(30 days)
Not Found
No
The document describes a physical intervertebral body fusion device and its materials, intended use, and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The changes described are related to the design of tantalum markers.
Yes
The device is described as an intervertebral body fusion device intended for use in patients with degenerative disc disease to facilitate fusion, which is a therapeutic intervention.
No
Explanation: The device is an intervertebral body fusion device and is intended for treatment (fusion), not for diagnosing medical conditions.
No
The device description explicitly states the device is manufactured from PEEK Optima® LT1 and includes tantalum markers, indicating it is a physical implantable device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an "intervertebral body fusion device used in the lumbar spine following discectomy." It is a physical implant designed to facilitate fusion between vertebrae.
- Intended Use: The intended use is for "intervertebral body fusion in the lumbar spine" in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
The device is a medical implant used in a surgical procedure, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The nvª, nvº, and nv‡ are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The nv3, nvP, and nv1 are an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The purpose of this submission is to make changes to the number and design of the tantalum markers.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies for confirming disc degeneration. Tantalum markers for radiographic visualization.
Anatomical Site
Lumbar spine, lumbosacral spine (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)
No FDA performance standards have been established for the nvª, nvº, and nv*. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards:
- Static and dynamic compression (per ASTM F2077) .
- . Subsidence (per ASTM F2267)
- . Expulsion
The results of these tests indication that the nvª, nvº, and nv໋ is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2016
Nvision Biomedical Technologies, LLC % Allison Komivama. Ph.D. AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego, California 92104
Re: K162426
Trade/Device Name: nvª, nvª, and nv Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 26, 2016 Received: August 30, 2016
Dear Dr. Komiyama:
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/Resourcesfor You/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,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name nva, nvP, and nv
Indications for Use (Describe)
The ny', nv", and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, or transforaminal approach.
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)
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Image /page/3/Picture/1 description: The image shows the logo for N vision Biomedical Technologies. The logo is in gold and black. The image also contains the text "K162426 Page 1 of 2".
510(k) Summary K162426
DATE PREPARED September 28, 2016
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, LLC 1350 N Loop 1604 E, Suite 103, San Antonio, TX 78232, USA Telephone: Fax: (866) 764-1139 Official Contact: Diana L. Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
nvª, nvº, and nv‡
COMMON NAME
Intervertebral Fusion Device with Bone Graft, Lumbar
DEVICE CLASSIFICATION
Intervertebral body fusion device (21 CFR 888.3080, Product Code MAX, Class II)
PREMARKET REVIEW
ODE/DOD/ASDB Orthopedic Panel
INDICATIONS FOR USE
The nv3, nv0, and nv1 are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.
4
Image /page/4/Picture/1 description: The image shows the logo for N-Vision Biomedical Technologies. The logo is in black and gold, with the words "N-Vision" in large letters. Below the logo, the words "Biomedical Technologies" are written in smaller letters. Above the logo, the text "K162426 Page 2 of 2" is written.
DEVICE DESCRIPTION
The nv3, nvP, and nv1 are an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The purpose of this submission is to make changes to the number and design of the tantalum markers.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
PREDICATE DEVICE IDENTIFICATION
The nv³, nvº, and nv• is substantially equivalent to the nv³, nvº, and nv• device by Nvision Biomedical Technologies, LLC, cleared in K142594 is the primary predicate.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the nvª, nvº, and nv*. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards:
- Static and dynamic compression (per ASTM F2077) .
- . Subsidence (per ASTM F2267)
- . Expulsion
The results of these tests indication that the nvª, nvº, and nv໋ is substantially equivalent to the predicate devices.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Nvision believes that the nv3, nv8, and nv is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has identical dimensions, the same indications for use, and uses the same materials as the devices cleared in K142594. The subject device has a similar design and similar technological characteristics to the devices cleared in K142594. The device uses the same instrumentation as those cleared in K142594.
CONCLUSION
The nvª, and nv• is considered substantially equivalent to the predicate devices based on the design control activities provided in the submission. Based on the summary of the testing that was performed, the identical indications for use, and similar technological characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices.