(84 days)
The CAPRI Corpectomy Cage Systems is a vertebral body replacement device intended for use in the thoracolumbar spine (T) to L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The CAPRI Corpectomy Cage Systems is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium) and adjustable (titanium and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).
Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
This document describes the CAPRI Corpectomy Cage System, a vertebral body replacement device. This summary focuses on its regulatory clearance and mechanical testing, not a study involving AI or human readers for diagnostic accuracy. Therefore, many of the requested categories (like sample size for test sets, expert qualifications, HRMC studies, etc.) are not applicable to the information provided.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Static Compression (per ASTM F2077) | Performed equally to or better than predicate devices. |
| Static Torsion (per ASTM F2077) | Performed equally to or better than predicate devices. |
| Dynamic Compression (per ASTM F2077) | Performed equally to or better than predicate devices. |
| Dynamic Torsion (per ASTM F2077) | Performed equally to or better than predicate devices. |
| Subsidence (per ASTM F2267) | Performed equally to or better than predicate devices. |
| Biocompatibility/Safety Testing: | |
| Bacterial Endotoxin Testing (BET)/ (LAL) testing (in accordance with ANSI/AAMI/ST72:2011) | Conducted. (Implicitly, the results met acceptance criteria for regulatory clearance, as the device was deemed substantially equivalent and cleared.) |
Note: The document states that the device "performed equally to or better than these systems" (referring to predicate devices) in the mechanical tests. This implies that the predicate devices' performance served as the acceptance criteria benchmark. The specific quantitative acceptance values are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a "test set" for an AI or diagnostic device. For the mechanical and biocompatibility testing, the sample size would refer to the number of physical devices or components tested. This detail is not provided in the summary.
- Data Provenance: Not applicable for the type of testing described (mechanical and biocompatibility testing of a physical device). The tests were conducted in a laboratory setting. There is no mention of patient data, clinical studies, or country of origin for such data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document describes mechanical and biocompatibility testing of a physical medical device, not a diagnostic device requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document describes mechanical and biocompatibility testing of a physical medical device.
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
- No. This is not a study of AI or a diagnostic device, so an MRMC comparative effectiveness study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This document describes a physical medical device (corpectomy cage), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" or reference standard would be the established performance characteristics and safety profiles of the predicate devices, along with the requirements of the ASTM standards (F2077, F2267). The device's performance was compared directly to these benchmarks.
- For biocompatibility testing (BET/LAL), the "ground truth" is compliance with the specified standard (ANSI/AAMI/ST72:2011), which sets limits for endotoxin levels to ensure safety.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI model is involved.
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August 31, 2017
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is likely for a specific department or office within the FDA.
K2M, Inc. Ms. Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K171704
Trade/Device Name: CAPRI Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: August 16, 2017 Received: August 17, 2017
Dear Ms. Giezen:
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 (reporting of medical device-
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related adverse events) (21 CFR 803); 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.
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 (DICE) 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. 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 (DICE) 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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K171704
Device Name CAPRI Corpectomy Cage System
Indications for Use (Describe)
The CAPRI Corpectorny Cage Systems is a vertebral body replacement device intended for use in the thoracolumbar spine (T) to L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The CAPRI Corpectorny Cage Systems is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
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 CAPRI Corpectomy Cage System
Submitter
K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 08/16/2017
Classification
| Trade Name: | CAPRI Corpectomy Cage System |
|---|---|
| Common Name: | Vertebral Body Replacement Device |
| Regulatory Class: | Class II |
Classification Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code MQP)
Predicate Device(s)
Primary Predicate:
- K2M CAPRI Corpectomy Cage System (K142016) 0 Additional Predicates:
Device Description
The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium) and adjustable (titanium and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).
Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
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Intended Use
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems
Technological Comparison to Predicate(s)
The CAPRI Corpectomy Cage System was compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.
Non-clinical Performance Evaluation
The CAPRI Corpectomy Cage System was mechanically tested and compared to predicate devices. The CAPRI Corpectomy Cage System performed equally to or better than these systems in static compression, static torsion, dynamic compression and dynamic torsion (per ASTM F2077) and subsidence per ASTM F2267. In addition, bacterial endotoxin testing (BET), also known as limulus amebocyte lysate (LAL) testing, was conducted in accordance with ANSI/AAMI/ST72:2011.
Conclusion
There are no significant differences between the CAPRI Corpectomy Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
§ 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.