(41 days)
The Synthes Distraction Osteogenesis System is intended for fracture fixation (open and closed), pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental bony or soft tissue defects.
The Synthes Distraction Osteogenesis System is an external ring fixation system. The system is comprised of wires and Schanz screws that are attached to rings with bolts, nuts and/or clamps; rods that interconnect the rings; and connecting plates, hinges, standoffs, posts and supports that complete the assembly of the fixator. The system components are made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR scanner and/or anywhere in the procedure room, including the center of the bore of the MR scanner. The Synthes Distraction Osteogenesis System is a modular and versatile system that is fully customizable. An individualized frame should be constructed for each case to suit the specific situation.
I am sorry, but the provided text from the 510(k) summary for the Synthes Distraction Osteogenesis System does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data.
The document discusses:
- Device Name and Sponsor
- Classification and Predicate Devices
- Device Description (components and materials)
- Intended Use
- A statement regarding substantial equivalence to other legally marketed devices.
- Correspondence from the FDA regarding the 510(k) clearance.
It explicitly states, "Substantial Documentation is provided which demonstrates that the Synthes (USA) Distraction Osteogenesis System is substantially equivalent to other legally marketed devices." This means the product's safety and effectiveness were primarily established by comparing it to existing, legally marketed devices, rather than through a new, comprehensive performance study with acceptance criteria.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
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510(k) Summary
Device Name:
Sponsor:
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JUL 2 7 2005
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1302 Wrights Lane East West Chester, PA 19380 Synthes (USA) Distraction Osteogenesis System
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- Class II, §888.3030 Single/multiple component bone fixation Classification: appliances and accessories
- Smith & Nephew Ilizarov External Fixation System Predicate Devices: Encore True/Lok External Fixation System
Synthes (USA)
(610) 719-5860
Device Description: The Synthes Distraction Osteogenesis System is an external ring fixation system. The system is comprised of wires and Schanz screws that are attached to rings with bolts, nuts and/or clamps; rods that interconnect the rings; and connecting plates, hinges, standoffs, posts and supports that complete the assembly of the fixator. The system components are made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR scanner and/or anywhere in the procedure room, including the center of the bore of the MR scanner.
The Synthes Distraction Osteogenesis System is a modular and versatile system that is fully customizable. An individualized frame should be constructed for each case to suit the specific situation.
- Intended Use: The Synthes Distraction Osteogenesis System is intended for fracture fixation (open and closed), pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental bony or soft tissue defects.
Substantial Documentation is provided which demonstrates that the Synthes Equivalence: (USA) Distraction Osteogenesis System is substantially equivalent to other legally marketed devices.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A
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Page ___________ of __________________________________________________________________________________________________________________________________________________________
determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S." are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051600
Trade/Device Name: Synthes (USA) Distraction Osteogenesis 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: July 21, 2005 Received: July 22, 2005
Dear Ms. Anderson:
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. Kathy Anderson
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 (240) 276-0120. 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/cdrl/dsma/dsmamain.html
Sincerely yours.
. Stip Purden
ark N. Melkerson Acting 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
510(k) Number (if known):
Device Name: Synthes (USA) Distraction Osteogenesis System
Indications for Use:
The Synthes Distraction Osteogenesis System is intended for fracture fixation (open and closed), pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental bony or soft tissue defects.
X = Prescription Use _ (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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
ad Neurological Devices
516(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.