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The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe.

Similar to predicate devices, industry standard intravascular catheter components and materials are used:

• Clear proximal polycarbonate female luer lock,
• -Stainless steel braid,
• Clear Pebax and Vestamid Shafts, -
• -Embedded platinum iridium radiopaque marker,
• Clear polycarbonate barrel piston syringe. -

Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process.

Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.

The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Aspire MAX Aspiration Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) device. Therefore, the information provided for acceptance criteria and study that proves the device meets the acceptance criteria is framed within the context of substantial equivalence testing and non-clinical performance, rather than a clinical study with human patients.

Based on the document, here's a breakdown of the requested information:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not present a formal table of "acceptance criteria" with specific quantitative thresholds for clinical performance metrics (e.g., sensitivity, specificity, or clinical outcome improvements). Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to legally marketed predicate devices through a series of non-clinical tests and comparisons of design, materials, and operating principles.

The "Device Performance" is demonstrated by passing these non-clinical tests, indicating the device functions as intended and is comparable to predicate devices.

Table of Comparison (derived from the document):

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence, not a clinical study. Therefore, some of the requested information (like expert consensus for ground truth or MRMC studies) is not applicable in this context.

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state "sample sizes" in terms of number of devices tested for each non-clinical test. It states "Non-clinical testing confirms the Aspiration Catheters and Aspirator passes all testing and meets specifications."
   • Data Provenance: The tests were conducted as part of the regulatory submission process for the device manufacturer, Control Medical Technology. The location of the testing facilities (e.g., Ethox and Nelson Labs mentioned for biocompatibility) would likely be in the US, but this is not explicitly stated as the origin of data.
   • Retrospective or Prospective: The testing was prospective, specifically conducted for this 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This was a non-clinical testing submission for substantial equivalence. "Ground truth" in this context refers to the defined specifications and parameters of the tests (e.g., tensile strength, aspiration volume, particulate limits) which are derived from industry standards (e.g., ISO, AAMI) and predicate device characteristics, not expert clinical consensus on patient data.

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

   • Not applicable. As this was non-clinical testing, there was no adjudication of expert opinions. Test results are objectively measured against defined specifications.

4. 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 medical device (catheter and aspirator), not an AI/imaging device, and no clinical study was performed. The concept of "human readers" and "AI assistance" is not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this 510(k) submission is established by engineering specifications, performance metrics derived from industry standards (ISO), and the characteristics of predicate devices that have already been legally marketed. For example, catheter dimensions, material properties, aspiration volume, and leak integrity are measured and compared against established parameters or the performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that involves a training set. The device design and manufacturing process are established through engineering and validated through non-clinical testing.

8. How the ground truth for the training set was established:

   • Not applicable. No training set was involved.

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The Merit Embolectomy Catheter is intended for use for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

The Merit Embolectomy Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90cm, 100 cm, and 110 cm proximal of the distal tip.

This document describes the premarket notification (510(k)) for the Merit Embolectomy Catheter (K100569). It primarily focuses on demonstrating substantial equivalence to a predicate device through safety and performance testing. However, it does NOT contain the specific information required to complete the table and answer the study-related questions.

Here's why and what can be extracted:

What's missing for your request?
The provided text is a 510(k) summary and FDA clearance letter. It outlines the device, its intended use, lists the tests performed, and states that acceptance criteria were met. However, it does not provide:

• The specific acceptance criteria values.
• The reported device performance values against those criteria.
• Details about any clinical studies (such as sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that would typically be associated with performance claims for AI-driven devices. Embolectomy catheters are physical devices, and their evaluation typically involves bench testing, animal models, and sometimes human clinical trials, but not in the format of AI performance metrics.

Extracted Information (based on the provided text):

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that a "battery of tests was performed... and were shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device," but it does not list these criteria or the test results.

2. Sample size used for the test set and the data provenance
Not applicable/provided for this type of device. The testing described is primarily bench-top (physical and mechanical properties) and biocompatibility, not data-driven performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided for this type of device. Ground truth as typically understood for AI/diagnostic devices is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/provided for this type of device.

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
No. This is a physical medical device (embolectomy catheter), not an AI/software device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for this type of device. The "ground truth" for this device would relate to its physical performance (e.g., successful clot removal in a model, material integrity, biocompatibility), which is assessed through the listed tests.

8. The sample size for the training set
Not applicable/provided for this type of device. There is no "training set" as this is not an AI/machine learning product.

9. How the ground truth for the training set was established
Not applicable/provided for this type of device.

Summary of Device and Testing (from the document):

• Device Name: Merit Embolectomy Catheter
• Intended Use: Removal of fresh, soft emboli and thrombi from vessels of the arterial system (not for cerebral vasculature).
• Regulatory Class: Class II
• Product Code: OEZ (initially DXE, updated to OEZ in 2021)
• Predicate Device: Pronto V3 Extraction Catheter, Model 5003 (K063371)
• Tests Performed: A comprehensive battery of tests was performed based on ISO standards and FDA requirements, covering:
  • Surface Condition
  • Force at Break
  • Freedom from Leakage (Pressure & Aspiration)
  • Dimensional Verification (OD, lengths, marks, tip angle)
  • Radio-detectability
  • Visual Inspection
  • Aspiration
  • Flow
  • Lubricious Coating Effectiveness (Lubricity and Durability, Accelerated Aging)
  • Coating Integrity (Dye Test)
  • Lubricious Coating Length
  • Guide Wire Compatibility
  • Stiffness (Proximal, Mid, Distal Section)
  • Kink Test (Proximal, Mid, Distal Section)
  • Marker Band Retention
  • Rapid Exchange Lumen Attachment
  • Simulated Use Testing:
    • Tortuous Path (Tracking, Guide Wire, Crossing a deployed stent, Soft emboli aspiration)
  • Biocompatibility Tests:
    • Cytotoxicity
    • Sensitization
    • Irritation
    • Acute Systemic Toxicity
    • Pyrogenicity
    • Genotoxicity
    • Hemocompatibility
  • Packaging Performance:
    • Bubble emission
    • Dye penetration
    • Seal peel tensile strength
    • Burst strength
    • Visual inspection (before and after accelerated aging and simulated shipping)

The document concludes that the device "meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device" based on these tests.

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The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The QXT catheter is designed to aspirate or extract soft thrombus from arterial vasculature. It has a dual-lumen design-an extraction lumen that allows for the removal of thrombus by aspiration and a rapid-exchange guidewire lumen that accommodates ≤0.014" diameter guidewires. A Y-adapter is bonded to the catheter's proximal end that facilitates the attachment of syringes and extension lines, and there is a self-sealing straight valve bonded to one port of the Y-adapter. The purpose of the straight valve is to provide a means of inserting and removing a stiffening mandrel, that is supplied with the device, while maintaining hemostasis during use. The catheter's outer diameter is a maximum of approximately 0.063" and its working length is approximately 137cm. The catheter is compatible with ≥6F guide catheters. There is a single radiopaque marker located near the distal tip, and the catheter's shaft has non-radiopaque positioning marks printed at approximately 95cm and 105cm proximal to the distal tip. Each device is supplied with a stiffening mandrel that is placed through the self-sealing straight valve, a 30mL VakLok syringe, and a 6 inch extension line that has a one-way stopcock. The QXT catheter is provided sterile and intended for single use.

The provided document is a 510(k) summary for the QXT Extraction Catheter, submitted to the FDA. It does not include acceptance criteria or the details of a study designed to prove the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and the results of bench testing for design verification.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based on the provided document. The document explicitly states: "No QXT catheter clinical evaluations were conducted." and focuses on "Bench testing was conducted on the QXT catheter and included an assessment of the device's physical properties and its ability to achieve its intended use."

The sections below highlight what would be provided if the document contained the requested information, but given the limitation, I can only state that such information is absent.

Acceptance Criteria and Device Performance:

The document does not provide a table of acceptance criteria and reported device performance directly related to proving the device meets specific performance thresholds in a clinical or structured performance study beyond general bench testing.

Study Details (Based on available information, which is limited to bench testing, not a formal study with acceptance criteria):

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

   • The document implies that multiple units of the QXT catheter were used for each bench test listed. However, specific sample sizes (e.g., "n=X" for each test) are not provided.
   • Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing given it's a 510(k) submission, likely conducted in the US (where Vascular Solutions, Inc. is located). The testing is prospective for the device's design verification.

2. 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):

   • Not applicable. Ground truth, in the context of an expert evaluation or clinical outcome, is not established for this submission as "No QXT catheter clinical evaluations were conducted." The bench tests assess physical properties and performance against engineering specifications or established test methods, not against expert-derived ground truth.

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

   • Not applicable. No expert adjudication process is described as there were no clinical evaluations or multi-reader studies.

4. 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:

   • No. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a medical catheter, not an AI-powered diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical medical instrument, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the bench tests, the "ground truth" or reference standard would be the pre-defined engineering specifications, industry standards, or established test methods for device performance (e.g., bond strength, kink resistance, thrombus extraction efficiency under controlled conditions). It is not derived from expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

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

8. How the ground truth for the training set was established:

   • Not applicable. This is a medical device, not an AI/ML algorithm.

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The FETCH™ Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi. Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.

The provided text is related to an FDA 510(k) premarket notification for the "FETCH Aspiration Catheter." It details the regulatory approval process and includes a brief device description and indications for use. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.

The document states: "Preclinical animal testing supported the substantial equivalency of the FETCH Aspiration Catheter to the predicate device for the indicated use." This indicates that animal testing was performed, but no details of the study design, acceptance criteria, or results are provided. The FDA 510(k) clearance process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical efficacy studies for many Class II devices.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
6. If a standalone performance study was done: "Preclinical animal testing" was mentioned, but no study details are provided to assess if it was a standalone performance study in the context of your request (e.g., in a human clinical setting or with detailed metrics).
7. The type of ground truth used: Not available beyond the mention of "preclinical animal testing."
8. The sample size for the training set: Not applicable/available, as this appears to be a medical device clearance, not an AI/algorithm-based device in the context of your question about training sets.
9. How the ground truth for the training set was established: Not applicable/available.

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