The NAJA 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 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 NAJA System may also be used in conjunction with other medical grade implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of the other implants.

Device Description

The NAJA™ Ligament Correction System (NAJA System) is a temporary implant 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 NAJA implant consists of a titanium alloy connector and a polyethylene terephthalate (PET) woven band. The NAJA System allows the spine to be secured to a rod construct without the use of a bone screw, and acts as an alternative to sublaminar wires and hooks.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding Cousin Biotech S.A.S.'s NAJATM Ligament Correction System. It details the device, its intended use, a comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them:

Overall Summary:
The NAJA™ Ligament Correction System is a temporary implant used in orthopedic surgery for stabilization and aid in fracture repair. The submission focuses on demonstrating "substantial equivalence" to existing predicate devices (K110348 - Zimmer Spine - Universal Clamp Spinal Fixation System and K922952 - Pioneer Surgical Technology - Songer Cable System) rather than proving de novo clinical effectiveness through large-scale human outcome studies. The performance testing is primarily bench-top (mechanical) and compliance with relevant ISO standards for sterilization, biocompatibility, and packaging. This is typical for Class II devices seeking 510(k) clearance, where substantial equivalence to a legally marketed predicate can be demonstrated through non-clinical data.

Key Findings Related to Acceptance Criteria and Study Proof:

Table of acceptance criteria and reported device performance:

Acceptance Criteria/Study Area	Standard/Criteria	Reported Device Performance/Findings
Packaging Shelf Life	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).	"Validation results indicate that the packaging for the NAJA System complies with the standards."
Biocompatibility	ISO 10993-1: 2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).	"Verification results indicated that the NAJA System patient contact materials comply with the standard."
Mechanical Performance (Bench Testing)	Static and dynamic band tension testing. Static axial grip and static torsional grip testing per ASTM F1798-13. Dynamic axial compression testing per ASTM F1717-15.	"Test results demonstrate that the NAJA System has substantially equivalent mechanical performance as compared to the predicates listed." (Specific numerical results are not provided in this summary, but the conclusion of equivalence is stated.)
Sterilization Assurance Level (SAL)	Sterility assurance level of 10-6. 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).	"Validation results indicate that the NAJA System complies with the standards" for gamma radiation sterilization to a SAL of 10^-6.
Substantial Equivalence (Overall Conclusion)	The device is as safe and as effective as the predicate devices.	"The results of these activities demonstrate that NAJA System is as safe and as effective as the predicate devices. Therefore, the NAJA System is considered substantially equivalent to the predicate devices." (This is the overarching "acceptance criterion" for 510(k) clearance, deemed met by the sum of the other tests.)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., how many devices or test specimens were tested for ASTM F1798-13 or F1717-15). It states "The following mechanical tests were performed..." but doesn't quantify the number of units tested. For the sterilization and biocompatibility, testing is typically performed on representative samples of the device or its materials as per the specific ISO standards.
- Data Provenance: The studies were conducted by the manufacturer, Cousin Biotech S.A.S., located in Wervicq-Sud, France. The data appears to be prospective in nature, as it's generated specifically for the regulatory submission to demonstrate compliance with standards for a new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This section is not applicable in the context of this 510(k) submission. This is a medical device (hardware) and not an AI/software device requiring human expert consensus for "ground truth" establishment on medical images or clinical outcomes. The "ground truth" for this device's performance is established by objective, verifiable engineering standards and laboratory measurements (e.g., tensile strength, biocompatibility assays, sterilization efficacy).
Adjudication method for the test set:
This section is not applicable. Since the testing is bench-top and objective (mechanical properties, chemical properties, microbiological sterility), there is no human interpretation or subjective assessment that would require an adjudication method. The results are typically quantitative measurements compared against predetermined acceptance limits derived from the relevant standards.
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 section is not applicable. The NAJATM Ligament Correction System is a physical implant, not an AI or imaging diagnostic device. Therefore, MRMC studies involving human readers are irrelevant to its performance assessment as described here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This section is not applicable. As stated above, this is a physical medical device, not an algorithm or software. Standalone performance as typically defined for AI/software devices is not relevant. The "standalone performance" of this device is its mechanical properties and biological inertness as demonstrated by the bench tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is defined by:
- Engineering Standards: Predetermined, scientifically established performance specifications and testing methodologies outlined in ISO and ASTM standards (e.g., ISO 11607, ISO 10993, ISO 11137, ASTM F1798, ASTM F1717).
- Physical Measurements: Test results (e.g., force, torque, sterility culture results, chemical analysis) demonstrating compliance with the quantitative and qualitative requirements of these standards.
- Comparison to Predicates: The ultimate "ground truth" for substantial equivalence in a 510(k) is that the device performs as safely and effectively as legally marketed predicate devices, which is demonstrated through a combination of engineering comparisons and the aforementioned bench testing.
The sample size for the training set:
This section is not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The device's design and manufacturing processes are developed through traditional engineering principles, not machine learning.
How the ground truth for the training set was established:
This section is not applicable for the same reasons as #8.

Summary

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April 10, 2018

Cousin Biotech S.A.S. Mr. Franck Pelletier Regulatory Affairs Director 8 Rue De L'abbe Bonpain Wervicq-Sud 59117 FRANCE

Re: K172206

Trade/Device Name: NAJATM Ligament Correction System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: March 6, 2018 Received: March 9, 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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Ronald P. Jean -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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Indications for Use

510(k) Number (if known) K172206

Device Name NAJATM Ligament Correction System

Indications for Use (Describe)

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 and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis. 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The NAJA System may also be used in conjunction with other medical grade implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of the 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 provided in accordance with 21 CFR §807.92(C)

Date Prepared:	April 9, 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
Trade Name:	NAJATM Ligament Correction System
Common Name:	Bone Fixation Cerclage, Sublaminar
ClassificationRegulation:	21 CFR §888.3010 - Bone Fixation Cerclage, Class II
Product Code:	OWI
Predicate Devices:	K110348 - Zimmer Spine - Universal Clamp Spinal Fixation System (Primary)K922952 - Pioneer Surgical Technology - Songer Cable System (Additional)
Device Description:	The NAJA™ Ligament Correction System (NAJA System) is atemporary implant intended to provide temporary stabilization as abone anchor during the development of solid bony fusion and aid inthe repair of bone fractures. The NAJA implant consists of a titaniumalloy connector and a polyethylene terephthalate (PET) woven band.The NAJA System allows the spine to be secured to a rod constructwithout the use of a bone screw, and acts as an alternative tosublaminar wires and hooks.
Intended Use:	The NAJA System is a temporary implant for use in orthopedicsurgery. The system is intended to provide temporary stabilization as abone anchor during the development of solid bony fusion and aid in therepair of bone fractures. The indications for use include the followingapplications:
	1. Spinal trauma surgery, used in sublaminar or facet wiring techniques.
	2. Spinal reconstructive surgery, incorporated into constructs for thepurpose of correction of spinal deformities such as idiopathic andneuromuscular scoliosis in patients 8 years of age and older, adultscoliosis, kyphosis and spondylolisthesis.
	3. Spinal degenerative surgery, as an adjunct to spinal fusions.
	The NAJA System may also be used in conjunction with othermedical grade implants made of titanium or cobalt chrome alloywhenever "wiring" may help secure the attachment of the otherimplants.
TechnologyComparison:	The NAJA System is substantially equivalent to the predicatesidentified in terms of intended use/indications for use, technologicalcharacteristics, device materials and function.
Shelf Life	The packaging for the NAJA System 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; and ISO 11607-2: 2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes. Validation results indicate that the packaging for the NAJA System complies with the standards.
Biocompatibility	NAJA System patient contact materials were 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 NAJA System patient contact materials comply with the standard.
Performance Testing – Bench	The following mechanical tests were performed on the NAJA System:Static and dynamic band tension testing Static axial grip and static torsional grip testing per ASTM F1798-13 Dynamic axial compression testing per ASTM F1717-15 Test results demonstrate that the NAJA System has substantially equivalent mechanical performance as compared to the predicates listed.
Conclusion	Verification and validation activities were conducted to establish the performance of NAJA System. The results of these activities demonstrate that NAJA System is as safe and as effective as the predicate devices.Therefore, the NAJA System is considered substantially equivalent to the predicate devices.

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Summary of Performance Testing:

The NAJA System is gamma radiation sterilized and was validated to a Sterilization 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; and
ISO 11137-2:2013, Sterilization of health care products Radiation . – Part 2: Establishing the sterilization dose.

Validation results indicate that the NAJA System complies with the standards.

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Regulation Number and Section

§ 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.