(122 days)
Not Found
No
The summary describes a physical implant device made of PEEK with embedded tantalum beads for visualization. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on mechanical properties and equivalence to a predicate device.
Yes
The device is used for intervertebral spinal fusion procedures in patients with degenerative disc disease, which involves treating and correcting a medical condition.
No
The device is an intervertebral body fusion device indicated for spinal fusion procedures, not for collecting or analyzing patient data to diagnose a condition.
No
The device description clearly details a physical implant made of PEEK with embedded tantalum beads, designed for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral spinal fusion procedures, which is a surgical intervention. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an implant made of PEEK with tantalum beads for visualization under X-ray. This is a physical implant, not a reagent, instrument, or software used to analyze biological samples.
- Performance Studies: The performance studies focus on mechanical properties like compression, shear, subsidence, and expulsion, which are relevant to the structural integrity and function of an implant. IVD performance studies typically involve metrics like sensitivity, specificity, accuracy, etc., related to the analysis of biological samples.
The device is a surgical implant used in a therapeutic procedure, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
Product codes
MAX
Device Description
VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-rav. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rav
Anatomical Site
from L2-S1 (lumbosacral 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
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)
The substantial equivalence is supported by bench testing comparing the modified InterFuse® T Intervertebral Body Fusion Device to the predicate un-modified device (K102277).
The performance of the modified device (InterFuse T) was tested, post gamma irradiation sterilization as detailed below:
- Static and Dynamic Compression; Static and Dynamic Compression Shear per ASTM F2077.
- Subsidence per ASTM F2267.
- Expulsion testing.
On the basis of performance data it is concluded that the modified device (InterFuse T -Intervertebral Body Fusion Device) is substantially equivalent to the unmodified InterFuse T device (K102277).
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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3. 510(k) SUMMARY
MAY 2 7 2011
510(k) SUMMARY [as required by section 807.92(c)]
| 510(k) Owner's Name: | Vertebral Technologies, Inc. | |
|---|---|---|
| Address: | 5909 Baker Road, Suite 550 | |
| Minnetonka, MN 55345 | ||
| Phone/Fax/Email: | Office - Direct: (952) 979-9357 | |
| Company Main Tel: (952) 912-5400 | ||
| Fax: (952) 912-5410 | ||
| email: sghai@vti-spine.com | ||
| Name of Contact Person: | Suresh Ghai, Ph.D. | |
| VP, Quality and Regulatory Affairs | ||
| Date prepared: | 25th January, 2011 | |
| Trade or Proprietary Name: | InterFuse®T - Intervertebral Body Fusion Device | |
| Common or Usual Name: | Intervertebral Body Fusion Device | |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumba | |
| 21 CFR § 888.3080 | ||
| Product code: MAX | ||
| Device Class: II |
3.1 LEGALLY MARKETED DEVICE TO WHICH YOUR FIRM IS CLAIMING EQUIVALENCE The modified InterFuse® T - Intervertebral Body Fusion Device is substantially equivalent in performance, indication, design and material to VTI's own InterFuse® T Intervertebral Body Fusion Device cleared under Premarket notification # K102277.
3.2 DEVICE DESCRIPTION
VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-rav. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).
Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification
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3.3 INTENDED USE OF THE DEVICE
The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
3.4 TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
The modified InterFuse® T - Intervertebral Body Fusion Device (current submission) is substantially equivalent in performance, indication, design and materials to InterFuse® T Intervertebral Body Fusion Device from Vertebral Technologies, Inc., cleared under 510(k) premarket notification # K102277.
3.5 SUMMARY AND CONCLUSIONS FROM THE NONCLINICAL TESTS SUBMITTED
The substantial equivalence is supported by bench testing comparing the modified InterFuse® T Intervertebral Body Fusion Device to the predicate un-modified device (K102277).
The basic design of the device has not changed from the 510(k) cleared device (K102277). Devices with a new AP length (i.e. 20 mm) are being added in this submission.
There is no change to the materials of construction of the device, manufacturing process, packaging materials, packaging configuration, sealing parameters (and sealing equipment), sterilization process and sterility assurance level. The shelf-life of the modified device has also not changed.
The performance of the modified device (InterFuse T) was tested, post gamma irradiation sterilization as detailed below:
- Static and Dynamic Compression; Static and Dynamic Compression Shear per ASTM F2077 .
- Subsidence per ASTM F2267 .
- Expulsion testing .
Substantial equivalence comparison between the modified InterFuse T and the predicate device is given in section 10.
The detailed performance results are given in section 11.
On the basis of performance data it is concluded that the modified device (InterFuse T -Intervertebral Body Fusion Device) is substantially equivalent to the unmodified InterFuse T device (K102277).
Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circular shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vertebral Technologies, Inc. % Suresh Ghai, Ph.D. VP, Quality & Regulatory Affairs 5909 Baker Road, Suite 550 Minnetonka, Minnesota 55345
MAY 2 7 2011
Re: K110226
Trade/Device Name: InterFuse T Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 03, 2011 Received: May 05, 2011
Dear Dr. Ghai:
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
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Page 2 - Suresh Ghai, Ph.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Eric S. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. STATEMENT OF INDICATION FOR USE
Indication for Use
KIIO226 510(k) Number (if known): Device Name: InterFuse® T - Intervertebral Body Fusion Device
Indications for Use:
The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Or
vision of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K110226
Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification
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