(58 days)
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide immobilization as an adjunct to fusion for various instabilities and conditions of the spine, which is a therapeutic purpose.
No
Explanation: This device is a Posterior Cervical Spine System, an implantable system used for spinal fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of physical implants (pedicle screws, rods, etc.) made from titanium alloys, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Posterior Cervical Spine System is a surgical implant intended to provide structural support and immobilization to the spine. It is physically implanted into the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Posterior Cervical Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2:
(1)Traumatic spinal fractures and/or traumatic dislocations.
(2)Instability or deformity.
(3)Failed previous fusions (e.g. pseudarthrosis).
(4)Tumors involving the cervical spine.
(5)Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
Product codes
NKG, KWP
Device Description
The Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.
The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.
The implants are provided as sterile or non-sterile, while the instruments are 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
craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Performance Data:
Biocompatibility testing 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".
Mechanical testing was performed per ASTM F2706-08, ASTM F543-17, and ASTM F1798-13 to demonstrate substantial equivalence with the predicate device. Tests included:
- Static axial compression bending test
- Static axial tensile bending test
- Static torsion test results
- Dynamic axial compression bending test
- Dynamic torsion test
- Torsional properties test
- Driving torque test
- Axial pullout strength test
- Static axial gripping capacity test
- Static axial torque test
Clinical Data:
No clinical performance data was provided to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
November 22, 2023
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Double Medical Technology Inc. Yan Zuo International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China
Re: K233078
Trade/Device Name: Posterior Cervical Spine System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: September 20, 2023 Received: September 25, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.11.22
08:22:10 -05'00'
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
for
2
Indications for Use
510(k) Number (if known) K233078
Device Name Posterior Cervical Spine System
Indications for Use (Describe)
The Posterior Cervical Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2:
(1)Traumatic spinal fractures and/or traumatic dislocations.
(2)Instability or deformity.
(3)Failed previous fusions (e.g. pseudarthrosis).
(4)Tumors involving the cervical spine.
(5)Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
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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| 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 | September 20th, 2023 |
| Proposed Device | |
| Trade/proprietary name | Posterior Cervical Spine System |
| Common or usual name | Posterior Cervical Spine System |
| Classification name | Posterior Cervical Screw System |
| Regulation number | 21 CFR 888.3075, 21 CFR 888.3050 |
| Product codes | NKG, KWP |
| Regulatory class | II |
| Classification panel | Orthopedic |
| Predicate Device | |
| Legally marketed device(s) to which equivalence is claimed | Primary predicate device: |
| K210449 Infinity™ OCT System | |
| Additional predicate device: | |
| K142838 Synapse Occipital-Cervical-Thoracic (OCT) System | |
| Reason for 510(k) submission | New device |
510(k) Summary
Device Description
The Posterior Cervical Spine System consists of pedicle screws, nut, rods, connectors, hook, transconnectors, laminar hooks, occipital plates and occipital screw.
The implants in Posterior Spine Cervical System is made from Ti-6A1-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472.
The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.
The implants are intended for single-use only, while the instruments are reusable.
Indications for Use
The Posterior Cervical Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of Page 1 of 3
4
the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T2:
- (1) Traumatic spinal fractures and/or traumatic dislocations.
- (2) Instability or deformity.
- (3) Failed previous fusions (e.g. pseudarthrosis).
- (4) Tumors involving the cervical spine.
- (5) Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
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
Non-Clinical Performance Data
Biocompatibility testing
The biocompatibility evaluation for the Posterior Cervical Spine 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".
Mechanical testing
The following tests were performed per ASTM F2706-08 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model, ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, and ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants on Posterior Cervical Spine System to demonstrate substantial equivalence with the predicate device.
- Static axial compression bending test
- O Static axial tensile bending test
- Static torsion test results
5
- Dynamic axial compression bending test
- Dynamic torsion test
- Torsional properties test ●
- Driving torque test
- Axial pullout strength test ●
- Static axial gripping capacity test
- Static axial torque test ●
Clinical Data
No clinical performance data was provided to demonstrate substantial equivalence.
Conclusion
The information provided within this premarket notification demonstrates that the proposed device is determined to be substantially equivalent (SE) to the predicate device.