(170 days)
Not Found
No
The summary describes a mechanical implant (expandable spinal spacer) and associated instruments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing, animal studies, and cadaver studies, which are typical for a physical implant, not an AI/ML-driven device.
Yes
The device is described as an "intervertebral body fusion device" and a "Vertebral Body Replacement device" used in spinal fusion procedures or to replace a collapsed/damaged vertebral body due to tumor or trauma, which are therapeutic medical interventions.
No
The device is described as an intervertebral body fixation system and vertebral body replacement, and its intended use is for spinal fusion procedures and to replace vertebral bodies. It is a therapy device used for treatment, not for diagnosing conditions.
No
The device description clearly states that the device consists of implants and instruments manufactured from titanium, stainless steel, and silicone rubber, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description and intended use: The description clearly states that the XY cor Expandable Spinal Spacer System is an implantable device used for spinal fusion and vertebral body replacement. It is surgically placed within the body.
- Lack of mention of biological samples or testing: The text does not mention any analysis of biological samples or any diagnostic testing being performed by the device.
Therefore, the device described is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six mon-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
When used as a Vertebral Body Replacement device, the XY cor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs 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 of time. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The XY cor Expandable Spinal Spacer System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using Alphatec Spine instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. These implants are intended for use with supplemental spinal fixation and bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine: L2 to S1 (Intervertebral Body Fusion), T1-L5 (Vertebral Body Replacement)
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
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)
An animal study was performed to evaluate fusion in a sheep model. A cadaver study was performed to validate the surgical technique and implantation of this device for the interbody cage indications. Mechanical testing was performed to demonstrate acceptable performance characteristics and substantial equivalence.
ASTM F2077: Static Axial Compression. Static Compressive Shear. Static Torsion. Cyclical Axial Compression, Cyclical Compressive Shear, Cyclical Torsion Testing ASTM F266, Static Subsidence
ASTM Draft Standard F-04.25.02.02, Static Expulsion Lateral and Flexion Extension Bending Subsidence
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.
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2016
Alphatec Spine, Incorporated Ms. Renée L. Murphy Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K160646
Trade/Device Name: XY cor Expandable Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: July 25, 2016 Received: July 26, 2016
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160646
Device Name XYcor® Expandable Spinal Spacer System
Indications for Use (Describe)
When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six mon-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
When used as a Vertebral Body Replacement device, the XY cor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs 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 of time. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Device Trade Name: XYcor® Expandable Spinal Spacer System
Manufacturer: Alphatec Spine, Inc., 5818 El Camino Real Carlsbad, CA 92008 USA Contact: Ms. Renée L. Murphy Senior Regulatory Affairs Specialist Phone: 760-494-6739
Prepared by: Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW、12th Floor Washington, DC 20005 Phone: (202) 552-5800 jeggleton(@mcra.com
Date Prepared: July 27, 2016
| Classification: | 21 CFR §888.3080, Intervertebral body fusion device
21 CFR §888.3060, Spinal intervertebral body fixation device |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| Class: | II |
| Product Codes: | MAX, MQP |
| Primary Predicate Device: | Alphatec Spine Novel Spinal Spacer System (K080699) |
|---|---|
| Additional Predicates: | Vertebration XYcor Spinal Implant (K082466) |
| Globus Medical LATIS Spacers (K123913) |
Indications for Use:
When used as an Intervertebral Body Fusion device, the XY cor Expandable Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients mav also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The XY cor Expandable Spinal Spacer System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
When used as a Vertebral Body Replacement device, the XY cor Expandable Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs 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 of time. The X Ycor Expandable Spinal Spacer System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA.
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Device Description:
The XY cor Expandable Spinal Spacer System is an intervertebral body fixation system and vertebral body replacement consisting of implants with various widths, and lordosis to accommodate individual patient pathology. The devices are intended to deploy using Alphatec Spine instruments once placed into the spinal interbody space. System implants and instruments are manufactured from implant grade titanium (Ti-6AI-4V ELI per ASTM F136) and surgical grade stainless steel and silicone rubber respectively. These implants are intended for use with supplemental spinal fixation and bone graft.
Comparison to Predicate Device:
The subject XY cor Expandable Spinal Spacer System is substantially equivalent to the predicate Alphatec Spine Novel Spinal Spacer System (K080699), XYcor Spinal System (K082644), and the Globus Medical LATIS Spacers (K123913) with respect to technological characteristics of indications, design, materials, function, and performance.
Substantial Equivalence:
The subject XY cor Expandable Spinal Spacer System and the cited predicates are similar in design, material, and indications for use. An animal study was performed to evaluate fusion in a sheep model. A cadaver study was performed to validate the surgical technique and implantation of this device for the interbody cage indications. Mechanical testing was performed to demonstrate acceptable performance characteristics and substantial equivalence.
ASTM F2077: Static Axial Compression. Static Compressive Shear. Static Torsion. Cyclical Axial Compression, Cyclical Compressive Shear, Cyclical Torsion Testing ASTM F266, Static Subsidence
ASTM Draft Standard F-04.25.02.02, Static Expulsion Lateral and Flexion Extension Bending Subsidence
Conclusion:
The Alphatec Spine XY cor Expandable Spinal Spacer System includes implant and instrument design modifications and the indications for use have been expanded to include lumbar interbody fusion. The 510(k) demonstrates substantial equivalence to predicate devices.