(120 days)
No
The summary describes a mechanical expandable interbody fusion device made of standard medical-grade materials. There is no mention of AI, ML, image processing, or any software-driven features that would suggest the use of these technologies. The performance studies are based on mechanical testing and finite element analysis, not AI/ML performance metrics.
Yes
The device is used for intervertebral body fusion of the spine to treat degenerative disc disease, which involves alleviating pain and restoring function, thereby providing therapeutic benefit to the patient.
No
The device is described as an intervertebral body fusion system, intended for treatment of degenerative disc disease, not for diagnosis.
No
The device description explicitly states it is manufactured from various metal alloys and is available in different shapes and sizes, indicating it is a physical implant, not software.
Based on the provided text, 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" and is an "interbody system." This describes a surgical implant used within the body to facilitate fusion, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the materials used for the implant (Titanium, Nitinol, MP35N) and its purpose as an "expandable lumbar interbody system." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the NuVasive MLX™ - Medial Lateral Expandable Lumbar Interbody System is a surgical implant, not an In Vitro Diagnostic device.
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 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.
Product codes
MAX
Device Description
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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NuVasive® Expandable Lumbar Interbody System (K130820), NuVasive® CoRoent® Titanium System (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.
0
Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized graphic element on the left, followed by the word "NUVASIVE" in bold, sans-serif font. Below "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font. The graphic element appears to be an abstract shape, possibly representing movement or innovation.
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).
1
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.
2
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
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support.
3
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
4
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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