(259 days)
The Cortical Fixation Systems are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
The Cortical Fixation Systems are available in two (2) models. The first one is the Cortical Fixation System (cortical button with fixed length loop). The second model is the Adjustable Cortical Fixation System (cortical button with adjustable length loop). These devices can be used with an Extended Plate which allows a larger surface of contact with the cortical bone. These products are anchor devices with titanium cortical button and are intended to be used as a soft tissue to bone fixation, especially for the ACL repair. The graft is passed through the loop and the titanium button ensures the tensioning and the fixation of the system.
The provided text describes the 510(k) summary for the Cousin Biotech Cortical Fixation Systems, which are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction. However, it does not contain a specific study that proves the device meets particular acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it details the design verification and validation activities performed to ensure the device is safe, effective, and performs as intended, and that it is substantially equivalent to predicate devices.
The acceptance criteria described are largely related to manufacturing, sterility, biocompatibility, and mechanical performance, rather than clinical efficacy as might be found in a study for an AI/CAD product.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Device Performance/Validation Result |
|---|---|---|
| Sterilization | ISO 11137-1:2006, Am1:2013 | Complies, SAL 10-6 |
| ISO 11137-2:2013 | Complies | |
| ISO 11737-1:2006, Cor1:2007 | Complies | |
| ISO 11737-2:2009 | Complies | |
| ISO 11135:2014 | Complies | |
| ISO 10993-7:2008, Cor1:2009 | Complies | |
| Pyrogenicity | FDA Guidance (21 Jan 16) | Non-pyrogenic |
| Shelf Life | ISO 11607-1:2006 | Complies |
| ISO 11607-2:2006 | Complies | |
| ASTM D4169-16 | Complies | |
| ASTM F1929-12 | Complies | |
| ASTM F1980-16 | Complies | |
| Biocompatibility | ISO 10993-1:2009 | Complies |
| Performance Testing | IEC 62366:2007 | Complies with predetermined specifications and standards |
| ISO 5832-3:2016 | Complies with predetermined specifications and standards | |
| ISO 14630:2012 | Complies with predetermined specifications and standards |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a medical device (surgical implant), not an AI/CAD system. Therefore, the concept of a "test set" in the context of diagnostic performance or AI algorithm evaluation is not applicable here. The performance testing refers to bench testing of the physical device, sterilization validation, shelf-life studies, and biocompatibility assessments. These types of tests do not typically involve patient "test sets" or data provenance in the way an AI study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device and study. The "ground truth" for these tests would be the established scientific and regulatory standards themselves (e.g., a specific sterility assurance level, a validated packaging seal strength, or a measured material property).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device and study. Adjudication methods are typically used in clinical trials or diagnostic studies where expert consensus is needed to establish a definitive diagnosis or outcome.
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. This is a physical surgical device, not a diagnostic imaging or AI assistance system, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation (V&V) activities described are the published national and international standards (e.g., ISO, ASTM, IEC) for sterilization, biocompatibility, packaging, and material properties, as well as the predetermined technical specifications of the device itself. These are objective engineering and scientific benchmarks, not clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable. This is a physical surgical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device.
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January 9, 2019
Cousin Biotech S.A.S. Franck Pelletier Regulatory Affairs Director 8 Rue De L'abbe Bonpain Wervicg-Sud. 59117 France
Re: K181086
Trade/Device Name: Cortical Fixation Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, GAT Dated: December 11, 2018 Received: December 12, 2018
Dear Mr. Pelletier:
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/cdrl/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, 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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Cortical Fixation Systems
Indications for Use (Describe)
The Cortical Fixation Systems are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
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 provided in accordance with 21 CFR §807.92(C)
| Submission Date: | April 23, 2018 |
|---|---|
| Submitter: | Cousin Biotech S.A.S.8 Rue De L'abbe Bonpain59117 Wervicq-Sud, France |
| Submitter Contact: | Ms. Mathilde ColletRegulatory Affairs EngineerPhone: +011 33 (3) 20144130Email: m.collet@cousin-biotech.com |
| ApplicationCorrespondent: | Mr. Franck PelletierRegulatory Affairs DirectorPhone: +011 33 (3) 20144119Email: f.pelletier@cousin-biotech.com |
| Manufacturing Site: | Cousin Biotech S.A.S.Allée des rosesF-59117 Wervicq-Sud, France |
| Model Name: | Cortical Fixation SystemAdjustable Cortical Fixation SystemExtended Plate for Cortical Fixation Systems |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| ClassificationRegulation: | 21 CFR §888.304021 CFR §878.5000 |
| Product Code: | MBIGAT |
| SubstantiallyEquivalent Devices: | K980155 – Smith & Nephew, Inc. – EndoButton CL Ultra (Primary)K100652 - Arthrex, Inc. - ACL TightRope (Additional)K083070 - Biomet Sports Medicine - ToggleLocTM System(Additional) |
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510(k) Summary provided in accordance with 21 CFR §807.92(C)
| Device Description: | the system. | loop). The second model is the Adjustable Cortical Fixation Systemthe cortical bone. These products are anchor devices with titaniumcortical button and are intended to be used as a soft tissue to bone | The Cortical Fixation Systems are available in two (2) models. The firstone is the Cortical Fixation System (cortical button with fixed length(cortical button with adjustable length loop). These devices can be usedwith an Extended Plate which allows a larger surface of contact withfixation, especially for the ACL repair. The graft is passed through theloop and the titanium button ensures the tensioning and the fixation of | ||
|---|---|---|---|---|---|
| Intended Use:Technology | The Cortical Fixation Systems are used for fixation of tendons andligaments during orthopedic reconstruction procedures such as anteriorcruciate ligament (ACL) reconstruction.The Cousin Biotech's Cortical Fixation Systems employ the same | ||||
| Comparison: | technological characteristics as the primary predicate device. | ||||
| Characteristic | Smith & Nephew, Incorporated /EndoButton CL Ultra(K980155) | Cousin Biotech S.A.S.Cortical Fixation Systems(Proposed Device) | |||
| Design | Titanium button with loop in PETpreloaded with two (2) polyesterbraids sutures (1 green, 1 white) | Titanium button with loop in PETpreloaded with two (2) polyester braidssutures (1 green, 1 white) | |||
| Sizes | EndoButton:width: 4 - 6 mmlength: 12 - 18 mm | The titanium button size is 4 mm(width) x 12 mm (length) x 1.5 mm(height).The extended plate size is 7 mm (width)x 20 mm (length) x 1.5 mm (height). | |||
| Suture loop span length:10 – 80 mm | The non-adjustable loop size isavailable from 15 mm to 40 mm.The adjustable loop size is capable ofprovided a loop from 15 mm to 40 mm. |
Ti-6Al-4V or Ti-6Al-4V ELI
Polyethylene Terephthalate (PET)
titanium alloy.
Polyester (PET)
Yes
Button
Loop
Traction
threads
Shipped Sterile
Any size is possible between both
Ti-6Al-4V or Ti-6Al-4V ELI titanium
Polyethylene Terephthalate (PET) for
Polyethylene (UHMWPE) for the
Polyester (PET) and colorant D&C
the non-adjustable loop
adjustable loop
values.
alloy.
Green
Yes
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510(k) Summary provided in accordance with 21 CFR §807.92(C)
Summary of Performance Testing:
| Sterilization | The Cortical Fixation System and Extended Plate are gamma radiation sterilized and were validated to a sterility assurance level of 10-6 in accordance with the following standards: |
|---|---|
| ISO 11137-1: 2006, Am1: 2013, Sterilization of health care products - Requirements for validation and routine control – Radiation sterilization; ISO 11137-2:2013, Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose; ISO 11737-1: 2006, Cor1: 2007, Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]; and ISO 11737-2: 2009, Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process. | |
| Validation results indicate that the Cortical Fixation System and Extended Plate comply with the standards. | |
| The Adjustable Cortical Fixation System is Ethylene Oxide sterilized and was validated in accordance with the following standard: | |
| ISO 11135:2014, Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices; and ISO 10993-7: 2008, Cor1: 2009, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]. | |
| Validation results indicate that the Adjustable Cortical Fixation System complies with the standards. | |
| The Cortical Fixation System, Adjustable Cortical Fixation System, and Extended Plate were tested for pyrogenicity as recommended by the following FDA guidance document: | |
| Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, 21 Jan 16. | |
| Validation results indicate that the Cortical Fixation System, Adjustable Cortical Fixation System, and Extended Plate are non-pyrogenic in accordance with the FDA guidance document. |
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provided in accordance with 21 CFR §807.92(C)
| Shelf Life | The packaging for the Cortical Fixation Systems was validated in accordance with the following standards:ISO 11607-1: 2006 Packaging for terminally sterilized medical devices – Part 1: requirements for materials, sterile barrier systems and packaging systems; ISO 11607-2: 2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes; ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems; ASTM F1929-12, Standard Test Method for Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration; and ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Validation results indicate that the packaging for the Cortical Fixation Systems complies with the standards. |
|---|---|
| Biocompatibility | The Cortical Fixation Systems patient contact materials was verified in accordance with the following standard:ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Verification results indicated that the Cortical Fixation Systems patient contact materials comply with the standard. |
| Performance Testing – Bench | The Cortical Fixation Systems were tested for performance in accordance with its predetermined specifications and the following standards:IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices; ISO 5832-3: 2016, Implants for surgery - Metallic materials – Part 3: Wrought titanium-6 aluminum-4 vanadium alloy; and ISO 14630: 2012, Non-active surgical implants – General requirements. Test results indicate that the Cortical Fixation Systems comply with its predetermined specifications and with the standards. |
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510(k) Summary provided in accordance with 21 CFR §807.92(C)
Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of Cortical Fixation System, Adjustable Cortical Fixation System and Extended Plate. The results of these activities demonstrate that the Cortical Fixation Systems are as safe, as effective, and perform as well as or better than the predicate devices.
Therefore, the Cortical Fixation Systems are considered substantially equivalent to the predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.