(30 days)
The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.
The provided document is a 510(k) summary for the Vy Spine™ VyLam™ Laminoplasty System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and a comparison of technological characteristics. It does not describe a study involving human subjects, AI/algorithm performance, or the establishment of ground truth by expert consensus for diagnostic purposes.
Therefore, most of the requested information about acceptance criteria, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and ground truth types cannot be found in this document.
However, I can extract information related to the performance data and the "acceptance criteria" (in this context, demonstrating equivalent mechanical strength).
Here's what can be extracted based on the provided text:
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA) for the additional implant plates.
1. A table of acceptance criteria and the reported device performance:
The document states: "FEA analyses for the additional plates' four-point bending (based on ASTM F2193) were performed to compare the strength of the additional plates to the standard plate in the predicate Vy Spine™ VyLam™ Laminoplasty System (K232471). The performance data verifies that the subject is substantially equivalent to the predicate Vy Spine™ Laminoplasty System (K232471)."
While a specific table is not provided, the "acceptance criteria" implicitly relates to the additional plates demonstrating equivalent or superior mechanical strength to the standard plate of the predicate device, as verified by FEA. The "reported device performance" is the conclusion that the performance data verifies substantial equivalence in strength.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical strength of new plates is comparable to predicate plates as per ASTM F2193 in four-point bending. | Performance data (FEA analyses) verifies subject is substantially equivalent to predicate in terms of strength. |
2. Sample size used for the test set and the data provenance:
- Sample Size: This was a computational study (FEA) rather than a study with a "test set" in the sense of patient data or a large number of physical parts tested. The "sample" would be the computational models of the specific new plates: VyLam™ Double Hook Plate, VyLam™ Inline Double Hook Plate, and VyLam™ Support Plate. The number of models is not explicitly stated beyond "additional plates."
- Data Provenance: Not applicable as this is a computational analysis, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical engineering analysis (FEA), not a medical image interpretation study. "Ground truth" in this context would be derived from accepted engineering principles and standards (ASTM F2193).
4. Adjudication method for the test set:
- Not applicable. This is a computational analysis.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used:
- For the mechanical performance, the "ground truth" is based on established engineering standards (ASTM F2193) and the mechanical properties of the predicate device, against which the new designs were compared via FEA.
8. The sample size for the training set:
- Not applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
In summary, the document describes a mechanical performance study using Finite Element Analysis (FEA) to demonstrate substantial equivalence of new implant plates to an existing predicate device based on their mechanical strength. It does not involve patient data, expert interpretations, or AI algorithm performance.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 16, 2024
Vy Spine, LLC Jordan Hendrickson Quality Operations Manager 545 W 500 South, Suite 100 Bountiful. Utah 84011
Re: K242784
Trade/Device Name: Vy Spine™ VyLam™ Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: September 16, 2024 Received: September 16, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242784
Device Name
Vy Spine™ VyLam™ Laminoplasty System
Indications for Use (Describe)
The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
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
Vy Spine, LLC 545 W 500 South Suite 100 Bountiful, UT 84010 Telephone: (866) 489-7746 Fax: (850) 597-8571
16 October 2024
Contact: Jordan Hendrickson, Operations Manager
| Common or Usual Name: | Interlaminal Fixation Appliance |
|---|---|
| Proposed Proprietary or Trade Name: | Vy Spine™ VyLam™ Laminoplasty System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis |
| Regulation Number: | 21 CFR 888.3050 |
| Product Code: | NQW |
| Primary Predicate: | Vy Spine™ VyLam™ Laminoplasty System(K232471) |
| Additional Predicate: | CENTERPIECE™ Plate Fixation System(K050082) |
Substantial Equivalence:
The subject Vy Spine™ VyLam™ Laminoplasty System is substantially equivalent to the primary predicate Vy Spine™ VyLam™ Laminoplasty System (K232471) and the additional predicate CENTERPIECE™ Plate Fixation System (K050082) in terms of intended use, indications for use, function, principle of operation, materials, size range, and strength.
Purpose:
The purpose of this Special 510(k) submission is for the addition of implant plates to the Vy Spine™ VyLam™ Laminoplasty System. These additional plates include: VyLam™ Double Hook Plate, VyLam™ Inline Double Hook Plate, and VyLam™ Support Plate.
Device Description:
The Vy Spine™ VyLam™ Laminoplasty System is comprised of implant and instrument components. The implant components, plates and screws, will hold the decompression after a laminoplasty procedure. The implant components are manufactured from Ti-6Al-4V ELI per ASTM F136 and are available in multiple anatomical sizes to accommodate various vertebral
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bodies. The instruments are manufactured from stainless steel per ASTM F899, high grade plastic, and silicone rubber.
Indications for Use:
The Vy Spine™ VyLam™ Laminoplasty System is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3 to T3) in skeletally mature patients. The system devices are designed for use with allogenic bone graft in order to prevent the allograft from expulsion or impinging on the spinal cord. One device may be used per vertebra.
Technological Modifications:
The subject Vy Spine™ VyLam™ Laminoplasty System's technological characteristics are the same as or similar to the predicate devices commercially distributed.
Performance Data and Substantial Equivalence:
FEA analyses for the additional plates' four-point bending (based on ASTM F2193) were performed to compare the strength of the additional plates to the standard plate in the predicate Vy Spine™ VyLam™ Laminoplasty System (K232471). The performance data verifies that the subject is substantially equivalent to the predicate Vy Spine™ Laminoplasty System (K232471).
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.