(120 days)
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.
The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, Nitinol SE508 conforming to ASTM F2063, and Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. 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 NuVasive® Expandable Lumbar Interbody System (K130820).
The NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody System, as described in the provided 510(k) summary, is a medical device for intervertebral body fusion. The submission does not detail specific acceptance criteria or an analytical study with defined performance metrics in the way one might expect for a diagnostic or AI-driven device.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. This means the primary "acceptance criteria" were met by proving that the modified design of the MLX System device does not introduce new worst-case performance scenarios compared to the established predicates.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain or improve mechanical performance compared to predicate devices, without introducing new worst-case scenarios. | Modifications to the MLX System were shown not to create new worst-case scenarios for performance. |
| Substantial equivalence in design, intended use, material composition, and function to predicate devices. | The subject device was found to be substantially equivalent to predicates in these areas. |
| Biocompatibility of materials. | Materials (Ti-6AI-4V ELI, Ti-6A1-4V, Nitinol SE508, Nickel-Cobalt-Chromium-Molybdenum alloy) conform to ASTM and ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance data section refers to "Finite Element Analysis (FEA), anterior shear impact testing, torsional separation testing and engineering rationale." These are typically engineering tests performed on a limited number of physical samples or computational models, not a "test set" of patient data as might be relevant for AI or diagnostic devices. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. For a device like the NuVasive MLX, ground truth is typically established through engineering standards, mechanical testing, and regulatory requirements, not through expert review of a "test set" in the context of diagnostic or AI performance.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are common in studies involving subjective expert review (e.g., for image interpretation). For a mechanical device, performance is typically assessed against quantifiable engineering specifications.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic devices, particularly those involving image interpretation with or without AI assistance, which is not the nature of the NuVasive MLX device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The NuVasive MLX is a physical implantable device, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
The ground truth used for this device's "performance" is based on engineering standards, mechanical testing results, and regulatory requirements (substantial equivalence). This includes:
- ASTM and ISO standards for material composition.
- Results from Finite Element Analysis (FEA).
- Results from anterior shear impact testing.
- Results from torsional separation testing.
- Engineering rationale to demonstrate no new worst-case scenarios.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. The NuVasive MLX is a physical medical device, not an AI or software product that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
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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 bv: A.
Olga Lewis Specialist. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: July 25, 2014
B. Device Name
Trade or Proprietary Name:
Common or Usual Name: Classification Name:
NuVasive® MLXTM - Medial Lateral Expandable Lumbar Interbodv Svstem Intervertebral Body Fusion Device 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 following predicate devices: NuVasive® Expandable Lumbar Interbody System (K130820) and NuVasive® CoRoent® Titanium System (K120918).
Device Description D.
The NuVasive MLX – Medial Lateral Expandable Lumbar Interbody System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, Nitinol SE508 conforming to ASTM F2063, and Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. 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 NuVasive® Expandable Lumbar Interbody System (K130820).
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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 spondvlolisthesis. 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.
G. Performance Data
Finite Element Analysis (FEA), anterior shear impact testing, torsional separation testing and engineering rationale was provided as the evidence that modified design of the MLX System device does not create new worst case for performance testing. Therefore, the subject device was found to be substantially equivalent to the predicates.
H. Conclusions
Based on the indications for use, technological characteristics, 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
Nuvasive, Incorporated Ms. Olga Lewis Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K140770
Trade/Device Name: NuVasive® 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 20, 2014 Received: June 23, 2014
Dear Ms. Lewis:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Olga Lewis
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140770
Device Name
Nu Vasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System
Indications for Use (Describe)
The Nu Vasive 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 Nu Vasive MLX - Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two continuous 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 Nu Vasive 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 Subpant 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)
Katherine D. Kavlock, PhD Division of Orthopedic Devices
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§ 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.