(170 days)
Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally; the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy.
Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanteric osteotomy during total hip arthroplasty.
The Cable-Ready Greater Trochanter Reattachment Short and Long (GTR) devices are used in combination with 1.8mm cobalt chrome alloy cerclage cables to stabilize fractures of the greater trochanter or reattach the greater trochanter after osteotomy in total hip replacement. The GTR devices are designed with two upper prongs that loop around the greater trochanter and two small fins on the lower side to prevent migration or rotation.
In addition to being used with the GTR devices, the cobalt chrome alloy 1.8mm cerclage cables, along with the stainless steel cables, can be used alone to secure bone fractures.
The provided FDA 510(k) summary for the Zimmer Cable-Ready® Cable Grip System (K151907) describes a medical device for bone fixation. However, it does not contain the detailed information necessary to complete the acceptance criteria table and the study description as requested.
This document focuses on establishing substantial equivalence for a physical medical device (bone cables and grip system) based on non-clinical performance (shelf life, biocompatibility, and fatigue testing), rather than an AI/software medical device requiring specific performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the following information from the provided text:
- Acceptance Criteria and Reported Device Performance (Table): The document states "A construct fatigue test...and an engineering analysis...demonstrate the subject devices are safe and effective," but it does not provide specific quantitative acceptance criteria or performance metrics (e.g., in terms of force, displacement, or number of cycles) that would typically be found for an AI device.
- Sample size used for the test set and the data provenance: Not applicable as it's not an AI/data-driven study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical data and conclusions were not needed for these devices to show substantial equivalence," indicating no human reader study was performed.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical device, not an algorithm.
- Type of ground truth used: Not applicable for an AI sense. The "ground truth" for this device would be its mechanical integrity and biocompatibility, demonstrated through non-clinical laboratory tests.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information regarding device performance:
The document mentions three non-clinical performance assessments:
- Shelf Life Accelerated aging testing: Concluded that sterile devices have a shelf life of 10 years.
- Biocompatibility testing: Conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation:
- A construct fatigue test for the GTR system.
- An engineering analysis for the 1.8mm cerclage cables.
These tests were used to demonstrate that the subject devices are safe and effective and substantially equivalent to predicate devices. However, no specific performance values or acceptance criteria for these tests are detailed in this summary.
Conclusion:
The provided document describes a traditional 510(k) submission for a physical orthopedic device and relies on non-clinical engineering and bench testing to demonstrate substantial equivalence. It does not involve AI or software, and therefore, the requested information pertaining to AI/ML device evaluation criteria (such as sensitivity, specificity, reader studies, ground truth establishment from expert consensus, etc.) is not present.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2015
Zimmer, Incorporated Ms. Dalene Binkley Senior Specialist. Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46580
Re: K151907
Trade/Device Name: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDQ Dated: December 14, 2015 Received: December 15, 2015
Dear Ms. Binkley:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K151907 Page 1 of 2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Cable-Ready® Cable Grip System: Cable-Ready® GTR System
Indications for Use (Describe)
Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally; the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Cable-Ready® Cable Grip System: Cable-Ready®1.8mm Cerclage Cables
Indications for Use (Describe)
Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanteric osteotomy during total hip arthroplasty.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Sponsor: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Dalene Binkley, MS, RACSenior Specialist, Trauma Regulatory AffairsTelephone: 574-372-4970Fax: (574) 372-4605 |
| Date: | July 10, 2015 |
| Trade Name: | This is a bundled traditional 510(k). The two systemsbundled in this submission are: |
| Cable-Ready® Cable Grip System: | |
| 1) Cable-Ready GTR System2) Cable-Ready 1.8mm Cerclage Cables | |
| Common Name: | Single/multiple component metallic bone fixationappliance and accessories and cerclage, bone fixation |
| Classification Namesand References: | Single/multiple component metallic bone fixationappliance and accessoriesRegulation Number: CFR 888.3030Classification Number: 87 KTT |
| Cerclage, fixationRegulation Number: CFR 888.3010Classification Number: 87 JDQ | |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Pioneer System GTR (Greater Trochanter Reattachment)(Pioneer Laboratories, Inc., K961267, cleared 6/27/96) |
| Extended GTR Device (Pioneer Surgical Technology,K000734, cleared 5/5/00) |
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Songer Cable System (Pioneer Laboratories, K935481, cleared 1/26/94)
| Device Description: | The Cable-Ready Greater Trochanter Reattachment Shortand Long (GTR) devices are used in combination with1.8mm cobalt chrome alloy cerclage cables to stabilizefractures of the greater trochanter or reattach the greatertrochanter after osteotomy in total hip replacement. TheGTR devices are designed with two upper prongs that looparound the greater trochanter and two small fins on thelower side to prevent migration or rotation.In addition to being used with the GTR devices, the cobaltchrome alloy 1.8mm cerclage cables, along with thestainless steel cables, can be used alone to secure bonefractures. |
|---|---|
| Intended Use: | Cable-Ready GTR System:The Cable-Ready GTR System is indicated for thereattachment of the greater trochanter following osteotomyin total hip arthroplasty. Additionally, the device is used toreattach the greater trochanter following fracture of thegreater trochanter, nonunion of fracture, or previousosteotomy.Cable-Ready 1.8mm Cerclage Cables:Cable-Ready 1.8mm Cerclage Cables - The 1.8mmcerclage cable can be used to secure fractures of theolecranon, patella, femur, humerus, and ankle, as well as toreduce and secure acromioclavicular dislocations. The1.8mm cables can also be used to reattach the greatertrochanter after trochanteric osteotomy during total hiparthroplasty. |
| Comparison to Predicate Device: | The subject devices incorporate similar or identicalmaterials, similar or identical indications for use, similaror identical sizes of implants, and the same technologicalcharacteristics as the predicate devices. |
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Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
- Shelf Life Accelerated aging testing conducted . shows that the sterile devices included in this submission have a shelf life of 10 years.
- Biocompatibility Biocompatibility testing of the . subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation A construct fatigue test . for the GTR system and an engineering analysis for the 1.8mm cerclage cables demonstrate the subject devices are safe and effective and substantially equivalent to the predicate devices.
Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to their respective predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.
§ 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.