(85 days)
Not Found
No
The document describes a physical implant (spacer) and associated screws for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.
Yes
The device is an intervertebral body fusion system used to treat cervical degenerate disc disease by facilitating fusion, which is a therapeutic purpose.
No
Explanation: The provided text describes the ClariVy™ Cervical IBF System as an intervertebral body fusion device, which is an implant used for treatment in the spine. It is not described as a tool or system used for diagnosis.
No
The device description explicitly states that the system is comprised of implant components made of materials like PEEK and Titanium, which are physical hardware components.
Based on the provided information, 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 ClariVy™ Cervical IBF System is described as an implantable spacer made of PEEK or PEEK with Titanium coating, designed to be inserted between vertebral bodies in the spine. It is a physical device used in surgery.
- Intended Use: The intended use is for intervertebral body fusion of the spine, a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the ClariVy™ Cervical IBF System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The ClariVy™ Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
The ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the ClariVyTM Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The ClariVy™ NanoVy™ Ti Cervical IBF components are made of PEEK Optima LT1 with CP Titanium coating. The ClariVyTM Cervical IBF System may also include Titanium alloy bone screws to secure the device to the vertebral body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C3 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)
Non-Clinical Testing: The ClariVyTM Cervical IBF-HS System has undergone Non-Clinical Testing using various ASTM Standards at a third party facility. No additional testing was performed on the ClariVy™ Ti Cervical IBF components. The nonclinical tests that demonstrate that the ClariVy™ Ti Cervical IBF is as safe, as effective, and performs as well or better than a legally marketed predicate device.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
May 12, 2023
Vy Spine, LLC Mr. Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee, Florida 32308
Re: K230414
Trade/Device Name: ClariVyTM Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: April 12, 2023 Received: April 13, 2023
Dear Mr. Hendrickson:
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 Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230414
Device Name ClariVyTM Cervical IBF System
Indications for Use (Describe)
The ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Clari Vy™ Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summarv
12 April 2023
Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee. FL 32308 Telephone: 866-489-7746 Fax: 850-597-8571
Contact: Jordan Hendrickson Operations Manager
| 510(k) Number: | K212715 |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Proposed Proprietary or Trade Name: | ClariVy™ Cervical IBF System |
| Classification Name: | Intervertebral Body Fusion Device |
| Regulation Number: | 21 CFR 888.3080 |
| Product Code: | ODP, OVE |
| Regulatory Classification: | Class II |
Substantial Equivalence
The ClariVy™ Cervical IBF System is substantially equivalent to the primary predicate device the ClariVy™ Cervical IBF System (K212715), and the additional predicate, LumiVy™ Lumbar IBF System (K223412). The ClariVy™ Cervical IBF System is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.
Device Description
The ClariVy™ Cervical IBF System is comprised of implants components. The implant component, the ClariVyTM Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The ClariVy™ NanoVy™ Ti Cervical IBF components are made of PEEK Optima LT1 with CP Titanium coating. The ClariVyTM Cervical IBF System may also include Titanium alloy bone screws to secure the device to the vertebral body.
Intended Use/Indications for Use
The ClariVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. The ClariVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerate disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The ClariVy™ Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.
4
Technological Modifications
The subject ClariVyTM NanoVy™ Ti Cervical IBF System differs from the primary predicate devices in terms of CP titanium coating.
Technological Characteristics
The subject ClariVyTM Cervical IBF System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
Non-Clinical Testing
The ClariVyTM Cervical IBF-HS System has undergone Non-Clinical Testing using various ASTM Standards at a third party facility.
No additional testing was performed on the ClariVy™ Ti Cervical IBF components.
Conclusions
The nonclinical tests that demonstrate that the ClariVy™ Ti Cervical IBF is as safe, as effective, and performs as well or better than a legally marketed predicate device.