The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.

The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Device Description

The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6Al-4V ELI alloy that conforms to ASTM F136.

The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.

The device is supplied in an appropriately labeled sterile packaging.

The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

AI/ML Overview

The provided text is a 510(k) Summary for Wenzel Spine's VariLift-C, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study for device performance against specific acceptance criteria.

Based on the provided information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of acceptance criteria for a new device performance study. Instead, it compares the characteristics of the VariLift Cervical Interbody Fusion System to its predicate devices (VariLift Cervical Interbody Fusion System K111123 and BAK®/C-Vista Interbody Fusion System P980048 S003) to establish substantial equivalence.

The "Performance Data" section explicitly states: "Whereas the only change submitted for this Premarket Notification is a change in the Indications for Use, no new performance data is being submitted."

The comparison table provided in the document focuses on features for substantial equivalence, not performance criteria:

Items	VariLift Cervical Interbody Fusion System	VariLift Cervical Interbody Fusion System (Predicate)	BAK®/C-Vista Interbody Fusion System (Predicate)
Sponsor	Wenzel Spine	Wenzel Spine	Zimmer
510(K) Number	N/A (current submission)	K111123	P980048 S003
Indications for Use	Per FDA Guidance	Per FDA Guidance	Per FDA Guidance
Material	Ti-6Al-4V alloy per ASTM F136	Ti-6Al-4V alloy per ASTM F136	PEEK Optima LT1
Implant Levels	One Level	One Level	One Level
# Implants per level	Single or Pairs	Single or Pairs	Single or Pairs
Supplemental Fixation	With or Without Supplemental Fixation	With Supplemental Fixation	With or Without Supplemental Fixation

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

Not applicable. This document is a 510(k) summary for substantial equivalence, not a report on a new device performance study with a test set. It does not contain information about a test set, sample size, or data provenance from a new study.

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

Not applicable. As no new performance study was conducted, there is no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No new performance study or test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to an interbody fusion device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

Not applicable. This document concerns a physical medical device (interbody fusion device), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. Since no new performance study was conducted to evaluate the device against specific criteria, there is no mention of ground truth being established for such a study. The "ground truth" for the submission is the regulatory acceptance of the predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device; hence, there is no training set involved.

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

Not applicable. As there is no training set, this question is not relevant.

In summary: The provided 510(k) summary focuses on demonstrating that the Wenzel Spine VariLift® Cervical Interbody Fusion System is "substantially equivalent" to existing, legally marketed devices. It explicitly states that "no new performance data is being submitted." Therefore, the document does not contain the detailed information about acceptance criteria, study sample sizes, expert qualifications, or ground truth establishment that would be present in a report for a new device performance study. The "study" here is the comparison to predicate devices to satisfy regulatory requirements for substantial equivalence.

Summary

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510(k) SUMMARY Wenzel Spine's VariLift-C

Date:	February 10, 2012
Contact:	Wenzel Spine, LLCSourabh MishraJAN 2 9 2013Chief Technical Officer206 Wild Basin RoadBuilding A, Suite 203512-501-4017Austin, TX 78746
Trade Name:Common Name:Product Class:Classification:	VariLift® Cervical Interbody Fusion DeviceIntervertebral body fusion deviceClass II21 CFR §888.3080 Orthosis, intervertebral body fusion device
Product Code:Panel Code:	ODP87
Name of Device and Name/Address of Sponsor

Wenzel Spine, LLC

206 Wild Basin Road Building A, Suite 203 Austin, TX 78746 512-501-4017

Device Description

The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.

The device is supplied in an appropriately labeled sterile packaging.

The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.

Predicate Devices

The VariLift-C was shown to be substantially equivalent to legally marketed predicate device. The predicate devices are the VariLift Cervical Interbody Fusion System (K11123) and the BAK/C Interbody Fusion Device (P980048).

SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The VariLift Cervical Interbody Fusion System is substantially equivalent to the VariLift-C device previously cleared and the BAK®/C Vista Cage in terms of intended use, design, and materials used. The table below compares the features and characteristics of the VariLift Cervical Interbody Fusion System to these predicate devices.

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K120603

Items	VariLift CervicalInterbody FusionSystem	VariLift CervicalInterbody FusionSystem	BAK®/C-Vista InterbodyFusion System
Sponsor	Wenzel Spine	Wenzel Spine	Zimmer
510(K) Number	N/A	K111123	P980048 S003
Indications for Use	Per FDA Guidance	Per FDA Guidance	Per FDA Guidance
Material	Ti-6Al-4V alloy perASTM F136	Ti-6Al-4V alloy perASTM F136	PEEK Optima LT1
Implant Levels	One Level	One Level	One Level
# Implants per level	Single or Pairs	Single or Pairs	Single or Pairs
Supplemental Fixation	With or WithoutSupplemental Fixation	With SupplementalFixation	With or WithoutSupplemental Fixation

Intended Use / Indications for Use

Performance Data

Whereas the only change submitted for this Premarket Notification is a change in the Indications for Use, no new performance data is being submitted.

Summary:

The VariLift-C Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the cervical disc space to facilitate biologic fusion. The indications for use of the VariLift-C Interbody Fusion Device are exactly the same as one of the predicate devices. Moreover, the device is very similar in its size to the predicate device. The materials used are also the same as in the predicate device. There are no significant differences in technological characteristics compared to the predicate devices, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, clinical data presented demonstrates that these differences do not adversely impact device performance, as discussed below.

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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 29, 2013

Wenzel Spine, LLC % Mr. Sourabh Mishra Chief Technical Officer 206 Wild Basin Road Building A. Suite 203 Austin, Texas 78746

Re: K120603

Trade/Device Name: VariLift-C® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 8, 2013 Received: January 11, 2013

Dear Mr. Mishra:

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 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

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Page 2 – Mr. Sourabh Mishra

forth in the quality systems (OS) 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

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K120603
Device Name: VariLift-C

Indications for Use:

Prescription Use V (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 OF NEEDED)

Stephanie; Bechtold -S 2013.01.29 15:43:40 -05'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K120603

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.