(147 days)
Not Found
No
The summary describes a physical implant (spacer) for spinal fusion and its material properties. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
Yes
The device is specifically indicated for intervertebral body fusion of the spine and the treatment of cervical degenerative disease, which falls under the definition of a therapeutic purpose for addressing a medical condition.
No
Explanation: The device is an intervertebral body fusion system (a spacer) designed for surgical implantation to facilitate fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the system is comprised of implant components made of additively manufactured Titanium, which are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral body fusion of the spine, which is a surgical procedure involving the implantation of a device. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a "spacer which inserts between vertebral bodies." This is a physical implant used to support and facilitate bone fusion.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies described are mechanical testing and bacterial endotoxin testing, which are relevant to the safety and function of an implantable device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The UniVy™ OsteoVy™-Ti Cervical IBF System does not fit this description.
N/A
Intended Use / Indications for Use
The UniVy™ OsteoVy™-Ti Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 UniVy™ OsteoVy™-Ti Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Ti Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
Product codes
ODP
Device Description
The UniVy™ OsteoVy™-Ti Cervical IBF System is comprised of implant components. The implant component is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject UniVy™ OsteoVy™-Ti Cervical IBF System spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14. The UniVy™ Osteo Vy™-Ti NanoVy™-HA Cervical IBF components’ surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
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
Prescription Use
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:
Mechanical testing performed on the predicates applies to the modified devices because there is no difference in size, dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite applied to the surface. Nonclinical testing performed on the UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF System supports substantial equivalence to other predicate devices. The following testing was performed:
• Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
• Device-specific adhesion testing of HA nanocoating surface integrity
The results demonstrate that the subject UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF System is substantially equivalent to other predicate devices for nonclinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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April 18, 2023
Vy Spine, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee. Florida 32308
Re: K223513
Trade/Device Name: UniVy™ OsteoVy™-Ti Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 20, 2023 Received: March 21, 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
1
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 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 (QS) 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 medical devices and radiation-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 L. 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
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Indications for Use
510(k) Number (if known) K223513
Device Name UniVyTM OsteoVyTM-Ti Cervical IBF System
Indications for Use (Describe)
The UniVy™ OsteoVy™-Ti Cervical IBF System is indicated for intervertebral body fusion of the spine in sketally mature patients. The system devices 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 UniVy™ OsteoVy™-Ti Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Ti Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
11 April 2023
Vy Spine, LLC 2236 Capital Circle NE Suite 103-1 Tallahassee, FL 32308 Telephone: (866) 489-7746 Fax: (850) 597-8571
Jordan Hendrickson Contact: Operations Manager
510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:
Intervertebral Body Fusion Device UniVyTM OsteoVyTM-Ti Cervical IBF System Intervertebral Body Fusion Device 21 CFR 888.3080 ODP
Substantial Equivalence:
The subject UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF components are substantially equivalent to the legally marketed primary predicate device UniVy™ OsteoVy™-Ti Cervical IBF System (K221162) and the secondary predicate device Alphatec IdentiTi NanoTec (K220782). The subject UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF components are equivalent to its commercially available predicate in terms of intended use, indications for use, design, function, principle of operation, materials, levels and methods of attachment, size range, strength, methods of manufacturing and sterilization, and use with supplemental fixation.
Device Description:
The UniVy™ OsteoVy™-Ti Cervical IBF System is comprised of implant components. The implant component is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject UniVy™ OsteoVy™-Ti Cervical IBF System spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14. The UniVy™ Osteo Vy™-Ti NanoVy™-HA Cervical IBF components' surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.
Intended Use / Indications for Use:
The UniVy™ OsteoVy™-Ti Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 UniVy™ OsteoVy™-Ti Cervical IBF System is intended for use at one level in the cervical
4
spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVyTM OsteoVy™-Ti Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
Non-Clinical Testing:
Mechanical testing performed on the predicates applies to the modified devices because there is no difference in size, dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite applied to the surface. Nonclinical testing performed on the UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF System
supports substantial equivalence to other predicate devices. The following testing was performed: · Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
· Device-specific adhesion testing of HA nanocoating surface integrity
The results demonstrate that the subject UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF System is substantially equivalent to other predicate devices for nonclinical testing.
Technological Modifications:
The subject UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF components incorporate a nanoscale hydroxyapatite surface treatment, identical to that provided on devices cleared in IdentiTi NanoTec. The UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF System implants contain a itanium alloy structure that is treated with nano-scale hydroxyapatite surface treatment, this material and nano-scale coating is identical to screws cleared in predicate Alphatec IdentiTi NanoTec (K220782). The indications for use are substantially equivalent to predicate devices. The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
Conclusion:
The subject UniVy™ OsteoVy™-Ti NanoVy™-HA Cervical IBF components are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device has equivalent technological characteristics to its predicate devices in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.