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 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 supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

Device Description

The implantable portion of VT's IFD device is made of PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion devices, 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 help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel tail, of each seqment 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 six segments for optimum coverage of the vertebral endplate. 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) and two anterior-posterior dimensions (20 mm and 25 mm) to fit a range of potential disc spaces. The device will also be produced in flat and 5 angled (lordotic) shapes to fit the anqular geometry of the disc at each disc level.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically an Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing data from a clinical study on device performance against specific acceptance criteria.

As such, it does not contain the following information that would typically be found in a clinical study report:

A table of acceptance criteria and reported device performance: The document only states that "All devices exceeded the minimum strength requirement which was used in the original validation testing referenced in K080673." It does not specify the minimum strength requirement or provide detailed performance data.
Sample sizes used for the test set and data provenance: No information on a test set (in the context of clinical or image-based AI studies) is provided. The "test" here refers to bench testing of the device itself.
Number of experts used to establish ground truth and their qualifications: Not applicable, as this is a device clearance based on bench testing, not an AI or diagnostic tool requiring ground truth from experts.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable for this type of device clearance.
Standalone (algorithm-only) performance: Not applicable, as this is a physical implantable device, not an algorithm.
Type of ground truth used: For the bench testing, the "ground truth" would be the established engineering standards (ASTM F2077-03) and the performance of the predicate device.
Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Study Details from the Provided Document:

The study described is a bench test to demonstrate that a modification to the InterFuse® Intervertebral Body Fusion Device (specifically the delivery system's tail and the sterilization method) does not negatively impact the device's performance compared to the predicate device.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Bench Test)	Reported Device Performance
Mechanical Strength: Must meet or exceed the minimum strength requirement from the original validation testing (referenced in K080673) for static compression after gamma sterilization, as per ASTM F2077-03.	"All devices exceeded the minimum strength requirement which was used in the original validation testing referenced in K080673."
Sterility: Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ with gamma irradiation.	"The sterilization by gamma irradiation was validated to give a Sterility Assurance Level of 10⁻⁶."
Biocompatibility: Non-toxic.	"The InterFuse device was found to be "Non toxic" by testing for cytotoxicity."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for the mechanical, sterility, or cytotoxicity tests. The document only states "All devices" regarding the mechanical test.
Data Provenance: The tests are "nonclinical tests submitted" and were performed by the manufacturer, Vertebral Technologies, Inc., to support their 510(k) submission. The exact location of testing (e.g., in-house lab, third-party lab) is not specified, but it would be considered internal company data for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this bench testing for a physical device. The "ground truth" or standard for performance is the ASTM standard and the predicate device's established performance.

4. Adjudication method for the test set:

Not applicable. The tests are objective measurements against specified engineering and biological standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, this type of study was not done. This is a physical implantable device, not a diagnostic or interpretative system that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used:

Mechanical Strength: Established engineering standards (ASTM F2077-03) and the previously validated performance of the predicate device (K080673).
Sterility: Industry-accepted standards for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
Biocompatibility: Standardized cytotoxicity testing methods to determine non-toxicity.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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1981988

JUL 8 0 2009

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

510(k) Owner's Name:

Address:

Phone/Fax/Email:

Vertebral Technologies, Inc.

5909 Baker Road, Suite 550 Minnetonka, MN 55345

Director, Regulatory Affairs

Intervertebral Body Fusion Device

Office: (952) 979-9357 Company Main Tel: (952) 912-5400 Fax: (952) 912-5410 Email: sghai@vti-spine.com

Name of Contact Person:

Date prepared:

Trade or Proprietary Name:

Common or Usual Name:

Classification Name:

Intervertebral Fusion Device with Bone Graft, Lumbar 21 CFR § 888.3080 Product code: MAX Device Class: II

InterFuse® Intervertebral Body Fusion Device

LEGALLY MARKETED DEVICE TO WHICH YOUR FIRM IS CLAIMING EQUIVALENCE

Suresh Ghai

30 JUNE, 2009

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.

DEVICE DESCRIPTION

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

page 1 of 2

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Ko91989

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) and two anterior-posterior dimensions (20 mm and 25 mm) to fit a range of potential disc spaces. The device will also be produced in flat and 5 angled (lordotic) shapes to fit the anqular geometry of the disc at each disc level.

INTENDED USE OF THE DEVICE

TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

The modified InterFuse® 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 # K080673. The implanted portion of both devices is exactly same in performance, indication, design and mater ials.

The design changes to the InterFuse device are limited to the configuration of the device tail, which is part of device segment delivery system and is not implanted into the patient.

The only other change to the device is use of a gamma irradiation sterilization process vs. the EtO sterilization of the un-modified device (K080673).

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 changes of the modified device are limited to the configuration of the tail, which is part of the delivery system for the seqments of the device. The tails are not implanted. The other change to the device is method of sterilization by gamma irradiation. The performance of the irradiated devices was tested for static compression in accordance with ASTM F2077-03 - Test methods for Intervertebral Body Fusion Devices to confirm that the gamma sterilization process did not have an impact on the device material. All devices exceeded the minimum strength requirement which was used in the original validation testing referenced in K080673.

The sterilization by gamma irradiation was validated to give a Sterility Assurance Level of 10°

The InterFuse device was found to be "Non toxic" by testing for cytotoxicity.

On the basis of performance data it is concluded that the modified device is substanti ally equivalent to the unmodified device (K080673).

Vertebral Technologies, Inc.

InterFuse Intervertebral Body Fusion Device Special 510(k) Pre-market Notification

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vertebral Technologies Inc. % Mr. Suresh Ghai Director, Regulatory Affairs 5909 Baker Road, Suite 550 Minnetonka, Minnesota 55345

JUL 3 0 2009

Re: K091988

Trade/Device Name: InterFuse Intervetebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: June 30, 2009 Received: July 2, 2009

Dear Mr. 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 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.

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Page 2 – Dr. Kelly J. Baker

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, "Mishranding 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Овавазтеки

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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Indication for Use

510(k) Number (if known): K091988

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 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 supplem ental 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)

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

510(k) Number

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

Regulation Number and Section

§ 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.