(518 days)
The NADIA SI Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The NADIA SI Fusion System is intended to provide support and structural stability during sacroiliac fusion surgery. The NADIA sacroiliac (SI) fusion system consist of different sizes of lattice fenestrated screws that accept cannulated instruments. NADIA screws are manufactured from titanium alloy per ASTM F136 and will be provided gamma sterilized. The screws are available in multiple lengths and diameters and are provided either uncoated or coated with hydroxyapatite. Instrumentation necessary for proper implantation is also included.
This document is a 510(k) Summary for a medical device called the "NADIA SI Fusion System". It's a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical trial results with specific acceptance criteria and detailed study designs typically found in clinical publications.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics against those criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone AI performance is not present or not applicable in this type of regulatory document.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations of this document type:
1. A table of acceptance criteria and the reported device performance
This document describes non-clinical (mechanical) testing and states that clinical data was also provided to support a substantially equivalent safety and effectiveness profile compared to the predicate. However, it does not present specific acceptance criteria or quantitative performance results for either the mechanical tests or the clinical data. The mechanical tests performed are listed as:
- ASTM F543-13, Annex 2: Driving Torque
- ASTM F543-13, Annex 1: Torsional Failure
- ASTM F543-13, Annex 3: Pushout Strength
- ASTM F2077-14: Compression Shear Fatigue Test
- ASTM F1264-16: Bending Fatigue Test
The "reported device performance" is a general statement that "The subject device was shown to be substantially equivalent to its legally marketed predicates in terms of design, intended use, material composition, function, and range of sizes." and that "Clinical data was also provided to support a substantially equivalent safety and effectiveness profile compared to the predicate." No specific metrics or thresholds are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Clinical data was also provided to support a substantially equivalent safety and effectiveness profile," but provides no details on the study design, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as this summary does not detail the methodology for ground truth establishment for any clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
An MRMC study is not mentioned in this document. This device is a physical implant (sacroiliac joint fusion system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable to the device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "clinical data" mentioned, the specific type of ground truth used is not specified. Given the nature of a fusion device, clinical outcomes data (e.g., pain reduction, fusion rates, functional improvement) would be expected, but no details are provided here.
8. The sample size for the training set
This information is not provided, and the concept of a "training set" is generally not applicable in the context of mechanical device testing or traditional clinical studies for implants, unless referring to a developmental or pilot phase, which is not detailed here.
9. How the ground truth for the training set was established
This information is not provided, and the concept of a "training set" ground truth is largely inapplicable here for the reason stated above.
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August 5, 2020
Ilion Medical Inc % Tania Fuentes-Davitt, Ph.D. Quality Assurance & Regulatory Affairs, Director 825 Nicollet Mall, Suite 715 Minneapolis, Minnesota 55402
Re: K190580
Trade/Device Name: NADIA SI Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: July 28, 2020 Received: July 31, 2020
Dear Dr. Fuentes-Davitt:
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,
for Colin O'Neill, M.B.E. Acting 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) K190580
Device Name NADIA SI Fusion System
Indications for Use (Describe)
The NADIA SI Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The purpose of this submission is to gain initial marketing authorization in the United States.
K190580 - Page 1 of 2
| 510(k) Number: | K190580 |
|---|---|
| Date of Summary: | July 21, 2020 |
| Applicant: | Ilion Medical, IncMedical Arts Building825 Nicollet Mall #715Minneapolis MN, USA 55402 |
| Applicant Contact (Primary): | Tania Fuentes Davitt, PhD, QA&RAmailto:taniafd@ilionmedical.comTel: 952-200-04441 |
| Applicant Contact (Secondary): | Betty Fuentes, CEOmailto:bfuentes@ilionmedical.comTel: 612-332-2324 |
| Proprietary Name: | NADIA SI Fusion System |
| Common Name: | Sacroiliac joint fusion device |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation NumberClassification Panel:Product Code | 888.3040OrthopedicOUR |
| Predicate Device (Primary): | Tenon Medical – Catamaran (K180818) |
| Predicate Device (Additional): | Globus – SI-LOK (K112028) |
Product Description:
The NADIA SI Fusion System is intended to provide support and structural stability during sacroiliac fusion surgery.
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The NADIA sacroiliac (SI) fusion system consist of different sizes of lattice fenestrated screws that accept cannulated instruments. NADIA screws are manufactured from titanium alloy per ASTM F136 and will be provided gamma sterilized. The screws are available in multiple lengths and diameters and are provided either uncoated or coated with hydroxyapatite.
Instrumentation necessary for proper implantation is also included.
Indication for Use:
The NADIA SI Fusion System is for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Technological Characteristics
The subject device was shown to be substantially equivalent to its legallymarketed predicates in terms of design, intended use, material composition, function, and range of sizes.
Performance Testing
Non-Clinical Testing
The following mechanical tests were performed to support substantial equivalence of the NADIA SI Fusion System:
ASTM F543-13, Annex 2: Driving Torque ASTM F543-13, Annex 1: Torsional Failure ASTM F543-13, Annex 3: Pushout Strength ASTM F2077-14: Compression Shear Fatigue Test ASTM F1264-16: Bending Fatique Test
Clinical Testing
Clinical data was also provided to support a substantially equivalent safety and effectiveness profile compared to the predicate.
Conclusion
Based on the performance data, and technological characteristics, the NADIA SI Fusion System is substantially equivalent to its legally-marketed predicate.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.