(29 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
No.
The device is an implantable medical device used as an adjunct to fusion for stabilization and immobilization of spinal segments. Once solid fusion occurs, the device serves no functional purpose and should be removed, indicating it does not provide long-term therapeutic effects but rather structural support during a healing process.
No
The device is a pedicle screw fixation system intended for surgical implantation to stabilize spinal segments, not to diagnose medical conditions.
No
The device description clearly states that PathFinder is a modification to an existing polyaxial screw design and is implanted using k-wires and cannulated screws, indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a screw system for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are mechanical testing, which is relevant for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
Product codes
NKB, MNI, MNH
Device Description
PathFinder is a modification to the existing Spinal Concepts Inc. InCompass polyaxial screw design. The design modification allows the components to be implanted through an open or mini open surgical technique. The mini-open surgical technique is conducted using k-wires and cannulated PathFinder screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, L1-S1, L3-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)
Mechanical testing data, including data collected in accordance with ASTM 1717 and ASTM 1798, was collected to verify that the design changes met established design requirements.
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
K030625 p1/2
Spinal Concepts, Inc. PathFinder
MAR 2 8 2003
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | Spinal Concepts, Inc.
5301 Riata Park Court, Bldg. F
Austin, TX 78727 | | | | | | | | | | | | | | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------|-----------|--|---------------|---------------------|--|-------------------------------|-------------------------------------------|--|---------------------|---------------------|--|-------------------|-------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | 1649384 | | | | | | | | | | | | | | | |
| CONTACT PERSON | PrimaryAlternateLisa PetersonDavid Hooper, Ph.D.Regulatory Affairs SpecialistDirector, Clinical and Regulatory AffairsPhone: 512-918-2700Phone: 512-918-2700Fax: 512-249-6734Fax: 512-249-6734 | | Primary | Alternate | | Lisa Peterson | David Hooper, Ph.D. | | Regulatory Affairs Specialist | Director, Clinical and Regulatory Affairs | | Phone: 512-918-2700 | Phone: 512-918-2700 | | Fax: 512-249-6734 | Fax: 512-249-6734 |
| | Primary | Alternate | | | | | | | | | | | | | | |
| | Lisa Peterson | David Hooper, Ph.D. | | | | | | | | | | | | | | |
| | Regulatory Affairs Specialist | Director, Clinical and Regulatory Affairs | | | | | | | | | | | | | | |
| | Phone: 512-918-2700 | Phone: 512-918-2700 | | | | | | | | | | | | | | |
| | Fax: 512-249-6734 | Fax: 512-249-6734 | | | | | | | | | | | | | | |
| DATE PREPARED | March 17, 2003 | | | | | | | | | | | | | | | |
| CLASSIFICATION NAME | MNI 888.3070- Pedicle Screw Spinal System
MNH 888.3070 – Spondylolisthesis Spinal Fixation
System
NKB 888.3070 - Pedicle Screw Fixation System,
Degenerative Disc Disease | | | | | | | | | | | | | | | |
| COMMON NAME | Spinal Fixation System | | | | | | | | | | | | | | | |
| PROPRIETARY NAME | Spinal Concepts Inc. PathFinder | | | | | | | | | | | | | | | |
| PREDICATE DEVICE | Spinal Concepts Inc. InCompass Spinal Fixation
System (K021564 and K023644). This is a design
modification per established design control
procedures. | | | | | | | | | | | | | | | |
DEVICE DESCRIPTION
PathFinder is a modification to the existing Spinal Concepts Inc. InCompass polyaxial screw design. The design modification allows the components to be implanted through an open or mini open surgical technique. The mini-open surgical technique is conducted using k-wires and cannulated PathFinder screws.
1
INDICATIONS:
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 into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
MECHANICAL TEST DATA
Mechanical testing data, including data collected in accordance with ASTM 1717 and ASTM 1798, was collected to verify that the design changes met established design requirements.
2
Image /page/2/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 often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Ms. Lisa Peterson Regulatory Affairs Specialists Spinal Concepts, Inc. 12012 Technology Blvd. Suite 100 Austin, Texas 78727
Re: K030625 Trade/Device Name: Pathfinder Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Fixation System Regulatory Class: III Product Code: NKB, MNI, MNH Dated: February 24, 2003 Received: February 27, 2003
Dear Ms. Peterson:
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 (OS) 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 - Ms. Lisa Peterson
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,
Mark N. Millikan
Colin M. Wittwer, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
Spinal Concepts, Inc. PathFinder (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 into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.
Mark N. Melkers
(Division Sign-Of (Division of General. Restorative and Neurological Devices
510(k) Number -
5
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109) OR
Over-The-Counter: (Optional Format 1-2-96)
Mark N Millkan
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K030625