(68 days)
The Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The Synthes 3.5 mm LCP Distal Humerus System consists of medial and postero-lateral distal humerus plates of various lengths and 2.7 mm locking screws. The plates are pre-contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate features locking compression holes and conical locking holes which accept 2.4, 3.5, & 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mm cancellous screws. The System will be available in Stainless Steel and Titanium.
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary for a medical device (Synthes 3.5 mm LCP Distal Humerus System) and an FDA clearance letter. It describes the device, its intended use, classification, and predicate devices, and concludes that it is substantially equivalent to legally marketed predicate devices.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Data on standalone algorithm performance.
- The type of ground truth used for any study.
- The sample size for a training set or how its ground truth was established.
Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria and study details.
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MAR - 1 2004
33995
page 10
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
| SPONSOR: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700Contact: Lisa M. Boyle |
|---|---|
| DEVICE NAME: | 3.5 mm LCP Distal Humerus System |
| CLASSIFICATION: | Class II, 21 CFR 888.3030: Single / Multiple component bone fixationappliances and accessories and 888.3040 Smooth/threaded metallic bonefixation fastener |
| PREDICATE DEVICE: | Synthes 3.5 mm LCP Reconstruction PlateSynthes 2.4 mm Cortex Screw, self-tapping |
| DEVICE DESCRIPTION: | The Synthes 3.5 mm LCP Distal Humerus System consists of medial andpostero-lateral distal humerus plates of various lengths and 2.7 mm lockingscrews. The plates are pre-contoured to match the anatomy of the distalhumerus with a limited contact low profile design. The plate featureslocking compression holes and conical locking holes which accept 2.4, 3.5,& 4.0 mm cortex screws, 2.4, 2.7 & 3.5 mm locking screws, and 4.0 mmcancellous screws. The System will be available in Stainless Steel andTitanium. |
| INTENDED USE: | The Synthes 3.5 mm LCP Distal Humerus System is indicated forintraarticular fractures of the distal humerus, comminuted supracondylarfractures, osteotomies, and non-unions of the distal humerus. |
| SUBSTANTIALEQUIVALENCE: | Docmentation is provided which demonstrates that the Synthes 3.5 mmLCP Distal Humerus System is substantially equivalent to other legallymarketed 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3-9-2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K033995 Trade/Device Name: Synthes (USA) 3.5 mm LCP Distal Humerus System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: December 22, 2003 Received: December 24, 2003
Dear Ms. Boyle:
This letter corrects our substantially equivalent letter of March 1, 2004 regarding the device named above. The product code was incorrectly listed as KTI. The correct product adde is listed above.
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 if(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 data of the Medical Device in 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 (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 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.
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Page 2 - Ms. Lisa M. Boyle
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 squaries. 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 prestice 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.
This letter will allow you to continue 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 the nomber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
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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Page __ 1 ____________________________________________________________________________________________________________________________________________________________________ l
510(k) Number (if known):
Device Name: Synthes (USA) 3.5 mm LCP Distal Humerus System
人053995
INDICATIONS/CONTRAINDICATIONS:
The Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal burnerus.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K633995 510(k) Number_
Synthes (USA) 3.5 mm LCP Distal Humerus System
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0004
§ 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.