(386 days)
Not Found
No
The 510(k) summary describes a mechanical implant system (plates, screws, and a screw-retaining rail lock) for cervical spine fixation. There is no mention of software, algorithms, image processing, AI, ML, or any data analysis components that would suggest the use of AI/ML technology. The performance studies focus on mechanical testing and material properties, not algorithmic performance.
Yes
The device is intended for anterior screw fixation of the cervical spine to provide stabilization as an adjunct to cervical fusion for various degenerative and traumatic conditions, indicating a direct therapeutic purpose.
No
This device is an implantable medical device used for stabilization as an adjunct to cervical fusion in the spine, not for diagnosing conditions.
No
The device description explicitly states that the system includes plates, screws, and a screw-retaining rail lock, which are physical hardware components.
Based on the provided text, the Captiva Spine SmartLOX Cervical Plate System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Captiva Spine SmartLOX Cervical Plate System clearly states it is an implant intended for anterior screw fixation of the cervical spine. It is a physical device implanted into the body, not used to test samples from the body.
- The intended use and device description focus on surgical implantation and stabilization of the spine. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies described are mechanical and corrosion tests, which are relevant for implanted devices, not IVDs.
Therefore, the Captiva Spine SmartLOX Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or 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 Captiva Spine SmartLOX Cervical Plate system is intended for anterior screw fixation of the cervical spine. This system has been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.
The Captiva Spine SmartLOX Cervical Plate System includes plates, screws, and a screw-retaining rail lock. The plates are available in a variety of lengths ranging from 20 to 110mm. Screws are offered in two diameters, a primary screw diameter and a rescue diameter. Primary screws are available in self-drilling, and both screw diameters are available in fixed and variable versions. Screw lengths range from 12 to 18mm in 2mm increments. The rails are assembled with the plate during the manufacturing process and their configuration varies with the plate length.
The Captiva Spine SmartLOX Cervical Plate System is supplied with the instrumentation necessary for implantation of the system. The Captiva Spine SmartLOX Cervical Plate System is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine
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)
Captiva Spine SmartLOX Cervical Plate System was evaluated to demonstrate equivalence to the predicate device. The worst-case implants were previously tested and performed equally to or better than the predicate devices in static compression, static torsion and dynamic compression in accordance with ASMT F1717. Engineering analysis of the proposed design changes included Design Failure Modes and Effect Analysis (FMEA) as well as a tabulated comparison between Captiva Spine SmartLOX Cervical Plate System and the predicates. The comparative analysis included product code, indications for use, material and screw/plate dimensions. Based on the completed engineering analysis's it was determined that the modified implants have the same indication for use, are within the previously cleared device size ranges, made of the same materials and do not represent new worst case for mechanical testing and therefore no new performance testing was required. No clinical or animal studies were performed. Corrosion susceptibility was tested per ASTM F2129-08 and Galvanic Corrosion was tested per ASTM F3044-14.
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 an emblem featuring 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
June 11, 2015
Captiva Spine, Incorporated % Rich Jansen, Pharm. D Regulatory Consultant Silver Pine Consulting, LLC 13540 Guide Avenue Apple Valley, Minnesota 55124
Re: K141332
Trade/Device Name: Captiva Spine SmartLOX Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 14, 2015 Received: May 15, 2015
Dear Dr. Jansen:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Rich Jansen, Pharm. D
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K141332
Device Name
Captiva Spine SmartLOX Cervical Plate System
Indications for Use (Describe)
The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) Summary
| Date Prepared:
Submitter Contact: | May 14, 2015
Dale Mitchell
Captiva Spine
967 Alternate A1A #1
Jupiter, FL 33477
877-772-5571
866-318-3224 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Rich Jansen, Pharm. D.
Silver Pine Consulting, LLC
612-281-5505
richj@s-pineconsulting.com |
| Trade Name: | Captiva Spine SmartLOX Cervical Plate System |
| Product Class: | Class II |
| Classification: | 888.3060 Spinal Intervertebral Body Fixation Orthosis |
| Product Codes: | KWQ |
| Panel Code: | 87 |
Reason for this Submission: This Traditional 510(k) involves several changes to the previously cleared Cervical Plate System that allow for:
-
- Modifications to cervical plate configurations
-
- Modifications to rail lock configuration
-
- Modifications to screw design configurations
-
- New or modified instrumentation
Indications for Use:
The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Device Descriptions:
The Captiva Spine SmartLOX Cervical Plate system is intended for anterior screw fixation of the cervical spine. This system has been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and
4
radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.
The Captiva Spine SmartLOX Cervical Plate System includes plates, screws, and a screwretaining rail lock. The plates are available in a variety of lengths ranging from 20 to 110mm. Screws are offered in two diameters, a primary screw diameter and a rescue diameter. Primary screws are available in self-drilling, and both screw diameters are available in fixed and variable versions. Screw lengths range from 12 to 18mm in 2mm increments. The rails are assembled with the plate during the manufacturing process and their configuration varies with the plate length.
The Captiva Spine SmartLOX Cervical Plate System is supplied with the instrumentation necessary for implantation of the system. The Captiva Spine SmartLOX Cervical Plate System is for single use only.
Predicate Device(s):
The Captiva Spine SmartLOX Cervical Plate System is substantially equivalent to the previously cleared Precision Surgery Ltd. Fixed, Variable and Corpectomy Cervical Plate System found in both K032815 and K073708 (primary predicate) and Medtronic Sofamor Danek Orion Anterior Cervical Plate System cleared per K042499.
Performance Standards:
Captiva Spine SmartLOX Cervical Plate System was evaluated to demonstrate equivalence to the predicate device. The worst-case implants were previously tested and performed equally to or better than the predicate devices in static compression, static torsion and dynamic compression in accordance with ASMT F1717. Engineering analysis of the proposed design changes included Design Failure Modes and Effect Analysis (FMEA) as well as a tabulated comparison between Captiva Spine SmartLOX Cervical Plate System and the predicates. The comparative analysis included product code, indications for use, material and screw/plate dimensions. Based on the completed engineering analysis's it was determined that the modified implants have the same indication for use, are within the previously cleared device size ranges, made of the same materials and do not represent new worst case for mechanical testing and therefore no new performance testing was required. No clinical or animal studies were performed.
Corrosion susceptibility was tested per ASTM F2129-08 and Galvanic Corrosion was tested per ASTM F3044-14.
Substantial Equivalence:
Captiva Spine concludes that there are no significant differences between the Captiva Spine SmartLOX Cervical Plate System and the other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in intended use, indications for use, fundamental technology including design, materials, sterility and operational principles.