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.

AI/ML Overview

This document refers to a Special 510(k) Pre-market Notification for the InterFuse® Intervertebral Body Fusion Device, which is essentially a modification of an already cleared device. Therefore, the "study" described is primarily focused on demonstrating that the modified device remains substantially equivalent to its predicate, rather than an entirely new clinical efficacy study.

Here's an analysis of the provided information, structured around your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Shelf-life Testing Protocol)	Reported Device Performance (from Accelerated Aging)
Seal integrity of packages (unspecified criteria)	Tested for seal integrity by dye penetration and bubble test (passed - implied by conclusion of equivalence)
Performance of aged devices (unspecified criteria)	Conformity with ASTM F2077-03 - Test methods for Intervertebral Body Fusion Devices (passed - implied by conclusion of equivalence)
Cytotoxicity (ISO 10993)	Tested for cytotoxicity (passed - implied by conclusion of equivalence)
2-year shelf-life at 55℃	Demonstrated a 2-year shelf-life based on accelerated aging at 55℃

Note: The document explicitly states that the acceptance criteria for seal integrity, performance, and cytotoxicity were "specified in the shelf-life testing protocol" but does not provide the specific criteria themselves. It only states that the tests were performed and implies successful adherence to these criteria to claim substantial equivalence. The primary change and therefore the primary acceptance criteria for this specific 510(k) was the extension of the shelf-life from 6 months (of the predicate) to 2 years.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The tests were performed on "packages" and "aged devices" at the end of the accelerated aging process. The number of samples tested for seal integrity, performance, and cytotoxicity is not provided.
Data Provenance: Not applicable in the traditional sense of patient data. The data is from bench testing and laboratory testing (accelerated aging, seal integrity, mechanical performance, cytotoxicity) conducted on the manufactured devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable for this type of submission. Ground truth, in the context of this 510(k) for a physical implant, is established by laboratory measurements against recognized standards (like ASTM F2077-03, ISO 10993) and internal protocols. There is no expert consensus on a "ground truth" for shelf-life, seal integrity, or material cytotoxicity in the way there would be for image interpretation.

4. Adjudication Method for the Test Set

Not applicable. This was a series of laboratory tests with objective pass/fail criteria based on established standards and internal protocols, not an expert panel adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging) where human readers are involved. This device is an implantable medical device, and the submission is about confirming its shelf-life and continued substantial equivalence, not its effectiveness in a reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth" here is based on objective measurements against established engineering and biocompatibility standards.
- Mechanical Integrity: Conformity to ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices).
- Biocompatibility: Conformity to ISO 10993 (Biological Evaluation of Medical Devices) for cytotoxicity.
- Packaging Integrity: Testing standards such as dye penetration and bubble test (implied, specific ASTM or ISO standard not mentioned but recognized tests for seal integrity).
- Shelf-life: Based on accelerated aging results correlated with real-time stability (ASTM F1980-07 for accelerated aging).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. A training set is used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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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.

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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

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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

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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:

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

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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 550Minnetonka, MN 55345
Phone/Fax/Email:	Office: (952) 979-9357Company Main Tel: (952) 912-5400Fax: (952) 912-5410Email: 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, Lumbar21 CFR § 888.3080Product code: MAXDevice 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

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

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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

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.