(70 days)
The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.
The CAYMAN LP Plate System are non-load bearing devices, each consisting of a plate and screw for attachment to the vertebral body. The plates are designed to be used as additions to spinal fusion procedures from the lateral and anterior approaches, forming a preventative barrier to intervertebral cage movement. Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO standards. Function: The plates are designed to be used in a spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.
The provided text describes the CAYMAN LP Plate System, a spinal implant, and its 510(k) summary for FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical testing. No information is provided in the document regarding acceptance criteria for an AI/ML device, nor any study proving an AI/ML device meets such criteria.
The document describes a medical device, the CAYMAN LP Plate System, which is a physical implant used in spinal fusion procedures. It is not an AI/ML device, and thus, the concepts of a "test set," "training set," "ground truth," "human readers," or "AI assistance" do not apply to the information presented.
Therefore, I cannot provide a table of acceptance criteria, details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.
The study described in the document is a nonclinical mechanical test to demonstrate the ability of the physical plates to resist migration or expulsion of graft material, and to show mechanical superiority to a legacy predicate device. This is a performance test for a physical medical device.
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May 15, 2019
K2m, Inc. Mr. Casey Hinckley Regulatory Affairs Specialist 600 Hope Parkway, SE Leesburg, Virginia 20175
Re: K190584
Trade/Device Name: CAYMAN LP Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 5, 2019 Received: March 6, 2019
Dear Mr. Hinckley:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190584
Device Name CAYMAN LP Plate System
Indications for Use (Describe)
The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
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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stryker
2 510(k) Summary
| 510(k) Summary: CAYMAN LP Plate System | |
|---|---|
| Submitter: | K2M, Inc. |
| Contact Person : | Casey HinckleyRegulatory Affairs SpecialistPhone: +1 (571) 919-2318Fax: +1 (866) 466-6109Email: casey.hinckley@stryker.com |
| Date Prepared: | March 5, 2019 |
| Trade Name: | CAYMAN LP Plate System |
| Common Name: | Appliance, fixation, spinal intervertebral body |
| Proposed Class: | Class II |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) |
| Product Code: | KWQ |
| Predicate Devices: | Primary Predicate: K2M CAYMAN Buttress Plate System (K080302)Additional Predicates: Innovasis Kestral Buttress Plate System (K181063),and Stryker LITe Plate System (K142699) |
| Device Description: | The CAYMAN LP Plate System are non-load bearing devices, each consistingof a plate and screw for attachment to the vertebral body. The plates aredesigned to be used as additions to spinal fusion procedures from the lateraland anterior approaches, forming a preventative barrier to intervertebralcage movement.Materials: The devices are manufactured from Ti6Al4V per ASTM and ISOstandards.Function: The plates are designed to be used in a spinal fusion procedures toprovide stabilization and buttressing of tissue in the intervertebral space. |
| Intended Use: | The CAYMAN LP Plate System is intended for use in spinal fusion proceduresas a means to maintain the relative position of weak bony tissue such asallografts or autografts. The device is not intended for load bearingindications. |
| 510(k) Summary: CAYMAN LP Plate System | |
| Summary of theTechnologicalCharacteristics | The CAYMAN LP Plate System is considered substantially equivalent to otherlegally marketed devices. They are similar in design, material, andindications for use. |
| Summary of thePerformance Data | Nonclinical testing was performed to demonstrate that the CAYMAN LP PlateSystem is substantially equivalent to its predicate devices.Mechanical tests were performed to test the ability of the plates to resistmigration or expulsion of the graft material. |
| Conclusion | The CAYMAN LP Plate System has identical indication, technologicalcharacteristics, and principles of operation as its predicates. The nonclinicaltest results demonstrated that the new CAYMAN LP plate is mechanicallysuperior to the legacy CAYMAN Buttress Plate. The CAYMAN LP PlateSystem was shown to be substantially equivalent to its predicate devices. |
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K190584 - Page 2 of 2
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§ 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.