(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (cervical plate and screws) for spinal fusion. There is no mention of software, algorithms, data analysis, or any terms related to AI/ML.
No.
This device is an implantable cervical plate system used for temporary stabilization of the spine during fusion, not for treating a disease or condition itself.
No
Explanation: The device is a Cervical Plate System used for temporary stabilization of the anterior spine and fixation of cervical vertebrae. It is an implantable device to aid fusion, not to diagnose a condition.
No
The device description explicitly states that the Cervical Plate System consists of physical components: anterior cervical spine plates and screws, made of titanium. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior interbody screw fixation from C2 to T1" and "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "Cervical Plate System" consisting of plates and screws made of titanium alloys. These are physical implants designed to be surgically placed.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.
- Performance Studies: The performance studies described are biocompatibility and mechanical testing, which are typical for surgical implants, not IVDs.
Therefore, the Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
2)trauma (including fractures);
3)tumors:
4)deformity(defined as kyphosis, lordosis,or scoliosis);
5)pseudoarthrosis;
6)failed previous fusions
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.
Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.
Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to T1
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)
5.7.1 Biocompatibility testing
The biocompatibility evaluation for the Cervical Plate System was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
5.7.2 Mechanical testing
The following tests were performed (per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model on Anterior Cervical Spine Plate System to demonstrate substantially equivalent of safety and efficacy with the predicate device.
- Static compression bending test
- Static torsion test
- Dynamic compression bending test
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.
K141632 ZEVO™ Anterior Cervical Plate System
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.
0
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March 14, 2023
Double Medical Technology Inc. Yan Zuo International RA Supervisor No. 18, Shanbianhong East Road, Haicang District Xiamen. Fujian 361026 China
Re: K223753
Trade/Device Name: Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 8, 2022 Received: December 14, 2022
Dear Yan Zuo:
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/cdrh/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, 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223753
Device Name Cervical Plate System
Indications for Use (Describe)
Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
2)trauma (including fractures);
3)tumors:
4)deformity(defined as kyphosis, lordosis,or scoliosis);
5)pseudoarthrosis;
6)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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3
K223753- 510(k) Summary
| 5.1 Submitter | |
|---|---|
| Name | Double Medical Technology Inc. |
| Address | No. 18, Shanbianhong East Road, Haicang District, Xiamen, |
| 361026, P. R. China | |
| Phone | +86 592 6885079 |
| Contact person | Yan Zuo |
| Date prepared | March 10th, 2023 |
| 5.2 Proposed Device | |
| Trade/proprietary name | Cervical Plate System |
| Common or usual name | Cervical Plate System |
| Classification name | Spinal Intervertebral Body Fixation Orthosis |
| Regulation number | 21 CFR 888.3060 |
| Product code | KQW |
| Regulatory class | II |
| Classification panel | Orthopedic |
| 5.3 Predicate Device | |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Primary predicate device: |
| K141632 ZEVO™ Anterior Cervical Plate System | |
| Reason for 510(k) | |
| submission | New device(Implant) |
K223753- 510(k) Summary
5.4 Device Description
Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.
Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.
Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
4
5.5 Indication for Use
Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with:
(1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- (2) trauma (including fractures);
- (3) tumors;
- (4) deformity(definedaskyphosis, lordosis,or scoliosis);
- (5) pseudoarthrosis;
- (6) failed previous fusions.
5.6 Comparison of Technological Characteristics with the Predicate Device
The rationale for substantial equivalence is based on consideration of the following characteristics:
Regulatory Classification: Same as the predicate devices
Indications for Use: Substantially equivalent (SE) to the predicate devices
Materials: Substantially equivalent (SE) to the predicate devices
Design Features: Substantially equivalent (SE) to the predicate devices
5.7 Non-Clinical Performance Data
5.7.1 Biocompatibility testing
The biocompatibility evaluation for the Cervical Plate System was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
5.7.2 Mechanical testing
The following tests were performed (per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model on Anterior Cervical Spine Plate System to demonstrate substantially equivalent of safety and efficacy with the predicate device.
- Static compression bending test
- Static torsion test
- Dynamic compression bending test
5.8 Clinical Data
No clinical performance data was provided to demonstrate substantially equivalence.
5
5.9 Conclusion
The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.