(48 days)
The Synthes (USA) Medium External Fixation System is intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.
Synthes Medium External Fixation System - MR Safe is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamps (four / six position) - MR Safe, the Medium Combination Clamp - MR Safe, the 8.0 mm/11.0 mm Combination Clamp - MR Safe and the Medium Open Adjustable Clamp - MR Safe. Also included in this MR Safe system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the Combination and Multi-Pin Clamps, respectively. These clamp accessories allow dynamization during bone healing and double stacking of the frame. The system accepts Synthes 8.0 mm carbon fiber rods (in lengths from 100 - 500 mm) and Schanz screws (in diameters of 4.0 - 5.0 mm). All frame elements are made from non-magnetic materials and are intended for use in the MR environment.
The provided document describes a 510(k) premarket notification for the "Synthes Medium External Fixation System - MR Safe." This device is a system of components that form a construct intended to treat stable and unstable fractures. The document is a regulatory submission to the FDA, asserting substantial equivalence to a predicate device.
Based on the information provided, it is not possible to describe acceptance criteria or a study proving the device meets those criteria, as detailed in your request. Medical device 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria, sample sizes, expert panels, or MRMC studies.
The document indicates that "Documentation is provided in this premarket notification that demonstrates that Synthes Medium External Fixation System -- MR Safe is substantially equivalent to other legally marketed devices." This implies that the 'study' conducted (though not explicitly detailed in these excerpts) would have been a comparison to the predicate device, focusing on similar technological characteristics and intended use, rather than a clinical trial with performance metrics against acceptance criteria.
Therefore, I cannot provide the requested information such as a table of acceptance criteria, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC study results, standalone performance, types of ground truth, or training set details. These elements are typically associated with performance studies, which are generally beyond the scope of the information included in this 510(k) summary and FDA clearance letter.
The FDA's letter (K040258) confirms that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed, subject to general controls provisions of the Act (e.g., registration, labeling, GMP). It does not imply a clinical study with detailed performance metrics as would be required for innovative devices or those requiring PMA.
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040a258
Page __________ of ___________________________________________________________________________________________________________________________________________________________
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| ----- | ---------------- | ------------- |
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Synthes Medium External Fixation System - MR Safe |
| Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone fixation appliances and accessories. |
| Predicate Devices: | Synthes Medium External Fixation System |
| Device Description: | Synthes Medium External Fixation System - MR Safe is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamps (four / six position) - MR Safe, the Medium Combination Clamp - MR Safe, the 8.0 mm/11.0 mm Combination Clamp - MR Safe and the Medium Open Adjustable Clamp - MR Safe. Also included in this MR Safe system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the Combination and Multi-Pin Clamps, respectively. These clamp accessories allow dynamization during bone healing and double stacking of the frame. The system accepts Synthes 8.0 mm carbon fiber rods (in lengths from 100 - 500 mm) and Schanz screws (in diameters of 4.0 - 5.0 mm). |
All frame elements are made from non-magnetic materials and are intended for use in the MR environment.
| Intended Use: | Intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures. |
|---|---|
| Material: | Stainless steel, titanium alloy and cobalt alloy |
| Substantial Equivalence: | Documentation is provided in this premarket notification that demonstrates that Synthes Medium External Fixation System -- MR Safe is substantially equivalent to other legally marketed 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 stylized eagle with three stripes forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2004
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K040258
Trade/Device Name: Synthes (USA) Medium External Fixation System - MR Safe Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: KTT Dated: February 3, 2004 Received: February 4, 2004
Dear Ms. Silvestri:
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 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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice 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.
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Page 2 - Ms. Angela J. Silvestri
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.
b. Mark M. Wilkerson
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 _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known):
040258
of pediatric and adult fractures.
Device Name:
Synthes (USA) Medium External Fixation System - MR Safe
Indications:
The Synthes (USA) Medium External Fixation System is intended for use in the construction of an external fixator frame for the treatment
Mark N Milliman
Division Sign Off
Division of and Neurologic
040258 510(k) Number_________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
CONFIDENTIAL 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.