(16 days)
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.
The Synthes Sternal Reconstruction System is a cable-based system comprised of stainless steel cable, cannulated screws and plates. The system is designed to allow for multiple sternal repair and reconstruction options. It can be used as follows: Cable only; Cable and cannulated screws; Cable, cannulated screws, and plates
This document from Synthes (USA) for their Sternal Reconstruction System is a 510(k) Premarket Notification summary, which is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, i.e., substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require extensive clinical studies or detailed performance criteria and studies in the same way a PMA (Premarket Approval) submission would.
Therefore, the provided text does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's a breakdown of why this information is absent, based on the nature of a 510(k) submission:
- Acceptance Criteria & Reported Performance: For 510(k) submissions, the primary "acceptance criterion" is often a demonstration of substantial equivalence to a predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics (often mechanical or bench testing for devices like this) to the predicate device. The document states "Comparative information presented supports substantial equivalence," but it does not provide a table of explicit acceptance criteria or reported device performance data beyond this general statement.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These elements are characteristic of clinical or diagnostic performance studies, which are generally not required for a 510(k) for a device like a sternal reconstruction system. Substantial equivalence is often established through non-clinical data (e.g., mechanical testing, materials characterization, biocompatibility) rather than human clinical trials.
- No information on test set sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance is provided because these concept are not applicable to the 510(k) provided.
- Ground Truth: For a mechanical device, "ground truth" would relate to its physical properties and functionality. The document doesn't detail how this was established, beyond the general statement of comparative information.
- No information regarding training set for a study or how its ground truth was established is provided because a study of that nature was not done or required.
In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a 510(k) submission for a medical device (Sternal Reconstruction System) which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical means, rather than presenting detailed clinical study results with acceptance criteria and performance data as typically found for diagnostic or AI-driven devices.
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MAY 3 0 2003
KC3/508
page 1 of 1
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: | Synthes (USA) Sternal Reconstruction System |
| CLASSIFICATION: | Class II § 21 CFR 888.3010: Cerclage, fixationClass II § 21 CFR 888.3030: Plate, fixation, boneClass II § 21 CFR 888.3040: Screws, fixation, bone |
| PREDICATE DEVICE: | Synthes Cerclage Wire (Pre-76) |
| DEVICE DESCRIPTION: | The Synthes Sternal Reconstruction System is a cable-based systemcomprised of stainless steel cable, cannulated screws and plates. Thesystem is designed to allow for multiple sternal repair and reconstructionoptions. It can be used as follows:Cable onlyCable and cannulated screwsCable, cannulated screws, and plates |
| INTENDED USE: | Synthes (USA) Sternal Reconstruction System is intended for use in sternalrepair and reconstruction. |
| SUBSTANTIALEQUIVALENCE: | Comparative information presented supports substantial equivalence. |
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Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping abstract shapes, possibly representing human figures or wings. The seal is black and white.
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Lisa Boyle Regulatory Associate Synthes USA 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K031508
Trade/Device Name: Syntehes (USA) Sternal Reconstruction System Regulation Number: 21 CFR 888.3010, 888.3030 and 888.3040 Regulation Name: Bone fixation cerclage, Single/multiple component metallic bone fixation appliances and accessories and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDQ, HRS, HWE Dated: May 12, 2003
Received: May 14, 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. Iisting 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 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 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
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Page 2 - Ms. Lisa Boyle
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.
Mark A. Milleson
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
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| 510(k) Number (if known): | K031508 |
|---|---|
| --------------------------- | --------- |
Synthes (USA) Sternal Reconstruction System Device Name:
Indications:
Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.
(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
Mark A. Millman
Divis noof General, Restorative and Neurological Devices
510(k) Number -
Confidential
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.