(142 days)
The Pioneer Spinous Process Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma and/or tumor. The Pioneer Spinous Process Fusion System is intended for use with bone graft material (i.e. allograph or autograph), not intended for stand-alone use.
The Pioneer Spinous Process Fusion Plate is a plate with spacer system designed to provide posterior fixation by physically linking adjacent spinous processes. All components of the Pioneer Spinous Process Fusion Plate are comprised of Titanium Alloy Ti6Al4V per ASTM F136. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The Pioneer Spinous Process Fusion Plate is a posterior, non-pedicle supplemental fixation device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | All components composed of Titanium Alloy Ti6Al4V per ASTM F136. The predicate device is composed of the same material. |
| Mechanical Performance (Static and Fatigue) | Static and fatigue disassociation testing at the locking interface between the screw and barrel was conducted. The device was found to be equivalent to the predicate device. |
| Dimensional Equivalence | A dimensional comparison between the subject and predicate Spinous Process Fusion Plate devices demonstrated no significant differences exist that would impact strength or function. |
| Intended Use Equivalence | The indication for use of the Pioneer Spinous Process Fusion Plate is the same as the predicate device. |
| Mechanism of Action Equivalence | Mechanism of action is identical to that of predicate systems. |
| Available Sizes Equivalence | Available sizes are identical to that of predicate systems. |
| Safety and Effectiveness (Overall Conclusion) | Based on dimensional comparison, static and fatigue testing, and similarities in intended use, design, and physical characteristics with predicate devices, the device is considered equivalent in terms of safety and effectiveness, and substantially equivalent to existing legally marketed devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of clinical data or a patient study. The performance data presented focuses on bench testing for mechanical properties and dimensional comparisons to a predicate device.
- Sample Size for Bench Testing (Static and Fatigue): Not explicitly stated in terms of number of units tested, but described as "testing at the locking interface between the screw and barrel."
- Data Provenance: The data is generated from in vitro (bench) testing and engineering comparisons, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective classification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "test set" is not clinical data requiring expert review for ground truth establishment. The evaluation relies on engineering principles and performance testing.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through material, design, and mechanical testing against a predicate device, not on assessing human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant (a fusion plate), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device, in the context of proving its equivalence, is established through:
- Engineering Specifications and Standards: Adherence to ASTM F136 for material composition.
- Mechanical Performance Standards: Successful completion of static and fatigue disassociation testing to demonstrate equivalence to a predicate device.
- Dimensional Comparison: Direct physical measurement and comparison to an existing predicate device.
- Predicate Device Performance: The safety and effectiveness of the existing predicate device serves as the benchmark against which the new device is compared.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device where a "training set" would be used. The evaluation is based on engineering design and testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no establishment of ground truth for it.
{0}------------------------------------------------
510(k) SUMMARY
OCT 2 2 2010
Pioneer Spinous Process Fusion Plate
| Sponsor: | Manufacturer | Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855 |
|---|---|---|
| Official ContactPhone:Fax: | Emily M. Downs(906) 225-5602(906) 226-4459 | |
| Representative/Consultant:Phone:Fax: | Barry E. Sands978-363-5277978-477-0206 | |
| Date prepared: | October 21, 2010 | |
| Device Name: | Pioneer Spinous Process Fusion Plate | |
| ClassificationName: | Spinal Interlaminal Fixation Orthosis | |
| ClassificationNumber: | Product Code/Classification Number:KWP/ 888.3050 – Spinal Interlaminal Fixation OrthosisClass II | |
| Description: | The Pioneer Spinous Process Fusion Plate is a plate with spacer systemdesigned to provide posterior fixation by physically linking adjacent spinousprocesses. | |
| All components of the Pioneer Spinous Process Fusion Plate are comprised ofTitanium Alloy Ti6Al4V per ASTM F136. | ||
| The system also contains Class 1 manual surgical instruments and cases thatare considered exempt from premarket notification. | ||
| Intended Use: | The Pioneer Spinous Process Fusion Plate is a posterior, non-pediclesupplemental fixation device intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinousprocesses for the purpose of achieving supplemental fusion in the followingconditions: degenerative disc disease (defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies);spondylolisthesis, trauma and/or tumor. The Pioneer Spinous Process FusionSystem is intended for use with bone graft material (i.e. allograph orautograph), not intended for stand-alone use. | |
| Material: | The Pioneer Spinous Process Fusion Plate is composed of Ti Alloy per ASTMF136. The predicate device is composed of the same material. | |
| Comparison toPredicateDevices | The indication for use of the Pioneer Spinous Process Fusion Plate is thesame as the predicate device. Implant material, mechanism of action, andavailable sizes for the Pioneer Spinous Process Fusion plate are identical tothat of predicate systems.. | |
| PerformanceData: | A dimensional comparison between the subject and predicate SpinousProcess Fusion Plate devices demonstrated that no significant differencesexist that would impact strength or function. This analysis concluded thatthe two devices were equivalent in terms of safety and effectiveness.In addition, static and fatigue disassociation testing at the locking interfacebetween the screw and barrel was conducted on the Pioneer SpinousProcess Fusion Plate and found to be equivalent to the predicate device. | |
| Performanceand SEDetermination: | Equivalence for Pioneer Spinous Process Fusion System is based onsimilarities of intended use, design, and physical characteristics whencompared to predicate devices. Therefore, Pioneer Surgical Technologybelieves that there is sufficient evidence to conclude that the PioneerSpinous Process Fusion Plate System is substantially equivalent to existinglegally marketed devices. |
1 of 2
{1}------------------------------------------------
'4
.
2 of 2
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the seal is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology, Inc. % Ms. Emily M. Downs Manager, Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855
OCT 2 2 2010
Re: K101525
Trade/Device Name: Pioneer Spinous Process Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: October 11, 2010 Received: October 12, 2010
Dear Ms. Downs:
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. Iisting 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
{3}------------------------------------------------
Page 2 - Ms. Emily M. Downs
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.hym 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,
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K101525
Indications for Use Statement
510(k) Number (if known): K101525
Device Name:
Pioneer Spinous Process Fusion Plate
Indications:
0CT 2 2 2010
The Pioneer Spinous Process Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer SPFP is intended for use with bone graft material (i.e. allograph or autograph), not intended for stand-alone use.
Prescription Use __ V (Per 21 CFR 801.109)
Over-the-Counter Use
(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Miller
(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
lof
§ 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.