Humerus Plate |
| DEVICE DESCRIPTION: | Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixationand rotational control for fractures of the proximal humerus and distal tibia.The plates feature a low profile limited contact dynamic compression plate(LC-DCP®) design and dynamic compression unit (DCU) screw holes.The blade portion of the plate is cannulated to accept a 2.0 mm guide wire.The plates are available in various sizes to accommodate varying patientanatomy. |
| INTENDED USE: | These plates are intended for the fixation of fractures and non-unions of theproximal humerus and distal tibia. |
| MATERIAL: | Implant quality stainless steel and commercially pure titanium |
Confidential
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 1999
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
K992837 Re: Synthes (USA) 3.5mm 90° Cannulated Limited Contact Angled Blade Plates Requlatory Class: II Product Code: KTW Dated: Auqust 20, 1999 August 23, 1999 Received:
Dear Ms. Silvestri:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. 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.
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Page 2 - Ms. Angela J. Silvestri
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) 594-4659. 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,
Foll
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
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510(k) Number (if known):
Synthes (USA) 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates Device Name:
Indications/Contraindications:
Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992831
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Synthes (USA) 3.5 mm 90° Cannulated LC-ABP 510(k) Confidential
§ 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.