(30 days)
The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nv- devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
The nv& is an intervertebral body fusion device used in the cervical 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 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 an anterior approach. 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.
This document is a 510(k) premarket notification from the FDA, classifying the medical device "nv°" an "Intervertebral Body Fusion Device." The document reviews the device's indications for use, device description, and comparison to predicate devices, but it does not contain information about software or AI/ML-driven components. Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, particularly regarding AI/ML performance metrics, cannot be extracted from this document.
The document discusses the substantial equivalence of the "nv°" device to previously cleared devices based on non-clinical testing such as engineering analysis of mechanical performance (compression, shear, torsion, subsidence, expulsion). The conclusion states that the device is substantially equivalent based on design control activities, identical indications for use, and similar technological characteristics, implying that no new clinical studies were required or conducted to demonstrate safety and efficacy compared to the predicate devices.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or AI/ML specific performance metrics, as these are not relevant to the content of this 510(k) premarket notification for this specific medical device.
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March 21, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nvision Biomedical Technologies, Inc. % Mr. Jeffrey Brittan Consultant Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008
Re: K190380
Trade/Device Name: nv° Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 18, 2019 Received: February 19, 2019
Dear Mr. Brittan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -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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Indications for Use
510(k) Number (if known)
Device Name nvC
Indications for Use (Describe)
The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nv- devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for NVision biomedical technologies. The logo features the letter N with a series of horizontal lines extending from the left side, followed by the word "VISION" in a bold, sans-serif font. Below the word "VISION" is the phrase "biomedical technologies" in a smaller, italicized font.
510(k) Summary
DATE PREPARED
February 4, 2018
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4754 Shavano Oak, Suite 101 San Antonio, TX 78249, USA Telephone: Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan Watershed Ideas Foundry Telephone: (714) 287-6780 jeffbrittan@watershedideas.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
nvº
COMMON NAME
Intervertebral Fusion Device with Bone Graft, Cervical
DEVICE CLASSIFICATION
Interverterbal Body Fusion Device (Classification Regulations: 21 CFR 888.3080, Product Codes: ODP, Class: II)
PREMARKET REVIEW
Orthopedic Panel
INDICATIONS FOR USE
The nv& is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nv& devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
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Image /page/4/Picture/0 description: The image shows the logo for Nvision biomedical technologies. The logo features a stylized letter N with a DNA strand design on the left side. The text "vision" is written in a bold, sans-serif font to the right of the N. Below the main logo, the words "biomedical technologies" are written in a smaller, italicized font.
DEVICE DESCRIPTION
The nv& is an intervertebral body fusion device used in the cervical 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 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 an anterior approach. 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 subject nv device is substantially equivalent to the previously cleared nv devices by Nvision Biomedical Technologies, Inc.
| 510(k) Number | Predicate Device Name / Manufacturer | PrimaryPredicate |
|---|---|---|
| K170074 | nvc from Nvision Biomedical Technologies | ✓ |
| K142328 | nvc from Nvision Biomedical Technologies |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the nv6 System. The following was performed to demonstrate safety based on recognized consensus standards and current industry practice:
- . Engineering analysis comparison of mechanical performance in compression/ compression shear, torsion, subsidence, and expulsion (reference ASTM F2077 and F2267).
The results of the engineering analysis indicate that the nv system is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the nv system is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has the same indications for use, utilizes identical materials and processing, and incorporates equivalent design features and technical characteristics as the devices cleared in K170074. The implant utilizes the same instrumentation as that cleared in the predicate system and is offered in the same heights and lordotic angles; the added footprint size does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence. These technological characteristics have undergone engineering analysis to ensure the device is as safe and effective as the predicates.
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Image /page/5/Picture/1 description: The image shows the logo for Nvision Biomedical Technologies. The logo features a stylized letter N with a DNA strand design on the left side. The text "VISION" is written in a bold, sans-serif font to the right of the N. Below the main text, the words "biomedical technologies" are written in a smaller, italicized font.
CONCLUSION
The 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 analysis 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.
§ 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.