(59 days)
Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The Small Fragment DCL system consists of limited-contact profile plates in straight, reconstruction, Oblique T- and Small T- plates of various sizes and 3.5 mm locking screws. The plates in this system also accept 2.7 mm and 3.5 mm cortex, and 4.0 mm cancellous screws. The plates feature a combination dynamic compression/locking screw hole. The system is available in either stainless steel or titanium.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.
The document is a safety and effectiveness summary for a traditional medical device (Synthes Small Fragment Dynamic Compression Locking (DCL) System) and is a 510(k) clearance letter from the FDA. It outlines the device description, indications for use, and its substantial equivalence to predicate devices, but lacks the specific details about AI/ML algorithm evaluation requested in your prompt.
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Summary of Safety and Effectiveness Information: 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| (610) 647-9700 | |
| CONTACT: | Angela Silvestri |
| DEVICE NAME: | Synthes Small Fragment Dynamic Compression Locking (DCL)System |
| DEVICE CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component metallic bone fixationappliances and accessories and 888.3040 Smooth/threaded metallicbone fixation fastener. |
| PREDICATE DEVICE: | Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade PlatesSynthes Small Reconstruction Plates, Synthes 2.7 mm ReconstructionPlates, and Synthes Small T-Plate. |
| DESCRIPTION OF DEVICE: | The Small Fragment DCL system consists of limited-contact profileplates in straight, reconstruction, Oblique T- and Small T- plates ofvarious sizes and 3.5 mm locking screws. The plates in this systemalso accept 2.7 mm and 3.5 mm cortex, and 4.0 mm cancellousscrews. The plates feature a combination dynamiccompression/locking screw hole. The system is available in eitherstainless steel or titanium. |
| INDICATIONS: | Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula,olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly inosteopenic bone. |
Sm. Frag. Dynamic Compression Locking System 510(k) Synthes (USA)
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2000
Ms. Angela J. Silvestri Manager, Regulatory Affairs SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301-1222
Re: K000684
Trade Name: Small Fragment Dynamic Compression Locking (DCL) System Regulatory Class: II Product Code: KTT Dated: February 25, 2000 Received: February 29, 2000
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 (GD) comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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.
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Page 2 - Ms. Angela J. Silvestri
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) 594-4595. 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,
vonne R. Kirchner.
Celia M. Witten, Ph.D., M.D. 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 Statement 1.0
Page _ l _____________________________________________________________________________________________________________________________________________________________________
1000684 510(k) Number (if known):
Synthes (USA) Small Fragment Dynamic Compression Locking (DCL) System_ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Donna R. Lochner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_KOOO 684
CONFIDENTIAL
(000003
§ 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.