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510(k) Data Aggregation
(14 days)
Accurate Medical Therapeutics Ltd
The Drakon™ and Sequre® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and Sequre® microcatheters are also intended for drug infusion in intraarterial therapy and infusion of embolic materials. The Drakon™ and Sequre® microcatheters should not be used in cerebral vessels.
The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 1.9 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
The provided FDA 510(k) Pre-Market Notification does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it detail a study involving human reader performance, ground truth establishment, or training/test set data for such a device.
The document pertains to the Drakon™ and Sequre® microcatheters, which are physical medical devices (intravascular catheters) used for infusing contrast media, drugs, or embolic materials. The "performance data" section (Section VII) outlines bench testing and biocompatibility testing conducted to demonstrate that the modified microcatheters are substantially equivalent to their predicate devices, and that these physical devices meet predefined acceptance criteria for metrics such as bead compatibility, tensile strength, burst pressure, torque strength, etc.
Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, and the provided text is for a physical medical catheter, I cannot extract the requested information as it does not exist in this document.
Therefore, I must state that the provided text does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD, human reader performance, training/test set details, or ground truth establishment relevant to an AI model. The document explicitly focuses on the substantial equivalence of a physical microcatheter based on bench testing.
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(30 days)
Accurate Medical Therapeutics Ltd.
The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer laver. which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
The provided text describes a 510(k) premarket notification for Drakon™ and Sequre® microcatheters. This document details the device description, indications for use, comparison with a predicate device, and performance data from various bench and biocompatibility tests. However, this document does not contain information about a study proving device performance against clinical acceptance criteria for an AI/algorithm-based device, or details about expert consensus, ground truth establishment, or multi-reader multi-case studies.
The information provided is typical for a traditional medical device (catheter) clearance, focusing on physical and biocompatibility testing. It doesn't involve AI or algorithms that would require the specific types of acceptance criteria and study designs outlined in your prompt (e.g., sensitivity, specificity, human reader improvement with AI).
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI device meets those criteria, as the provided document pertains to a physical medical device (microcatheter) and not an AI or algorithmic device.
The "acceptance criteria" mentioned in the document refer to the criteria for passing the various bench tests (e.g., tensile strength, burst pressure) and biocompatibility tests, not clinical performance metrics for an AI system.
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(85 days)
Accurate Medical Therapeutics Ltd.
The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels.
The SeQure® NF and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.
The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.
The SeQure® NF and SeQure® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The SeQure®'s distal end has side holes and two radiopaque markers while the SeQure® NF's distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters.
The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood.
The SeQure® NF and the SeQure® microcatheters are sterile single lumen devices and are available in several different diameters and lengths.
This document describes the regulatory submission for the SeQure® NF and SeQure® microcatheters, demonstrating their substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here refer to the performance standards and testing outcomes that were required for FDA clearance, rather than acceptance criteria for a diagnostic AI algorithm. Similarly, the "study that proves the device meets the acceptance criteria" refers to the engineering bench tests, biocompatibility tests, and animal studies conducted to demonstrate the safety and performance of the catheters according to established medical device standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device (catheters) are implicitly defined by the successful completion of various performance tests, demonstrating that the device is safe and performs as intended, comparable to the predicate device. The document states that "All tests met the predefined acceptance criteria."
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity, Irritation, Systemic Toxicity, SC5b-9 Complement Activation Assay, ASTM Hemolysis, Pyrogen Study, ASTM Partial Thromboplastin Time, In-Vivo Thrombogenicity, ISO Maximization Sensitization Test. Conformance to ISO 10993 series. | All tests completed with passing results. |
| Sterilization & Packaging | Sterilization validation (ISO 11135-1), Shelf life testing, Packaging testing. | All tests successfully completed. |
| Bench Testing | Bead Compatibility, Vessel Flow Dynamic Indication (Beads Reflux), Embolization Coil Compatibility, Strain Relief, Bend Radius, Torque Transmission, Air Leakage, Liquid Leakage, Burst Pressure, Power Injection, Tensile, Torque Strength, Guidewire & Guide Catheter Compatibility; Dimensional and Visual Inspection, Corrosion, Preconditioning and Injected Substances Compatibility, Usability, Acute Particulate Matter Evaluation, Trackability. | All tests met the predefined acceptance criteria. |
| GLP Animal Study | Assessment of safety and usability (observing adverse events, malfunction, and ability of users to perform required tasks), Gross pathology and histopathology evaluation. | No adverse events occurred; devices performed well without malfunction to users' satisfaction; users were able to perform required tasks; gross pathology and histopathology evaluation was also conducted. The test met the predefined acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Test Set (Applicable to Animal Study): The document does not explicitly state the number of animals used in the GLP Animal Study. It refers to the study as "GLP Animal Study" implying a sufficient sample size for regulatory purposes, but the specific number is not provided.
- Data Provenance: The GLP Animal Study was performed at the Asaf Harophe GLP facility in Israel. The document does not specify if it was retrospective or prospective, but GLP (Good Laboratory Practice) studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the context of this device submission. The device is a physical catheter, not an AI diagnostic algorithm requiring expert annotation for ground truth. The "ground truth" for proving safety and performance comes from objective physical and chemical tests, and pre-clinical animal studies, not human expert consensus on interpreted data.
4. Adjudication method for the test set
Not applicable as this is not an AI diagnostic algorithm study. The animal study involved "different users" for comparison to the predicate device, and the evaluation included gross pathology and histopathology which would be interpreted by qualified personnel, but a specific adjudication method isn't detailed as it would be for reader-based image interpretation.
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
Not applicable. This is a submission for a physical medical device (catheter), not an AI algorithm, so no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance and safety was established through:
- Objective Test Results: Passing results from various bench tests (e.g., burst pressure, trackability, tensile strength) and biocompatibility tests (e.g., cytotoxicity, hemolysis) against predefined, quantitative acceptance criteria.
- Animal Study Observations and Pathology: Direct observation of device performance, absence of adverse events, and histology/pathology findings from the animal study.
8. The sample size for the training set
Not applicable. This is 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 was used for this type of device submission.
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