(17 days)
Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
The LCP Proximal Femur Plates are contoured to match the anatomy of the proximal femur with a limited contact low profile design. The plate has dynamic compression holes combined with conical shaped threaded screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0 mm locking screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates and screws are available in a various lengths.
The provided submission does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. Instead, it is a 510(k) premarket notification summary for a medical device (Synthes (USA) LCP Proximal Femur Plate and Screws), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance efficacy data against pre-defined acceptance criteria.
The document discusses:
- Device Description: The physical characteristics and components of the Synthes (USA) LCP Proximal Femur Plate and Screws.
- Intended Use/Indications for Use: The medical conditions and anatomical locations for which the device is designed to be used (various fractures of the proximal femur).
- Predicate Device: The previously cleared device to which the new device is being compared (Synthes 4.5mm Broad Locking Compression Plate (LCP)).
- Substantial Equivalence: A statement indicating that comparative information supports substantial equivalence, which is the core of a 510(k) submission.
Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.
In a 510(k) submission, the "study" demonstrating that the device meets criteria typically takes the form of comparison to a predicate device, showing that the new device is as safe and effective as a legally marketed device. This often involves:
- Bench testing (mechanical, materials, biocompatibility) to show similar performance characteristics to the predicate.
- Sometimes, a review of clinical literature for similar devices.
- Rarely, in certain 510(k)s, clinical data might be included if there are significant differences from the predicate, but it's not the primary mechanism for clearance.
The provided document summarizes a successful 510(k) submission, indicating the FDA found the device substantially equivalent to its predicate. This implies that the device met the regulatory requirements for clearance without requiring detailed efficacy studies in the way a PMA (Premarket Approval Application) would, where acceptance criteria and comprehensive clinical study results would be mandatory.
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Ko30858P
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3.0 Summary of Safety and Effectiveness Information [510(k) Summary]
APR 0 4 2003
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | Synthes (USA) LCP Proximal Femur Plate and Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3030: Plate , Fixation, BoneClass II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. |
| PREDICATE DEVICE: | Synthes 4.5mm Broad Locking Compression Plate (LCP) |
| DEVICE DESCRIPTION: | The LCP Proximal Femur Plates are contoured to match the anatomy of theproximal femur with a limited contact low profile design. The plate hasdynamic compression holes combined with conical shaped threaded screwholes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0mm locking screws, and 7.3 mm cannulated locking & cannulated conicalscrews. The plates and screws are available in a various lengths. |
| INTENDED USE: | Synthes LCP Proximal Femur Plate is intended for fractures of the femurincluding: fractures of the trochanteric region, trochanteric simple,cervicotrochanteric, trochanterodiaphyseal, multifragmentarypertrochanteric, intertrochanteric, intertrochanteric reversed, or transverseor with additional fracture of medial cortex. Fractures of the proximal endof the femur combined with ispsilateral shaft fractures, metastatic fractureof the proximal femur and osteotomies of the proximal femur. |
| SUBSTANTIALEQUIVALENCE: | Comparative information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 4 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K030858
Trade/Device Name: Synthes (USA) LCP Proximal Femur Plate and Screws Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: March 12, 2003 Received: March 18, 2003
Dear Ms. Boyle:
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 mav 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
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Page 2 - Ms. Lisa M. Boyle
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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milliken
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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2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K030858 |
|---|---|
| Device Name: | Synthes (USA) LCP Proximal Femur Plate and Screws |
Indications: Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| K Number K030858 | |
| Prescription Use(Per 21 CFR 801.109) | OR Over-The-Counter Use |
§ 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.