The NuVasive® VersaTie System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium alloy whenever "wiring" may help secure the attachment of other implants.

Device Description

The NuVasive® VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium allov or cobalt-chromium allov rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided text is a 510(k) summary for the NuVasive® VersaTie System, a bone fixation cerclage device. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by nonclinical performance data.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list formal "acceptance criteria" with numerical thresholds typically seen for AI/software-as-a-medical-device (SaMD) clearances (e.g., sensitivity, specificity, AUC). Instead, for this Class II mechanical device, the performance is demonstrated through biomechanical testing, compared to a predicate device.

Acceptance Criterion (Implied)	Reported Device Performance
Mechanical Strength	Demonstrated substantial equivalence to predicate device Zimmer® Universal Clamp Spinal Fixation System (K142053)
Static Band Tensile Strength	Testing performed. Results demonstrated substantial equivalence.
Static and dynamic band pull-through	Testing performed. Results demonstrated substantial equivalence.
Static rod-connector axial slip	Testing performed per ASTM F1798. Results demonstrated substantial equivalence.
Static rod-connector axial moment	Testing performed per ASTM F1798. Results demonstrated substantial equivalence.
Material Composition	Equivalent to predicate device.
Biocompatibility	Not explicitly detailed in the summary, but implicit for implantable devices.

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

Sample Size: The document does not specify exact sample sizes (e.g., number of bands, clamps, or test repetitions) for each type of mechanical test. It mentions "nonclinical testing" was performed.
Data Provenance: The data is from nonclinical (in vitro/benchtop) testing, not human patient data. There is no country of origin for the data in the context of patient cohorts, as it's a mechanical device test. The tests were performed to demonstrate substantial equivalence for regulatory submission in the USA (FDA).

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

This information is not applicable. The "ground truth" for mechanical testing is established by the physical properties and performance measured during the tests, adhering to recognized standards (e.g., ASTM F1798). It does not involve human experts establishing a ground truth in the way medical imaging or diagnostic algorithms do.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for expert review of human data, typically in diagnostic or screening studies, not for biomechanical testing of a medical device.

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

This information is not applicable. The device (NuVasive® VersaTie System) is a physical, implantable medical device for spine fixation, not an AI or diagnostic imaging system. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

This information is not applicable, as the device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established biomechanical and material science principles and standards, specifically referenced ASTM F1798. The performance relative to the predicate device serves as the benchmark for "truth" in terms of substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI device that requires a training set.

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

This information is not applicable. This is not a machine learning or AI device.

Summary

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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other.

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

July 15, 2016

NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121

Re: K161265

Trade/Device Name: NuVasive® VersaTie System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: May 3, 2016 Received: May 5, 2016

Dear Ms. Adams:

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

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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 yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161265

Device Name Nu Vasive® VersaTie System

Indications for Use (Describe)

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondy lolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, with lines suggesting motion.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Cynthia Adams Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: May 2, 2016

B. Device Name

Trade or Proprietary Name:	NuVasive® VersaTie System
Common or Usual Name:	Bone Fixation Cerclage, Sublamina
Classification Name:	Bone Fixation Cerclage
Device Class:	Class II
Classification:	21 CFR § 888.3010
Product Code:	OWI

C. Predicate Devices

The subject device is substantially equivalent to the primary predicate device Zimmere Universal Clamp Spinal Fixation System (K142053), and additional predicate device Implant, S.A. JAZZTM System (K151740). NuVasive Reline® System (K143684) is a reference device.

D. Device Description

E. Intended Use

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction 2. of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font, also in gray.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt-chromium alloy whenever "wiring" may help secure the attachment of other implants.

F. Technological Characteristics

As was established in this submission, the subject NuVasive® VersaTie System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject NuVasive® VersaTie System is substantially equivalent to the predicate device. The following testing was performed:

Static Band Tensile Testing
Static and dynamic band pull-through, static rod-connector axial slip, static rodconnector axial moment per ASTM F1798

The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate.

Conclusions H.

The subject NuVasive® VersaTie System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.