K Number
K153105
Device Name
MLX™ - Medial Lateral Expandable Lumbar Interbody System
Date Cleared
2016-07-11

(258 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
Device Description
The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6Al-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to MLX - Medial Lateral Expandable Lumbar Interbody System (K140770).
More Information

No
The document describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing and finite element analysis.

Yes
The device is intended for intervertebral body fusion of the spine and treatment of degenerative disc disease, which are therapeutic interventions.

No

Explanation: This device is an implant for intervertebral body fusion of the spine, specifically designed to treat degenerative disc disease. Its purpose is therapeutic (fusion) rather than diagnostic (identifying or characterizing a medical condition).

No

The device description explicitly states the system is manufactured from materials like Ti-6Al-4V ELI and Nitinol, and that the implants are available in different shapes and sizes. This indicates a physical, hardware-based medical device, not a software-only one.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for "intervertebral body fusion of the spine." This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device is described as an "Expandable Lumbar Interbody System" made of specific materials (Titanium and Nitinol) and available in various shapes and sizes. This is consistent with a surgical implant.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.

IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a condition directly within the body.

N/A

Intended Use / Indications for Use

The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Product codes

MAX

Device Description

The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6Al-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to MLX - Medial Lateral Expandable Lumbar Interbody System (K140770).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine, from L2 to S1

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Nonclinical testing was performed to demonstrate that the subject NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is substantially equivalent to the predicate device. The following testing was performed:

  • Dynamic axial compression per ASTM F2077
  • Dynamic torsion per ASTM F2077
  • Static push-out per ASTM Draft Standard F-04.25.02.02 (work item Z8423Z)
    Additionally, Finite Element Analysis (FEA) and engineering rationale were provided as the evidence that modified design of the MLX System device does not create new worst case for performance testing. The subject device was found to be substantially equivalent to the predicates.

Key Metrics

Not Found

Predicate Device(s)

K140770, K130820, K151374, K120918

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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

July 11, 2016

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

Re: K153105

Trade/Device Name: MLX™-Medial Lateral Expandable Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 21, 2016 Received: June 22, 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

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" (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 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K153105

Page 1 of 1

510(k) Number (if known)

K153105

Device Name

NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System

Indications for Use (Describe)

The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

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)

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

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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:

A. Submitted by:

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

Date Prepared: June 21, 2016

B. Device Name

Trade or Proprietary Name:NuVasive® MLX™ – Medial Lateral Expandable Lumbar
Interbody System
Common or Usual Name:Intervertebral Body Fusion Device
Classification Name:Spinal Intervertebral Body Fixation orthosis
Device Class:Class II
Classification:21 CFR § 888.3080
Product Code:MAX

C. Predicate Devices

The subject MLX – Medial Lateral Expandable Lumbar Interbody System is substantially equivalent to the primary predicate device, MLX - Medial Lateral Expandable Lumbar Interbody System (K140770), and additional predicate devices, NuVasive® Expandable Lumbar Interbody System (K130820), MLX – Medial Lateral Expandable Lumbar Interbody System (K151374), and NuVasive® CoRoent® Titanium System (K120918).

Device Description D.

The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6Al-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to MLX - Medial Lateral Expandable Lumbar Interbody System (K140770).

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E. Intended Use

The NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.

The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System. The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

F. Technological Characteristics

As was established in this submission, the subject NuVasive MLX - Medial Lateral Expandable Lumbar Interbody 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.

Performance Data G.

Nonclinical testing was performed to demonstrate that the subject NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is substantially equivalent to the predicate device. The following testing was performed:

  • Dynamic axial compression per ASTM F2077 ●
  • Dynamic torsion per ASTM F2077
  • Static push-out per ASTM Draft Standard F-04.25.02.02 (work item Z8423Z)

Additionally, Finite Element Analysis (FEA) and engineering rationale were provided as the evidence that modified design of the MLX System device does not create new worst case for performance testing. The subject device was found to be substantially equivalent to the predicates.

H. Conclusions

Based on the indications for use, technological characteristics, performance data, and comparison to predicate devices, the subject NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.