(155 days)
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, 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. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.
The Vy Spine™ LumiVy™ Lumbar IBF System is comprised of implants components. The implant component, the Vy Spine™ LumiVy™ Lumbar IBF System device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Vy Spine™ LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body.
The provided text is a 510(k) summary for the Vy Spine™ LumiVy™ Lumbar IBF System. It details the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed. However, it does not contain information about studies involving acceptance criteria and device performance in the context of AI or specific performance metrics typically associated with medical device studies involving such criteria (e.g., sensitivity, specificity, accuracy).
The "Non-Clinical Testing" section explicitly states that the RELIANCE Lumbar IBF System (the predicate device) underwent "various ASTM Standard tests at a third party facility," and that the subject device "has similar design, sizes, indication of use & biocompatibility as the predicate devices." This implies that the current device's equivalence is established based on its similarity to a legally marketed predicate device that has already met certain performance standards through non-clinical testing (e.g., mechanical, material, biocompatibility tests), rather than a new standalone clinical study with specific acceptance criteria and performance metrics.
Therefore, most of the requested information regarding acceptance criteria for device performance, sample sizes, expert involvement, ground truth, MRMC studies, or standalone algorithm performance, and training set details, is not present in the provided document, as these typically relate to the evaluation of diagnostic or AI-powered devices, not primarily mechanical implants like intervertebral body fusion systems.
The document primarily focuses on establishing substantial equivalence based on design, materials, and intended use to an existing predicate device, backed by non-clinical (mechanical/material) testing.
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February 16, 2022
Vy Spine™, LLC Jordan Hendrickson Operations Manager 2236 Capital Circle NE, Suite 103-1 Tallahassee, Florida 32308
Re: K212930
Trade/Device Name: LumiVy" Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 17, 2021 Received: January 18, 2022
Dear Jordan 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
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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, 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) K212930
Device Name Vy Spine™ LumiVyTM Lumbar IBF System
Indications for Use (Describe)
The Vy Spine™ LumiVyTM Lumbar IBF System, when used as an Intervertebral Body Fusion device, 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. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesss. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.
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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K212930 Page 1 of 2
510(k) Summary
16 December 2021
Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 Telephone: 866-489-7746 850-597-8571 Fax:
Jordan Hendrickson Contact: Operations Manager
Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code: MAX
Intervertebral Body Fusion Device Vy Spine™ LumiVy™ Lumbar IBF System Class II, Intervertebral Body Fusion Device 21 CFR 888.3080
Substantial Equivalence
The Vy Spine™ LumiVyTM Lumbar IBF System is substantially equivalent to the primary predicate device Reliance Lumbar IBF (K183049). The Vy Spine™ LumiVy™ Lumbar 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 Vy Spine™ LumiVy™ Lumbar IBF System is comprised of implants components. The implant component, the Vy Spine™ LumiVy™ Lumbar IBF System device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Vy Spine™ LumiVy™ Lumbar IBF System may also include bone screws manufactured from Titanium alloy to secure the device to the vertebral body.
Intended Use/Indications for Use
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device, 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. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Vy Spine™ LumiVy™ Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Additional supplemental fixation is not necessary for the LumiVy™ -AS implants if the integrated screws are implanted.
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Non-Clinical Testing
The RELIANCE Lumbar IBF System (K183049) has undergone Non-Clinical Testing using various ASTM Standard tests at a third party facility. The subject Vy Spine™ LumiVyTM Lumbar IBF System has similar design, sizes, indication of use & biocompatibility as the predicate devices.
Technological Modifications
The subject Vy Spine™ LumiVy™ Lumbar IBF System differs from the primary predicate devices in terms of additional sizes.
Technological Characteristics
The subject Vy Spine™ Lumbar 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.
§ 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.