(30 days)
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal instabilities or deformities, which falls under therapeutic use.
No
This device is a spinal system (pedicle screws, rods, nuts, crosslink members, and hooks) used for immobilization and stabilization of spinal segments, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of physical components like pedicle screws, rods, nuts, crosslink members, and hooks, all manufactured from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
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 system used to provide immobilization and stabilization of spinal segments within the body as an adjunct to fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, nuts, and hooks made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (within the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological imparment, fracture, soliocations, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by auto genouville graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
The subjects of this Special 510(k) submission are the addition of polyaxial crosslink components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The hooks can be used for single or multiple level fixation. The polyaxial hooks have attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.
The laminar hooks are inserted inferior and superior around the polyaxial pedicle hooks are inserted inferior and superior around the pedicles. The double laminar hooks are available in standard and polyaxial configurations. The low profile of the hooks allows it to be used in conjunction with a pedicle screw assembly without any problem of superimposition.
The laminar hooks are inserted under the lamina and the polyaxial pedicle hooks are inserted under the pedicle. The low profile of the hook allows it to be used in conjunction with a pedicle screw assembly without any poblem of superimposition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, and sacral spine, L5-S1 vertebrae, lumbar and sacral spine (L3 to sacrum)
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)
The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96.
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.
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
510(k) Summary of Safety and Effectiveness
| (1) Submitter's name: | Encore Orthopedics, Inc. |
|---|---|
| Submitter's address: | 9800 Metric Blvd, Austin, TX 78758 |
| Submitter's telephone number: | (512) 834-6255 |
| Contact person: | Joanna Droege |
| Date summary prepared: | October 15, 2001 |
| (2) Trade or proprietary device name: | PASS Spinal System |
| Common or usual name: | Pedicle screw spinal system |
| Spinal interlominal fixation enthesis |
NOV 1 5 2001Classification name:
Spinal interlaminal fixation orthosis Class II
- (3) Legally marketed predicate device: PASS Spinal System (K001024)
(4) Subject device description:
The subjects of this Special 510(k) submission are the addition of polyaxial crosslink components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The hooks can be used for single or multiple level fixation. The polyaxial hooks have attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.
The laminar hooks are inserted inferior and superior around the polyaxial pedicle hooks are inserted inferior and superior around the pedicles. The double laminar hooks are available in standard and polyaxial configurations. The low profile of the hooks allows it to be used in conjunction with a pedicle screw assembly without any problem of superimposition.
The laminar hooks are inserted under the lamina and the polyaxial pedicle hooks are inserted under the pedicle. The low profile of the hook allows it to be used in conjunction with a pedicle screw assembly without any poblem of superimposition.
(5) Subject device intended use:
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological imparment, fracture, soliocations, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by auto genouville graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
(6) Performance data:
The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96.
(7) Basis for substantial equivalence:
The PASS Spinal System Hooks are equivalent to the other spinal systems commercially available that incorporate pedicle screws, rods, and crosslinking members.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2001
Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
Re: K013431
Trade Name: PASS Spinal System Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, MNH Dated: October 15, 2001 Received: October 16, 2001
Dear Ms. Droege:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542
2
Page 2 - Ms. Joanna Droege
of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark A McKenna
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Tevice Name: __ Additional Components to PASS Spinal System
Indications For Use:
NOV 1 5 2001
Additional Components to PASS Spinal System
Indications For Use
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to The I AOO opinal byoton of spinal segments in skeletally mature patients as an adjunct provide in the treatment of the following acute and chronic instabilities or deformities of thoracic, to hasler in the troumont of the relieving and objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion Spondylollotholio (Crace e and removal of the implants after the attainment of a solid fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺕ ﺗ 3 Over-The-Counter Use OR Prescription Use / (per 21 CFR 801.109) (Optional Format 1-2-96)_ ral. Restorative ally Heurological Devices 510(k) Number -