(75 days)
The Renovis Lumbar Interbody Fusion (LIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis LIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment.
The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.
The Renovis S134 ALIF System must be used with supplemental fixation cleared by the FDA for use in the lumbar spine.
The purpose of this submission is an additional offering to the Renovis lumbar interbody fusion system portfolio. The S134 Anterior Lumbar Interbody Fusion (ALIF) System implants (cages) are intervertebral body fusion devices with a screw-less design that requires supplemental fixation. The S134 ALIF cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The PEEK markers are manufactured from Tantalum.
The Renovis S134 ALIF System cages are to be used with supplemental fixation, and are intended to be used with autogenous bone graft.
The Renovis S134 ALIF System is used with device specific instruments including trials.
The Renovis S134 ALIF System implants comply with the following material standards:
- ASTM F2026-08 Standard Specification for PEEK Polymers for Surgical . Implant Applications
- ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant ● Applications
The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user).
The provided document, K142095, is a 510(k) premarket notification for the Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics that would typically apply to software or diagnostic devices (e.g., sensitivity, specificity, accuracy).
Intervertebral body fusion devices like the Renovis S134 ALIF System are typically evaluated based on mechanical testing, material compatibility, and similarity to previously cleared devices. The "acceptance criteria" here refer to the regulatory requirements for showing substantial equivalence, which primarily involve comparing design, materials, manufacturing, indications for use, and performance testing (often mechanical) against a predicate device.
Therefore, the requested information elements related to clinical study design, sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable in the context of this specific regulatory submission for an intervertebral body fusion device.
However, I can extract the relevant information regarding the demonstration of substantial equivalence.
Demonstration of Substantial Equivalence for Renovis S134 ALIF System
The Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device, the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System (K140106). The acceptance criteria for this type of submission involve showing that the new device does not raise new questions of safety or effectiveness when compared to the legally marketed predicate.
1. Table of Acceptance Criteria (Substantial Equivalence) and Reported Device Performance
| Acceptance Criteria Category | Description of Criteria (for substantial equivalence) | Reported Device Performance/Comparison to Predicate |
|---|---|---|
| Indications for Use | The indications for use of the new device should be the same or very similar to the predicate, or any differences should not raise new questions of safety or effectiveness. | Same Indications: Both the Renovis S134 and the Renovis S128 (predicate) are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1, with or without Grade 1 spondylolisthesis/retrolisthesis. Both require autogenous bone graft and at least six months of non-operative treatment. |
| Technological Characteristics | Device design, materials, and manufacturing processes should be similar to the predicate, or any differences should be mitigated by testing or scientific rationale. | Similarities: The S134 ALIF implants have the same footprint (ID and OD profile dimensions), materials, and manufacturing methods as the S128 ALIF System implant. |
Materials: Both use PEEK and additively manufactured/machined Titanium, with Tantalum markers. Materials comply with ASTM F2026, ASTM F136, and ASTM F560.
Manufacturing: Not explicitly detailed as different; implied to be similar. |
| Performance Testing (Mechanical) | For implants, mechanical testing (e.g., fatigue, static strength) is generally required to ensure durability and safety under simulated physiological loads. | Engineering Rationale and FEA: "Comparison of technological characteristics, engineering rationale and FEA were used to determine that this design change does not introduce a new worst case." This implies that mechanical performance was assessed and deemed equivalent or superior to the predicate through engineering analysis. Specific test values are not provided in this summary. |
| Sterilization | The sterilization methods of the new device should be compatible with the materials and design, and validated. | Similar Offerings: The S134 ALIF implants are provided gamma sterilized, and non-sterile (requiring sterilization by the end user), similar to the predicate offerings. |
| Effect on Safety & Effectiveness | The new device should not raise new questions of safety or effectiveness compared to the predicate. | Conclusion: "The offering of implants that are not standalone and require supplemental fixation does not raise new issues of safety or effectiveness." The submission concludes that the S134 ALIF System is substantially equivalent to the predicate device based on the similarities. |
| Need for Supplemental Fixation | The primary difference is the S134 requires supplemental fixation, whereas the S128 can be used stand-alone with its cover plate and screws, or with supplemental fixation if fewer than four screws are used. | The S134 ALIF System is explicitly "a screw-less design that requires supplemental fixation" and "must be used with supplemental fixation cleared by the FDA for use in the lumbar spine." This difference in fixation strategy from the S128 (which included integrated fixation for stand-alone use) was assessed and deemed not to raise new issues of safety or effectiveness, as supplemental fixation is a known clinical practice. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable (N/A). This is a 510(k) premarket notification for an implantable medical device, not a performance study for a diagnostic or AI/software device. The submission relies on comparative analysis, engineering rationale, and mechanical testing (not detailed) rather than a clinical trial with a "test set" of patients or data in the way a diagnostic device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A. The concept of "ground truth" established by experts for a test set of data is not applicable to this type of device submission. The evaluation is based on engineering principles, materials science, and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods are relevant for clinical trials or diagnostic performance studies involving human interpretation. This is not applicable here.
5. 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
N/A. This is a physical implantable device, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical implantable device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. As explained above, the concept of "ground truth" in this context is not applicable. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by design comparisons, material standards compliance, and engineering rationale/testing.
8. The sample size for the training set
N/A. This is not a study involving a training set for an algorithm.
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no training set mentioned in this context.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.