(89 days)
Not Found
No
The document describes a mechanical pedicle screw system and its modifications, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a pedicle screw fixation system intended to provide temporary stabilization following spinal fusion surgery, and it is used in the treatment of various spinal instabilities and deformities.
No
The PathFinder system is described as a pedicle screw fixation system intended to provide temporary stabilization following surgery to fuse the spine. Its indications for use relate to various acute and chronic instabilities or deformities that require surgical intervention and fusion, rather than diagnosing them.
No
The device description explicitly states it is a "pedicle screw fixation system" consisting of "various screws and rods," which are physical hardware components.
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 PathFinder system is a pedicle screw fixation system designed for surgical implantation to stabilize the spine. It is a physical implant used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the PathFinder - Mini-Open Posterior Approach device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When intended for pedicle screw fixation from L1-S1, the indications include 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
Product codes
NKB, MNH, MNI
Device Description
The Abbott Spine, Inc. PathFinder® system is a pedicle screw fixation system designed to allow for use of an open or mini open surgical technique. The approved Pathfinder® system consists of various screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine.
The subject device is the result of modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject device shares the same intended use and fundamental scientific technology as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L1-S1, thoracic, lumbar, and sacral spine, L3 and S1
Indicated Patient Age Range
skeletally mature patients
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)
NONCLINICAL PERFORMANCE AND CONCLUSION:
The subject device is the result of modifications to the existing PathFinder® 6.5mm polyaxial pedicle Screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject device has the same intended use and is substantially equivalent to the predicate device.
Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device.
CLINICAL PERFORMANCE AND CONCLUSIONS:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K07 1174
Page 1 of 2
ABBOTT SPINE 510(k) Summary
JUL 2 5 2007
| SUBMITTER: | Abbott Spine (formerly Spinal Concepts, Inc.) |
|---|---|
| ESTABLISHMENT REGISTRATION | |
| NUMBER: | 1649384 |
| CONTACT PERSON: | Roger Brown |
| DVP Clinical and Regulatory Affairs | |
| Telephone: 512.533.1038 | |
| Fax: 512.258.0995 | |
| DATE: | June 22, 2007 |
| TRADE NAME: | PathFinder® System |
| COMMON NAME: | Spinal Fixation System |
| CLASSIFICATION NAME: | PEDICLE SCREW SPINAL SYSTEM |
| CLASSIFICATION REFERNCE: | 21 CFR § 888.3070 (MNI, MNH, NKB) |
| PREDICATE DEVICE: | PathFinder® System manufactured by Abbott Spine |
| K030625 cleared March 28, 2003. |
DEVICE DESCRIPTION:
The Abbott Spine, Inc. PathFinder® system is a pedicle screw fixation system designed to allow for use of an open or mini open surgical technique. The approved Pathfinder® system consists of various screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine.
The subject device is the result of modifications to the existing PathFinder® 6.5mm polyaxial pedicle screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject device shares the same intended use and fundamental scientific technology as the predicate device.
1
INDICATIONS:
K071174
Page 2 of 2
PathFinder® - Mini-Open Posterior Approach
When intended for pedicle screw fixation from L1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or opinal og instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), turnor, and failed previous fusion.
As pedicle screw system placed between L3 and S1, the indications include Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
COMPAIRSON TO PREDICATE DEVICE:
PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL):
NONCLINICAL PERFORMANCE AND CONCLUSION:
substantially equivalent to the predicate device.
The subject device is the result of modifications to the
Screws resulted in the inclusion of a 4.5mm polyaxial pedicle screw to the Pathfinder System. The subject
existing PathFinder® 6.5mm polyaxial pedicle
device has the same intended use and is
Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device.
CLINICAL PERFORMANCE AND CONCLUSIONS:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2007
Abbot Spine % Mr. Roger Brown Divisional Vice President Clinical and Regulatory Affairs 5301 Riata Park Court, Bldg. F Austin, TX 78727
Re: K071174/S1
Trade/Device Name: Pathfinder® System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: June 22, 2007 Received: June 26, 2007
Dear Mr. Brown:
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.
If your device is classified (see above) into either 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.
3
Page 2 -- Mr. Roger Brown
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 (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO 7 1174
Device Name:
PathFinder® System (Adjunct to InCompass Spinal Fixation System)
Indications for Use:
PathFinder - Mini-Open Posterior Approach
When intended for pedicle screw fixation from L1-S1, the indications include 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking info consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Mark A. Mikerson | |
|---|---|
| (Division Sign-Off, | |
| Division of General. Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K071174 |
510(k) Number
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