(506 days)
Not Found
No
The device description and intended use focus on mechanical components (cables, screws, grommets) for spinal fixation. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are mechanical, not related to algorithmic performance.
Yes
The device is described as a "Posterior Cable Screw System" intended to "reduce pars defect and to stabilize the spinal operative site during fusion procedures," which actively treats a medical condition.
No
The device is described as a system for stabilizing the spinal operative site during fusion procedures and reducing pars defects, which are therapeutic and not diagnostic functions.
No
The device description explicitly mentions physical components like "cables," "screws," and a "spinous process Grommet," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Posterior Cable Screw System is a surgical implant designed to stabilize the spine during fusion procedures. It is used in vivo (within the body) and is a mechanical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Posterior Cable Screw System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
Product codes (comma separated list FDA assigned to the subject device)
MNI, JDQ
Device Description
Proprietary Name: Pioneer Posterior Cable Screw
Common Name: Posterior Cable Screw
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 and the sacrum (spinal operative site)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical information was presented to support a determination of SE.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
K022908 P'//
JAN 2 2 2004
DATA:
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR: | Pioneer Surgical Technology |
|---|---|
| 375 River Park Circle | |
| Marquette, Michigan 49855-1781 | |
| Contact: Jonathan Gilbert |
Pioneer Posterior Cable Screw DEVICE NAME:
The classification of pedicle screw spinal system (§888.3070) and CLASSIFICATION: cerclage (§888.3010) is Class II, as per the Code of Federal Regulations, Title 21. The product codes are MNI and JDQ, respectively.
The ParsFix Cable-Screw System (K003351 - SE 01/24/01, Spinal PREDICATE DEVICE: Concepts, Inc. - Austin, TX)
| DEVICE | Proprietary Name: Pioneer Posterior Cable Screw |
|---|---|
| DESCRIPTION: | Common Name: Posterior Cable Screw |
- The Posterior Cable Screw System is designed as an adjunct to any INTENDED USE: stainless steel, rigid, posterior fixation cleared/approved for trauma and sponylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
Implant grade stainless steel (ASTM F138 and ISO 5832-1.) MATERIAL:
Mechanical information was presented to support a determination of PERFORMANCE SE.
The Pioneer Posterior Cable Screw system is similar to the BASIS OF components of a previously cleared device. The material is SUBSTANTIAL comprised of implant grade stainless steel. Supplemental fixation EQUIVALENCE: devices are intended for use with the device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
Mr. Jonathan Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855-1781
Re: K022908
Trade/Device Name: Pioneer Posterior Cable Screw Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3010 Regulation Name: Pedicle screw spinal system, Bone fixation cerclage Regulatory Class: II Product Code: MNI, JDQ Dated: November 28, 2003 Received: December 2, 2003
Dear Mr. Gilbert:
We have reviewed your Scction 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 Amendnents. or 10 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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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.
2
Page 2 - Mr. Jonathan Gilbert
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Mark A. Milkersson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
K022908 510(k) Number (if known):
Pioneer Posterior Cable Screw Device Name:
INDICATIONS:
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Counter Use_
(Per 21 CFR 801.109)
X
OR
Over-The-
for Mark n Wilkerson
Prative