(27 days)
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No
The summary describes a physical interbody fusion device and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The modification described is related to titanium markers.
Yes.
The device is intended for spinal fusion procedures to treat degenerative disc diseases, aiming to alleviate pain and restore stability.
No
Explanation: This device is an interbody fusion cage intended for spinal fusion procedures, providing support to the spine. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is an "Intervertebral Body Fusion Device" made of titanium, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to provide structural support and facilitate bone growth.
- Device Description: The device is described as an intervertebral body fusion device made of titanium. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status.
IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing samples taken from the body. This device is a therapeutic implant used to treat a condition (DDD) by providing structural support during spinal fusion.
N/A
Intended Use / Indications for Use
The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.
Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.
The PATHWAY device can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery.
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provide support to the spine for a posterior surgery.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The proposed modification to the PATHWAY Intervertebral Body Fusion Devices (PLIF and TLIF) is to The proposed mountedion with the currently cleared titanium (Ti-6Al-4V) markers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Spinal fusion procedure at one or two contiguous levels (L2-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data was originally performed on the PATHWAY Device (K080281). The proposed changes do not impact the mechanical performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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