(145 days)
The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
The EVOS Cabling System is used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures and osteotomies. The EVOS Cabling System may be used for supplementary fracture fixation when used with bone plates or screws. The EVOS Cabling System includes a sterile, stainless-steel cable implant (ASTM F1314) packaged together with a stainless-steel crimp (ASTM F138). Non-sterile, reusable instruments are also provided to facilitate proper implantation of the cable-crimp implant.
This is a 510(k) summary for a medical device (EVOS Cabling System), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI/ML evaluation is not applicable and not present in the provided text.
The document discusses the substantial equivalence of the EVOS Cabling System to predicate devices based on non-clinical evidence. It outlines mechanical performance testing, MR safety evaluation, packaging and sterilization testing, biological safety evaluation, and pyrogenicity evaluation. However, these are standard device evaluation methods and not related to AI/ML performance.
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Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) % Jaclyn Holli Regulatory Affairs Specialist RTI Surgical, Inc 375 River Park Circle Marquette, Michigan 49855
Re: K201497
Trade/Device Name: EVOS Cabling System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: October 9, 2020 Received: October 13, 2020
Dear Jaclyn Holli:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
October 28, 2020
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For; Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201497
Device Name EVOS Cabling System
Indications for Use (Describe)
The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
| 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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary per 21 CFR 807.92 EVOS Cabling System
| Date Prepared | October 27, 2020 |
|---|---|
| 510(k) Owner/Manufacturer | Pioneer Surgical Technology, Inc.(DBA RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855, USARegistration #1833824 |
| Submitter/ContactPerson | Jaclyn Holli – Regulatory Affairs SpecialistRTI Surgical, Inc.Phone: 1.906.226.9909Email: jholli@rtix.com |
| Trade Name ofDevice | EVOS Cabling System |
| Common Name | Cerclage, Fixation |
| ClassificationName | Bone Fixation Cerclage |
| Classification | Class II per 21 CFR 888.3010Product code JDQ |
| Panel | Orthopedic Device Panel |
| Predicate | Primary Predicate: Orthopedic Cabling System (K031162)Additional Predicate: SDB Cerclage System (K992616) |
| Description ofDevice | The EVOS Cabling System is used in orthopedic trauma andreconstructive surgeries to reduce and stabilize fractures andosteotomies. The EVOS Cabling System may be used forsupplementary fracture fixation when used with bone plates orscrews.The EVOS Cabling System includes a sterile, stainless-steel cableimplant (ASTM F1314) packaged together with a stainless-steelcrimp (ASTM F138). Non-sterile, reusable instruments are alsoprovided to facilitate proper implantation of the cable-crimp implant. |
| Purpose ofSubmission | To obtain FDA Clearance of the EVOS Cabling System. There areno prior submissions for the subject system. |
| Indications forUse | The EVOS Cabling System is intended to be used in generalorthopaedic repair procedures including patellar fractures, generalcerclage, trochanteric reattachment, femoral and tibial fractures,prophylactic banding, olecranon fractures, ankle fractures, fixationof spiral fractures in conjunction with intramedullary nail and screwfixation techniques. |
| Summary ofTechnologicalCharacteristics | The subject EVOS Cabling System has the same intended use andtechnological characteristics as the predicates and the followingsimilarities: |
| Fundamental technology and intended uses: orthopediccable cerclage to reduce and stabilize fractures for bonefixation Overall design: multistrand, bundled cable with amechanism to resist tension and lock the construct (crimpor clamp cerclage) Principles of operation (cable passage around bone,cerclage tensioning and fixation) Materials: metallic, stainless steel alloys with well-established manufacturing processes and biological safety Sterility: sterile via gamma radiation Single Use, Rx only Packaging: double sterile barrier packaging with a 5-yearshelf life Mechanical performance sufficient to perform its intendeduse Same instrumentation types The minor differences in the design characteristics do not raisedifferent issues of safety or effectiveness as evidenced by the non-clinical testing. The subject EVOS Cabling System will be labeledas magnetic resonance (MR) conditional for which performancetesting has been submitted for support of this claim. There are noother differences in technological characteristics between thesubject and predicate devices. | |
| Discussion ofSupportingClinical Evidenceand Non-ClinicalEvidence | The following non-clinical evidence was submitted and relied uponfor a determination of substantial equivalence:Mechanical performance: static and dynamic tensile testingof the construct strength. MR Safety evaluation determined the devices are MRConditional via the following standard methods: ASTM F2052-15, Standard Test Method forMeasurement of Magnetically Induced DisplacementForce on Medical Devices in the MagneticResonance Environment ASTM F2213-17, Standard Test Method for |
| Medical Devices in the Magnetic ResonanceEnvironment ASTM F2182-11a, Standard Test Method forMeasurement of Radio Frequency Induced HeatingNear Passive Implants During Magnetic ResonanceImaging ASTM F2119-07 (Reapproved 2013), Standard TestMethod for Evaluation of MR Image Artifacts fromPassive Implants Implant packaging and sterilization testing and evaluations,relying on equivalency to predicate device design andpackage configuration Instrument (and case components that keep the instrumentsin place during transit and sterilization) sterilization testingand evaluations, relying on subject validation testing ISO 10993-1 Biological safety evaluation, relying onmaterial and manufacturing process equivalency topredicate devices. Pyrogenicity evaluation of the devices based on currentindustry practice and FDA guidance for batch releasetesting: endotoxin limit of 20 EU per device using theLimulus amebocyte lysate (LAL) assay. There are no clinical tests relied on in this premarket notificationsubmission for a determination of substantial equivalence. | |
| Conclusion | The evidence provided in this premarket notification submissionsupports substantial equivalence of the subject EVOS CablingSystem to the predicate devices. |
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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.