K Number
K093675
Device Name
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
Date Cleared
2009-12-23

(26 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InterFuse® 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse 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 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.
Device Description
VTI's Intervertebral Body Fusion device is made of PEEK (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 and to aid in position retention when assembled in the disc space. 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 stop to or sior in the unjudent cogment with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.
More Information

No
The summary describes a physical implantable device made of PEEK for spinal fusion. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The device description focuses on its material, structure, and physical properties.

Yes
The device is indicated for intervertebral spinal fusion procedures to treat degenerative disc disease and is used with bone graft and internal spinal fixation systems, directly aiming to treat a medical condition.

No
The provided text describes a medical device, the InterFuse® Intervertebral Body Fusion Device, which is used for spinal fusion procedures. It is an implant designed to aid in the physical process of fusing vertebrae, not to diagnose a condition. Its function is therapeutic, not diagnostic.

No

The device description clearly states the device is made of PEEK and has embedded tantalum beads, indicating it is a physical implant, not software.

Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Function: The InterFuse® Intervertebral Body Fusion Device is a physical implant designed to facilitate spinal fusion. It is surgically placed within the body.
  • Intended Use: The intended use clearly states it's for "intervertebral spinal fusion procedures" and is used in the patient, not on a sample from the patient.
  • Device Description: The description details the physical materials and construction of the implant.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

The device is a surgical implant used in a therapeutic procedure, not a diagnostic test performed in vitro.

N/A

Intended Use / Indications for Use

The InterFuse® 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse 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 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 Intervertebral Body Fusion device is made of PEEK (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 and to aid in position retention when assembled in the disc space. 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 stop to or sior in the unjudent cogment with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray

Anatomical Site

L2-S1 (lumbar spine, lumbosacral spine)

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Prescription Use, 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

The substantial equivalence is supported by bench testing comparing the modified InterFuse® Intervertebral Body Fusion Device to the predicate device (K080673). The two (2) years shelf-life is based on accelerated aging at 55℃ carried out per ASTM F 1960-07. At the end of the 2-your enomine of the performance of the aged devices was peer lest, dye penchation and beberdance with ASTM F2077-03 - Test methods for Intervertebral Body Fusion Devices. The aged devices were also tested for cytotoxicity (ISO intervertebral Body Fusion Devices. The agon as not the acceptance criteria specified in the shelf-life testing protocol.

Key Metrics

Not Found

Predicate Device(s)

K 080673

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

A final order reclassifying shortwave diathermy (SWD) intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-

25923/physical-medicine-devices-reclassification-of-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K093675 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

1

Image /page/1/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 symbol of a human figure embracing a bird, which is the department's emblem. The image is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Vertebral Technologies, Inc. % Suresh Ghai, Ph.D. Director, Quality and Regulatory Affairs 5909 Baker Road, Suite 550 Minnetonka, Minnesota 55345

DEC 2 3 2009

Re: K093675

Trade/Device Name: InterFuse® Intervertebral Body Fusion Device Regulation Number: 21 CFR 888-3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 25, 2009 Received: November 27, 2009 .

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.

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

2

Page 2 - Suresh Ghai, Ph.D.

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

2. STATEMENT OF INDICATION FOR USE

Indication for Use

510(k) Number (if known): _ Ko 93675 Device Name: InterFuse® Intervertebral Body Fusion Device

Indications for Use:

The InterFuse® 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse 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 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)

signature

(Divisio : Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Vertebral Technologies, Inc. Vertebral Fechnologies, Into.
InterFuse Intervertebral Body Fusion Device Special 510(k), Pre-market Notthcarto 510(k) Number

4

LU 1x675
Page 1 of 2

3. 510(k) SUMMARY

510(k) SUMMARY [as required by section 807.92(c)]

DEC 2 3 2009

510(k) Owner's Name:Vertebral Technologies, Inc.
Address:5909 Baker Road, Suite 550
Minnetonka, MN 55345
Phone/Fax/Email:Office: (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.
Director, Quality and Regulatory Affairs
Date prepared:25 NOV, 2009
Trade or Proprietary Name:InterFuse® Intervertebral Body Fusion Device
Common or Usual Name:Intervertebral Body Fusion Device
Classification Name:Intervertebral Fusion Device with Bone Graft, Lumbar
21 CFR § 888.3080
Product code: MAX
Device Class: Il

3.1 LEGALLY MARKETED DEVICE TO WHICH YOUR FIRM IS CLAIMING EQUIVALENCE

The modified InterFuse® 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 080673.

3.2 DEVICE DESCRIPTION

VTI's Intervertebral Body Fusion device is made of PEEK (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 and to aid in position retention when assembled in the disc space. 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 stop to or sior in the unjudent cogment with the adjacent segment. The exposed rail of each segment is removed after the adjacent segment is installed. The modular system allows for as

Vertebral Technologies, Inc. InterFuse Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

5

few as three segments to be used, although most patients will require between four and suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) to fit a range of potential disc min) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.

INTENDED USE OF THE DEVICE 3.5

The InterFuse® Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion The mien-ose "mervertional Body" dolly in degenerative disc disease (DDD) at one or two procedures in skelotally meters patisms finned as discogenic back pain with degeneration of the contiguous levels non E2-O1. DDD is doingraphic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse 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 device is indicated for use with autogenous bone graft and to be used with intent use device in indication systems that have been cleared for use by the FDA in the lumbosacral spine.

3.6 TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

The modified InterFuse® Intervertebral Body Fusion Device is substantially equivalent in The modified interFuse "Intervettebral Body InterFuse Intervenebral Body Fusion Device periormance, moreador, booger and lease premarket notification # K080673 . The modified device hom our company (v r), occured andor promotive of the unmodified device (K080673).

3.7 SUMMARY AND CONCLUSIONS FROM THE NONCLINICAL TESTS SUBMITTED

The substantial equivalence is supported by bench testing comparing the modified InterFuse® Intervertebral Body Fusion Device to the predicate device (K080673).

The design of the device has not changed from the 510(k) cleared device (K080673). The only change is the expiry date/shelf life on the labels. The modified device has 2 years I he only change is the oxpily athe shelf-life of the unmodified device (K080673).

The two (2) years shelf-life is based on accelerated aging at 55℃ carried out per ASTM The two (2) your shalf-life, the packages were tested for seal integrity by F 1960-07. At the end of the 2-your enomine of the performance of the aged devices was peer lest, dye penchation and beberdance with ASTM F2077-03 - Test methods for Intervertebral Body Fusion Devices. The aged devices were also tested for cytotoxicity (ISO intervertebral Body Fusion Devices. The agon as not the acceptance criteria specified in the shelf-life testing protocol.

On the basis of performance data and packages testing it is concluded that the modified On the basio of pointly equivalent to the unmodified device (K080673).

Vertebral Technologies, Inc. InterFuse Intervertebral Body Fusion Device Special 510(k) Pre-market Notification