(266 days)
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
The Nanovis Intervertebral Body Fusion System consists of implants (cages) and related instruments intended to be used for intervertebral body fusion procedures involving the cervical (C2 - T1) and lumbar (L2 - S1) spine. The cages are available in a variety of shapes and sizes to accommodate the individual anatomic and clinical circumstances of each patient, and are available in two materials: polyetheretherketone (PEEK) and titanium alloy (Ti-6AI-4V ELI).
The provided text is a 510(k) Summary for the Nanovis Intervertebral Body Fusion System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study report detailing clinical performance and acceptance criteria for a novel device against predetermined benchmarks.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance defined in terms of clinical accuracy metrics (e.g., sensitivity, specificity for a diagnostic device).
- Details about a "test set" for performance evaluation against ground truth (e.g., sample size, data provenance).
- Information on "experts" establishing ground truth or adjudication methods.
- A "multi-reader multi-case (MRMC) comparative effectiveness study" or its effect size.
- A "standalone (algorithm only without human-in-the-loop performance)" study.
- The "type of ground truth used" in the context of device performance metrics.
- Training set sample size or how ground truth was established for a training set.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: The Nanovis system has the same intended use as the predicate devices for spinal fusion.
- Technological Characteristics: The device is made of the same materials (PEEK and titanium alloy), has similar overall shapes, and encompasses the same range of physical dimensions as the predicate devices.
- Performance Testing: While performance testing was done, it was focused on mechanical testing against engineering standards to confirm that the device's physical properties are comparable to the predicates, not on clinical performance metrics. The standards mentioned are:
- ASTM F2077 (static and dynamic axial compression, and static and dynamic torsion)
- ASTM F2267 (subsidence)
- Draft standard ASTM F04.25.02.02 (expulsion)
The document explicitly states: "Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." This is the core argument for 510(k) clearance, not the achievement of specific clinical performance acceptance criteria.
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Nanovis Intervertebral Body Fusion System
510(k) Summary
Nanovis, LLC
Nanovis Intervertebral Body Fusion System
K110442
November 2, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Nanovis, LLC5865 East State Road 14Columbia City, IN 46725 |
|---|---|
| Telephone: | +1 (877) 907-6266 |
| Fax: | +1 (260) 625-3834 |
Official Contact:
Representative/Consu
Matt Hedrick President and Chief Operating Officer Matt.hedrick@nanovisinc.com
| ultant: | Kevin A. Thomas, PhD |
|---|---|
| Floyd G. Larson | |
| PaxMed International, LLC | |
| 11234 El Camino Real, Suite 200 | |
| San Diego, CA 92130 | |
| Telephone: +1 (858) 792-1235 | |
| Fax: +1 (858) 792-1236 | |
| Email: kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Name:
Classification Regulations: Product Code:
Classification Panel: Reviewing Branch:
Nanovis Intervertebral Body Fusion System Intervertebral body fusion device Intervertebral body fusion device
21 CFR 888.3080, Class II ODP, MAX
Orthopedic and Rehabilitation Devices Panel Orthopedic Spine Devices Branch
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510(k) Summary K110442
Nanovis Intervertebral Body Fusion System
INTENDED USE
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
DEVICE DESCRIPTION
.
The Nanovis Intervertebral Body Fusion System consists of implants (cages) and related instruments intended to be used for intervertebral body fusion procedures involving the cervical (C2 - T1) and lumbar (L2 - S1) spine. The cages are available in a variety of shapes and sizes to accommodate the individual anatomic and clinical circumstances of each patient, and are available in two materials: polyetheretherketone (PEEK) and titanium alloy (Ti-6AI-4V ELI).
EQUIVALENCE TO MARKETED DEVICE
Nanovis, LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the Nanovis Intervertebral Body Fusion System is substantially equivalent in indications and design principles to the following predicate devices each of which has been determined by FDA to be substantially equivalent to preamendment devices, or that were the subject of approved PMA applications and were subsequently reclassified as Class II devices:
LDR Spine Cervical Interbody Fusion System from LDR Spine USA, K091088; Novel® Spinal Spacer System from Alphatec Spine, Inc., K081730; Choice Spine Cervical Interbody Spacer System from Choice Spine, LP, K091531; CORNERSTONE® PSR Spinal System from Medtronic Sofamor Danek, K100214; Synthes Oracle Spacer from Synthes Spine, K072791;
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L-Varlock Lumbar Cage from Kiscomedica, S.A., K080537; WAVE and LOOP Cages from Advanced Medical Technologies AG, K080401; Ardis Spacer from Abbot Spine, Inc. (now Zimmer Spine), K073202; Lumbar I/F Cage with VSP Spine System from DePuy AcroMed, P960025; and Spinal USA Intervertebral Body Fusion Device from Spinal USA, K080314, K081196, and K092193.
The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of the same materials, have similar overall shape, and encompass the same range of physical dimensions including height, width, depth, and lordosis. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 (static and dynamic axial compression, and static and dynamic torsion), ASTM F2267 (subsidence), and the draft standard ASTM F04.25.02.02 (expulsion).
Overall, the Nanovis Intervertebral Body Fusion System is similar to the predicate devices in intended use, design principles, materials and overall dimensions.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 9 2011
Nanovis, LLC % PaxMed International, LLC Kevin A. Thomas, PhD 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K110442
Trade/Device Name: Nanovis Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: October 04, 2011 Received: October 04, 2011
Dear Dr. Thomas:
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
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Page 2 -- Kevin A. Thomas, PhD
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Sincerely yours,
Erine Keith
✔ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
X 110442
Device Name:
Nanovis Intervertebral Body Fusion System
Indications for Use:
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-SI. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KII0442 510(k) Number_
§ 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.