(142 days)
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No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for use in achieving supplemental fusion in conditions such as degenerative disc disease, spondylolisthesis, trauma, and tumor, which are medical conditions that require treatment to restore function or alleviate symptoms.
No
The device is described as a "posterior, non-pedicle supplemental fixation device" and a "plate with spacer system designed to provide posterior fixation". Its intended use is for "achieving supplemental fusion" in various conditions, and it is explicitly stated that it is "not intended for stand-alone use" and is used "with bone graft material". These descriptions indicate a therapeutic purpose (fixation and fusion) rather than a diagnostic one.
No
The device description explicitly states it is a plate with spacer system comprised of Titanium Alloy and includes manual surgical instruments, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Pioneer Spinous Process Fusion Plate is a physical implant designed to be surgically placed in the spine. It is used for mechanical fixation and support during bone fusion.
- Intended Use: The intended use clearly describes a surgical procedure involving the spine, not the analysis of biological samples.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside of the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
non-cervical spine (T1-S1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A dimensional comparison between the subject and predicate Spinous Process Fusion Plate devices demonstrated that no significant differences exist that would impact strength or function. This analysis concluded that the two devices were equivalent in terms of safety and effectiveness.
In addition, static and fatigue disassociation testing at the locking interface between the screw and barrel was conducted on the Pioneer Spinous Process Fusion Plate and found to be equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) SUMMARY
OCT 2 2 2010
Pioneer Spinous Process Fusion Plate
| Sponsor: | Manufacturer | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Official Contact
Phone:
Fax: | Emily M. Downs
(906) 225-5602
(906) 226-4459 |
| | Representative/
Consultant:
Phone:
Fax: | Barry E. Sands
978-363-5277
978-477-0206 |
| | Date prepared: | October 21, 2010 |
| Device Name: | Pioneer Spinous Process Fusion Plate | |
| Classification
Name: | Spinal Interlaminal Fixation Orthosis | |
| Classification
Number: | Product Code/Classification Number:
KWP/ 888.3050 – Spinal Interlaminal Fixation Orthosis
Class II | |
| Description: | 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. | |
| Intended Use: | 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. | |
| Material: | The Pioneer Spinous Process Fusion Plate is composed of Ti Alloy per ASTM
F136. The predicate device is composed of the same material. | |
| Comparison to
Predicate
Devices | The indication for use of the Pioneer Spinous Process Fusion Plate is the
same as the predicate device. Implant material, mechanism of action, and
available sizes for the Pioneer Spinous Process Fusion plate are identical to
that of predicate systems.. | |
| Performance
Data: | A dimensional comparison between the subject and predicate Spinous
Process Fusion Plate devices demonstrated that no significant differences
exist that would impact strength or function. This analysis concluded that
the two devices were equivalent in terms of safety and effectiveness.
In addition, static and fatigue disassociation testing at the locking interface
between the screw and barrel was conducted on the Pioneer Spinous
Process Fusion Plate and found to be equivalent to the predicate device. | |
| Performance
and SE
Determination: | Equivalence for Pioneer Spinous Process Fusion System is based on
similarities of intended use, design, and physical characteristics when
compared to predicate devices. Therefore, Pioneer Surgical Technology
believes that there is sufficient evidence to conclude that the Pioneer
Spinous Process Fusion Plate System is substantially equivalent to existing
legally marketed devices. | |
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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
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