(161 days)
The NuVasive AP Expandable XLIF 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 AP Expandable XLIF 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 AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.
The NuVasive AP Expandable XLIF System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3 and Ti-6Al-4V conforming to ASTM 1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
This document is a 510(k) Summary for the NuVasive® AP Expandable XLIF System, an intervertebral body fusion device. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not to establish performance criteria through a clinical study involving AI or human readers.
Therefore, the requested information components related to acceptance criteria, ground truth, sample sizes for test and training sets, expert adjudication, and multi-reader multi-case (MRMC) studies are not applicable to the content provided in this 510(k) summary. These components are typically associated with performance evaluations of AI/ML-driven devices or clinical trials, neither of which are described here.
The document focuses on demonstrating substantial equivalence through nonclinical testing and comparison to predicate devices, as is standard for many Class II medical devices seeking 510(k) clearance.
Here's the relevant information based on the provided text, addressing the request by noting the inapplicability of many points:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Axial Compression (per ASTM F2077) | Not explicitly stated (implied substantial equivalence to predicate) | Results demonstrated no new worst-case for performance testing. |
| Dynamic Axial Compression (per ASTM F2077) | Not explicitly stated (implied substantial equivalence to predicate) | Results demonstrated no new worst-case for performance testing. |
| Compression Shear (per ASTM F2077) | Not explicitly stated (implied substantial equivalence to predicate) | Results demonstrated no new worst-case for performance testing. |
| Torsion Testing (per ASTM F2077) | Not explicitly stated (implied substantial equivalence to predicate) | Results demonstrated no new worst-case for performance testing. |
| Lateral Collapse testing | Not explicitly stated (implied substantial equivalence to predicate) | Results demonstrated no new worst-case for performance testing. |
| Expulsion and Subsidence Analysis | Not explicitly stated (implied substantial equivalence to predicate) | Results demonstrated no new worst-case for performance testing. |
2. Sample size used for the test set and the data provenance
Not applicable. No "test set" in the context of AI/ML or clinical data performance evaluation is described. The performance data refers to nonclinical (mechanical) testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" derived from expert review of data is established for this type of nonclinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method" is described as there is no human review of data to establish ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical implant, not an AI-driven diagnostic or assistive system. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for the performance data in this context is based on engineering specifications and physical measurements compliant with ASTM standards, not clinical ground truth like pathology or expert consensus. The comparison is against predicate devices and their established performance characteristics.
8. The sample size for the training set
Not applicable. There is no AI/ML model, and therefore no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model, and therefore no "training set" or corresponding ground truth establishment process.
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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 Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: June 5, 2014
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name:
NuVasive® AP Expandable. XLIF System 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 NuVasive AP Expandable XLIF System is substantially equivalent to the following predicate devices: NuVasive Expandable Lumbar Interbody System (K130820) and NuVasive CoRoent Sterile System (K132601).
D. Device Description
The NuVasive AP Expandable XLIF System is manufactured from Ti-6AI-4V ELI conforming to ASTM F136 and ISO 5832-3 and Ti-6Al-4V conforming to ASTM 1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
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E. Intended Use
The NuVasive AP Expandable XLIF 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 AP Expandable XLIF 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 AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) that are cleared by the FDA for use in the lumbar spine.
F. Technological Characteristics
As was established in this submission, the subject AP Expandable XLIF 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
Nonclinical testing was performed to demonstrate that the subject AP Expandable XLIF System is substantially equivalent to other predicate devices. The following testing was performed:
- Static and dynamic axial compression, compression shear, and torsion testing per . ASTM F2077
- · · Lateral Collapse testing
- Expulsion and Subsidence Analysis .
The results demonstrate that the subject AP Expandable XLIF System presents no new worstcase for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject AP Expandable XLIF System has been shown to be substantially equivalent to legally marketed predicate devices, and as safe and effective for its intended use.
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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 2, 2014
NuVasive, Incorporated Ms. Cynthia Adams Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121
Re: K140162
Trade/Device Name: NuVasive® AP Expandable XLIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 5, 2014 Received: June 6, 2014
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 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. Cynthia Adams
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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Form Approved: OMB No. 0910-0120
Explration Date: January 31, 2017 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140162
Device Name
NuVasive® AP Expandable XLIF System
Indications for Use (Describe)
The NuVasive AP Expandable XLIF 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 AP Expandable XLIF 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 AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/rod 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 FOR A BOOK OF CHE BE THE 11 11 11:11 1. Not 2017 12:
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, Ph Division (
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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.