(167 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical delivery of a physical implant for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Interbody Fusion System" intended to "restore intervertebral disc height, provide anterior column support and maintain structural stability of the motion segment to facilitate intervertebral body fusion" in patients with degenerative disc disease. This indicates a direct therapeutic action on the body's structure and function.
No
The XCage™ Interbody Fusion System is a surgical implant designed for spinal fusion, not for diagnosing medical conditions. Its purpose is to restore disc height, provide support, and facilitate fusion after discectomy.
No
The device description clearly states it is an expandable lumbar intervertebral body fusion device made of PEEK and Titanium alloy, and includes reusable manual surgical instruments. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal intervertebral body fusion with autogenous bone graft. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is a physical implantable system (cage, shell, shim) made of materials like PEEK and Titanium alloy, designed to provide structural support and facilitate bone fusion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). XCage™ system Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Ouroboros XCage™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1 and is intended for intervertebral lumbar fusion. The XCage™ Spacer consists of a Shell and a Shim component that are offered in a range of sizes to accommodate variation in patient anatomy. The Shell component is a rectangular frame with struts on all four sides that allow for insertion into the intervertebral body space in a nonexpanded form, and subsequent expansion following the insertion of the Shim component. The Shim component has a tapered front end that inserts into and expands the Shell component to the desired vertical and horizontal dimensions. When fully inserted, the Shim locks within the Shell to provide structural stability for interbody fusion. An integrated "Core" in the Shell serves to anchor the delivery instrument during Shim insertion. Protrusions on the superior and inferior surfaces of the Spacer grip the adjacent vertebral endplates to resist expulsion. The XCage™ Spacer is to be filled with autogenous bone graft material. Once implanted, the XCage™ Spacer is designed to restore intervertebral disc height, provide anterior column support and maintain structural stability of the motion segment to facilitate intervertebral body fusion.
The Ouroboros XCage™ Shell is manufactured from polyetheretherketone (PEEK) per ASTM F2026, and has integrated tantalum radiographic markers per ASTM F560. The XCageTM Shim and Core are made from Titanium alloy per ASTM F136.
The Ouroboros XCage™ Interbody Fusion System includes a set of re-useable manual surgical instruments for delivery of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine from L2 to S1
Indicated Patient Age Range
skeletally mature individuals
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 in accordance with Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007. The following tests were performed to support the substantial equivalence of the XCage™ Interbody Fusion System to its predicates:
- Static and dynamic axial compression (ASTM F2077)
- Static and dynamic compression shear (ASTM F2077)
- Subsidence (ASTM F2267)
In addition, Simulated Use testing of the XCage™ Interbody Fusion System was performed using both bench and cadaveric models.
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.
0
MAY 0 1 2014
510(k) Summary XCage™ Interbody Fusion System
Traditional 510(k)
Company:
Ouroboros Medical, Inc. 47757 Fremont Blvd. Fremont, CA 94538
FDA Establishment 3010033846 Registration Number:
Correspondent Contact Information:
John To CTO, Regulatory Affairs Tel: (510) 933-3441 Fax: (866) 931-5422 Email: jto@ouromed.com
November 14, 2013
Date Prepared:
Device Common Name: Intervertebral Body Fusion Device
Device Classification: Class II per 21 CFR 888.3080
Intervertebral Fusion Device with Bone Graft, Lumbar Classification Name:
Product Code: MAX
Purpose of Submission: To achieve premarket clearance for the XCage™ Interbody Fusion System
Predicate Device Information:
The XCage™ Interbody Fusion System is substantially equivalent to the Globus Medical, Inc. Caliber® (K102293), Globus Medical, Inc. Patriot® (K072970) and Spine Wave, Inc. StaXx® IB (K123461). All are Class II intervertebral body fusion devices per 21 CFR § 888.3080 and Classification Code MAX.
Description of Device:
The Ouroboros XCage™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to
1
Traditional 510(k) Premarket Notification XCageTM Interbody Fusion System November 14, 2013
S1 and is intended for intervertebral lumbar fusion. The XCage™ Spacer consists of a Shell and a Shim component that are offered in a range of sizes to accommodate variation in patient anatomy. The Shell component is a rectangular frame with struts on all four sides that allow for insertion into the intervertebral body space in a nonexpanded form, and subsequent expansion following the insertion of the Shim component. The Shim component has a tapered front end that inserts into and expands the Shell component to the desired vertical and horizontal dimensions. When fully inserted, the Shim locks within the Shell to provide structural stability for interbody fusion. An integrated "Core" in the Shell serves to anchor the delivery instrument during Shim insertion. Protrusions on the superior and inferior surfaces of the Spacer grip the adjacent vertebral endplates to resist expulsion. The XCage™ Spacer is to be filled with autogenous bone graft material. Once implanted, the XCage™ Spacer is designed to restore intervertebral disc height, provide anterior column support and maintain structural stability of the motion segment to facilitate intervertebral body fusion.
The Ouroboros XCage™ Shell is manufactured from polyetheretherketone (PEEK) per ASTM F2026, and has integrated tantalum radiographic markers per ASTM F560. The XCageTM Shim and Core are made from Titanium alloy per ASTM F136.
The Ouroboros XCage™ Interbody Fusion System includes a set of re-useable manual surgical instruments for delivery of the device.
Indications for Use:
The XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). XCage™ system Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine ..
Comparison to Predicate Device
The equivalence of XCage™ Interbody Fusion System to the predicates is supported by similarity in intended use, indications for use, technical characteristics, materials and performance.
2
Traditional 510(k) Premarket Notification XCage™ Interbody Fusion System November 14, 2013
Performance Data
Mechanical testing was conducted in accordance with Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007. The following tests were performed to support the substantial equivalence of the XCage™ Interbody Fusion System to its predicates:
- Static and dynamic axial compression (ASTM F2077) .
- Static and dynamic compression shear (ASTM F2077) .
- . Subsidence (ASTM F2267)
In addition, Simulated Use testing of the XCage™ Interbody Fusion System was performed using both bench and cadaveric models.
Conclusion
The Ouroboros XCage™ Interbody Fusion System is similar to its predicate devices with respect to intended use, indications for use, technical characteristics, materials and performance. The information presented within this premarket notification application demonstrates that it is substantially equivalent to the Globus Medical Caliber® Spacer (K102293), the Globus Medical Patriot® Spacer (K072970) and Spine Wave, Inc. StaXx® IB (K123461), all commercially available interbody fusion devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
May 1, 2014
Ouroboros Medical. Incorporated Mr. John To Chief Technical Officer & Regulatory Affairs 47757 Fremont Boulevard Fremont, California 94538
Re: K133514
Trade/Device Name: XCage™ Interbody Fusion System . Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 3. 2014 Received: April 4, 2014
Dear Mr. To:
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. Iabeling, 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 (sec above) into cither 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 roublish 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 mate 1971 has intatutes 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
4
Page 2 - Mr. John To
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" (21 CFR 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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known) K133514
Device Name XCage™ Interbody Fusion System
Indications for Use (Describe)
The XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in sketally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectory. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). XCage™ system Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
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