(92 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the cervical plate and screws, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical implant intended to temporarily stabilize the anterior spine as an adjunct to fusion, treating various conditions like degenerative disc disease, trauma, and tumors. Its direct physical interaction and therapeutic purpose classify it as a therapeutic device.
No
This device is a surgical implant (anterior cervical plate) used for temporary stabilization during spinal fusion, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of titanium alloy (plates and screws) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Tangis Anterior Cervical Plate is a physical implant designed for surgical fixation of the cervical spine. It is a mechanical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use clearly states it's for "anterior screw fixation to the cervical spine" as an "adjunct to fusion." This is a surgical procedure, not a diagnostic test.
The provided information describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- deformity (defined as kyphosis, lordosis, or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Tangis Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (20 mm – 92 mm), addressing multiple levels of fixation (one to four). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm, 4.25 mm, and 4.75 mm) and a variety of lengths (10 mm - 20 mm). All components are made from titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
Indicated Patient Age Range
skeletally mature patients
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)
No FDA performance standards have been established for the Tangis Anterior Cervical Plate. The following tests were performed to demonstrate safety based on current industry standards:
- Static and dynamic compression (per ASTM F1717)
- Static torsion (per ASTM F1717)
The results of these tests indication that the Tangis Anterior Cervical Plate is substantially equivalent to the 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2016
Nvision Biomedical Technologies, LLC % Allison Komiyama, Ph.D., RAC Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego, California 92104
Re: K161524
Trade/Device Name: Tangis Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 2, 2016 Received: August 3, 2016
Dear Dr. Komiyama:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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.
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
2
Indications for Use
510(k) Number (if known) к161524
Device Name Tangis Anterior Cervical Plate
Indications for Use (Describe)
The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · spondylolisthesis.
- · trauma (i.e. fractures or dislocations),
- tumors,
- · deformity (defined as kyphosis, lordosis, or scoliosis),
- · pseudarthrosis,
- · failed previous fusion,
- · spinal stenosis
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for nVision Biomedical Technologies. The "n" in "nVision" is gold and stylized, while the rest of the word is in black. Below "nVision" is the text "BIOMEDICAL TECHNOLOGIES" in a smaller, gold font.
510(k) Summary
DATE PREPARED
May 31, 2016
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103, San Antonio, TX 78232, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana L. Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies +1 (619) 208-7888 Telephone: Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
Tangis Anterior Cervical Plate
COMMON NAME
Anterior Cervical Plate
DEVICE CLASSIFICATION
Spinal intervertebral body fixation orthosis (21 CFR 888.3060, Product Code KWQ, Class II)
PREMARKET REVIEW
ODE/DOD/ASDB Orthopedic Panel
INDICATIONS FOR USE
The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- o degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- . spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors,
- . deformity (defined as kyphosis, lordosis, or scoliosis),
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Image /page/4/Picture/0 description: The image shows the logo for Nvision Biomedical Technologies. The logo features a stylized letter 'n' in gold, followed by the word 'vision' in black. Below the word 'vision' are the words 'BIOMEDICAL TECHNOLOGIES' in a smaller, gold font. The logo is clean and modern, reflecting the company's focus on biomedical technology.
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis
DEVICE DESCRIPTION
The Tangis Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (20 mm – 92 mm), addressing multiple levels of fixation (one to four). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm, 4.25 mm, and 4.75 mm) and a variety of lengths (10 mm - 20 mm). All components are made from titanium alloy per ASTM F136.
PREDICATE DEVICE IDENTIFICATION
The Tangis Anterior Cervical Plate is substantially equivalent to the following predicates:
| 510(k)
Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|------------------|--------------------------------------------------------------------------|----------------------|
| K151553 | Anterior Cervical Plate System / Osteomed Implantes, LTDA | ✓ |
| K031276 | ACLP System / Synthes Spine | |
| K022965 | Blackstone™ “Classic” Anterior Cervical Plate / Blackstone Medical, Inc. | |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Tangis Anterior Cervical Plate. The following tests were performed to demonstrate safety based on current industry standards:
- . Static and dynamic compression (per ASTM F1717)
- . Static torsion (per ASTM F1717)
The results of these tests indication that the Tangis Anterior Cervical Plate is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the Tangis Anterior Cervical Plate is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions, and uses similar or identical materials as the devices cleared in K151553, K031276, and K022965. The subject device has the same intended use and similar technological characteristics to the devices cleared in K151553 and K022965. The device has similar instrumentation to the device cleared in K151553, and K031276.
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CONCLUSION
The Tangis Anterior Cervical Plate is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including static and dynamic compression as well as static torsion (per ASTM F1717), it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices.