The ny', nv", and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, or transforaminal approach.

Device Description

The nv3, nvP, and nv1 are an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The purpose of this submission is to make changes to the number and design of the tantalum markers.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the nv³, nvº, and nv¹ intervertebral body fusion devices:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from industry standards)	Reported Device Performance (Summary of Test Results)
Static and dynamic compression (per ASTM F2077)	Meets criteria, indicating substantial equivalence to predicate devices.
Subsidence (per ASTM F2267)	Meets criteria, indicating substantial equivalence to predicate devices.
Expulsion	Meets criteria, indicating substantial equivalence to predicate devices.

Explanation: The document states, "No FDA performance standards have been established for the nvª, nvº, and nv*. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards." Therefore, the acceptance criteria are implicitly meeting the current industry standards as defined by ASTM F2077 and ASTM F2267 for static/dynamic compression and subsidence, respectively, and passing an "expulsion" test. The device's reported performance is that it met these criteria and was found to be "substantially equivalent to the predicate devices."

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

Sample Size for Test Set: This information is not provided in the document. The document only lists the types of non-clinical tests performed (static/dynamic compression, subsidence, expulsion) but does not specify the number of devices or test conditions used for each.
Data Provenance: The data is "non-clinical testing" conducted by the manufacturer, Nvision Biomedical Technologies, LLC. The provenance (e.g., country of origin, retrospective/prospective) of the data itself isn't explicitly stated beyond being lab-based mechanical testing.

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

This information is not applicable/provided. The study described is non-clinical bench testing of a physical device's mechanical properties, not a clinical study involving human patients or expert review of medical images/data. Therefore, there's no concept of "ground truth" established by medical experts in this context.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As above, this was non-clinical bench testing, so there was no adjudication process involving experts comparing results. The "adjudication" would be a comparison of measured mechanical properties against pre-defined engineering acceptance limits for the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable/provided. The document describes the marketing clearance for an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant here.

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

This information is not applicable/provided. As explained in point 5, this is not an AI/SaMD product.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing is the pre-defined mechanical performance specifications set by relevant ASTM standards (ASTM F2077 for static/dynamic compression and ASTM F2267 for subsidence), and an unspecified internal expulsion test criteria. The device's performance was compared against these established engineering and material standards.

8. The Sample Size for the Training Set

This information is not applicable/provided. This is a physical, implantable medical device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

This information is not applicable/provided. As explained in point 8, there is no concept of a "training set" for this type of 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.

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

September 29, 2016

Nvision Biomedical Technologies, LLC % Allison Komivama. Ph.D. AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego, California 92104

Re: K162426

Trade/Device Name: nvª, nvª, and nv Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 26, 2016 Received: August 30, 2016

Dear Dr. Komiyama:

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/Resourcesfor You/Industry/default.htm. 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 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,

Lori A. Wiggins -S

for

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

510(k) Number (if known)

K162426

Device Name nva, nvP, and nv

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/1 description: The image shows the logo for N vision Biomedical Technologies. The logo is in gold and black. The image also contains the text "K162426 Page 1 of 2".

510(k) Summary K162426

DATE PREPARED September 28, 2016

MANUFACTURER AND 510(k) OWNER

Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103, San Antonio, TX 78232, USA Telephone: Fax: (866) 764-1139 Official Contact: Diana L. Langham, Director of Regulatory and Corporate Compliance

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com

PROPRIETARY NAME OF SUBJECT DEVICE

nvª, nvº, and nv‡

COMMON NAME

Intervertebral Fusion Device with Bone Graft, Lumbar

DEVICE CLASSIFICATION

Intervertebral body fusion device (21 CFR 888.3080, Product Code MAX, Class II)

PREMARKET REVIEW

ODE/DOD/ASDB Orthopedic Panel

INDICATIONS FOR USE

The nv3, nv0, and nv1 are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

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Image /page/4/Picture/1 description: The image shows the logo for N-Vision Biomedical Technologies. The logo is in black and gold, with the words "N-Vision" in large letters. Below the logo, the words "Biomedical Technologies" are written in smaller letters. Above the logo, the text "K162426 Page 2 of 2" is written.

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The nv³, nvº, and nv• is substantially equivalent to the nv³, nvº, and nv• device by Nvision Biomedical Technologies, LLC, cleared in K142594 is the primary predicate.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the nvª, nvº, and nv*. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards:

Static and dynamic compression (per ASTM F2077) .
. Subsidence (per ASTM F2267)
. Expulsion

The results of these tests indication that the nvª, nvº, and nv໋ is substantially equivalent to the predicate devices.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Nvision believes that the nv3, nv8, and nv is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has identical dimensions, the same indications for use, and uses the same materials as the devices cleared in K142594. The subject device has a similar design and similar technological characteristics to the devices cleared in K142594. The device uses the same instrumentation as those cleared in K142594.

CONCLUSION

The nvª, and nv• is considered substantially equivalent to the predicate devices based on the design control activities provided in the submission. Based on the summary of the testing that was performed, the identical indications for use, and similar technological characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the 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.