(126 days)
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No
The document describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical implant intended to facilitate spinal fusion and provide structural stability in patients with degenerative disc disease, which aligns with the definition of a therapeutic device.
No
This device is an implantable medical device (lumbar cage system) used for spinal fusion, providing structural stability rather than diagnosing a condition.
No
The device description explicitly states it is comprised of a cage implant and instruments, which are physical hardware components made of titanium alloy.
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: The SpineView X-Pac Expandable Lumbar Cage System is a physical implant designed to be surgically placed in the lumbar spine to facilitate fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab setting).
- Intended Use: The intended use clearly describes a surgical procedure to treat degenerative disc disease by implanting a device, not a diagnostic test performed on a sample.
Therefore, the SpineView X-Pac Expandable Lumbar Cage System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SpineView X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.
Product codes
MAX
Device Description
The Spine View X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes to accommodate varying anatomy. The primary difference between the previously cleared and the modified cage models is that the expansion of the upper plate is parallel to the bottom housing, whereas the previously cleared device expands at an angle. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295. The Spine View X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1), thoracolumbar spine
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
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Summary of Performance Studies
Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, and subsidence was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate. Expulsion testing was also conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2016
Spine View, Incorporated % Ms. Nancy Lincé Regulatory Affairs Consultant Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K160856
Trade/Device Name: SpineView X-Pac Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 1, 2016 Received: July 5, 2016
Dear Ms. Lincé:
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 Part 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/Resourcesfor You/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 yours,
Lori A. Wiggins -S
for 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)
K160856
Device Name
SpineView X-Pac Expandable Lumbar Cage System
Indications for Use (Describe)
The SpineView X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name, Address, Phone, and Fax Number of Applicant
Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 743-5090 Fax: (510) 490-1753
B. Contact Person
Nancy Lincé Regulatory Affairs Consultant Lincé Consulting, LLC
Date Prepared C.
March 25, 2016
D. Device Name and Classification
| Trade Name: | SpineView X-Pac Expandable Lumbar Cage System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| CFR Classification: | 21 CFR§888.3080 |
| Classification Name: | Intervertebral Body Fusion Device |
| Product Code: | MAX |
E. Predicate Device
The Spine View X-Pac Expandable Lumbar Cage System is substantially equivalent to the previously cleared Spine View X-Pac Expandable Lumbar Cage System, K152539.
F. Device Description
The Spine View X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and instruments. The implants are used to provide structural stability in skeletally mature
4
individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes to accommodate varying anatomy. The primary difference between the previously cleared and the modified cage models is that the expansion of the upper plate is parallel to the bottom housing, whereas the previously cleared device expands at an angle. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136 and ASTM F1295.
The Spine View X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before use.
Indications for Use / Intended Use G.
The Spine View X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion.
The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.
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H. Technological Comparison
The technological characteristics of the Spine View X-Pac Expandable Lumbar Cage System implants are similar to the predicate in terms of design, dimensions, intended use, materials, and performance characteristics.
l. Performance Data
Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, and subsidence was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate. Expulsion testing was also conducted.
J. Basis for Substantial Equivalence
The Spine View X-Pac Expandable Lumbar Cage System is similar to the predicate with respect to technical characteristics, performance and intended use. The information provided supports the substantial equivalence of the X-Pac Expandable Lumbar Cage System to the legally marketed predicate.