(104 days)
No
The device description focuses on the physical characteristics and materials of the spinal system, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is designed to facilitate interbody spinal fusion in patients with Degenerative Disc Disease, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device, the CAPSTONE® L Spinal System, is an interbody fusion device designed for surgical implantation to facilitate fusion between vertebral bodies. Its purpose is treatment, specifically providing support and correction during lumbar interbody fusion surgeries, not to diagnose a condition.
No
The device description clearly states the device consists of physical spacers made of PEEK with tantalum markers, and is used with reusable instrumentation. This indicates it is a hardware device, not software-only.
Based on the provided information, the CAPSTONE® L Spinal System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to be implanted in the body to facilitate interbody fusion in the spine. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details a physical implant made of PEEK with tantalum markers, designed to be inserted between vertebrae. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are used outside the body to examine specimens and provide information for diagnosis, monitoring, or screening. The CAPSTONE® L Spinal System is an implantable surgical device.
N/A
Intended Use / Indications for Use
The CAPSTONE® L Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CAPSTONE® L Spinal System is used for patients diagnosed 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 minimally invasive lateral approach.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The CAPSTONE® L Spinal System consists of spacers of various widths and heights made of PEEK with tantalum markers. The spacers can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The implant has non-lordotic and 6° lordotic options. The superior and inferior surfaces of the implant are designed with teeth that interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants are provided sterile by gamma irradiation, and are to be used with supplemental fixation. CAPSTONE® L Spinal System is used with new reusable instrumentation that enables the surgeon to implant the devices via a lateral approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar or lumbo-sacral vertebral bodies, L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Mechanical testing was conducted according to FDA guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices", and the following standards:
- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices .
- Static Compression O
- Static Compression-Shear o
- Dynamic Compression o
- Dynamic Compression-Shear 0
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of the . Intervertebral Body Fusion Device under Static Axial Compression
Expulsion testing was also conducted. All mechanical testing met the predetermined acceptance criteria.
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
§ 888.3080 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.
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