(183 days)
The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
The TRANSLACE™ Spinal Tethering System consists of temporary implants and a reusable instrument for use in orthopedic spinal surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. This system will allow the spine to be secured to a rod construct without the use of a bone screw. It will act as an alternative to sublaminar wires and hooks.
This system consists of:
Connector Tether Tensioner Accessory – system specific tray which may be used to transport and sterilize the subject instruments. The subject TRANSLACE™ Spinal Tethering System devices will be available in similar sizes as the predicate systems.
The provided text describes a 510(k) premarket notification for the Medtronic TRANSLACE™ Spinal Tethering System, which is a medical device. This document is a regulatory submission to the FDA seeking clearance based on substantial equivalence to existing predicate devices, not an AI or diagnostic device that would involve performance metrics like sensitivity, specificity, or reader studies. Therefore, the questions about acceptance criteria, study data, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this type of device and submission.
The document discusses the following types of studies and criteria, relevant to medical hardware/implantable devices:
1. Acceptance Criteria and Device Performance (as related to spinal implants):
The acceptance criteria for this device are focused on biocompatibility and mechanical performance to ensure it is as safe and effective as its predicate devices. The document states that the device meets these criteria through various tests.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Test Type) | Reported Device Performance / Assessment |
|---|---|
| Biocompatibility | The biocompatibility evaluation was conducted in accordance with FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" issued June 16, 2016. The subject implants are classified as permanent, >30 day body contact. Tests conducted include: • Chemical Characterization • Cytotoxicity • Acute Systemic Toxicity • Material Mediated Pyrogenicity • Implantation Results: Based on the results, no additional testing was required, indicating the device met biocompatibility criteria. The materials (Titanium-6 Aluminum-4 Vanadium ELI, polyester, stainless steel) are identified as identical to or compliant with predicate devices and relevant ASTM standards (ASTM F136, ASTM F899, ASTM A564, ASTM A693, ASTM A276). |
| Mechanical Testing | Evaluated in accordance with "Guidance for Industry and FDA Staff – Spinal System 510(k)'s". A combination of engineering rationales and testing were used. Tests Completed: • Tether Grip Static Testing (ASTM F1798) • Tether Grip Fatigue Testing (ASTM F1798) • Static Axial Grip Testing (ASTM F1798) • Static Axial Rotational Grip Testing (ASTM F1798) • Compression Fatigue Testing (ASTM F1717) • Static Weld Testing • Cadaver and/or True-Trainer (Sawbone) Validation Testing • Instructions to Support Reprocessing Validation Results: The results of these tests demonstrated the substantial equivalence of the subject devices to the predicates. The validation activities were completed and met the predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Test set: The specific sample sizes for each mechanical and biocompatibility test are not explicitly enumerated in this summary. Instead, it refers to industry standards (ASTM) which would define the required sample sizes for such tests.
- Data Provenance: The data comes from bench testing and laboratory evaluations conducted by Medtronic Sofamor Danek USA, Inc. The document does not specify country of origin for the data beyond being part of a US submission by a US entity. It is the result of direct scientific and engineering evaluations, not retrospective or prospective clinical data from human subjects in the context of an AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a mechanical/biocompatibility study of a spinal implant is established through objective physical and chemical testing against defined standards (e.g., ASTM standards, ISO standards related to biocompatibility) and engineering principles, not through expert consensus on diagnostic images. No experts, in the sense of human readers/interpreters, are involved in generating the "ground truth" for these performance metrics.
4. Adjudication method for the test set:
- This question is not applicable. Adjudication methods are relevant for subjective interpretations, common in clinical studies or AI diagnostic performance evaluations (e.g., resolving disagreements among radiologists). The mechanical and biocompatibility tests described here rely on objective measurements and established protocols, not subjective human judgment requiring adjudication.
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:
- This question is not applicable. MRMC studies are used to evaluate the diagnostic performance of software, often AI-powered, and how it impacts human reader performance. The TRANSLACE™ system is a physical spinal implant, not a diagnostic AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. "Standalone performance" refers to the performance of a diagnostic algorithm or AI system by itself. The TRANSLACE™ system is a physical surgical device, not an algorithm. Its "performance" is measured by its material properties, mechanical strength, and biological safety.
7. The type of ground truth used:
- The "ground truth" for this device's performance evaluation is based on objective engineering and biological standards. This includes:
- Biocompatibility standards: ISO-10993 and specific tests (cytotoxicity, implantation, etc.) providing a biological "ground truth" for safety.
- Mechanical standards: ASTM standards (e.g., F1798, F1717) and specific mechanical tests providing an engineering "ground truth" for strength and stability.
- Material specifications: Compliance with ASTM standards for specific materials (e.g., titanium, stainless steel).
8. The sample size for the training set:
- This question is not applicable. This is not an AI or machine learning device requiring a "training set." The device is evaluated against established physical and biological benchmarks, not a dataset from which an algorithm learns.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this type of medical device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Inc. Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place
May 16, 2017
Re: K163181
Memphis. Tennessee 38132
Trade/Device Name: TRANSLACE™ Spinal Tethering System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: April 18, 2017 Received: April 19, 2017
Dear Ms. Evans:
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 of medical devicerelated 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.
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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" (21 CFR 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,
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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Indications for Use
510(k) Number (if known) K163181
Device Name TRANSLACETM Spinal Tethering System
Indications for Use (Describe)
The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
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) |
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510(k) SUMMARY
MEDTRONIC Sofamor Danek TRANSLACE™ Spinal Tethering System
April 2017
| Submitter: | Medtronic Sofamor Danek, USA Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901)396-3133 | |
| Fax: (901) 346-9738 | |
| Contact Person | Claire Evans |
| Senior Regulatory Affairs SpecialistDirect Telephone: (901)399-0804 | |
| Date Prepared | April 18, 2017 |
| Name of Device | TRANSLACE™ Spinal Tethering System |
| Common Name | Connector, Tether, Tensioner |
| Trade Name | TRANSLACE™ Spinal Tethering System |
| Regulatory Class,Regulation Number,Regulation Name, andDevice Product Code | Class II 21 CFR 888.3010 Bone Fixation Cerclage OWI |
| Predicate Devices | K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – Primary PredicateK143350 K2M Nile Alternate Fixation System (S.E. 2/25/2015)The predicates have not been subject to a design related recall. |
| Reference Devices | K101074 CD Horizon® Spinal System (S.E. 6/22/2010) |
| K152338 Vertex Reconstruction System (S.E. 10/28/2015) | |
| K152241 Medtronic Transportation/Sterilization Cassette System(S.E.1/20/2016) | |
| Description of Device | The TRANSLACE™ Spinal Tethering System consists oftemporary implants and a reusable instrument for use inorthopedic spinal surgery. The system is intended to providetemporary stabilization as a bone anchor during the developmentof solid bony fusion and aid in the repair of bone fractures. Thissystem will allow the spine to be secured to a rod constructwithout the use of a bone screw. It will act as an alternative tosublaminar wires and hooks. |
| This system consists of:Connector Tether Tensioner Accessory – system specific tray which may be used to transport and sterilize the subject instruments. The subject TRANSLACE™ Spinal Tethering System devices will be available in similar sizes as the predicate systems. | |
| Indications for Use | The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:Spinal trauma surgery, used in sublaminar or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions. The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants. |
| Comparison ofTechnologicalCharacteristics with thePredicate Devices: | The TRANSLACE™ Spinal Tethering System has the same fundamental technology; polyester, titanium and stainless steel material as the predicate devices. The predicate and subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the spine.K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – Primary Predicate K143350 Nile Alternative Fixation System (S.E. 2/25/2015) |
| The following performance data were provided in support of | |
| substantial equivalence. | |
| Biocompatibility | |
| The biocompatibility evaluation for the TRANSLACE™ Spinal | |
| Tethering System devices was conducted in accordance with | |
| FDA's Guidance for Industry and FDA Staff "Use of International | |
| Standard ISO-10993, Biological Evaluation of Medical Devices | |
| Part 1: Evaluation and Testing within a Risk Management | |
| Process" issued June 16, 2016. | |
| The subject implants are temporary implants and will be classified | |
| as permanent, >30 day body contact according to with FDA's | |
| Guidance for Industry and FDA Staff "Use of International | |
| Standard ISO-10993, Biological Evaluation of Medical Devices | |
| Part 1: Evaluation and Testing within a Risk Management | |
| Process" issued June 16, 2016. | |
| The subject Connector is manufactured from identical materials as | |
| Performance Data: | the predicate devices, in accordance with the following ASTM |
| standard: | |
| • ASTM F136 – Standard Specification for Wrought | |
| Titanium-6 Aluminum-4 Vanadium ELI (Extra Low | |
| Interstitial) Alloy for Surgical Implant Applications | |
| The subject Tether is manufactured from polyester and titanium. | |
| The following tests have been conducted to ensure | |
| biocompatibility: | |
| • Chemical Characterization | |
| • Cytotoxicity | |
| • Acute Systemic Toxicity | |
| • Material Mediated Pyrogenicity | |
| • Implantation | |
| Based on the results, no additional testing was required. | |
| The subject instrument is an external communicating devices and | |
| is classified as limited, up to 24 hours of body contact according | |
| to with FDA's Guidance for Industry and FDA Staff "Use of | |
| International Standard ISO-10993, Biological Evaluation of | |
| Medical Devices Part 1: Evaluation and Testing within a RiskManagement Process" issued June 16, 2016. This instrument ismanufactured from the same medical grade stainless steel as thepredicate devices in accordance with the following ASTMstandards: | |
| ASTM F899 – Standard Specification for WroughtStainless Steel for Surgical Instruments ASTM A564 – Standard Specification for Hot-Rolled andCold Finished Age-Hardening Stainless Steel Bars andShapes ASTM A693 – Standard Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheetand Stripe ASTM A276 – Standard Specification for Stainless Barsand Shapes | |
| The system specific tray used for shipment and sterilization ofinstruments is manufactured from stainless steel, aluminum, nyloncoated stainless steel, radel, polypropylene with the bracketssecuring the instruments into the case/tray made of silicone and/ornylon coated stainless steel and/or polypropylene. Thesematerials are non-patient contacting and indirect patient contactingand are the same materials as the predicate. Therefore, no newbiocompatibility testing is required. | |
| Mechanical Testing | |
| In accordance with, Guidance for Industry and FDA Staff – SpinalSystem 510(k)'s", Medtronic has evaluated the subject devices todemonstrate substantial equivalence to the predicate devices. Acombination of engineering rationales and testing were used toestablish substantial equivalence. The following bench testingwas completed and the results of these tests demonstrated thesubstantial equivalence of the subject devices to the predicates. | |
| Tether Grip Static Testing (ASTM F1798) Tether Grip Fatigue Testing (ASTM F1798) Static Axial Grip Testing (ASTM F1798) Static Axial Rotational Grip Testing (ASTM F1798) Compression Fatigue Testing (ASTM F1717) | |
| Static Weld Testing The following validation activities were completed and met the predetermined acceptance criteria. Cadaver and/or True-Trainer (Sawbone) Validation Testing Instructions to Support Reprocessing Validation. | |
| Conclusion: | Based on the risk analysis, test results, and additional supporting documentation provided in the pre-market notification, the subject TRANSLACET™ Spinal Tethering System is as safe and effective as the following predicates: K110348 Zimmer Universal Clamp (S.E. 8/11/2011) –Primary Predicate K143350 Nile Alternative Fixation System (S.E. 2/25/2015) |
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§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.