(161 days)
TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions
The TRYPTIK2C-Plate Anterior Cervical Plate System consists of a range of anterior cervical plates and polyaxial (variable angle) bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) and functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.
This is a 510(k) premarket notification for a medical device called the "TRYPTIK2C-Plate Anterior Cervical Plate System". The document describes the device, its intended use, and provides a summary of testing conducted to demonstrate its substantial equivalence to legally marketed predicate devices.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds against specific performance metrics for the TRYPTIK2C-Plate, but rather implies comparison to predicate devices. The "reported device performance" is described in terms of mechanical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate devices according to ASTM F1717-15 for: | - Static Compression Bending results demonstrate comparable mechanical properties to predicate devices. |
| - Static Compression Bending | - Static Tension Bending results demonstrate comparable mechanical properties to predicate devices. |
| - Static Tension Bending | - Static Torsion results demonstrate comparable mechanical properties to predicate devices. |
| - Static Torsion | - Dynamic Compression Bending results demonstrate comparable mechanical properties to predicate devices. |
| Acceptable static push-out strength | - Static push-out testing has been conducted according to an in-house protocol. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical testing (e.g., number of plates or screws tested). It also does not provide information on the data provenance, such as the country of origin or whether the study was retrospective or prospective. The testing described is non-clinical/bench testing, not human or animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The study is a non-clinical/bench testing study of a medical implant's mechanical properties, not a diagnostic or prediction algorithm requiring expert review for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as it's a non-clinical mechanical testing study.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical implant (anterior cervical plate system), not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of study is the established mechanical testing standards (ASTM F1717-15) and the mechanical properties of the legally marketed predicate devices. The performance of the new device is compared against these benchmarks to establish substantial equivalence.
8. The sample size for the training set
This information is not applicable. This is a mechanical testing study for a physical implant, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical implant's mechanical testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2016
SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 route de pré-bois, CP1813 Geneva, 1215 SWITZERLAND
Re: K153042
Trade/Device Name: TRYPTIK2C-plate® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 3, 2016 Received: March 7, 2016
Dear Mr. Pennesi:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
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" (21CFR 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 yours,
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K153042 | ||
|---|---|---|---|
| Device Name | TRYPTIK2C-Plate® Anterior Cervical Plate System | ||
| Indications for Use (Describe) | TRYPTIK2C-Plate® Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions | ||
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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TRADITIONAL 510k TRYPTIK2c-Plate ANTERIOR CERVICAL PLATE SYSTEM
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510(k) SUMMARY
| SPINEART | |
|---|---|
| Submitted by | International Center Cointrin |
| 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Contacts | Franck PENNESI Director of Industry & Quality |
| Phone : +41 22 570 1246 Fax : +41 22 799 40 26 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) | |
| Mail : idrubaix@nordnet.fr | |
| Date Prepared | March 3rd 2016 |
| Common Name | Anterior Cervical Plate System |
| Trade Name | TRYPTIK2C-Plate Anterior Cervical Plate System |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ Appliance, Fixation, Spinal Intervertebral Body |
| CFR section | 888.3060 Spinal intervertebral body fixation orthosis |
| Device panel | ORTHOPEDIC |
| Primary predicate: IST Anterior Cervical Plate System manufactured by Innovative | |
| Legally marketedpredicate devices | Spinal Technologies Inc (K072650) |
| Other predicates: Synthes Cervical Vertabrae Plates manufactured by Depuy | |
| Synthes (K792352); Synthes Anterior Cervical Vertebrae Plate manufactured by | |
| Synthes USA (K926453); Tosca Anterior Cervical Plate System manufactured by | |
| Signus Medizintechnik GMBH (K043082);Spider Cervical Plating (SCP) System | |
| manufactured by X-SPINE SYSTEMS, INC. (K052292) | |
| Indications for use | TRYPTIK2C-Plate Anterior Cervical Plate System is intended to be used for |
| temporary stabilization of the cervical spine (C2-C7) during the development of | |
| solid spinal fusion in patients with instability caused by the following | |
| degenerative disc disease (as defined by neck pain of discogenic origin with | |
| degeneration of the disc confirmed by patient history and radiographic studies), | |
| trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity | |
| (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions |
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| Description of the device | The TRYPTIK2C-Plate Anterior Cervical Plate System consists of a range of anterior cervical plates and polyaxial (variable angle) bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (C2-C7) and functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine. |
|---|---|
| TechnologicalCharacteristics | The TRYPTIK2C-Plate Anterior Cervical Plate System consists of 1-level, 2-level, 3-level and 4-level plates with cancellous and cortical variable-angle bone screws. The Plate configurations are ranging in total lengths from 20mm (1-level) to 92mm (4-level). The plate is 2.4mm thick and 16.5mm wide and incorporates integrated expansive rings for anti-back out of the bone screws that functions as a one-step locking mechanism. The Screw range comes in two diameters, Ø 4.0 and Ø 4.5, and length is ranging from 12mm to 18mm with 2mm increment.The TRYPTIK2C-Plate Anterior Cervical Plates and screws are all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. The TRYPTIK2C-Plate Anterior Cervical Plates and screws are delivered sterile (gamma sterilization). The TRYPTIK2C-Plate Anterior Cervical Plate System is supplied with all the surgical instruments required for its installation. |
| Discussion of Testing | The following non-clinical tests were conducted according to ASTM F1717-15: Static Compression Bending, Static Tension Bending, Static Torsion and Dynamic Compression Bending. Results demonstrate comparable mechanical properties to the predicate devices. Additionally, static push-out testing has been conducted according to an in-house protocol. |
| Comparison to PredicateDevices | The indications for use, design features and materials of the TRYPTIK2C-Plate Anterior Cervical Plates and screws are substantially equivalent to those of the predicate devices. The substantial equivalence of the TRYPTIK2C-Plate Anterior Cervical Plates and screws is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification |
| Conclusion | Based on the above information, the TRYPTIK2C-Plate Anterior Cervical Plates and screws can be considered as substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. |
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.