(27 days)
The CD HORIZON® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.
The CD HORIZON® Growth Rod Conversion Set consists of a variety of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct which can be surgically lengthened on a periodic basis as the patient grows. The CD HORIZON® Growth Rod Conversion Set components are manufactured from stainless steel or titanium alloy and are designed to interact with rod-based pedicle screw/hook constructs in which the rods range in diameter from 3.5mm to 5.5mm. The CD HORIZON® Growth Rod Conversion Set is specifically to be used with any traditional CD HORIZON® Spinal System (3.5mm) fusion construct cleared for pediatric usage. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE® Spinous Process Plates and/or Shape Memory Alloy (SMA) Staples. The CD HORIZON® Growth Rod Conversion Set is limited to a posterior approach. The CD HORIZON® Growth Rod Conversion Set connectors are provided in both sterile and non-sterile form. The sterile implants are sterilized via gamma irradiation.
This device is a CD HORIZON® Growth Rod Conversion Set and the 510(k) summary (K150200) describes a submission to add sterile connectors and set screws to the existing device, utilizing gamma irradiation and sterile packaging. This submission is about a modification to an existing medical device, specifically regarding its packaging and sterilization process, rather than a new device with performance metrics related to diagnostic accuracy or clinical outcomes. Therefore, the standard elements for performance criteria and a study proving those criteria (as might be expected for an AI/ML device or a device with clinical efficacy claims) are not applicable in the usual sense.
However, I can extract the relevant information regarding the "acceptance criteria" and the "study" that proves the device meets them, reinterpreting these terms in the context of this specific 510(k) submission.
Acceptance Criteria and Device Performance (in the context of sterilization and packaging):
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance/Compliance |
|---|---|---|
| Material Biocompatibility | Manufactured from stainless steel (ASTM F138) or titanium alloy (ASTM F136). Materials must have a well-characterized level of local biological response and a long history of clinical use. | Subject devices use identical materials to predicate device (K133904), which are in accordance with ASTM F138 and ASTM F136. No additional biocompatibility testing required due to established history and standards compliance. |
| Mechanical Performance | No design changes made to the implants. Device must not represent a "new worst case" compared to the predicate device. | No mechanical testing performed on subject connectors and set screws; deemed not necessary as no design changes were made. The evaluation determined that subject devices do not represent a new worst case. |
| Sterilization Efficacy | Sterilization must meet recognized standards for radiation sterilization. | Sterilization is via gamma irradiation. Compliance with ANSI/AAMI/ISO 11137-1:2006/A1:2013 and ANSI/AAMI/ISO 11137-2:2013 demonstrated. |
| Packaging Integrity | Packaging must maintain sterility and withstand shipping. | Compliance with ASTM F88/F88M-09 (Seal Strength), ASTM D4169-09 (Performance Testing of Shipping Containers), and ASTM F1929-98 (Detecting Seal Leaks in Porous Medical Packaging) demonstrated. |
| Substantial Equivalence | The device (with new sterilization/packaging) must be substantially equivalent to the predicate device. | Based on risk analysis, packaging and sterilization rationales, and supporting documentation, the subject components are substantially equivalent to the predicate devices in K133904. |
Study Information (reinterpreted for sterilization and packaging validation):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a "sample size" for a clinical or performance test set in the traditional sense, as this submission is focused on sterilization and packaging validation. Instead, the "testing" involved adherence to established standards and protocols for manufacturing, sterilization, and packaging. These standards (e.g., ISO, ASTM) would have their own sample size requirements for their validation methods, but these are not enumerated here.
- Data Provenance: The data is based on adherence to international and US standards for medical device manufacturing, materials, sterilization, and packaging. This is generally laboratory-based testing conducted by the manufacturer or contracted labs, rather than data from specific countries or retrospective/prospective studies on patient populations.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this specific submission. The "ground truth" here is adherence to established engineering, materials science, and sterilization standards, validated by standard test methods rather than expert consensus on clinical data. The FDA reviewers are experts in regulatory compliance and relevant scientific fields.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a spinal implant component, not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is adherence to validated engineering standards and material specifications (ASTM F136, ASTM F138, ISO 11137, ASTM D4169, ASTM F88, ASTM F1929) for material composition, sterilization efficacy, and packaging integrity. The primary "ground truth" for the overall submission is demonstrating substantial equivalence to a previously cleared predicate device (K133904) based on these technical considerations.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device and does not involve a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the study/evidence presented:
The "study" in this context refers to the engineering and validation documentation provided by Medtronic Sofamor Danek USA, Incorporated to demonstrate that the changes (sterile connectors with pre-loaded set screws and gamma irradiation sterilization) to the CD HORIZON® Growth Rod Conversion Set do not alter its fundamental scientific technology or safety and effectiveness compared to the predicate device.
The evidence relies on:
- Material Equivalence: Stating that the materials (stainless steel per ASTM F138 or titanium alloy per ASTM F136) are identical to those in the predicate device and have a long history of safe clinical use.
- Design Equivalence: Confirming that no design changes were made to the implants themselves.
- Sterilization Validation: Referring to compliance with ISO 11137-1 and ISO 11137-2 for gamma irradiation.
- Packaging Validation: Referring to compliance with ASTM F88/F88M, ASTM D4169, and ASTM F1929 for seal strength, shipping, and leak detection.
- Risk Analysis: Performed to support the claim that the modified device does not represent a new worst case.
The conclusion is that, based on this documentation and adherence to standards, the modified device is substantially equivalent to the predicate device due to identical design, materials, method of implantation, and intended use, with only the sterilization and packaging method being updated.
§ 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.