(263 days)
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No
The document describes a mechanical implant and its intended use and performance testing, with no mention of AI or ML technology.
Yes
The device is described as a "temporary implant for use in orthopedic surgery" intended to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures" which are therapeutic purposes.
No
The device is an implantable system for temporary stabilization, not a tool for diagnosis.
No
The device description explicitly states that the NAJA System consists of a titanium alloy connector and a polyethylene terephthalate (PET) woven band, which are physical components, not software. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- NAJA System Function: The NAJA System is a temporary implant used in orthopedic surgery. Its purpose is to provide mechanical stabilization to the spine during fusion and fracture repair. It is a physical device that is surgically placed within the body.
- Lack of Specimen Analysis: The description of the NAJA System does not mention any analysis of biological specimens. Its function is entirely based on its physical properties and placement within the body.
The information provided clearly describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
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:
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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.
Product codes
OWI
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Spinal, bone fractures
Indicated Patient Age Range
8 years of age and older (for idiopathic and neuromuscular scoliosis)
Intended User / Care Setting
Orthopedic surgery, Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Sterilization: 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
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)
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. 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 Bonpain | |
| 59117 Wervicq-Sud, France | |
| Submitter Contact: | Ms. Mathilde Collet |
| Regulatory Affairs Engineer | |
| Phone: +011 33 (3) 20144130 | |
| Email: m.collet@cousin-biotech.com | |
| Application | |
| Correspondent: | Mr. Franck Pelletier |
| Regulatory Affairs Director | |
| Phone: +011 33 (3) 20144119 | |
| Email: f.pelletier@cousin-biotech.com | |
| Manufacturing Site: | Cousin Biotech S.A.S. |
| Allée des roses | |
| F-59117 Wervicq-Sud, France | |
| Trade Name: | NAJATM Ligament Correction System |
| Common Name: | Bone Fixation Cerclage, Sublaminar |
| Classification | |
| Regulation: | 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 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. | |
| Intended Use: | 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: | |
| 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques. | |
| 2. 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. | |
| Technology | |
| Comparison: | The NAJA System is substantially equivalent to the predicates |
| identified in terms of intended use/indications for use, technological | |
| characteristics, 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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