(85 days)
INTEGRA® Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
The INTEGRA "Total Foot System consists of a variety of bone plates and screws intended to be used in fixating fractures, osteotomies, and fusions in the adult foot. The various plate designs are divided into forefoot, midfoot, and rearfoot applications. Plate designs include MPJ fusion, Opening Wedge, Calcaneus, Dwyer, Interpositioning, Lapidus, Reconstruction, 2-10 Hole Tarsalis, fibula, and fibula tubular plates. Screws include both locking and non-locking designs. All plates and screws are manufactured from ASTM F136 Ti-6Al-4V ELI alloy.
The provided text describes a 510(k) premarket notification for the "INTEGRA® Total Foot System," a medical device consisting of bone plates and screws. This type of submission is for demonstrating "substantial equivalence" to existing legally marketed devices, rather than proving efficacy through clinical studies with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies.
The study described is a design verification and substantial equivalence comparison to predicate devices, not a study to prove performance against specific acceptance criteria.
Here's why the requested information is not available in this document:
- Acceptance Criteria and Reported Device Performance: The document states, "All new or redesigned components to this system were examined, and results of the verification activities demonstrated that the tests were acceptable and the components substantially equivalent to the predicate devices identified." It does not provide specific quantitative acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or objective metrics) or actual performance data for the device. The "performance" being evaluated here is primarily mechanical and material equivalence to predicates.
- Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the context of clinical performance or algorithm evaluation. The "tests" mentioned are verification activities on the physical components.
- Number of Experts and Qualifications: Not applicable. There is no mention of experts establishing ground truth for a test set.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study relates to the diagnostic performance of humans with and without AI assistance, which is irrelevant for a bone fixation system.
- Standalone Performance: Not applicable. This term refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device like a bone fixation system.
- Type of Ground Truth Used: Not applicable in the context of diagnostic performance. The "ground truth" for this device would be established engineering standards and material properties, compared against the predicate devices.
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, the provided K123000 document details a 510(k) submission for a bone fixation system. The "study" referenced is a technical verification of components and a demonstration of substantial equivalence to existing predicate devices based on design, materials, and intended use. It does not involve the types of performance studies or acceptance criteria that would be relevant for a diagnostic or AI-driven device, as implied by the questions.
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K123000(pg 1/2)
Integra LifeSciences Corporation Traditional 510(k) Premarket Notification INTEGRA® Total Foot System
510(K) SUMMARY
INTEGRA® Total Foot System
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Facsimile: 609.275.9445
Stephen Beier Senior Specialist, Regulatory Affairs Telephone: 609.936.5436
Date Summary was prepared:
September 26, 2012
Name of the device:
Proprietary Name: INTEGRA Total Foot System Common Name: Plate, Fixation, Bone Product Code: HRS Subsequent Product Code: HWC (Screw, Fixation, Bone) Classification Panel: Orthopedic
Substantial Equivalence:
INTEGRA Total Foot System is substantially equivalent in function and intended use to the predicate device detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K100502 | HRS; HWC | Ascension Total PlateSystem | Integra LifeSciencesCorporation, formallyAscension Orthopedics,Inc. |
| K091614 | HRS; HWC | Osetomed Foot PlatingSystem | Osteomed, L.P. |
| K094037 | KTT | TC Plating System | Orthopro, LLC |
| K102282 | HRS | VariAx Locked PlatingSystem | Howmedica OsteonicsCorp |
| K063049 | HRS | Synthes (USA) ModularMini Fragment LCPSystem | Synthes (USA) |
Device Description:
The INTEGRA "Total Foot System consists of a variety of bone plates and screws intended to be used in fixating fractures, osteotomies, and fusions in the adult foot. The various plate designs are divided into forefoot, midfoot, and rearfoot applications. Plate designs include MPJ fusion, Opening Wedge, Calcaneus, Dwyer, Interpositioning, Lapidus, Reconstruction, 2-10 Hole Tarsalis,
DEC 2 1 2012
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Integra LifeSciences Corporation Traditional 510(k) Premarket Notification INTEGRA® Total Foot System
fibula, and fibula tubular plates. Screws include both locking and non-locking designs. All plates and screws are manufactured from ASTM F136 Ti-6Al-4V ELI alloy.
Intended Use:
INTEGRA Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
Substantial Equivalence Comparison:
Components of the INTEGRA Total Foot System are similar in design and materials to the predicate devices: (K100502, K091614, K094037, K102282, and K063049).
Testing and Test Results:
The INTEGRA® Total Foot System and Ascension `Total Foot System (K100502) are both systems comprised of titanium plates and screws with identical indications for use. Additional predicate devices have been included to justify the inclusion of new components to the system.
All new or redesigned components to this system were examined, and results of the verification activities demonstrated that the tests were acceptable and the components substantially equivalent to the predicate devices identified.
Conclusion:
The INTEGRA Total Foot System is substantially equivalent to the commercially marketed devices, Ascension Total Foot System (K100502). Additional predicate devices to this system include Osteomed Foot Plating System (K091614), OrthoPro TC Plating System (K094037), Stryker VariAx Locked Plating System (K102282), and the Synthes Modular Mini Fragment LCP System (K063049).
The designs and design modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the predicate devices, nor do they raise any new issues of safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Integra LifeSciences Corporation % Mr. Stephen H. Beier Senior Specialist, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536
December 21, 2012
Re: K123000
Trade/Device Name: INTEGRA® Total Foot 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: September 26, 2012
Received: September 27, 2012
Dear Mr. Beier:
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 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. Stephen H. Beier
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Director . Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
INTEGRA® Total Foot System Device Name:
Indications For Use: INTEGRA® Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Krishna Asundi
Division of Orthopedic Devices
Page 1 of 1
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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.