(14 days)
No
The device description and performance studies focus on the mechanical properties and design of an intervertebral body fusion device, with no mention of AI or ML capabilities.
No
The device is an intervertebral body fusion device used to facilitate fusion, not directly treat a disease or condition.
No
Explanation: This device is an intervertebral body fusion device, meaning it is designed to treat degenerative disc disease and facilitate fusion, not diagnose it. Its use is based on pre-confirmed diagnoses through history and radiographic studies.
No
The device description explicitly states the devices are manufactured from PEEK and include tantalum markers, indicating they are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to facilitate a physical process (fusion), not to diagnose a condition by testing samples from the body.
- Device Description: The description details a physical implant made of PEEK with tantalum markers. This is consistent with a medical device for implantation, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on mechanical properties and equivalence to predicate devices, which are relevant for surgical implants, not diagnostic accuracy.
In summary, the device is a surgical implant used for spinal fusion, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The nvª, nv, and nv are intended for intervertebral body fusion 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. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
Product codes
MAX
Device Description
The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced 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 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
Not Found
Anatomical Site
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 nv4, nv7, and nv1. The following was performed to demonstrate safety per methods of the previous submission:
- Engineering analysis comparison of mechanical performance in compression/ compression shear, subsidence, and expulsion (reference ASTM F2077 and F2267).
The results of the engineering analysis indicate that the nv3, nvP and nv system is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162426, K142594, K170855, K180502
Reference Device(s)
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.
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January 13, 2020
Nvision Biomedical Technologies, Inc. % Mr. Jeffrey Brittan Vice President of Product Realization Watershed Ideas Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008
Re: K193645
Trade/Device Name: nvª, nvP, and nvb Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 27, 2019 Received: December 30, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent L. Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193645
Device Name nvª, nvª, and nv
Indications for Use (Describe)
The nv3, nv8, and nv are intended for intervertebral body fusion 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. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
| 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 shows the logo for Nvision Biomedical Technologies. The logo features a stylized "N" with a series of vertical lines to the left of the "N". The rest of the company name, "vision biomedical technologies", is written in a sans-serif font to the right of the "N". The words "biomedical technologies" are written in a smaller font size and in a lighter color than the rest of the logo.
510(k) Summary
DATE PREPARED
January 6, 2020
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan, Vice President of Product Realization Watershed Idea Foundry Telephone: (714) 287-6780 Email: jeffbrittan@watershedideas.com
PROPRIETARY NAME OF SUBJECT DEVICE
nvª, nvP, and nvt
COMMON NAME Intervertebral Fusion Device with Bone Graft, Lumbar
DEVICE CLASSIFICATION
Interverterbal Body Fusion Device (Classification Regulations: 21 CFR 888.3080, Product Codes: MAX, Class: II)
PREMARKET REVIEW
Orthopedic Panel
INDICATIONS FOR USE
The nva, 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 prior to 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, posterior, or transforaminal approach. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.
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Image /page/4/Picture/0 description: The image shows the logo for NVision biomedical technologies. The logo features the letter N with a DNA strand design on the left side. The words "biomedical technologies" are written in a smaller font size below the main logo.
DEVICE DESCRIPTION
The nv4, nvP, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 or PEEK Optima HA Enhanced 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 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 subject nv2, nv8, and nv system is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K162426 | Nvision Biomedical's nva, nvp, and nvt system | ✓ |
| K142594 | Nvision Biomedical's nva, nvp, and nvt system | |
| K170855 | Siats LLC's T-Rex Standalone ALIF | |
| K180502 | Renovis Surgical Technologies, Inc's S128 ALIF System |
The following reference devices are also cited in this submission:
- Nvision Biomedical's Vector Hammertoe Correction System (K183055) ●
- Omnia Medical, LLC's Omnia Medical VBR (K172323) .
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the nv4, nv7, and nv1. The following was performed to demonstrate safety per methods of the previous submission:
- . Engineering analysis comparison of mechanical performance in compression/ compression shear, subsidence, and expulsion (reference ASTM F2077 and F2267).
The results of the engineering analysis indicate that the nv3, nvP and nv system is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the nv2, nv2 and nv modifications are substantially equivalent to the predicate devices. The subject implants maintain the same features as the previously cleared devices but add a wider range of footprint size and lordotic angle options. The subject implants will continue to be manufactured from PEEK Optima LT1 but also add the option of PEEK Optima HA Enhanced. In addition, minor size/positioning adjustments to the nvª implant mate holes further enhance surgeon ease of use following the same surgical technique. These modifications do not change the intended use or performance of the device and do 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/0 description: The image shows the logo for Nvision Biomedical Technologies. The logo has a stylized "N" with a series of short, parallel lines to the left of the "N". The word "VISION" is next to the "N" in all caps. Below the logo is the text "biomedical technologies" in a smaller font.
CONCLUSION
Based on the engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed nv3, nv7 and nv1 options are assessed to be substantially equivalent to the predicate devices.