(90 days)
The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and osteopenic bone.
The Synthes 3.5 mm VA-LCP Proximal Tibia Plate System consists of pre-contoured bone fixation plates intended for the treatment of fractures of the proximal tibia. Variable angle screws can be angled up to 15 degrees from the normal trajectory prior to locking the screw to the plate. Percutaneous instrumentation will allow the variable angle plates and screws to be applied through minimally invasive techniques.
The provided text describes the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. This is not a study that evaluates an AI/ML powered device, therefore, many of the requested criteria are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured?) | Reported Device Performance (How did it perform?) |
|---|---|
| Fatigue strength | "comparable mechanical performance to the predicate" |
| Bending moment | "comparable mechanical performance to the predicate" |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "Static and dynamic construct testing" and "mechanical testing," but it does not specify the sample size for these tests (e.g., number of plates or screws tested).
The data provenance is from laboratory mechanical testing conducted by the manufacturer, Synthes. It is not human-derived data and therefore not retrospective or prospective in the medical sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This criterion is not applicable as the study is a mechanical validation of a physical medical device, not a diagnostic or AI-powered device requiring expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
This criterion is not applicable for the same reason as point 3. Mechanical testing results are objective measurements, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This criterion is not applicable. The device is a physical bone fixation system, not a software or AI-assisted diagnostic tool that would involve human readers or an AI-enabled workflow.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This criterion is not applicable. The device is a physical implant, not an algorithm, and therefore does not have a "standalone" algorithmic performance. The mechanical testing implicitly represents "standalone" performance of the physical device under simulated conditions.
7. Type of Ground Truth Used
The ground truth used was mechanical engineering standards and predicate device performance. The goal was to demonstrate that the novel device's mechanical properties (fatigue strength, bending moment) were comparable to those of existing, legally marketed predicate devices.
8. Sample Size for the Training Set
This criterion is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing processes are informed by engineering principles and prior device knowledge, but not in the same way an AI model is "trained."
9. How the Ground Truth for the Training Set Was Established
This criterion is not applicable for the same reason as point 8.
Summary of the Study and Acceptance Criteria from the document:
The study described is a mechanical performance evaluation aimed at demonstrating the substantial equivalence of the Synthes 3.5 mm VA-LCP Proximal Tibia Plate System to its predicate devices.
Acceptance Criteria: The device was expected to show comparable mechanical performance in terms of fatigue strength and bending moment when compared to the predicate devices.
Study Description:
- Study Type: Static and dynamic construct mechanical testing.
- Purpose: To assess the fatigue strength and bending moment of the subject device.
- Conclusion: "The results of the mechanical evaluation confirm that the subject device is substantially equivalent to the predicate."
In essence, the "acceptance criteria" here were met by showing that the new device's mechanical behavior was not inferior to the established, safe, and effective predicate devices.
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JUN - 4 2012
3.0 510(k) Summary
Page ________ of _____________________________________________________________________________________________________________________________________________________________
| Sponsor: | SynthesThomas N. Shéa1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6809 |
|---|---|
| Device Name: | Synthes 3.5 mm VA-LCP Proximal Tibia Plate System |
| Classification: | Product Code - HRS/HWC, Plate, Fixation, Bone, Class II,§888.3030 - (Single/multiple component metallic bone fixationappliances and accessories.) |
| Predicate Devices: | Synthes 4.5mm LCP Proximal Tibia Plate K011978Synthes LCP Proximal Tibia Plate K052390Synthes Large Fragment Dynamic Compression Locking (DCL)System K000682OrthoPediatrics PediLoc™ Locking Plate System K083286 |
| Device Description: | The Synthes 3.5 mm VA-LCP Proximal Tibia Plate System consistsof pre-contoured bone fixation plates intended for the treatment offractures of the proximal tibia. Variable angle screws can be angledup to 15 degrees from the normal trajectory prior to locking the screwto the plate. Percutaneous instrumentation will allow the variableangle plates and screws to be applied through minimally invasivetechniques. |
| Intended Use: | The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents inwhich the growth plates have fused including: simple, comminuted,lateral wedge, depression, medial wedge, bicondylar combination oflateral wedge and depression, periprosthetic, and fractures withassociated shaft fractures. Plates can also be used for treatment ofnonunions, malunions, tibial osteotomies and osteopenic bone. |
| SubstantialEquivalence: · | Information presented supports substantial equivalence of the Synthes3.5 mm VA-LCP Proximal Tibia Plate System to the predicatedevices, Synthes 4.5mm LCP Proximal Tibia Plate K011978. SynthesLarge Fragment Dynamic Compression Locking (DCL) SystemK000682, and Orthopediatrics PediLoc Locking Plate SystemK083286. The proposed tibia plates have the same indications foruse, are similar in shape/design and incorporate the same fundamentaltechnology.Static and dynamic construct testing was conducted on the proposedplates and screws in order to demonstrate comparable mechanicalperformance to the predicate. The mechanical testing was designed toassess the fatigue strength and bending moment of the subject device. |
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and the comments of the count
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The results of the mechanical evaluation confirm that the subject . device is substantially equivalent to the predicate.
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Premarket Notification 510(k) Synthes 3.5 mm VA-LCP Proximal Tibia Plate System
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 talons, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) Products LLC % Mr. Thomas N. Shea Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
JUN - 4 2012
Re: K120689
Trade/Device Name: Synthes 3.5 mm VA-LCP Proximal Tibia Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II
Product Code: HRS. HWC Dated: March 2, 2012 Received: March 6, 2012
Dear Mr. Shea:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Thomas N. Shea
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR. Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
510(k) Number (if known): (120689
Device Name:
Synthes 3,5 mm VA-LCP Proximal Tibia Plate System
Indications for Use:
The Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and i osteopenic bone.
Prescription Use · AND/OR X (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RRRuch for
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 120689
Premarket Notification 510(k) Synthes 3.5 mm VA-LCP Proximal Tibia Plate System
§ 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.