(24 days)
The Release® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Release® Laminoplasty Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
The Release Laminoplasty Fixation System consists of a variety of sizes of implantable plates and screws that are attached to the lamina after a laminoplasty or laminectomy procedure. The implantable components are manufactured from medical grade ASTM F 136 Titanium alloy. The system also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes a 510(k) premarket notification for a medical device called the "Release® Laminoplasty Fixation System." It includes information about the device's intended use, classification, and a summary of performance data. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered device or diagnostic.
This document is a regulatory submission for a physical implantable device (plates and screws for spinal fixation), not an AI/ML-driven diagnostic or medical device. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment is not applicable to the content provided.
The "Non-Clinical Performance Data" section mentions:
- ASTM F543 (screw insertion torque, torque to failure, pull-out)
- ASTM F2193 cantilever bend testing
- Finite Element Analysis
These are standard mechanical and material performance tests for physical orthopedic implants, not software or AI-based diagnostics. The document explicitly states: "Clinical performance data was not provided in this submission for a determination of substantial equivalence." This further indicates that no clinical study (which would be relevant for establishing performance characteristics in the context of AI) was conducted or reported in this submission.
Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.
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January 21, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology, Incorporated (DBA RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K153735
Trade/Device Name: Release® Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: December 22, 2015 Received: December 28, 2015
Dear Ms. Pleaugh:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 yours,
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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Indications for Use
510(k) Number (if known)
K153735
Device Name Release® Laminoplasty Fixation System
Indications for Use (Describe)
The Release® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Release® Laminoplasty Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
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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Image /page/3/Picture/0 description: The image shows the logo for "rti surgical". The "rti" is in white text on a blue rounded square. The "i" in "rti" has a green dot above it. To the right of the blue square, the word "surgical" is written in gray.
510(k) Summary As required per 21 CFR Section 807 92
| Date: | December 22, 2015 |
|---|---|
| 510(k) Owner /Manufacturer: | Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USATelephone: 906-226-9909Fax: 906-226-4455 |
| Contact Person: | Sarah Pleaugh, Regulatory Affairs Specialist |
| Device trade/proprietary name: | Release® Laminoplasty Fixation System |
| Classificationregulation: | 21 CFR 888.3050; Spinal interlaminal fixation orthosis |
| Device class: | 2 |
| Product code: | NQW |
| Review panel: | Orthopedic |
| Predicate device | Pioneer Release Laminoplasty Plating System (K113218)DePuy Spine, Inc. MOUNTAINEER® Laminoplasty System(K091994) |
| Description: | The Release Laminoplasty Fixation System consists of avariety of sizes of implantable plates and screws that areattached to the lamina after a laminoplasty or laminectomyprocedure. The implantable components are manufacturedfrom medical grade ASTM F 136 Titanium alloy. The systemalso contains Class I manual surgical instruments andcases that are considered exempt from premarketnotification. |
| Purpose of thissubmission: | To modify the previously cleared Pioneer ReleaseLaminoplasty Plating System (Primary Predicate - K113218). |
| Intended Use/Indications forUse: | The Release Laminoplasty Fixation System is intended foruse in the lower cervical and upper thoracic spine (C3 toT3) in laminoplasty procedures. The Release LaminoplastyFixation System is used to hold the graft material in place inorder to prevent the graft material from expulsion, orimpinging the spinal cord. |
| Technologicalcharacteristics: | The subject system has the same technologicalcharacteristics (overall design, material, principles ofoperation, and anatomical location of use) as the predicate.The subject modifications do not impact the technologicalcharacteristics as compared to K113218 |
| SubstantialEquivalence: | The 510(k) includes a summary of the technologicalcharacteristics of the subject device as compared to thepredicate device. The device has the same technologicalcharacteristics (i.e., design, material, principles of operation,intended use) as the predicate device. The modifications tothe predicate K113218 system do not raise new issues ofsafety or effectiveness. |
| Non-ClinicalPerformance Data: | ASTM F543 (screw insertion torque, torque to failure, pull-out), ASTM F2193 cantilever bend testing, and FiniteElement Analysis were provided to show equivalentmechanical performance. The subject device, as evaluated,has demonstrated substantial equivalence to the predicates. |
| ClinicalPerformance Data: | Clinical performance data was not provided in thissubmission for a determination of substantial equivalence. |
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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.