(255 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is a therapeutic device as it is intended for "temporary stabilization of the cervical spine...during the development of solid spinal fusion" in patients with various conditions, directly addressing and treating these medical issues.
No
This device is an anterior cervical plate system designed for temporary stabilization during spinal fusion, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium alloy and nitinol, intended for surgical implantation. It also mentions surgical instruments for installation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary stabilization of the cervical spine... during the development of solid spinal fusion." This describes a surgical implant used to support the spine, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details the physical components of the device (plates, screws, materials) and how it is implanted onto the anterior portion of the vertebral body. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific markers, or provide diagnostic information about a patient's health status based on in vitro testing.
In summary, the TRYPTIK2C-Plate® Anterior Cervical Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The TRYPTIK2 C-Plate Anterior Cervical Plate System consists of 1-level, 2-level, 3-level and 4-level plates with cancellous and cortical fixed-angle and 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. 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 22mm.
The TRYPTIK2C-Plate® Anterior Cervical Plates and screws are all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136 with an expansive ring made of Nitinol conforming to ASTM F2063.
The TRYPTIK2 C-Plate Anterior Cervical Plates and screws are delivered sterile (gamma sterilization). The TRYPTIK2 C-Plate Anterior Cervical Plate System is supplied with all the surgical instruments required for its installation. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were conducted:
- Static push-out testing of the screw per in-house protocol
- Corrosion Testing per ASTM F2129-17
The result of these studies shows that the Tryptik2 ACP device shows a very good behavior with regards to the pitting corrosion resistance. Tryptik2 ACP meets or exceeds the performance of the predicate device. Therefore the Tryptik2 ACP device is substantially equivalent to its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K153042, K100265, K052292, K050451
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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February 26, 2018
SPINEART Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates Geneva, Switzerland
Re: K171797
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: KWQ Dated: January 26, 2018 Received: January 29, 2018
Dear Franck 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 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,
Vincent J. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
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, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions
Type of Use (Select one or both, as applicable)
X 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
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | This submission is intended to address a line extension of the Tryptik®2 Anterior |
| Cervical Plate system and introduce a design change of the clip that constitutes | |
| the anti-back out mechanism of the cervical plate. | |
| Submitted by | SPINEART |
| 3 Chemin du Pré Fleuri | |
| 1228 PLAN LES OUATES | |
| GENEVA SWITZERLAND | |
| Contacts | Franck PENNESI Chief Technical Officer |
| Phone : +41 22 570 1200 Fax : +41 22 594 8306 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | June 12, 2017 |
| 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 |
| Legally marketed | |
| predicate devices | Primary predicate: Tryptik2c-Plate Anterior Cervical Plate manufactured by |
| Spineart K153042 | |
| Additional predicates: Diamond Anterior Cervical Plate System manufactured by | |
| Amendia, Inc (K100265), Spider Cervical Plating (SCP) System manufactured by X- | |
| Spine Systems, Inc (K052292) and Vectra System manufactured by Synthes Spine | |
| CO.LP (K050451) | |
| 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 | |
| Description of the device | The TRYPTIK2 C-Plate Anterior Cervical Plate System consists of 1-level, 2-level, 3-level and 4-level plates with cancellous and cortical fixed-angle and 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. 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 22mm. |
| The TRYPTIK2C-Plate® Anterior Cervical Plates and screws are all made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136 with an expansive ring made of Nitinol conforming to ASTM F2063. | |
| The TRYPTIK2 C-Plate Anterior Cervical Plates and screws are delivered sterile (gamma sterilization). The TRYPTIK2 C-Plate Anterior Cervical Plate System is supplied with all the surgical instruments required for its installation. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device | |
| Technological | |
| characteristics compared | |
| to the predicate devices | As was established in this submission the Tryptik2 ACP is substantially equivalent and has the same technological characteristics to its predicate devices in areas including function, material composition, design, range of sizes and mechanical performance. |
| Discussion of Testing | The following non-clinical tests were conducted: |
- Static push-out testing of the screw per in-house protocol
- Corrosion Testing per ASTM F2129-17
The result of these studies shows that the Tryptik2 ACP device shows a very good behavior with regards to the pitting corrosion resistance. Tryptik2 ACP meets or exceeds the performance of the predicate device. Therefore the Tryptik2 ACP device is substantially equivalent to its predicate devices. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the Tryptik2 ACP has demonstrated substantial equivalence to the identified predicate devices. |
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