(60 days)
Not Found
No
The summary focuses on the material properties and mechanical performance of the device, with no mention of AI or ML.
Yes
This device is intended to treat cervical disc degeneration and spinal instability, alleviate symptoms like radiculopathy and myelopathy, and promote interbody fusion, which are all therapeutic actions.
No.
This device is an implantable fusion system used for anterior cervical interbody fusion, not a diagnostic device. It is used in conjunction with imaging studies (radiographs, CT, MRI) to confirm the patient's condition, but the device itself does not perform diagnosis.
No
The device description explicitly states that the system consists of "implants and instruments for implantation" and describes the physical characteristics of the implant, including its material (PEEK), surface features (titanium scaffold, nanotubes), and dimensions. This clearly indicates a physical medical device, not a software-only one.
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 anterior cervical interbody fusion. This is a therapeutic device used in vivo (within the body) to treat a medical condition (cervical disc degeneration and/or instability).
- Device Description: The device description details a physical implant made of PEEK with a titanium scaffold and nanotechnology features. This is a physical device intended for implantation, not a reagent, instrument, or system used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is structural support and promoting fusion.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / Indications for Use
Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nanoroughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Anatomic PEEK™ Cervical Fusion System with Nanotechnology consists of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 µm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Anatomic PEEK™ devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Anatomic PEEK™ devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographs, CT, MRI
Anatomical Site
Cervical spine, C2 to T1
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)
Mechanical testing of the worst case Anatomic PEEK™ implants included static and dynamic axial compression and static and dynamic torsion according to ASTM F2077. In addition, subsidence tests according to ASTM F2267 and expulsion tests were performed. The mechanical test results demonstrate that the Anatomic PEEK™ performance is substantially equivalent to the predicate devices. Additionally, MR Compatibility testing per ASTM F2503 was performed. The results demonstrate that the Anatomic PEEK™ implants can be safely scanned in an MR system.
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.
Nano FortiCore® (Nanovis, LLC – K191822), Cascadia Interbody System (K2M, Inc. – K160125), MC+ (LDR Holding, K091088), Anatomic PEEK™ Cervical Fusion System (Medtronic Sofamor Danek USA, Inc. – K192502)
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.
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June 2, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nanovis LLC % Karen Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K230936
Trade/Device Name: Anatomic PEEK™ Cervical Fusion System with Nanotechnology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 31, 2023 Received: April 3, 2023
Dear Karen Warden:
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,
Katherine D. Kavlock -S
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230936
Device Name
Anatomic PEEKIM Cervical Fusion System with Nanotechnology
Indications for Use (Describe)
Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nanoroughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open 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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510(k) Summary
| Date: | 31 May 2023 |
|---|---|
| Sponsor: | Nanovis Spine, LLC |
| 5865 East State Rd. 14 | |
| Columbia City, Indiana 46725 USA | |
| (877) 907-6266 | |
| (260) 625-3834 | |
| Sponsor Contact: | Brian More, CEO |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | Anatomic PEEK™ Cervical Fusion System with Nanotechnology |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Classification Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Device Description: | The Anatomic PEEK™ Cervical Fusion System with Nanotechnology |
| consists of implants and instruments for implantation. The upper and lower | |
| surfaces of the implant incorporate a three-dimensional titanium scaffold | |
| with interconnected pores averaging 523 µm, and pore interconnections | |
| averaging 229 µm in diameter. | |
| This product demonstrates the requirements for nanotechnology. The | |
| surface has been deliberately manipulated to produce nanoscale | |
| dimensions which exhibit specific properties. The scaffold of the Anatomic | |
| PEEK™ devices is electrochemically treated to possess a controlled | |
| nanotopography composed of nanotube arrays having a pore size diameter | |
| between 30-90 nanometers. Calcium and phosphate are incorporated into | |
| the nanotube surface. The scaffold with nanotubes assists in securing the | |
| implant in the intervertebral space and provides radiographic confirmation of | |
| the implant location. | |
| The Anatomic PEEK™ devices are available in a variety of sizes to | |
| accommodate the individual anatomic and clinical circumstances of each | |
| patient. | |
| Indications for Use: | Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices |
| including those with macro-, micro-, and nano-roughened surface textured | |
| features are indicated for use for anterior cervical interbody fusion in | |
| skeletally mature patients with cervical disc degeneration and/or cervical | |
| spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), | |
| that results in radiculopathy, myelopathy, and/or pain at multiple contiguous | |
| levels from C2 to T1. These patients should have had at least six weeks of | |
| non-operative treatment. The Anatomic PEEK™ device is to be used with | |
| supplemental fixation; the hyperlordotic implants (≥ 10°) are required to be | |
| used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion | |
| System with Nanotechnology is also required to be used with autogenous | |
| bone and/or allograft bone graft comprised of cancellous and/or | |
| corticocancellous bone graft, and/or demineralized allograft bone with bone | |
| marrow aspirate, and is to be implanted via an open anterior approach. | |
| Materials: | The Anatomic PEEK™ implants are manufactured from |
| polyetheretherketone (PEEK-OPTIMA® LT1) per ASTM F2026. The integral | |
| scaffold (OsteoSync) is manufactured from CP titanium (Grade 2) as | |
| described by ASTM F67. Instruments are manufactured from medical grade | |
| stainless steel per ASTM F899 and include silicone handles. | |
| Primary Predicate: | Nano FortiCore® (Nanovis, LLC – K191822) |
| Additional Predicate: | Cascadia Interbody System (K2M, Inc. – K160125), MC+ (LDR Holding, |
| K091088), Anatomic PEEK™ Cervical Fusion System (Medtronic Sofamor | |
| Danek USA, Inc. – K192502) | |
| Performance Data: | Mechanical testing of the worst case Anatomic PEEK™ implants included |
| static and dynamic axial compression and static and dynamic torsion | |
| according to ASTM F2077. In addition, subsidence tests according to ASTM | |
| F2267 and expulsion tests were performed. | |
| The mechanical test results demonstrate that the Anatomic PEEK™ | |
| performance is substantially equivalent to the predicate devices. | |
| Additionally, MR Compatibility testing per ASTM F2503 was performed. The | |
| results demonstrate that the Anatomic PEEK™ implants can be safely | |
| scanned in an MR system. | |
| Technological | |
| Characteristics: | The Anatomic PEEK™ Cervical Fusion System with Nanotechnology |
| possesses the same technological characteristics as one or more of the | |
| predicate devices. These include: | |
| basic design (structural column),material (reinforced polymer) andsizes (comparable to those offered by the predicates)Therefore the fundamental scientific technology of the Anatomic PEEK™ | |
| Cervical Fusion System with Nanotechnology is the same as previously | |
| cleared devices. | |
| Conclusion: | The Anatomic PEEK™ Cervical Fusion System with Nanotechnology |
| possesses the same intended use and technological characteristics as the | |
| predicate devices. Therefore the Anatomic PEEK™ Cervical Fusion System | |
| with Nanotechnology is substantially equivalent for its intended use. |
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