(164 days)
The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) for the following indications:
Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Trauma (i.e., fractures or dislocations) Spinal stenosis Tumors (primary and metastatic) Failed previous fusions Pseudarthrosis Deformity (i.e., kyphosis, lordosis and/or scoliosis)
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Synthes Vectra-One System consists of titanium plates with an integrated one-step blocking mechanism. This blocking mechanism consists of a resilient clip pre-assembled in each bone-screw-receiving hole's radial groove to block a bone screw from backing out in the event of lost bone purchase. This construct allows either a Fixed Angle Screw (a screw with fixed insertion angle) or Variable Angle Screw (a screw with a range of insertion angle which permits the screw-head to angulate inside the bone-screw-hole after being threaded into a bone) to be used. The Vectra-One System uses the identical and compatible bone-screws from the Synthes Vectra System (K050451). Furthermore, the integrated one-step blocking mechanism is identical to the mechanism from the Synthes Vectra System (K050451).
The provided document, K071667, is a 510(k) Summary for the Synthes Vectra-One System. This device is a spinal intervertebral body fixation orthosis. The summary focuses on establishing substantial equivalence to predicate devices based on design, function, material, and intended use, rather than demonstrating performance against specific quantitative acceptance criteria of a novel device. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert adjudication, and sample sizes is not explicitly provided in the document for this type of medical device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit for spinal fixation systems) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (Synthes Anterior Cervical Vertebra Plates (K926453), Synthes Vectra System (K050451), Synthes Cervical Vertebrae Plates (K792352), DePuy Spine UniPlate Anterior Cervical Plate System (K042544)) in design, function, material, and intended use. | The Synthes Vectra-One System is described as a result of design modifications to the predicate devices. It is stated to be substantially equivalent to the predicates in design, function, material, and intended use. The integrated one-step blocking mechanism is identical to the mechanism from the Synthes Vectra System (K050451). The System uses identical and compatible bone-screws from the Synthes Vectra System (K050451). |
| Mechanical/Biomechanical Performance (e.g., strength, stability, screw retention) | Bench testing results demonstrate that the Synthes Vectra-One System is substantially equivalent to the predicate devices. (Specific quantitative criteria or results are not provided in this summary.) |
| Clinical Safety and Effectiveness | Clinical data and conclusions were not needed for this device. (This indicates that the FDA considered the substantial equivalence demonstrated through design and bench testing sufficient to infer clinical safety and effectiveness based on the predicate devices.) |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not applicable/Not specified in the provided document. The submission relies on design comparison and bench testing, not a clinical test set in the traditional sense.
- Data provenance: Not explicitly stated for specific test data, but the bench testing would have been conducted by the manufacturer, Synthes Spine.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. "Ground truth" in the context of device performance would typically refer to established engineering standards or the performance of predicate devices. The document does not detail specific expert panels for interpreting test results beyond the manufacturer's internal engineering and regulatory teams and eventually the FDA's review.
4. Adjudication method for the test set:
- Not applicable/Not specified. As there's no clinical "test set" with subjective interpretations, an adjudication method for ground truth is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical medical implant (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical performance, the "ground truth" implicitly refers to engineering standards and direct comparison with the mechanical and material properties of the predicate devices. The concept of "ground truth" as pathology results or outcomes data is not directly applicable to the non-clinical bench testing for this type of device.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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Page 1 of 2
NOV 3 6 2007
510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Stacey BonnellAssociate Regulatory Affairs SpecialistTelephone: 610-719-5895 Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com |
| Date Prepared: | November 26, 2007 |
| Trade Name: | Synthes Vectra-One System |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation OrthosisClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code KWQ |
| Predicates: | Synthes Anterior Cervical Vertebra Plates (K926453)Synthes Vectra System (K050451)Synthes Cervical Vertebrae Plates (K792352)DePuy Spine UniPlate Anterior Cervical Plate System (K042544) |
| Device Description: | The Synthes Vectra-One System consists of titanium plates with an integratedone-step blocking mechanism. This blocking mechanism consists of a resilientclip pre-assembled in each bone-screw-receiving hole's radial groove to block abone screw from backing out in the event of lost bone purchase. This constructallows either a Fixed Angle Screw (a screw with fixed insertion angle) orVariable Angle Screw (a screw with a range of insertion angle which permits thescrew-head to angulate inside the bone-screw-hole after being threaded into abone) to be used. The Vectra-One System uses the identical and compatiblebone-screws from the Synthes Vectra System (K050451). Furthermore, theintegrated one-step blocking mechanism is identical to the mechanism from theSynthes Vectra System (K050451). |
| Intended Use/ Indications for Use: | The Vectra-One System is intended for anterior plate and screw fixationof the cervical spine (C2-C7) for the following indications:Degenerative disc disease (DDD) (defined as neck pain ofdiscogenic origin with degeneration of the disc confirmed byhistory and radiographic studies) Spondylolisthesis Trauma (i.e., fractures or dislocations) Spinal stenosis Tumors (primary and metastatic) Failed previous fusions Pseudarthrosis Deformity (i.e., kyphosis, lordosis and/or scoliosis) |
| Warning: This device is not intended for screw attachment or fixation tothe posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. | |
| 510(k) Summary | |
| Comparison ofthe device topredicatedevice(s): | The Synthes Vectra-One System is a result of design modifications to thepredicate devices. It is substantially equivalent to the predicates in design,function, material, and intended use. |
| PerformanceDate(Non-Clinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Bench testing results demonstrate that the Synthes Vectra-One System issubstantially equivalent to the predicate devices. |
| Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
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Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of wavy lines, possibly representing human profiles.
Public Health Service
NOV 3 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes Spine % Ms. Stacey Bonnell 1302 Wrights Lane East West Chester, PA 19380
Re: K071667
Trade/Device Name: Synthes Vectra-One System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 27, 2007 Received: November 28, 2007
Dear Ms. Bonnell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
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Page 2 - Ms. Stacey Bonnell
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Spine
Indications for Use Statement
510(k) Number: K071667 (if known)
Device Name: Synthes Vectra-One System
Indications for Use:
The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) for the following indications:
- Degenerative disc disease (DDD) {defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- " Spondylolisthesis
- · Trauma (i.e., fractures or dislocations)
-
- Spinal stenosis
- · Tumors (primary and metastatic)
- " Failed previous fusions
- Pseudarthrosis
- · Deformity (i.e., kyphosis, lordosis and/or scoliosis)
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
| Prescription Use(21 CFR 801 Subpart D) | AND / OR | Over-the-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|
| -------------------------------------------- | ---------- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | L071667 |
§ 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.