(56 days)
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.
The device is offered in both Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) and PEEK (Polyetheretherketone). This interbody device is offered in both sterile and non-sterile forms.
The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15 mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally; the Titanium Alloy version of this device offers lateral windows for visibility of the autogenous bone graft.
The purpose of this submission is to add a new inserter to the PERIMETER® Interbody Fusion Device system and to provide the package insert for this reusable device as well as other instruments for use with PERIMETER® Interbody Fusion Device. Additionally, the package insert for Medtronic's CATALYST® instruments, which can also be used with PERIMETER® Interbody Fusion Device, is provided. The modified design of the subject PERIMETER® Interbody Fusion Device does not affect the device's intended use or alter the device's fundamental scientific technology.
This 510(k) premarket notification (K113642) is for a modification to an existing medical device, the PERIMETER® Interbody Fusion Device. The primary purpose of the submission is to add a new inserter to the system and provide updated package inserts. It explicitly states that the "modified design of the subject PERIMETER® Interbody Fusion Device does not affect the device's intended use or alter the device's fundamental scientific technology." Therefore, there are no clinical studies on human subjects to prove device performance or establish new acceptance criteria. The approval relies on demonstrating substantial equivalence to previously cleared devices and adherence to relevant non-clinical testing standards.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (as per relevant standards) | Reported Device Performance (as described in the 510(k)) |
|---|---|---|
| Device Design | Substantially equivalent to predicate PERIMETER® Interbody Fusion Device (K090353 & K111525) and CAPSTONE® Spinal System (K103731) inserter for design, materials, and fundamental scientific technology. | The subject PERIMETER® Interbody Fusion Device and the new two-piece inserter are constructed of the same materials and represent the same fundamental scientific technology as their respective predicate devices. |
| Cleaning & Sterilization | Validation and assessment according to ISO 17664, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, AAMI TIR 12, ANSI/AAMI ST79 & A1, AAMI TIR 30, and ANSI/AAMI ST81. | Cleaning and sterilization validations and assessments have been conducted according to the listed standards. |
| Risk Analysis | Comprehensive risk analysis completed. | A risk analysis was completed. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission is for a modification to an existing device, focusing on non-clinical testing and substantial equivalence. There are no new clinical studies or test sets involving human patients where a sample size would be traditionally reported for device performance.
- Data Provenance: Not applicable for clinical data. The data provenance described relates to manufacturing and reprocessing standards for medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts/Qualifications: Not applicable. As there is no clinical test set for new device performance, there's no "ground truth" to be established by experts in the context of clinical outcomes or diagnostic accuracy. The "ground truth" here is compliance with engineering and sterilization standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is for evaluating diagnostic accuracy or reader performance with medical imaging devices, which is not relevant to an interbody fusion device and its inserter.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This applies to AI/ML algorithms, which are not part of this device submission.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering specifications and material properties: Demonstrating that the new inserter design and materials are equivalent to already cleared devices.
- Compliance with recognized industry standards: For cleaning, sterilization, and manufacturing processes (listed in section V, IX, and X).
- Risk analysis: Identifying and mitigating potential risks associated with the device and its modifications.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This refers to AI/ML device development, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As above, this is for AI/ML device development.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a non-clinical equivalency assessment and adherence to recognized standards.
The key aspects of this "study" are:
- Comparison to Predicate Devices: The submission establishes substantial equivalence by demonstrating that the PERIMETER® Interbody Fusion Device, including the new inserter, is identical in terms of indications for use, intended use, performance specifications, and fundamental technological characteristics to its predicate devices (PERIMETER® Interbody Fusion Device cleared in K090353 and K111525, and the CAPSTONE® Spinal System [K103731] for the inserter design).
- Design Control Processes: Medtronic's internal design control processes were used to assess the instrument modifications.
- Cleaning and Sterilization Validations: Extensive validations were performed and submitted demonstrating adherence to a comprehensive set of international and national standards (ISO 17664, ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, AAMI TIR 12, ANSI/AAMI ST79 & A1, AAMI TIR 30, ANSI/AAMI ST81). These validations ensure that the new reusable inserter and other instruments can be safely cleaned and sterilized for clinical use.
- Risk Analysis: A completed risk analysis supports the safety and effectiveness of the modified system.
In essence, the "proof" is a comprehensive documentation package demonstrating that the changes made (primarily a new inserter and updated instructions) do not introduce new safety or effectiveness concerns and that the device remains functionally equivalent to its cleared predicate.
§ 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.