The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.

Device Description

The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titanium alloy (Ti-6AL-4V ELI per ASTM F136), multiple component system comprised of a variety of nonsterile, single use implantable components. The system consist of plates and lock screw. The components are available in a variety of lengths and sizes in order to accommodate patient anatomy.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Z-Clamp ISP System. It is focused on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for diagnostic accuracy or efficacy through clinical studies. Therefore, much of the requested information regarding diagnostic device performance, expert review, and MRMC studies is not available in these documents.

Here's a breakdown of the available information and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely defined by its mechanical performance compared to the predicate device, as it's a spinal fixation orthosis. The document states that the device performs "as well as or better than the predicate devices" in several mechanical tests. Since the predicate device is already marketed, this implies that its established mechanical performance serves as the de facto acceptance criteria.

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (Z-Clamp ISP System)
Mechanical performance of a legally marketed predicate device (K141508 Spineart, Romeo 2Pad) across various tests (Static torsion, Static compression bending, Dynamic compression bending, Static foam pull-off, Static plate dissociation).	Performs as well as or better than the predicate devices in Static torsion test, Static compression bending test, Dynamic compression bending test, Static foam pull-off test and Static plate dissociation test.

2. Sample Size for the Test Set and Data Provenance

This is not applicable to this type of submission. The performance assessment is based on mechanical testing of the device itself, not on a test set of patient data.

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

This is not applicable. Ground truth, in the context of device performance, would relate to its physical and mechanical properties, not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable. The device's performance is determined through reproducible mechanical tests, not based on expert adjudication of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess diagnostic performance. The Z-Clamp ISP System is a physical spinal implant.

6. Standalone Performance Study (Algorithm Only)

No standalone performance study of an algorithm was done. This device is not an algorithm; it's a physical medical device. The "performance" refers to its mechanical integrity and function.

7. Type of Ground Truth Used

The "ground truth" for this device is established through standardized mechanical testing. The tests performed were:

Static torsion test
Static compression bending test
Dynamic compression bending test
Static foam pull-off test
Static plate dissociation test

These tests are specifically designed to assess the physical properties and structural integrity of the spinal fixation system under various forces, using methods "according to a modified ASTM F1717." The results are quantitative measurements against established engineering and material science standards for similar devices.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical medical device like this spinal clamp. This term is relevant for machine learning algorithms.

9. How Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the organization's name and national affiliation. The logo is simple, clean, and uses a monochromatic color scheme.

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

October 20, 2016

Zavation, LLC Mr. Milton Phillips Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K161016

Trade/Device Name: Z-Clamp ISP System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 20, 2016 Received: September 21, 2016

Dear Mr. Phillips:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161016

Device Name Z-Clamp ISP System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510K Summary

Date:	September 20, 2016
Submitter:	Zavation, LLC220 Lakeland ParkwayFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact person:	Milton Phillips
Trade name:	Z-CLAMP ISP System
Classification:	Spinal Interlaminal Fixation Orthosis21 CFR 888.3050Product Code: PEKRegulatory Class: IIPanel Code: 87
Primary Predicate:

K141508 Spineart, Romeo 2Pad

Device Description:

Indications for Use:

The Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction to fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e. fracture or dislocation) and /or tumor. The Z-Clamp ISP System is not intended for standalone use.

{4}------------------------------------------------

K161016 Page 2 of 2

Technological Characteristics:

The Z-CLAMP ISP System possesses the same technological characteristics, design and principles of operation as the predicates. These include: basic design, material, intended use and indications.

Performance Data:

Static torsion test, static compression bending test, dynamic compression bending test, static foam pull-off test and static plate dissociation test were performed according to a modified ASTM F1717 on a worst-case construct. The mechanical test results demonstrated the Z-CLAMP ISP System performs as well as or better than the predicate devices.

Conclusion:

The Z-CLAMP ISP System is substantially equivalent to the predicate device referenced above.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.