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The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 24 Guidewire is intended to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries.

The Drivewire 24 Guidewire is a 0.024" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only. The Drivewire 24 Guidewire is comprised of a stainless steel hypotube that is cut along its length to provide flexibility and tip deflection ability through control of the handle, an inner Nitinol braided flexible coil, an inner core wire, and a handle. The inner core wire runs inside the hypotube from the distal end to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal section of the hypotube, forming a deflectable tip. The hypotube is marked with fluoro-safe markers to provide visual clues to the user to initiate fluoroscopy guided insertion. In order to actuate the tip deflection in two directions, the Drivewire 24 Guidewire handle contains a tube assembly section. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. The handle assembly has neutral landmarks to identify the location where the tip is straight. The Drivewire 24 Guidewire has a hydrophilic coating on its distal segment in order to reduce the friction of the guidewire while navigating. The Drivewire 24 Guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to have patient contact.

The information provided does not describe an AI/ML device but rather a medical guidewire. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable here.

This document, K233791, is a 510(k) premarket notification for the Drivewire 24 Guidewire, a physical medical device. The submission demonstrates substantial equivalence to a predicate device (Aristotle 24 Guidewire) through non-clinical testing.

Here's an analysis of the provided information, framed to address the prompt's questions where applicable, but explicitly noting the absence of AI/ML-specific details:

1. A table of acceptance criteria and the reported device performance

The document provides a table of "Non-Clinical Testing" which outlines various bench tests, their methods, and results indicating they met acceptance criteria. While specific numerical acceptance criteria are not always stated, the results confirm successful performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Tests: The specific number of devices tested for each bench test is not explicitly stated, but the results refer to "All devices," implying a sufficient sample was used to statistically validate the findings against acceptance criteria. Data provenance for bench tests is typically from the manufacturer's internal labs.
• Biocompatibility Tests: The description mentions "test article extract" or "test articles," indicating samples of the device or its materials were used according to ISO 10993 standards.
• Animal Study: The study was conducted in "domestic swine." The number of animals or devices used per animal is not specified but is implicitly sufficient for a GLP study.

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 question is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert ground truth for interpretation. The "Usability Evaluation" mentioned that "Physicians evaluated the guidewire in clinically relevant simulated use models," implying expert input, but details on their number or qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML diagnostic study requiring expert adjudication of results.

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. No MRMC study was performed as this is a physical medical device. The efficacy is demonstrated through non-clinical testing and comparison to a predicate device.

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 (expert consensus, pathology, outcomes data, etc)

For a physical device like a guidewire, the "ground truth" is established through physical and material science measurements, functional performance testing against defined engineering specifications, and biological safety testing against established international standards (e.g., ISO 10993). In the animal study, the "ground truth" for thrombogenicity was the direct examination of devices, renal arteries, and downstream organs for thrombus absence.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML model was involved.

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The Columbus Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Columbus Guidewire is intended to facilitate the selective placement of therapeutic catheters. This device is not intended for use in coronary arteries.

The Columbus guidewire is a 0.014" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only. The Columbus guide wire is comprised of a Nitinol braided flexible distal cable, a proximal shaft, an inner core wire and a handle. The braided cable is attached to the proximal shaft via inner connector. The inner core wire runs inside the shaft and the cable from the distal end of the cable to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal cable, forming a deflectable tip. In order to actuate the tip deflection in two directions, the Columbus guidewire handle contains a tube assembly section which enables continuous stroke by a self-locking feature. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. Two models are available, Columbus LR (large radius) PN: GWPP4464 which has radius curvature of 4mm and Columbus SR (small radius) PN: GWPP4463 which has radius curvature of 2mm. The Columbus guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to contact the patient's body.

The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed in the document provided, specifically for the Columbus Guidewire (K200374).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria (Non-Clinical Performance Tests) and Reported Device Performance:

The document lists various performance bench tests that the Columbus Guidewire underwent, along with the standards they followed and the results. The acceptance criteria for these tests are implied by the "Pass" result, indicating that the device met the requirements outlined in the specified FDA Guidance or ISO standards.

2. Sample Size Used for the Test Set and the Data Provenance:

• Animal Testing (Pre-Clinical GLP Studies):

  • Sample Size: "a total of 5 swine" were used across two controlled GLP studies.
  • Data Provenance: The studies were conducted in "domestic swine," which implies prospective animal studies. The country of origin is not explicitly stated but is likely where Rapid-Medical Ltd. or its contract research organization operates, given that the company is based in Israel. The studies are described as "controlled GLP studies," indicating a high standard of preclinical research.

• Bench Tests: The document does not specify the exact sample sizes (e.g., number of guidewires tested for each parameter). The data provenance is laboratory-based non-clinical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Animal Testing: The document states "assessments by well qualified experts in accordance with recognized methods, standards, and guidelines." While the exact number of experts is not specified, their qualification is noted as "well qualified experts." This likely refers to veterinary professionals, pathologists, or interventional specialists involved in the animal studies. Specific experience levels (e.g., "10 years of experience") are not provided.

• Bench Tests: The "ground truth" for bench tests is established by adherence to specified engineering standards and internal requirements, not typically by human expert consensus in the same way as clinical or image-based studies. The "experts" involved would be the engineers and quality assurance personnel conducting and interpreting the tests.

4. Adjudication Method for the Test Set:

• Animal Testing: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for the expert assessments in the animal studies. It implies a direct assessment by "well qualified experts" following recognized methods, which inherently requires agreement on the observed outcomes (e.g., presence/absence of perforations, thrombus).

• Bench Tests: Adjudication is not typically applicable in the classical sense for bench tests. The "ground truth" is determined by measured physical properties against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not conducted. This type of study (comparing human readers with and without AI assistance on various cases) is generally relevant for AI/imaging devices. The Columbus Guidewire is a mechanical medical device, and its evaluation focuses on physical performance, safety, and functional equivalence rather than diagnostic performance aided by AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

This question is not applicable to the Columbus Guidewire. This device is a physical, mechanical medical guidewire, not an algorithm or AI system. Its "performance" is inherently human-in-the-loop, as it requires a physician to operate it. The bench tests evaluated the device's inherent mechanical properties and functionality.

7. The Type of Ground Truth Used:

• Animal Testing: The ground truth was established through direct observation and assessment by "well qualified experts" during and after the animal procedures. This included angiographic assessment for perforations/dissections/thrombus, and macroscopic assessment of internal organs for thrombi. This can be considered a form of outcomes data (in vivo biological response) from a controlled study.

• Bench Tests: The "ground truth" for bench tests was based on engineering specifications, physical measurements, and adherence to established national and international standards (e.g., FDA Guidewire Guidance, ISO 11070).

8. The Sample Size for the Training Set:

This information is not applicable and not provided in the document. The Columbus Guidewire is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for a physical medical device like the Columbus Guidewire.

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The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2.

The Comaneci Embolization Assist Device consists of three device models: Comaneci, Comaneci Petit, and Comaneci 17 (see Table 1). The Comaneci Embolization Assist Device is intended for temporary use and is introduced through an endovascular approach to the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width < 10 mm. The device consists of a nitinol fine wire mesh region at the distal end mounted on a flexible shaft that expands and contracts when the physician pulls a core wire that is coated with polytetrafluoroethylene (PTFE) and connected to a handle with a control slider made of a styrene-butadiene copolymer (Figures 1 and 2). The fine wire mesh region on the Comaneci Embolization Assist Device is unique in that it is not self-expandable but is directly controlled by the physician to size this region of the device to the parent vessel. The wires of the mesh are radiopaque, which allows the physician to visualize the mesh under fluoroscopy. The Comaneci and Comaneci Petit models are delivered through a microcatheter with an internal diameter (ID) of 0.021 inches and the Comaneci 17 is delivered through a microcatheter with an ID of 0.017 inches. The devices are packaged in a sterile pouch and are intended for single use only.

The Comaneci Embolization Assist Device is a Class II device (Product Code: PUU, Regulation Number: 21 CFR 882.5955) intended for temporary use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.

The acceptance criteria for the Comaneci Embolization Assist Device, as derived from the provided text, are multifaceted, encompassing non-clinical bench testing, animal studies, and a retrospective clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly presented in a single table with numerical targets, but rather are implicitly defined by the successful outcomes of various tests and the conclusions drawn from them. Below is a structured presentation of the implicit acceptance criteria based on the described studies and the reported device performance.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a multi-faceted approach involving extensive non-clinical bench testing, an animal study, and a retrospective clinical case series. The "Summary of Clinical Information" section specifically details the human study.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size (Clinical Study): 63 consecutively treated patients with 64 intracranial aneurysms.
• Data Provenance:
  • Country of Origin: The study was conducted outside the United States (OUS) at two sites: Walton Center in Liverpool, United Kingdom, and University Hospital St. Ivan Rilski in Sofia, Bulgaria.
  • Retrospective or Prospective: Retrospective post-market collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Imaging Data (Technical Success and Safety): Independently analyzed by the Angiography and Noninvasive Imaging Core Lab at University of California - Los Angeles. The number of experts is not specified.
• Adverse Events: Adjudicated independently by the Department of Neurology at the University of Southern California. The number of experts is not specified.
• Qualifications of Experts: The specific qualifications (e.g., years of experience, subspecialty certification) of the experts for both imaging analysis and AE adjudication are not explicitly detailed beyond their affiliation with known university medical departments/labs.

4. Adjudication Method for the Test Set

• Imaging Data: Independent analysis by a core lab (UCLA). No specific "2+1" or "3+1" consensus method is described, implying independent interpretation rather than a multi-reader consensus process for a single finding.
• Adverse Events: Independently adjudicated by a department (USC Neurology). Similar to imaging, a specific multi-expert consensus method (e.g., 2+1) is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not explicitly done to evaluate how human readers improve with AI vs. without AI assistance. The clinical study was a retrospective case series focused on device performance and safety with standard human intervention. The device is a mechanical assist device, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists interpreting images). Therefore, this type of MRMC study is not applicable to the Comaneci device's function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The Comaneci device is a physical, mechanical embolization assist device, not an algorithm. Its performance is inherently tied to human use in a medical procedure. Standalone performance for a device of this type would refer to bench testing (which was performed) or animal studies (which were performed), demonstrating the device's mechanical integrity and biological interaction. It does not relate to an algorithm's performance without human interaction.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for clinical outcomes (technical success and adverse events) was established through a combination of:
  • Independent analysis of imaging data (angiography) by a core lab for technical success (e.g., aneurysm occlusion, coil prolapse).
  • Independent adjudication of adverse events by a neurology department based on collected CRF data.
  • Patient follow-up data (up to 3 months post-procedure) to assess clinical abnormalities or sequelae related to events like coil prolapse.
  • For the purposes of this device, the "ground truth" concerning the clinical outcomes is defined by these independent expert evaluations and the observed clinical course.
• Animal Study: Ground truth was established by:
  • Angiographic evaluations at termination to assess blood flow, aneurysm filling, and coil presence.
  • Gross and histological evaluations (light microscopy, SEM) of tissue sections for injury, inflammation, and endothelial loss.
  • Clinical observation of animals (morbidity, thrombosis, infection, hemorrhage).

8. The Sample Size for the Training Set

• The document does not mention a "training set" in the context of device development or evaluation, as this pertains more to AI/machine learning models. For a physical medical device, development involves iterative design, bench testing, and animal studies, which collectively inform and "train" the design, but not in the sense of a data science training set. The clinical study was a retrospective data collection for validation, not a dataset used for iterative model training.

9. How the Ground Truth for the Training Set Was Established

• As a "training set" in the data science sense is not explicitly mentioned or used for this mechanical device, the concept of establishing ground truth for it is not applicable here. The development and verification process relied on engineering principles, bench testing standards, animal models, and human clinical experience.

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