(60 days)
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a "posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments ... as an adjunct to fusion" in the treatment of various spinal conditions, clearly indicating its role in treating and managing a medical condition.
No
Explanation: The CapLOX II/TowerLOX Pedicle Screw System is described as a "posterior, non-cervical pedicle fixation system" and an "implant device" intended for "immobilization and stabilization of spinal segments" as an "adjunct to fusion." Its purpose is to physically support the spine, not to identify or determine the nature of a disease or condition.
No
The device description clearly states it is an "implant device made from a titanium alloy" and includes physical components like screws and rods. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the CapLOX II/TowerLOX Pedicle Screw System is an implant device made from titanium alloy. It is surgically implanted into the spine.
- Intended Use: The intended use describes the device's function in providing immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant used for spinal fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Product codes
MNH, MNI
Device Description
The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and prelordosed configurations. The system includes set screws, and rods alone with the associated instrumentation to complete the procedure and implant construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, L5-S1 vertebra, L3 to the sacrum/ilium
Indicated Patient Age Range
skeletally mature patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2015
Captiva Spine % Mr. Kenneth C. Maxwell II Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K151116
Trade/Device Name: CapLOX II/TowerLOX Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 5, 2015 Received: June 8, 2015
Dear Mr. Maxwell:
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 - Mr. Kenneth C. Maxwell II
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" (21 CFR 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
CapLOX II/TowerLOX Pedicle Screw System
Indications for Use (Describe)
The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid 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) |
| 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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (9/13)
Page 2 of 2
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510(K) SUMMARY
| Submitter's Name: | Captiva Spine |
|---|---|
| Submitter's Address: | 967 N Alternate A1A Ste 1 |
| Jupiter, FL 33477 | |
| Submitter's Telephone: | 877-772-5571 |
| Contact Person: | Kenneth C. Maxwell |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 24 April 2015 |
| Trade or Proprietary Name: | CapLOX II/TowerLOX Pedicle Screw System |
| Common or Usual Name: | Pedicle Screw System |
| Classification: | Class II per 21 CFR §888.3070 |
| Product Code: | MNI, MNH |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and prelordosed configurations. The system includes set screws, and rods alone with the associated instrumentation to complete the procedure and implant construct.
INDICATIONS FOR USE
The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
TECHNICAL CHARACTERISTICS
CapLOX II/TowerLOX Pedicle Screw System is made from titanium alloy that conforms to ASTM F136, and no material changes are being proposed as part of this submission. The subject
5
and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- . Structural support mechanism
The additions to the system include the following implants and instruments:
- Modular extended tab (tower) pedicle screw head assembly ●
- Instrumentation and rotating rods to facilitate rod insertion when using tower pedicle screw ● head assembly
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K131538 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | Primary |
CONCLUSION
The subject modified is CapLOX II/TowerLOX Pedicle Screw System very similar to previously cleared CapLOX II/TowerLOX Pedicle Screw System. The subject CapLOX II/TowerLOX Pedicle Screw System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that the CapLOX II/TowerLOX Pedicle Screw System is substantially equivalent to the predicate devices.