(61 days)
Synthes (USA) LCP Proximal Humerus Plate, long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The Synthes LCP Proximal Humerus Plates, long are pre-contoured to match the anatomy of the proximal humerus with a limited contact low profile design. The plate features locking holes and combination locking and compression holes which accept 2.7, 3.5, & 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium. These plates will be offered as an addition to the Synthes Small Fragment LCP (formerly DCL) System.
The provided document is a 510(k) summary for the Synthes LCP Proximal Humerus Plates, long. It details the device's classification, predicate devices, description, and intended use. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document explicitly states under "Substantial Equivalence": "Documentation is provided which demonstrates that Synthes LCP Proximal Humerus Plates, long is substantially equivalent to other legally marketed Synthes devices." This indicates that the device was approved based on its substantial equivalence to previously cleared predicate devices, rather than through a new clinical or performance study establishing specific acceptance criteria and demonstrating achievement of those criteria.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
This type of information is typically found in premarket approval (PMA) applications or more detailed clinical study reports, not usually in a 510(k) summary based on substantial equivalence.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. There is a registered trademark symbol to the right of the word. To the left of the word is a circular logo with a design inside. There is a horizontal line below the word.
041860
page 1 of 1
SEP - 8 2004
| 3.0 | 510(k) Summary | |
|---|---|---|
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 | |
| Device Name: | Synthes (USA) LCP® Proximal Humerus Plates, Long | |
| Classification: | Class II, 21 CFR §888.3030Single/multiple component metallic bone fixation appliances andaccessories | |
| Predicate Device: | Synthes LCP Proximal Humerus PlatesSynthes Small Fragment DCL System | |
| Device Description: | The Synthes LCP Proximal Humerus Plates, long are pre-contouredto match the anatomy of the proximal humerus with a limitedcontact low profile design. The plate features locking holes andcombination locking and compression holes which accept 2.7, 3.5,& 4.0 mm cortex screws, 3.5 mm locking screws, and 4.0 mmcancellous screws. The System will be available in Stainless Steeland Titanium. These plates will be offered as an addition to theSynthes Small Fragment LCP (formerly DCL) System. | |
| Intended Use: | Synthes (USA) LCP Proximal Humerus Plate, long is indicated forfractures and fracture dislocations, osteotomies, and non-unions ofthe proximal humerus, particularly in osteopenic bone. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that Synthes LCPProximal Humerus Plates, long is substantially equivalent to otherlegally marketed Synthes devices. |
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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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301
Re: K041860
Ro+1600
Device Name: Synthes (USA) LCP® Proximal Humerus Plates, long Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: July 8, 2004 Received: July 9, 2004
Dear Ms. Musgnung :
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave teviewed your beceren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreations of the enactment date of the Medical Device Amendments, or to commerce pror to rias 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de nees that have been rolat 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 r ou may, diorerors, mians of the Act include requirements for annual registration, listing of general controlo provision 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 If your device is exassinou controls. Existing major regulations affecting your device can may or sations to outsil and 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 r toase of acrised that the rearmination that your device complies with other requirements of the Act that I DA has made a avoid regulations administered by other Federal agencies. You must or any I 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 OF R Part 877) facems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality of over is one of the Act); 21 CFR 1000-1050.
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Page 2 -- Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premits that notheadon. The PPA maing of casification 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 If you desire specific advice for your ac not one of one of the regulation entitled, the regulation entitled, the Colliact the Office of Compilation" (21CFR Part 807.97). You may obtain Milsblaining Uy tereforee to premientonsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark A. Milburn
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
KO4180
510(k) Number (if known):
Device Name:
Synthes (USA) LCP® Proximal Humerus Plates, long
Indications:
Synthes (USA) LCP Proximal Humerus Plate, long is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.
X Prescription Use _ (Per 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 IP NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milburn
Jivision Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K041860
000004
§ 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.