(111 days)
Not Found
No
The 510(k) summary describes a mechanical implant system (plate and screws) and its intended use for spinal fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on mechanical testing of the device.
Yes
The device is described as an "anterior cervical fixation system" used for various medical conditions like "degenerative disc disease," "spondylolisthesis," and "trauma," indicating its use in treating health conditions.
No
The device description indicates that the Origin Anterior Cervical Plate System is an anterior cervical fixation system comprised of a titanium plate and bone screws, used for surgical fixation in various spinal conditions. Its intended use lists conditions like degenerative disc disease, trauma, and deformities, but its function is to provide stabilization, not to diagnose these conditions.
No
The device description explicitly states it is comprised of a titanium plate and bone screws, 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 "interior cervical fixation" for various spinal conditions. This describes a surgical implant used to stabilize the spine.
- Device Description: The description details a "titanium plate, and bone screws," which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits.
Therefore, the Origin Anterior Cervical Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Origin Anterior Cervical Plate System is interior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvature (i.e., scoliosis, kyphosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
Origin Anterior Cervical Plate System is an anterior cervical fixation system comprised of a titanium plate, and bone screws, both in multiple sizes. The Plate features multiple holes designed to receive and secure bone screws. The Plate System is provided non-sterile and is intended for single use.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
C2-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
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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)
Origin Anterior Cervical Plate System was tested in accordance with the recommendations from the FDA Guidance for Spinal Systems 510(K) submission. This testing included static and dynamic axial compression bending and static torsion testing. A review of the performance data demonstrates substantial equivalence 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.
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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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Orthopaedic & Spine Development % Mr. Roger White President Phiama. Inc. 236 McKinley Park Lane Louisville. Colorado 80027
Re: K193494
Trade/Device Name: Origin™ 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: March 18, 2020 Received: March 20, 2020
Dear Mr. Roger White:
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
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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 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 (OS) 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,
Colin O'Neill, M.B.E. Acting 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
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Indications for Use
510(k) Number (if known)
K193494
Device Name Origin™ Anterior Cervical Plate System
Indications for Use (Describe)
The Origin Anterior Cervical Plate System is interior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvature (i.e., scoliosis, kyphosis), tumor, pseudoarthrosis, and failed previous fusion.
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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510(k) Summary Origin™ Anterior Cervical Plate System
1. Submitter Information
| Submitter: | Orthopaedic & Spine Development (OSD) |
|---|---|
| Address: | Technopôle Agroparc – BP 11211 |
| 84911 Avignon Cedex 9, France | |
| Telephone: | +33 (0)4-32-74-01-10 |
| Telefax: | +33 (0)4-90-80-02-39 |
| Contact: | Roger White |
| rwhite@phiama.com | |
| 303-550-2451 | |
| Date Prepared: | December 16, 2019 |
2. Device Information
| Trade Name: | Origin™ Anterior Cervical Plate |
|---|---|
| Common Name: | System Anterior Cervical Fixation |
| Classification: | System Class II per 21 CFR 888.3060 |
| Classification Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Product Code: | KWQ |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new Anterior Cervical Fixation System.
4. Predicate Device Information
The Origin Anterior Cervical Plate System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| TriforeTM Cervical Plating | ||
| System | NeuroStructures, Inc. | K171112 |
| TERRACETM Anterior Cervical | ||
| Plate System | CoreLink | K163104 |
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5. Device Description
Origin Anterior Cervical Plate System is an anterior cervical fixation system comprised of a titanium plate, and bone screws, both in multiple sizes. The Plate features multiple holes designed to receive and secure bone screws. The Plate System is provided non-sterile and is intended for single use.
6. Intended Use
The Origin Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
7. Comparison of Technological Characteristics
The substantial equivalence of the Origin Anterior Cervical Plate System to the predicate devices is shown by the similarity in intended use, indications for use, materials, implant dimensions, and performance.
8. Performance Data
Origin Anterior Cervical Plate System was tested in accordance with the recommendations from the FDA Guidance for Spinal Systems 510(K) submission. This testing included static and dynamic axial compression bending and static torsion testing. A review of the performance data demonstrates substantial equivalence to the predicate devices.
9. Conclusion
Based on the indications for use, technological characteristics, biocompatibility, performance results, and comparison to the predicates, the Origin Anterior Cervical Plate System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.