(48 days)
The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine:
- Fractures .
- Dislocation .
- Failed previous fusion (Pseudoarthrosis) .
- Spinal stenosis .
- Degenerative spondylolisthesis with objective evidence of neurological impairment .
- Spinal deformations such as scoliosis or kyphosis. .
- Loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone 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.
The PASS LP also includes hooks and rods and sacral/iliac screws indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformilies or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft . Pediatric pedicle screw fixation is limited to a posterior approach.
The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks,sacral plates, iliac screws, clamps, nuts and crosslink components.
Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy
This device submission (K132575) is for a modification to an existing device, the PASS LP Spinal System (K123138), by adding "Precontoured S-Rods" and "Unit Rods". As such, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than conducting a new comprehensive performance study against a specific set of acceptance criteria in the traditional sense.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Soundness (Implied) | "The products are as mechanically sound as other devices commercially" |
| Geometric Similarity (Implied) | "the geometry is similar to predicates devices (equivalent angles, similar diameter)" |
| Material Properties (Implied) | "the materials used have similar properties." |
Explanation: In this 510(k) submission, the "acceptance criteria" are implied through the concept of "substantial equivalence." The sponsor asserts that the modified components (Precontoured S-Rods and Unit Rods) are equivalent to existing, legally marketed predicate devices based on their mechanical soundness, geometric similarity, and material properties. There are no explicit quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) mentioned in this document that would typically be associated with a new device's performance study. Instead, the approach is to show that the new components are comparable to already-approved ones.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. No performance testing involving a "test set" of patient data or clinical samples was conducted.
- Data Provenance: Not applicable. The demonstration of substantial equivalence was based on descriptive information and comparison to predicate devices, not on data derived from patient studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used, and therefore no adjudication was required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. This submission does not involve an AI device or a comparative effectiveness study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This submission does not involve an algorithm or AI device.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of clinical or diagnostic performance. For this device filing, the "ground truth" for demonstrating substantial equivalence is the established performance and safety of the predicate devices. That is, the predicate devices are considered safe and effective, and the new device components are shown to be equivalent to them.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This submission does not involve an AI device or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. No training set was used.
Summary of the Study:
The "study" in this context is a descriptive comparison for substantial equivalence, not a performance study in the traditional sense involving clinical data or benchmarks. The core of the demonstration is the following statement:
"Descriptive information is sufficient to demonstrate the substantial equivalence of the subject rods. No performance testing was necessary."
This means that the manufacturer presented engineering and design documentation (e.g., blueprints, material specifications, mechanical properties of the materials) for the new "Precontoured S-Rods" and "Unit Rods." They then compared this descriptive information to similar characteristics of already-approved predicate devices (PASS LP Spinal System K123138, USS, Click'X, VAS, Dual-Openin, Small Stature K022949, BacFix Spinal fixation System K983260).
The FDA's decision to clear the device (K132575) indicates that they agreed that this descriptive comparison was sufficient to establish substantial equivalence for the addition of these specific components to an existing system, and that no new performance testing (such as mechanical or clinical studies) was required.
§ 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.