(132 days)
The iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or post-operative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication.
The iO-Flex Catheter is designed for use with the iO-Flex Wire.
The iO-Flex Catheter is comprised of two primary components: (1) Y-Adapter with a rotating hemostasis valve (RHV) and (2) a flexible catheter body. The Y-Adapter consists of two ports: (1) a central guidewire port with rotating hemostasis valve and (2) a side port for connection of a standard syringe for the irrigation, injection and / or aspiration of fluids at the surgical site. The central guidewire port with RHV allows for insertion of the iO-Flex Catheter over the Baxano iO-Flex Wire. The flexible catheter shaft contains external markers for depth adjustment by the clinician.
The Baxano iO-Flex Catheter underwent several non-clinical performance studies to demonstrate its functional performance and ensure it met product specifications.
1. Acceptance Criteria and Reported Device Performance:
| Assessment | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional | Met product specifications | Satisfied all dimensional requirements |
| Flexibility / Kink Resistance | Met product specifications | Satisfied all functional performance requirements |
| Leak | Met product specifications | Satisfied all functional performance requirements |
| Guidewire Compatibility | Met product specifications | Satisfied all functional performance requirements |
| Ink Adhesion | Met product specifications | Satisfied all functional performance requirements |
| Flow Rate | Met product specifications | Satisfied all functional performance requirements |
| Tensile Strength | Met product specifications | Satisfied all functional performance requirements |
| Biocompatibility (Cytotoxicity, Irritation/Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Sensitization/Maximization, Pyrogenicity) | Demonstrated to be biocompatible for intended use | Demonstrated to be biocompatible for intended use |
| Ease of Introduction and Positioning (Cadaver Model) | Met product specifications | Satisfied all functional performance requirements |
| Irrigation and Injection of Fluids (Cadaver Model) | Met product specifications | Satisfied all functional performance requirements |
| Aspiration (Cadaver Model) | Met product specifications | Satisfied all functional performance requirements |
| Compatibility with Commercially-available Hemostatic Matrices (Cadaver Model) | Demonstrated ability to introduce | Validated ability to introduce |
2. Sample Size and Data Provenance:
- Bench Performance Testing: The specific sample size for each bench test (dimensional, flexibility, leak, etc.) is not explicitly stated. The nature of these tests suggests multiple units were tested to ensure consistency and reliability. Data provenance is implied to be from internal testing conducted by Baxano, Inc.
- Biocompatibility Testing: Not specified for each test, but standard procedures typically involve a sufficient number of samples to meet GLP regulations and ISO 10993-1 guidelines. Data provenance is from GLP-compliant testing conducted according to FDA and ISO standards.
- Cadaver Model Testing: Not specified, but "a cadaver model" suggests a limited number of cadavers were used for the design validation testing. The data is prospective, generated specifically for this validation.
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number or qualifications of experts used to establish a ground truth for a test set in the traditional sense of a clinical study with expert review.
- For the bench performance testing, acceptance criteria would have been established by engineering and quality assurance experts at Baxano, Inc., based on product specifications and industry standards.
- For the biocompatibility testing, ground truth was established by adherence to recognized international standards (ISO-10993-1) and FDA guidance, with testing conducted by qualified personnel in a GLP-compliant environment.
- For the cadaver model testing, "clinician" input is implied for assessing performance (e.g., ease of introduction). While not explicitly stated as "experts," these would be individuals with medical expertise in relevant spinal procedures.
4. Adjudication Method:
No formal adjudication method (like 2+1 or 3+1) is mentioned in the context of expert review for establishing ground truth, as this was not a comparative clinical trial. Performance was assessed against pre-defined engineering and biological safety specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed or is mentioned. This device is a catheter, and the evaluation focused on its physical and functional performance, not on interpretation by human readers.
6. Standalone Performance:
Yes, all the performance data presented (bench testing, biocompatibility, and cadaver model testing) represents the standalone performance of the iO-Flex Catheter. The tests assess the device's inherent characteristics and functionality without human-in-the-loop performance measurement.
7. Type of Ground Truth Used:
- Bench Performance Testing: Ground truth was established by adherence to pre-defined product specifications (e.g., dimensional tolerances, tensile strength values, flow rates).
- Biocompatibility Testing: Ground truth was based on the results of validated biological tests (e.g., cytotoxicity assays, irritation tests) as interpreted against the acceptance limits of the ISO 10993-1 standard.
- Cadaver Model Testing: Ground truth was based on functional observation and assessment by clinicians/testers against pre-defined performance requirements related to ease of use, fluid delivery, and compatibility.
8. Sample Size for the Training Set:
This document describes pre-market testing for a medical device (catheter), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The presented studies are validation studies for the device itself.
9. How the Ground Truth for the Training Set was Established:
As there is no AI component or training set, this question is not applicable. The device's performance was validated against established engineering, biological, and functional specifications directly.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).