(164 days)
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench testing, not clinical studies involving data analysis.
Yes
The device is intended for fixation of the cervical spine (C2-C7) for various medical indications such as degenerative disc disease, trauma, spinal stenosis, and tumors, which are all conditions that require medical therapy.
No
The device description clearly states "The Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7)", indicating it is a surgical implant for treatment, not for diagnosis.
No
The device description explicitly states it consists of "titanium plates with an integrated one-step blocking mechanism" and "bone-screws," which are physical 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 describes a surgical implant for fixing the cervical spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details titanium plates and screws with a blocking mechanism, which are physical components used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on bench testing of the mechanical properties of the implant, not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes Vectra-One System is substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
K926453, K050451, K792352, K042544
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
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NOV 3 6 2007
510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Stacey Bonnell |
| Associate Regulatory Affairs Specialist | |
| Telephone: 610-719-5895 Facsimile: 610-719-5102 | |
| Email: bonnell.stacey@synthes.com | |
| Date Prepared: | November 26, 2007 |
| Trade Name: | Synthes Vectra-One System |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Class II | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product 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 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). | |
| Intended Use/ 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. | |
| 510(k) Summary | |
| Comparison of | |
| the device to | |
| predicate | |
| device(s): | The Synthes Vectra-One System is a result of design modifications to the |
| predicate devices. It is substantially equivalent to the predicates in design, | |
| function, material, and intended use. | |
| Performance | |
| Date | |
| (Non-Clinical | |
| and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Bench testing results demonstrate that the Synthes Vectra-One System is | |
| substantially 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.
3
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
4
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 |