(51 days)
Not Found
No
The document describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing, not algorithmic performance.
Yes.
The device is intended for anterior screw fixation to the C2-T1 for various medical indications such as degenerative disease, trauma, tumors, deformity, and failed previous fusions, which are all conditions that require therapeutic intervention.
No.
The device is an anterior cervical plate system intended for surgical fixation of the cervical spine, not for diagnosing conditions.
No
The device description explicitly states it consists of plates and screws made from titanium alloy, which are hardware components.
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 "anterior screw fixation to the C2-T1)" for various spinal conditions. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description confirms it consists of plates and screws made of titanium alloy, designed for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the C2-T1) for the following indications: degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Product codes
KWO
Device Description
The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures. This submission seeks clearance for redesigned Insignia plates and screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies
Nonclinical testing was presented on the Insignia Anterior Cervical Plate System using the performance criteria proposed in Guidance for Industry and Food and Drug Administration Staff, Spinal Plating Systems- Performance Criteria for Safety and Performance Based Pathway, issued on December 11, 2020. The following testing was performed in support of the subject devices:
- . Static compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
- Dynamic compression testing per ASTM F1717 ●
- Screw push-out testing
The results demonstrate that the subject Insignia Anterior Cervical Plate System is substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
December 15, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alphatec Spine, Inc. Sandy Gill Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K213443
Trade/Device Name: Insignia™ 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: October 22, 2021 Received: October 25, 2021
Dear Sandy Gill:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213443
Device Name Insignia™ Anterior Cervical Plate System
Indications for Use (Describe)
The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the C2-T1) for the following indications: degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
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) |
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Image /page/3/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the rest of the letters are black. There is a trademark symbol to the right of the "c".
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|-----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Sandy Gill
Regulatory Affairs Specialist
Contact Phone: (760) 431-9286 |
| | Date Summary Prepared: | October 21, 2021 |
| II. | DEVICE | |
| Name of Device: | Insignia™ Anterior Cervical Plate System |
|---|---|
| Common or Usual Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| (21 CFR 888.3060) | |
| Regulatory Class: | Class II |
| Product Code: | KWQ |
III. LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K200995 | KWQ | Insignia Anterior Cervical Plate | |
| System | Alphatec Spine, | ||
| Inc. |
IV. DEVICE DESCRIPTION
The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures. This submission seeks clearance for redesigned Insignia plates and screws.
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Image /page/4/Picture/0 description: The image shows the "atec" logo. The "a" is green, and the "tec" is dark blue. There is a trademark symbol to the right of the "c".
V. INDICATIONS FOR USE
The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: 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), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
This submission introduces new Insignia plates and screws. The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
VII. PERFORMANCE DATA
Nonclinical testing was presented on the Insignia Anterior Cervical Plate System using the performance criteria proposed in Guidance for Industry and Food and Drug Administration Staff, Spinal Plating Systems- Performance Criteria for Safety and Performance Based Pathway, issued on December 11, 2020. The following testing was performed in support of the subject devices:
- . Static compression testing per ASTM F1717
- Static torsion testing per ASTM F1717
- Dynamic compression testing per ASTM F1717 ●
- Screw push-out testing
The results demonstrate that the subject Insignia Anterior Cervical Plate System is substantially equivalent to other predicate devices for nonclinical testing.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.