(67 days)
The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The Synthes 3.5mm LCP Clavicle Plate System consists of metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle.
Here's an analysis of the provided text regarding the Synthes 3.5mm LCP Clavicle Plate System, focusing on the acceptance criteria and the study that "proves" the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K101536, K073186, K000684) in intended use and design. | "The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design." The intended use and device description are provided, demonstrating alignment with the predicate devices' general function (fixation of clavicle fractures). |
| Substantial equivalence in mechanical strength. | "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in terms of mechanical strength." Specifically, "Testing conducted to support the substantial equivalence for the Synthes 3.5mm LCP Clavicle Plate System was performed to assess the bending strength of the subject device compared to the predicate." |
| Identical manufacturing methods, packaging, and sterilization to predicate devices. | "In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical." |
| Comparable mechanical and functional properties. | "Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject Synthes 3.5mm LCP Clavicle Plate System to the predicate devices." (This is a broader statement encompassing the specific bending strength test). |
| Material composition (stainless steel and titanium alloy). | "The subject and predicate devices are made from stainless steel and titanium alloy." |
Study Details and Analysis:
The provided document describes a 510(k) Premarket Notification, not a clinical study in the traditional sense involving human subjects or extensive clinical efficacy data. The "study" referenced here is focused on demonstrating substantial equivalence to already legally marketed predicate devices, a requirement for 510(k) clearance.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of the number of unique devices tested. The document mentions "testing conducted" to assess bending strength. For mechanical testing of medical devices, sample sizes are typically determined by statistical power analysis to detect differences, often involving multiple units of each design.
- Data Provenance: The testing was conducted by Synthes (USA), the device manufacturer. The data is internal testing data. There is no mention of country of origin for clinical data because this is not a clinical trial; it's a mechanical testing report.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" as it relates to expert consensus for clinical disease states is not relevant here. The "ground truth" for mechanical testing is established by engineering principles, validated testing methodologies, and comparisons to established performance benchmarks (the predicate devices). The experts involved would be qualified engineers and technicians performing the mechanical tests, but their number and specific qualifications are not detailed in this summary.
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Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical image interpretation or diagnosis. For mechanical testing, if multiple tests are run, results are compared against a pre-defined acceptance criterion (e.g., maximum load, deflection, fracture point) of the predicate device. Discrepancies would likely be resolved through re-testing or investigation into the testing methodology, not expert adjudication in the clinical sense.
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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:
- No. This is a medical device (bone plate and screws), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study is completely irrelevant and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical implantable medical device, not an algorithm. Therefore, "standalone algorithm" performance is not applicable.
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The type of ground truth used:
- The "ground truth" for this submission is the mechanical performance of the predicate devices. The subject device's mechanical properties (specifically bending strength) were compared against those of the predicate devices. This comparison, along with identical materials and other features, forms the basis for demonstrating substantial equivalence.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical medical device's mechanical testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" described is a benchtop mechanical testing comparison between the Synthes 3.5mm LCP Clavicle Plate System (subject device) and its predicate devices (Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System, Synthes 3.5mm LCP Clavicle Plate System, and Synthes Small Fragment Dynamic Compression Locking System).
- Objective: To demonstrate substantial equivalence of the subject device to the predicate devices, primarily in terms of mechanical strength (specifically bending strength).
- Methodology: Mechanical testing was performed on the subject device and compared to the predicate devices. The document highlights that "functional and mechanical testing demonstrates the comparable mechanical & functional properties." It also states that manufacturing methods, packaging, and sterilization are identical, and materials are the same (stainless steel and titanium alloy).
- Conclusion: The results of the mechanical testing, coupled with similarities in intended use, design, materials, and manufacturing processes, led the FDA to determine that the device is "substantially equivalent" to the legally marketed predicate devices, thereby clearing it for market.
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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a small "R" in a circle to the right of the word, indicating that it is a registered trademark.
AUG - 8 2011
3.0 510(k) Summary
Page _________________________________________________________________________________________________________________________________________________________________________
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Date Prepared: May 31, 2011
| Sponsor: | Synthes (USA)Thomas N. Shea1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941 |
|---|---|
| Device Name: | Synthes 3.5mm LCP Clavicle Plate System |
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone fixationappliance and accessories. |
| PredicateDevices: | Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System (K101536) |
| Synthes 3.5mm LCP Clavicle Plate System (K073186) | |
| Synthes Small Fragment Dynamic Compression Locking System(K000684) | |
| DeviceDescription: | The Synthes 3.5mm LCP Clavicle Plate System consists of metallicplates and screws that offer screw to plate locking designed for variousfracture modes of the clavicle. |
| Intended Use: | The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixationof fractures, malunions, non-unions, and osteotomies of the clavicle inadults, and in both adolescents (12-18 years) and transitional adolescents(18-21 years), in which the clavicular growth plates have fused or inwhich the growth plates will not be crossed by the plate system. |
| SubstantialEquivalence: | The features of the subject components are substantially equivalent tothe predicate devices based on similarities in intended use and design.Mechanical testing demonstrates substantial equivalence of the subjectcomponents to the predicate devise in terms of mechanical strength. Inaddition, the intended use, manufacturing methods, packaging, andsterilization of the predicate and subject components are identical. |
| The subject and predicate devices are made from stainless steel andtitanium alloy. Functional and mechanical testing demonstrates thecomparable mechanical & functional properties of the subject Synthes3.5mm LCP Clavicle Plate System to the predicate devices. | |
| Testing conducted to support the substantial equivalence for the Synthes3.5mm LCP Clavicle Plate System was performed to assess the bendingstrength of the subject device compared to the predicate. |
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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 lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Thomas N. Shea Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
AUG - 8 2011
Re: K111540
Trade/Device Name: Synthes 3.5mm LCP Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: May 31, 2011 Received: June 2, 2011
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Thomas N. Shea
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 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" (2111,Free) 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 yours.
ea
M
Mark N. Melker 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): _ KJ11540
Device Name: Synthes 3.5mm LCP Clavicle Plate System
Indications for Use:
The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
Prescription Use __ X (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)
for M. Mellersm
(Division Sign-Off (Division Sigh on Sign of Orthopedic, Division of Restorative Devices
510(k) Number K111540
Premarket Notification 510(k): Synthes 3.5mm LCP Clavicle 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.