(24 days)
No
The summary describes a mechanical fixation system (plates and screws) and manual surgical instruments. There is no mention of AI, ML, image processing, or any software-based functionality that would typically incorporate these technologies. The performance studies are mechanical and structural, not related to algorithmic performance.
No.
The device is an implantable system (plates and screws) used to hold graft material in place after a laminoplasty or laminectomy procedure, which is a structural rather than a therapeutic function.
No.
The device is a surgical fixation system used to hold graft material in place after a laminoplasty or laminectomy procedure, not to diagnose a condition.
No
The device description explicitly states it consists of implantable plates and screws made of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "holding the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord" during laminoplasty procedures. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details implantable plates and screws made of titanium alloy, along with surgical instruments. These are physical devices used in a surgical procedure, not reagents or instruments used to examine specimens in vitro (outside the body).
- Anatomical Site: The specified anatomical site is the spine, which is part of the human body. IVDs analyze samples taken from the body (like blood, urine, tissue), not devices implanted into the body.
IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
NQW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3 to T3)
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
ASTM F543 (screw insertion torque, torque to failure, pull-out), ASTM F2193 cantilever bend testing, and Finite Element Analysis were provided to show equivalent mechanical performance. The subject device, as evaluated, has demonstrated substantial equivalence to the predicates. Clinical performance data was not provided in this submission for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Pioneer Release Laminoplasty Plating System (K113218), DePuy Spine, Inc. MOUNTAINEER® Laminoplasty System (K091994)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of a human face in profile, with three overlapping faces.
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 Circle | |
| Marquette, MI 49855 USA | |
| Telephone: 906-226-9909 | |
| Fax: 906-226-4455 | |
| Contact Person: | Sarah Pleaugh, Regulatory Affairs Specialist |
| Device trade/ | |
| proprietary name: | Release® Laminoplasty Fixation System |
| Classification | |
| regulation: | 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 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. | |
| Purpose of this | |
| submission: | To modify the previously cleared Pioneer Release |
| Laminoplasty Plating System (Primary Predicate - K113218). | |
| Intended Use/ | |
| Indications for | |
| Use: | 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. | |
| Technological | |
| characteristics: | The subject system has the same technological |
| characteristics (overall design, material, principles of | |
| operation, and anatomical location of use) as the predicate. | |
| The subject modifications do not impact the technological | |
| characteristics as compared to K113218 | |
| Substantial | |
| Equivalence: | The 510(k) includes a summary of the technological |
| characteristics of the subject device as compared to the | |
| predicate device. The device has the same technological | |
| characteristics (i.e., design, material, principles of operation, | |
| intended use) as the predicate device. The modifications to | |
| the predicate K113218 system do not raise new issues of | |
| safety or effectiveness. | |
| Non-Clinical | |
| Performance Data: | ASTM F543 (screw insertion torque, torque to failure, pull- |
| out), ASTM F2193 cantilever bend testing, and Finite | |
| Element Analysis were provided to show equivalent | |
| mechanical performance. The subject device, as evaluated, | |
| has demonstrated substantial equivalence to the predicates. | |
| Clinical | |
| Performance Data: | Clinical performance data was not provided in this |
| submission for a determination of substantial equivalence. |
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