The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used supplemental fixation systems.

Device Description

The Tranquil-L Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this traditional 510(k) is to gain clearance for additional implant footprints for the ALIF surgical approach.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Tranquil-L Interbody System." It outlines the device's indications for use, its classification, and a comparison to predicate devices, along with performance data.

However, the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

Instead, this document pertains to a physical orthopedic implant device (intervertebral body fusion device) designed for spinal surgery. The "performance data" mentioned refers to mechanical engineering principles and mechanical testing (e.g., compression, compression shear, subsidence, and expulsion testing) of the physical implant, not the performance of a software algorithm or AI.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample size for test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study and effect size.
Standalone algorithm performance.
Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

This document describes the regulatory clearance process for a traditional physical medical device based on substantial equivalence to existing predicate devices, focusing on its mechanical properties and intended surgical use. It is not about an AI/ML-driven diagnostic or therapeutic device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 21, 2018

Nexus Spine, LLC Mr. Jared Crocker Director of Quality and Regulatory Affairs 2825 E Cottonwood Parkway, Suite 330 Salt Lake City, Utah 84121

Re: K181702

Trade/Device Name: Tranquil-L Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 27, 2018 Received: July 31, 2018

Dear Mr. Crocker:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -S

For 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) K181702

Device Name Tranquil-L Interbody System

Indications for Use (Describe)

The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in sketally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used supplemental fixation systems.

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

X 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}------------------------------------------------

510(k) Summary K181702

Submitter:	Nexus Spine LLC
Contact Person:	Mr. Jared Crocker, Director of Quality and Regulatory Affairs2825 East Cottonwood Parkway Suite 330Salt Lake City, UT 84121Telephone: (801) 702-8592Fax: (801) 702-8585
Date Prepared:	September 20, 2018
Trade Name:	Tranquil-L Interbody System
Classification, Nameand Number:	Class IIIntervertebral body fusion device21 CFR 888.3080
Product Code:	MAX

Predicate Device(s):

Manufacturer	Device	510(k) Number
Primary Predicate
Nexus Spine LLC	Tranquil-L Interbody System	K170297
Additional Predicates
HD LifeSciences LLC	HD Lumbar Interbody System	K170676
DePuy Synthes Spine	Synthes SynCage Evolution Spacer	K122639
Captiva Spine LLC	Pivotec Lumbar Interbody System	K092017

Device Description:

The purpose of this traditional 510(k) is to gain clearance for additional implant footprints for the ALIF surgical approach.

510k Summary K181702 1 of 2

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

Indications for Use: The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used with FDA cleared supplemental fixation systems. Both the subject and the primary predicate device are intended for Statement of Technological intervertebral body fusion of the spine in skeletally mature patients with Comparison: degenerative disc disease. The technological characteristics of the subject Tranquil-L Interbody System are equivalent to the primary and additional predicate devices. When compared to a predicate, and as confirmed by performance data presented in the submission, the addition of implant footprints for the ALIF surgical approach to the Tranquil-L Interbody System does not affect substantial equivalence of the Tranquil-L System. Performance Data: Using principles of mechanical engineering it was determined that the ALIF embodiment does not introduce a new worst case in compression, compression shear, or subsidence; for these test modes, results of mechanical testing on the system's worst case TLIF and PLIF constructs was presented and cleared under K170297, and those instances constitute worse case scenarios relative to all ALIF constructs. However, a new worstcase was identified for expulsion. Therefore, expulsion testing was performed on the worst case ALIF construct and compared to a legally marketed predicate. Results of this testing demonstrate substantial equivalence regarding resistance to expulsion loading. Conclusion: Documentation provided demonstrates the Tranquil-L Interbody System is substantially equivalent to predicate devices.

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.