(196 days)
The UniVy™ OsteoVy™ 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™ Cervical IBF System is intended for use at one level in the cervical 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 UniVy™ OsteoVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
The UniVy" OsteoVy™ 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™ Cervical IBF spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14.
This document is a 510(k) Premarket Notification from the FDA regarding the UniVy™ OsteoVy™ Cervical IBF System, an intervertebral body fusion device. The purpose of this notification is to determine if the device is substantially equivalent to a legally marketed predicate device.
Based on the provided text, the device in question is a physical medical implant, not an AI/ML-driven device or diagnostic tool. Therefore, the information requested about acceptance criteria, study data provenance, expert ground truthing, MRMC studies, standalone performance, training sets, and how ground truth for training was established is not applicable to this document. These criteria are specifically relevant for regulatory submissions of AI/ML software as a medical device (SaMD) or clinical decision support systems.
However, I can extract information related to the device's substantial equivalence and non-clinical testing, which serves a similar purpose in demonstrating safety and effectiveness for a physical device.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
For a physical device like an intervertebral body fusion system, the "acceptance criteria" are typically related to mechanical performance, material properties, and biocompatibility, often defined by adherence to recognized ASTM standards. The document states that the subject device (UniVy™ OsteoVy™ Cervical IBF System) leverages the test results of a predicate device (Reliance Cervical IBF System) because of their substantial equivalence.
| Acceptance Criterion (Implicitly based on predicate testing) | Reported Device Performance (Implied by equivalence) |
|---|---|
| Mechanical Performance (e.g., static and dynamic compression, expulsion resistance) in accordance with various ASTM standards (e.g., ASTM F2077, ASTM F2267) | Met standards; subject device has the same general design. |
| Material Biocompatibility (Titanium 6Al-4V ELI conforming to ASTM F3001-14) | Met standards; subject device uses the same material. |
| Sterilization Effectiveness | Met standards; subject device has the same sterilization method. |
2. Sample Size for Test Set and Data Provenance:
- Not Applicable. This device is not an AI/ML system, so there isn't a "test set" in the context of diagnostic performance evaluation. The "testing" refers to non-clinical bench testing.
- The document states: "The predicate Reliance Cervical IBF System (K202266) has undergone non-clinical testing using various ASTM standards at a third party facility." The specific sample sizes for these biomechanical tests are not provided in this document but would be detailed in the original predicate device's 510(k) submission and the test reports.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This concept of "ground truth" established by experts is relevant for diagnostic or AI/ML performance evaluation, not for the mechanical testing of a physical implant.
4. Adjudication Method:
- Not Applicable. This is relevant for expert consensus in diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is specifically for evaluating the effectiveness of a diagnostic tool or AI assistance in a clinical reading environment. This device is a surgical implant.
6. Standalone Performance:
- Yes, in the sense of non-clinical bench testing. The "standalone performance" for this device refers to its mechanical and material properties tested in a lab setting, against established ASTM standards, independent of human interaction in a diagnostic context. The document implies that the UniVy™ OsteoVy™ Cervical IBF System's standalone performance is equivalent to its predicate through the "non-clinical testing" section.
7. Type of Ground Truth Used:
- Not Applicable for AI/ML "ground truth." For a physical medical device, the "ground truth" equivalent would be the objective measurements from laboratory testing against pre-defined engineering and material standards (e.g., ultimate tensile strength, fatigue life, biocompatibility markers, conformity to material specifications). These are derived from established scientific and engineering principles and standardized test methods, not expert consensus on clinical images or pathology.
8. Sample Size for the Training Set:
- Not Applicable. This device does not use a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable.
In summary, the provided document describes a 510(k) premarket notification for a physical spinal implant. The criteria for AI/ML device evaluation are not relevant here. The substantial equivalence of the UniVy™ OsteoVy™ Cervical IBF System is established by demonstrating that it has equivalent technological characteristics (material, design, function, intended use, etc.) to a legally marketed predicate device (Reliance Cervical IBF System, K202266), which has already undergone the necessary non-clinical bench testing to prove its safety and effectiveness.
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November 4, 2022
Vy Spine, LLC Mr. Jordon Henderson Member-Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee, Florida 32308
Re: K221162
Trade/Device Name: UniVyTM OsteoVy™ Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: September 30, 2022 Received: October 5, 2022
Dear Mr. Henderson:
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
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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
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Indications for Use
510(k) Number (if known) K221162
Device Name
Vy Spine™ UniVy™ OsteoVy™ Cervical IBF System
Indications for Use (Describe)
The UniVy™ OsteoVy™ 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™ Cervical IBF System is intended for use at one level in the cervical 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 UniVy™ OsteoVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
| 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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K221162
510(k) Summary
19 April 2022
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: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:
Intervertebral Body Fusion Device UniVy™ OsteoVy™ Cervical IBF System Intervertebral Body Fusion Device 21 CFR 888.3080 ODP
Substantial Equivalence:
The subject UniVy" OsteoVy" Cervical IBF System is substantially equivalent to the legally marketed primary predicate device, the Reliance Cervical IBF System (K202266) and the secondary predicate devices, Nexxt Spine Matrixx™ System (K171140) and Vy Spine ClariVy" Cervical IBF System (K212715). The subject UniVy" OsteoVy™ Cervical IBF System is 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™ 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™ Cervical IBF spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14.
Intended Use / Indications for Use:
The UniVy" OsteoVy" 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
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intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The UniVy™ OsteoVy™ Cervical IBF System is intended for use at one level in the cervical 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 UniVy" OsteoVy"" Cervical IBF System is to be used in patients who have six weeks of nonoperative treatment.
Non-Clinical Testing:
The predicate Reliance Cervical IBF System (K202266) has undergone non-clinical testing using various ASTM standards at a third party facility. The subject UniVy" OsteoVy"" Cervical IBF System has the same material, general design, sizes, indication of use and biocompatibility as the primary predicate device, and the predicate device performance test results will be leveraged in favor of the UniVy™ OsteoVy™ Cervical IBF System.
Technological Modifications:
The UniVy" OsteoVy" Cervical IBF System intends to market the primary predicate device design, with the only design change being a reduction to the diameter of the implant inserter holes. The subject UniVy OsteoVy Cervical IBF system is substantially equivalent to the predicate devices in terms of sterilization and biocompatibility.
Technological Characteristics:
The subject UniVy" OsteoVy" Cervical IBF System is 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.
§ 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.