The Nu Vasive® 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10° 20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The Nu Vasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Device Description

The subject NuVasive 3DP Interfixated System are interbody implants manufactured from titanium alloy (Ti-6A1-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

AI/ML Overview

This document describes the NuVasive® 3DP Interfixated ALIF System, an intervertebral body fusion device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the device was tested to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly that the device performs comparably to or better than the predicate devices in the specified mechanical tests, and meets relevant ASTM and ANSI/AAMI standards. The "Reported Device Performance" is that the device "meets the same criteria as the predicate devices."

Acceptance Criteria (Implicit)	Reported Device Performance
Static Compression (per ASTM F2077)	Meets criteria of predicate devices
Dynamic Compression (per ASTM F2077)	Meets criteria of predicate devices
Static Compression Shear (per ASTM F2077)	Meets criteria of predicate devices
Dynamic Compression Shear (per ASTM F2077)	Meets criteria of predicate devices
Static Torsion (per ASTM F2077)	Meets criteria of predicate devices
Dynamic Torsion (per ASTM F2077)	Meets criteria of predicate devices
Gravimetric and Particulate analysis (ASTM F1714 and F1877)	Meets criteria of predicate devices
Subsidence and screw push-out analysis	Meets criteria of predicate devices
Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016	Meets criteria of predicate devices

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

The document does not specify the exact sample sizes (number of devices tested) for each physical performance test. It only lists the types of tests performed. The data provenance is from nonclinical testing performed by the manufacturer, NuVasive, Incorporated. The nature of these tests (mechanical and material property tests) implies the data is prospective for the specific device being evaluated. No information on country of origin of the data is provided beyond the manufacturer being based in San Diego, California.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a medical implant, and the approval is based on physical and mechanical performance testing, not on the interpretation of medical images or clinical data by experts to establish a "ground truth" in the way it would be for an AI/diagnostic device. The ground truth for such a device is established by adherence to engineering standards and comparison to well-established predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the evaluation is based on objective measurements from engineering tests against established standards and comparisons to predicate devices, not on subjective expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This device is an implant, and its effectiveness is determined through mechanical testing and clinical outcomes (which are not part of this 510(k) summary directly, but are implied by the safety and performance).

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

Not applicable. This device is a physical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established by:

Adherence to recognized consensus standards (e.g., ASTM F2077, ASTM F1714, ASTM F1877, ANSI/AAMI ST72:2011/(R)2016) for intervertebral body fusion devices.
Comparison to predicate devices with a history of safe and effective use. The "ground truth" is that if the new device performs equivalently or better than these established predicates under defined test conditions, it is considered safe and effective for its intended use.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

Summary

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March 25, 2020

NuVasive, Incorporated Jessica LeBlanc Sr. Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

Re: K193593

Trade/Device Name: NuVasive® 3DP Interfixated ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 27, 2020 Received: February 28, 2020

Dear Jessica LeBlanc:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Brent Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193593

Device Name NuVasive® 3DP Interfixated ALIF 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)

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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.

Jessica LeBlanc Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego. California 92121 Telephone: (858) 909-3302

Date Prepared: March 24, 2020

510(k) Number: K193593

B. Device Name

Trade or Proprietary Name:	NuVasive® 3DP Interfixated ALIF System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device

Device Class:	Class II
Classification:	21 CFR § 888.3080
Product Code:	OVD

C. Predicate Devices

The subject NuVasive 3DP Interfixated ALIF System is substantially equivalent to the primary predicate device NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230).

D. Device Description

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with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

E. Indications for Use

The NuVasive 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

F. Technological Characteristics

As was established in this submission, the subject NuVasive 3DP Interfixated ALIF 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 the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject NuVasive 3DP Interfixated ALIF System is substantially equivalent to other predicate devices. The following testing was performed:

Static Compression (per ASTM F2077) ●
Dynamic Compression (per ASTM F2077) ●
Static Compression Shear (per ASTM F2077) ●
Dynamic Compression Shear (per ASTM F2077)
Static Torsion (per ASTM F2077) ●
Dynamic Torsion (per ASTM F2077)
Gravimetric and Particulate analysis (ASTM F1714 and F1877)
Subsidence and screw push-out analysis
Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016

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The results demonstrate that the subject NuVasive 3DP Interfixated ALIF System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates.

Conclusions H.

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive 3DP Interfixated ALIF System has been shown to be substantially equivalent to legally marketed 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.