(84 days)
Synthes 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone.
The Synthes 1.5mm Mini Fragment LCP System consists of low-profile plates of various shapes as well as locking and cortex screws which are intended to treat small bones and small fragments. The plates and screws of the 1.5mm Mini Fragment LCP System are available in stainless steel and titanium.
This document is a 510(k) summary for the Synthes (USA) 1.5mm Mini Fragment LCP System. It outlines the device's classification, predicate devices, description, and intended use as part of a submission to the FDA. The letter on page 1 confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices.
Based on the provided document, the device is a medical implant system and not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria, study details, ground truth, experts, and human-in-the-loop performance are not applicable.
Here's a breakdown of the requested information based on the provided document, addressing what is present and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance reports in the context of an engineering or clinical study. The FDA's determination of "substantial equivalence" is the primary outcome, meaning the device performs as safely and effectively as a legally marketed predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics for this device type within the document. For medical devices like this, relevant "acceptance criteria" generally revolve around demonstrating equivalence in materials, design, and intended use to a predicate device, as well as meeting general safety and performance manufacturing standards. This is assessed through various engineering tests and comparisons which are summarized for the 510(k) rather than detailed as acceptance criteria tables in this summary. | Substantial Equivalence: The FDA determined the device is "substantially equivalent" to predicate devices, implying it meets the necessary safety and effectiveness standards for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided: This is a submission for a medical implant (bone fixation system), not an AI/ML device that would typically involve a "test set" of data for performance evaluation in the way the question implies. The "testing" for such a device would involve mechanical and material characterization, biocompatibility, and potentially animal or cadaver studies, none of which are detailed in this 510(k) summary.
3. 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 / Not provided: As above, this pertains to AI/ML device evaluation and is not relevant to this medical implant submission. The "ground truth" for a bone fixation system is typically established through engineering principles, mechanical testing, and clinical outcomes, not expert consensus on data sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided: This is relevant to expert review of data for AI/ML devices, not for a medical implant device's 510(k) submission.
5. 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 / Not provided: This is specifically for AI/ML driven diagnostic or assistive devices, not for a bone fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided: This refers to AI/ML algorithm performance and does not apply to this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided in this summary directly: For a bone fixation system, "ground truth" related to its effectiveness and safety would involve:
- Mechanical Testing Data: Demonstrating strength, fatigue, and torsional properties meet industry standards and are comparable to predicate devices.
- Biocompatibility Testing: Ensuring materials are safe for implantation.
- Clinical Literature/Experience with Predicate: Reliance on the established safety and efficacy of the predicate devices.
- Intended Use Clinical Outcomes: While not explicitly detailed as "ground truth data" in this summary type, the intended use implies the device is expected to achieve stable fixation, facilitate healing, and accommodate osteopenic bone, which are ultimately assessed through clinical outcomes over time.
8. The sample size for the training set
- Not applicable / Not provided: This concept applies to AI/ML models, not traditional medical devices like this bone fixation system.
9. How the ground truth for the training set was established
- Not applicable / Not provided: This concept applies to AI/ML models, not traditional medical devices like this bone fixation system.
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K09004749 1/1)
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| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941APR -1 200 | |
| Device Name: | Synthes (USA) 1.5mm Mini Fragment LCP System | |
| Classification: | Class 11, §888.3030 - Single / multiple component metallic bonefixation appliance and accessories. | |
| Predicate Device: | Synthes Modular Mini Fragment LCP SystemSynthes Stainless Steel Modular Hand System | |
| Device Description: | The Synthes 1.5mm Mini Fragment LCP System consists of low-profile plates of various shapes as well as locking and cortex screwswhich are intended to treat small bones and small fragments. Theplates and screws of the 1.5mm Mini Fragment LCP System areavailable in stainless steel and titanium. | |
| Intended Use: | Synthes 1.5mm Mini Fragment LCP System is indicated forfixation of small bones and small fragments, osteotomies,arthrodeses, replantations, and reconstructions of small bones andsmall fragments, particularly in osteopenic bone. | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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Image /page/1/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 stripes forming its body and wing. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Pkwy. West Chester, PA 19380
APR - 1 2009
Re: K090047 Trade/Device Name: Synthes (USA) 1.5mm Mini Fragment LCP 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 Dated: January 5, 2009 Received: January 7, 2009
Dear Mr. Nittinger:
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 - Mr. Karl J. Nittinger
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240).276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bachus
Mark N. Melk 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 |
|---|---|
| 510(k) Number (if known): | K090047 (pg1/1) |
| Device Name: | Synthes (USA) 1.5mm Mini Fragment LCP System |
| Indications for Use: | Synthes 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone. |
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)
Charles Beecher for
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K090047
§ 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.