(266 days)
P970015, P950002, P950019, P960025, K043479
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No
The document describes a physical interbody fusion and vertebral body replacement device made of PEEK and Tantalum. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is indicated for intervertebral body fusion of the lumbar spine for degenerative disc disease and to replace a vertebral body due to tumor or trauma/fracture, which are conditions requiring treatment.
No
Explanation: The device is an intervertebral body fusion device and a vertebral body replacement device, which are implantable medical devices used for structural support and fusion in the spine, not for diagnosing medical conditions.
No
The device description explicitly states the device is comprised of physical implants manufactured from PEEK and Tantalum alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the DiFUSION Technologies XIPHOS System is an implantable device used for spinal fusion and vertebral body replacement. It is surgically placed within the patient's body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical implant intended to provide structural support and facilitate fusion in the spine. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intervertebral Body Fusion Device:
The DiFUSION Technologies XIPHOS Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Vertebral Body Replacement Device:
The DiFUSION Technologies XIPHOS System of implants is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The XIPHOS System is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft bone.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MOP
Device Description
The DiFUSION Technologies XIPHOS Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options.
The XIPHOS System will be offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS PLIF, posterior lumbar approach and 2) XIPHOS TLIF, transforaminal lumbar approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Lumbar spine, from L2 to S1. Thoracolumbar spine (from T1 to L5)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-03
- Static and dynamic compression-shear testing, conducted in accordance with ASTM F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
- Wear Debris Characterization, conducted in accordance to ASTM F1877
The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the XIPHOS System is substantially equivalent to the predicate 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.
P970015, P950002, P950019, P960025, K043479
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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DiFUSION Technologies XIPHOS Interbody Fusion System
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Premarket Notification
| SUBMITTED BY | DIFUSION Technologies
701 Brazos Street, Suite 500
Austin, TX 78701 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT
REGISTRATION NUMBER | Pending |
| OWNER/OPERATOR
NUMBER | Pending
OCT 1 2010 |
| CONTACT PERSON | Primary
Jami Hafiz
Director of Development
Phone: 612-804-4180
Fax: 512-628-3084 |
| SUBMISSION PREPARED BY | Lisa Peterson
QA Consulting, Inc.
Phone: 512-507-0746 |
| DATE PREPARED | January 6, 2010 |
| CLASSIFICATION NAME | Intervertebral Fusion Device with Bone Graft, Lumbar
Spinal Intervertebral Body Fixation Orthosis |
| DEVICE CLASS | Class II |
| REGULATION NUMBER | 888.3080 (Product Code: MAX)
888.3060 (Product Code: MQP) |
| COMMON NAME | Intervertebral Body Fusion Device (MAX)
Spinal Vertebral Body Replacement Device (MQP) |
| PROPRIETARY NAME | DIFUSION Technologies XIPHOS Interbody Fusion System |
| IDENTIFICATION OF PREDICATE
DEVICE(S) | Predicate devices include several recently down classified
cages, as well as various cleared VBR systems:
- LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015,
Medtronic Sofamor Danek, Approved 9/10/03) - BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03)
- RAY® Threaded Fusion Cage (P950019, Stryker, Approved
9/4/03) - Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05)
- MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05) |
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