(254 days)
The Ion Facet Screw System 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
· 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 system is intended for use with bone graft material.
The Ion Facet Screw System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments that assist the user in implanting a titanium facet screw into the facets to fixate the facet joint. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.
The provided text is a 510(k) Premarket Notification from the FDA regarding the Ion Facet Screw System. This document clears the device for market based on substantial equivalence to existing predicate devices.
**Crucially, this document does not contain information about acceptance criteria for device performance studies or the studies themselves for a new device. Instead, it demonstrates substantial equivalence to previously cleared devices through non-clinical performance data and a comparison of technological characteristics. **
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies in the way you might expect for a novel device undergoing clinical trials or rigorous standalone algorithm evaluation.
Here's what I can extract based on the provided text, and where I must state that the information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) clearance. The document asserts substantial equivalence based on a comparison to predicate devices, rather than establishing new acceptance criteria for a novel device's clinical performance. The "performance data" listed are for non-clinical aspects.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2018 | Met: "Biocompatibility per ISO 10993-1:2018" |
| Sterilization Validation: Conformance to ISO 17665-1:2006/(R) 2013 | Met: "Sterilization validation per ISO 17665-1:2006/(R) 2013" |
| Mechanical Static and Dynamic Testing: Conformance to ASTM F543, ASTM F1264, and ASTM F2193 | Met: "Mechanical static and dynamic testing per ASTM F543, ASTM F1264, and ASTM F2193." |
| V/V Mechanical and Safety Testing: (Specific criteria not detailed in document) | Met: "V/V Mechanical and Safety Testing" |
Note: These are non-clinical performance data points demonstrating the device's fundamental characteristics and safety, not clinical efficacy or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
Not provided. This document does not describe a clinical test set in the traditional sense for evaluating device performance against a ground truth. The "test set" here refers to the materials and conditions used in the non-clinical tests listed above.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not provided. This information would be relevant for studies involving expert consensus on medical image interpretation or clinical outcomes, which is not the type of study described in this 510(k) clearance document.
4. Adjudication Method
Not provided. Adjudication methods are typically used when multiple experts review cases to establish a ground truth, which is not applicable to the non-clinical tests mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed/Not applicable. The document focuses on demonstrating substantial equivalence to predicate devices, not on showing human readers improve with AI assistance. The Ion Facet Screw System is a physical medical device, not an AI or diagnostic software.
6. Standalone Performance Study (Algorithm Only)
Not performed/Not applicable. As a physical medical device (facet screws), there is no 'algorithm-only' standalone performance study.
7. Type of Ground Truth Used
For the non-clinical performance data:
- Biocompatibility: Reference standards from ISO 10993-1.
- Sterilization: Reference standards from ISO 17665-1.
- Mechanical Testing: Reference standards from ASTM F543, ASTM F1264, and ASTM F2193.
- V/V Mechanical and Safety Testing: Implied internal company safety and mechanical specifications.
There is no clinical ground truth established or used in this document for the device's efficacy, as this is a 510(k) clearance for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set of data.
9. How Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
Summary Explanation:
The provided document, an FDA 510(k) clearance letter, states that the Ion Facet Screw System is "substantially equivalent" to legally marketed predicate devices. This means that new clinical studies demonstrating the device's performance against specific acceptance criteria (as you might expect for a novel drug or a truly new device with an unknown risk profile) were not required or performed for this clearance. Instead, the manufacturer provided non-clinical performance data (biocompatibility, sterilization, mechanical testing) and compared the technological characteristics and indications for use to existing, cleared devices. The FDA then determined that these comparisons sufficiently demonstrate that the new device is as safe and effective as the predicate devices.
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February 25, 2022
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SurGenTec, LLC Andrew Shoup Chief Operating Officer 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K211855
Trade/Device Name: Ion Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: January 5, 2022 Received: January 10, 2022
Dear Andrew Shoup:
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 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-reporting
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combination-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 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,
for
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
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Indications for Use
510(k) Number (if known) K211855
Device Name Ion Facet Screw System
Indications for Use (Describe)
The Ion Facet Screw System 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
· 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 system is intended for use with bone graft material.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SurGenTec, LLC
510(k) Summary 5.0
| 5.1 Submitter InformationSubmitter: | Surgentec, LLC911 Clint Moore RdBoca Raton, FL 33487Telephone: 561-990-7882 |
|---|---|
| Contact: | Andrew ShoupChief Operating OfficerTelephone: 561-990-7882Email: ashoup@surgentec.com |
| Date Prepared: | June 15th, 2021 |
| 5.2 Name of DeviceDevice Proprietary Name: | Ion Facet Screw System |
| Device Common Name: | Screw, Facet Screw Spinal Device |
| Classification Regulation: | Unclassified, Pre-Amendment |
| Panel: | Orthopedic |
| Product Code: | MRW |
| 5.3 Legally Marketed Predicate DevicePrimary Predicate: | ALLYTM Facet ScrewsPROVIDENCE MEDICAL TECHNOLOGY, INC.510(k) number: K163374 |
| Additional Predicate: | SS Fenestrated Facet Screw SystemSPECTRUM SPINE, LLC510(k) number: K132126 |
5.4 Device Description
The Ion Facet Screw System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments that assist the user in implanting a titanium facet screw into the facets to fixate the facet joint. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.
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5.5 Indication for Use
The Ion Facet Screw System 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 ●
- 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 system is intended for use with bone graft material.
5.6 Technological Characteristics and Substantial Equivalence
The subject Ion Facet Screw System is substantially equivalent to the predicate SS Fenestrated Facet Screw System previously cleared in 510k K132126 and the ALL Y™ Facet Screws previously cleared in 510k K163374. Both devices are contained in a device tray containing the required components to action the device, not provided sterile but can be sterilized via steam sterilization prior to use and are intended for posterior surgical treatment of the facet. All characteristics and indications between the Ion Facet Screw System and the predicates are similar, therefore the subject device is substantially equivalent to the predicate devices.
5.7 Performance Data
The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicates.
- Biocompatibility per ISO 10993-1:2018 ●
- Sterilization validation per ISO 17665-1:2006/(R) 2013
- Mechanical static and dynamic testing per ASTM F543, ASTM F1264, and ● ASTM F2193.
- . V/V Mechanical and Safety Testing
5.8 Conclusion
The design characteristics of the Ion Facet Screw System do not raise different questions of safety and effectiveness. Non-clinical study data supports that the device is substantially equivalent to predicate devices.
N/A