(86 days)
Synthes Dynamic Compression Locking Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.
Synthes One-Third Tubular DCL Plate line extension is a threaded version of the currently marketed Synthes Third Tubular Plate. The threaded plates will accept locking screws and therefore can be included as part of the Small Fragment DCL System. The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy.
This document is a 510(k) premarket notification for a medical device and, as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data. Therefore, many of the requested elements for an AI/device performance study are not applicable or cannot be extracted from this type of regulatory submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable for this Submission Type)
This document does not describe specific quantitative acceptance criteria or a study with reported device performance in the way one would expect for an AI or diagnostic device approval. Instead, it demonstrates "substantial equivalence" to a previously approved predicate device.
The "performance" is implicitly deemed acceptable if the device is substantially equivalent to a device already deemed safe and effective. The key "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device has the same intended use, technological characteristics, and safety/efficacy profile as the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Intended Use: Same as predicate device. | "Synthes One-Third Tubular DCL Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System." This is stated to be the same intended use as other plates in the system. |
| Technological Characteristics: Same as predicate device, or differences do not raise new questions of safety or effectiveness. | "The Synthes One-Third Tubular Plate has the same technological characteristics as the predicate device/ system identified above. Both will be offered in the same materials and with the same sterility options. The only difference is that these new plates will have the locking threads and be offered as a part of the Synthes Small Fragment DCL System." The addition of locking threads is implicitly considered not to raise new safety/efficacy questions given the overall system context. |
| Safety and Efficacy: No new questions of safety or efficacy are raised by the differences. | "The new plates have the same intended use as other plates in the system and there is no change in safety or efficacy." This statement is a direct assertion. This is typically supported by engineering testing (e.g., mechanical strength), biocompatibility data (if materials changed), and comparison to clinical performance of the predicate, though detailed results are not in this summary. The FDA's letter states: "we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." implying accepted safety and efficacy. |
Non-Applicable / Not Provided Information for AI/Diagnostic Study:
Due to the nature of this submission (a 510(k) for a mechanical implant line extension), the following information typically relevant for an AI/diagnostic device performance study is not available or not applicable:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, not an AI or diagnostic device that relies on a "test set" of patient data in this context. Substantial equivalence is typically demonstrated through engineering tests (e.g., biomechanical), material testing, and comparison to the predicate's design and use.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of clinical expert consensus is not a concept for this type of mechanical device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device does not have an "algorithm-only" performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/diagnostic study. The "truth" for this device relates to its mechanical properties, biocompatibility, and intended function matching that of similar approved devices.
- The sample size for the training set: Not applicable. This device does not use a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a regulatory submission demonstrating substantial equivalence for a medical implant line extension. It is not an article describing a performance study for an AI or diagnostic device, and therefore the majority of the requested information about such a study is not present. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence as defined by the FDA's 510(k) pathway.
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JUL 2 7 2001
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011335
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3. Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Matthew M. Hull(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes One-Third Tubular DCL Plate |
| Regulation & Classification | Class II, §888.3030 - Plate, Fixation, Bone(HRS) |
| Predicate Device | Synthes Third Tubular Plate (Pre-Amendment)Synthes Small Fragment Dynamic Compression Locking (DCL)System (K000684) |
| Device Description | Synthes One-Third Tubular DCL Plate line extension is a threadedversion of the currently marketed Synthes Third Tubular Plate. Thethreaded plates will accept locking screws and therefore can beincluded as part of the Small Fragment DCL System. The new plateshave the same intended use as other plates in the system and there isno change in safety or efficacy. |
| Intended Use | Synthes Dynamic Compression Locking Plate System is intended forfixation of fractures, osteotomies, and non-unions of the clavicle,scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, andfibula, particularly in osteopenic bone as a part of the Synthes SmallFragment DCL System. |
| TechnologicalCharacteristics | The Synthes One-Third Tubular Plate has the same technologicalcharacteristics as the predicate device/ system identified above. Bothwill be offered in the same materials and with the same sterilityoptions. The only difference is that these new plates will have thelocking threads and be offered as a part of the Synthes SmallFragment DCL System. |
Abbreviated 510(k): Synthes One-Third Tubular Plate for the Small Fragment DCL System (Line Extension) CONFIDENTIAL
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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 features a stylized graphic of three human profiles facing right, layered on top of each other. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Public Health Service
JUL 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew M. Hull, RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K011335
Trade Name: Synthes One-Third Tubular DCL Plate Regulation Number: 21 CFR 888.3030 Regulatory Class: II Product Code: HRS Dated: April 30, 2001 Received: May 2. 2001
Dear Mr. Hull:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Matthew M. Hull, RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Bmtcheetuthor
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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8. Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications/ Contraindications:
KO11335
Synthes One-Third Tubular Plate
Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.
(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_
взткишичкортскии
(Division Sign-Off) (Division Sign of General, Restorative DIVision of Neurological Devices
Abbreviated 510(k): Synthes One-Third Tubular1fdffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffff nt DCL System (Line Extension) CONFIDENTIAL
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§ 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.