(86 days)
The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating 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 Pioneer Release Laminoplasty Plating System consists of implantable plates and screws that will act as a buttress to maintain decompression after a laminoplasty procedure. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This document describes the acceptance criteria and the study that proves the Pioneer Release Laminoplasty Plating System meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Static Four-Point Bend per ASTM F2193 | Functioned as intended |
| Fatigue Four-Point Bend per ASTM F2193 | Functioned as intended |
| Axial Screw Pull-Out per ASTM F543 | Functioned as intended |
| Substantial Equivalence to Predicate System | Achieved |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated in the provided document. The document mentions "standard testing" per ASTM F2193 and ASTM F543, implying that the number of samples would conform to the requirements of these standards.
- Data Provenance: The study appears to be a laboratory-based performance test conducted by the manufacturer, Pioneer Surgical Technology. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in a clinical setting. The tests were performed on the device components themselves.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable. This device is a medical implant, and its performance was evaluated through mechanical testing, not by expert review of imaging or clinical data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation was based on mechanical test results against established ASTM standards, not on expert adjudication of clinical or imaging data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed. This study focuses on the mechanical performance of a spinal implant system. MRMC studies are typically used for diagnostic or screening devices where human readers interpret data, often with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this study was established by recognized ASTM standards (F2193 and F543) for the mechanical performance of spinal implants. The device's ability to maintain its structural integrity and mechanical properties under specified loads, as defined by these standards, constituted the success criteria.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable, as no training set was used.
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长川多218
JAN 2 6 2012
4.0 510(k) Summary
| Sponsor: | Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 225-5861Contact: Sarah McIntyre or Emily DownsPrepared: October 28, 2011 |
|---|---|
| Device Name: | Pioneer Release Laminoplasty Plating System |
| Classification: | Class II; NQW/ 888.3050 - Spinal interlaminal fixation orthosisPanel Code: 87 |
| Predicate Devices: | K091994 DePuy Spine, Inc. Mountaineer Laminoplasty System (SE 1/7/10)K050082 Medtronic CENTERPIECE Plate Fixation System (SE 6/6/05) |
| Description: | The Pioneer Release Laminoplasty Plating System consists of implantable platesand screws that will act as a buttress to maintain decompression after alaminoplasty procedure. The system also contains Class 1 manual surgicalinstruments and cases that are considered exempt from premarket notification. |
| Intended Use: | The Pioneer Release Laminoplasty Plating System is intended for use in the lowercervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. ThePioneer Release Laminoplasty Plating System is used to hold the graft material inplace in order to prevent the graft material from expulsion, or impinging the spinalcord. |
| Material: | The Pioneer Release Laminoplasty Plating System components are manufacturedfrom biocompatible, implant grade ASTM F136 titanium alloy. |
| Performance Data: | Static and fatigue four point bend standard testing per recognized ASTM F2193and axial screw pull-out per ASTM F543 standards were performed to establishsubstantial equivalence. The test results demonstrate that the Pioneer ReleaseLaminoplasty Plating System functioned as intended and performed in a mannersubstantially equivalent to that of a predicate system. |
| Performance andSE Determination: | Equivalence for the Pioneer Release Laminoplasty Plating System is based onsimilarities of intended use, design, and physical characteristics when compared topredicate devices. Therefore, Pioneer Surgical Technology believes that there issufficient evidence to conclude that the Pioneer Release Laminoplasty PlatingSystem is substantially equivalent to existing legally marketed devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 6 2012
Pioneer Surgical Technology, Inc. % Ms. Sarah McIntyre 375 River Park Circle Marquette, Michigan 49855
Re: K113218
Trade/Device Name: Pioneer Release Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: October 28, 2011 Received: November 01, 2011
Dear Ms. McIntyre:
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
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Page 2 - Ms. Sarah McIntyre
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours
for Bott Dasolin Dik
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 3.0
KII 3218 510(k) Number (if known):
Device Name:
Pioneer Release Laminoplasty Plating System
Indications:
The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
KII3218 510(k) Number.
§ 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.