(50 days)
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
- · Spondylolisthesis
- · Spondvlolysis
- · Pseudoarthrosis or failed previous fusions which are symptomatic
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.
The provided text is a 510(k) Pre-market Notification summary for a medical device (Ion 3D Facet Screw) and does not describe a clinical study with an AI component or detailed performance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering justifications and non-clinical performance testing.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available within this document.
Here's a breakdown of the information that can be extracted and a clear indication of what is not present:
1. Table of acceptance criteria and reported device performance:
The document doesn't provide specific numerical acceptance criteria or performance metrics in a table format as would be seen for a diagnostic AI device. Instead, it relies on demonstrating that the device's mechanical performance is not "worst-case" compared to predicates and that it meets standards for biocompatibility and sterilization.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Not a new worst-case compared to predicate. | Finite element analysis and engineering justifications provided to demonstrate this. |
| Biocompatibility | Meets ISO 10993 standards. | Biocompatibility Assessment per ISO 10993 was performed. |
| Sterilization | Validated sterilization process. | Sterilization Validation was performed. |
| Cleaning | Validated cleaning process. | Cleaning Validation was performed. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical testing (mechanical, biocompatibility, sterilization, cleaning) rather than a clinical performance study with test data. The "test set" here refers to the physical devices and materials tested.
- Data Provenance: Not applicable. The testing is primarily laboratory-based and simulated.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. Ground truth as typically understood for AI or diagnostic devices (e.g., expert consensus on pathology images) is not relevant to this type of mechanical and material testing. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO 10993).
4. Adjudication method for the test set:
- Not applicable. There is no mention of adjudication, as this type of testing does not involve subjective expert review for establishing ground truth from clinical data.
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. An MRMC study was not conducted. This device is a surgical implant (facet screw) and associated instruments, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical implant and surgical tools; there is no standalone algorithm to evaluate.
7. The type of ground truth used:
- For mechanical performance: Engineering principles and simulation models (Finite Element Analysis) as surrogate for clinical performance under defined loads.
- For biocompatibility: International standard ISO 10993.
- For sterilization and cleaning: Industry-accepted validation protocols and standards.
8. The sample size for the training set:
- Not applicable. This document refers to a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved for this type of device submission.
{0}------------------------------------------------
December 4, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure. The FDA name is written in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
SurGenTec, LLC Richard Sharp Director of Engineering 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K243265
Trade/Device Name: Ion 3D Regulatory Class: Unclassified Product Code: MRW, FMF, HTR Dated: September 27, 2024 Received: October 15, 2024
Dear Richard Sharp:
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" (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
{1}------------------------------------------------
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS 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 (OS) 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 Rule"). 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-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 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).
{2}------------------------------------------------
Sincerely,
Image /page/2/Picture/3 description: The image contains the text "Colin O'neill-S" on the left side of the image. On the right side of the image is the letters "FDA" in a large, light blue font. The letters "FDA" are partially transparent, allowing the background to show through.
Colin O'Neill, M.B.E. 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
{3}------------------------------------------------
Indications for Use
| Submission Number (if known) | K243265 |
|---|---|
| Device Name | Ion 3D |
Indications for Use (Describe)
The lon 3D Facet Screw may be used in conjunction with the lon 3D GraftRasp to perform posterior spinal fusion. The lon 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The lon 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
- · Spondylolisthesis
- · Spondvlolysis
- · Pseudoarthrosis or failed previous fusions which are symptomatic
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The lon 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
{4}------------------------------------------------
510(k) Summary
| Submitter: | SurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Phone: 561-990-7882Email: richard@surgentec.com |
|---|---|
| Official Correspondent: | Mr. Richard SharpDirector of EngineeringSurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Email: richard@surgentec.com |
| Date Prepared: | October 15, 2024 |
| Trade Name: | Ion 3D |
| Common Name: | Facet Screw Spinal Device, Piston Syringe and Bone Rasp |
| Classification: | Unclassified21 CFR 880.5860 |
| Product Code: | MRW, FMF, HTR |
| Primary Predicate: | Ion 3D Facet Screw (K241416) |
| Additional Predicate: | Ion Facet Screw System (K211855) |
Device Description:
The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.
Indications for Use:
The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
- Spondylolisthesis
- Spondylolysis
- Pseudoarthrosis or failed previous fusions which are symptomatic .
{5}------------------------------------------------
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).
Substantial Equivalence:
The subject Ion 3D Facet Screw with graft windows and cannulation is substantially equivalent to the previously cleared versions in K211855 and K241416 with respect to intended use, materials, design, and function.
Performance Testing:
The following evaluations have been performed on the subject Ion 3D Facet Screws and instruments.
- A finite element analysis and engineering justifications were provided justify that the subject Ion 3D Facet Screws do not represent a new worst case for mechanical performance.
- Biocompatibility Assessment per ISO 10993 ●
- . Sterilization Validation
- . Cleaning Validation
Conclusion:
The subject Ion 3D Facet Screw is substantially equivalent to the cited predicate devices.
N/A