(56 days)
No
The description focuses on the material, mechanical design, and intended surgical use of a spinal fusion device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for intervertebral spinal fusion procedures to treat degenerative disc disease, which is a therapeutic intervention.
No
This device is designed for intervertebral spinal fusion procedures and is implanted to facilitate bone growth, rather than to diagnose medical conditions.
No
The device description clearly states it is made of implant grade PEEK-OPTIMA® and has embedded tantalum beads, indicating it is a physical implantable device, not software.
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 InterFuse® T - Intervertebral Body Fusion Device is an implantable medical device made of PEEK and tantalum beads. Its intended use is for spinal fusion procedures in the lumbosacral spine. It is surgically implanted into the body to facilitate bone growth and stabilize the spine.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any specimens taken from the body. The device itself is the therapeutic intervention.
- Input Modality: The input modality mentioned is x-ray, which is an imaging technique used to visualize the implanted device and the fusion process, not to analyze biological specimens.
Therefore, the InterFuse® T - Intervertebral Body Fusion Device falls under the category of an implantable surgical device, not an In Vitro Diagnostic device.
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 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.
Product codes
MAX
Device Description
VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Poly ether ether ketone), 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-ray. 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 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. The Anterior - Posterior (AP) length of the device is 24 mm. The middle seament (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
Not Found
Anatomical Site
L2-S1
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 InterFuse® T Intervertebral Body Fusion Device to the predicate device (K091988).
The performance of the modified device (InterFuse T) was tested, post gamma irradiation sterilization, in accordance with ASTM F2077-03 and ASTM 2067 - 04 as detailed below:
- Device durability was verified by static and dynamic compression testing per ASTM F2077-03.
- Device durability was also verified by static and dynamic compression shear testing per ASTM F2077-03.
- Static Expulsion testing.
- Subsidence testing was conducted per ASTM F2267-04.
The packaged and sterilized InterFuse T device was also tested for cytotoxicity (per ISO 10993-5:2009) and was found to be non-toxic.
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 device (K091988).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
3. 510(k) SUMMARY
6 2010
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: sqhai@vti-spine.com Name of Contact Person: Suresh Ghai, Ph.D. VP, Quality and Regulatory Affairs Date prepared: 10 August, 2010 Trade or Proprietary Name: InterFuse® T - Intervertebral Body Fusion Device Common or Usual Name: Intervertebral Body Fusion Device Intervertebral Fusion Device with Bone Graft, Lumbar Classification Name: 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® Intervertebral Body Fusion Device cleared under Premarket notification # K 091988.
3.2 DEVICE DESCRIPTION
VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Poly ether ether ketone), 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-ray. 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 is installed. Each segment has a vertical slot through the
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- K102277
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. The Anterior - Posterior (AP) length of the device is 24 mm. The middle seament (B) comes in two widths (9 mm or 10 mm).
3.5 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.
3.6 TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
InterFuse® T - Intervertebral Body Fusion Device is substantially equivalent in performance, indication, design and materials to InterFuse® Intervertebral Body Fusion Device from our company (VTI), cleared under premarket notification # K091988.
3.7 SUMMARY AND CONCLUSIONS FROM THE NONCLINICAL TESTS SUBMITTED
The substantial equivalence is supported by bench testing comparing the InterFuse® T Intervertebral Body Fusion Device to the predicate device (K091988),
The basic design of the device has not changed from the 510(k) cleared device (K091988). The device will be assembled (intra-operatively) via Transforminal Lumbar Interbody Fusion (TLIF) technique as compared to the un-modified device which is assembled (intraoperatively) via Unilateral Posterior Lumbar Interbody Fusion (UPLIF) technique.
The InterFuse T Intervertebral Body Fusion Device (the modified device) is assembled (intraoperatively) using the same rail and slot system as done for unmodified InterFuse IFD (K091988).
The performance of the modified device (InterFuse T) was tested, post gamma irradiation sterilization, in accordance with ASTM F2077-03 and ASTM 2067 - 04 as detailed below:
- Device durability was verified by static and dynamic compression testing per ASTM a. F2077-03.
- Device durability was also verified by static and dynamic compression shear testing b. per ASTM F2077-03.
- Static Expulsion testing. c.
- Subsidence testing was conducted per ASTM F2267-04. ત.
Vertebral Technologies, Inc. InterFuse T Intervertebral Body Fusion Device Special 510(k) Pre-market Notification
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Substantial equivalence comparison between InterFuse T and InterFuse P (predicate device) performance results is given in section 10.
02277
The detailed performance results are given in section 11.
The packaged and sterilized InterFuse T device was also tested for cytotoxicity (per ISO 10993-5:2009) and was found to be non-toxic.
There is no change to the packaging (materials, packaging configuration, sealing equipment, sealing parameters), sterilization process or sterility assurance level.
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 device (K091988).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vertebral Technologies, Inc % Mr. Suresh Ghai, Ph.D. VP, Quality & Regulatory 5909 Baker Road, Suite 550 Minnetonka, Minnesota 55345
OCT 6 2010
Re: K102277
Trade/Device Name: InterFuse® T Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: İntervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 13, 2010 Received: September 14, 2010
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
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Page 2 - Mr. Suresh Ghai, Ph.D.
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 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2. STATEMENT OF INDICATION FOR USE
Indication for Use
510(k) Number (if known): 1102277 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 X (Part 21 CFR 801 Subpart D)
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. Orthopedic. and Restorative Devices
K102277 510(k) Number
19
4761261