Search Results

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Riptide™ Aspiration System is designed to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Riptide™ Aspiration System is designed for use within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries. The Riptide™ Aspiration System is composed of the following components:

• Arc™ Catheter .
• Riptide™ Aspiration Tubing .
• Riptide™ Aspiration Pump ●
• Riptide™ Collection Canister with Intermediate Tubing .

The Arc™ Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. A lubricous, tapered liner is used to create a structure that has both proximal stiffness and distal flexibility. The Arc™ Catheter has a radiopaque marker band encapsulated at the distal tip for visualization under fluoroscopy. The Arc™ Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion. The Arc™ Catheter is the only component of the Riptide™ Aspiration System that is used intravascularly.

The Riptide™ Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the Arc™ Catheter. The Riptide™ Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Aspiration Tubing is connected to the Riptide™ Collection Canister (outside of the sterile environment) while the distal end of the Riptide™ Aspiration Tubing is connected to the Arc™ Catheter (inside the sterile environment). The Riptide™ Collection Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide™ Aspiration System. The vacuum pressure of the Riptide™ Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide™ Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single-use and the repository for aspirated material. The Riptide™ Collection Canister is placed into the receptacle of the Riptide™ Aspiration Pump while the Intermediate Tubing is connected to the vacuum inlet port.

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the Riptide™ Aspiration System to its predicate device, the Penumbra System® and Penumbra Pump MAX™.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists numerous tests conducted on various components of the Riptide™ Aspiration System, with an explicit statement that the device met the acceptance criteria for each. The specific acceptance criteria values are generally not quantified in the "Results" column, but rather stated qualitatively (e.g., "met the acceptance criteria").

Table 1: Acceptance Criteria and Reported Device Performance (Summary)

Study Information:

The provided document describes non-clinical bench testing and non-clinical animal testing. It explicitly states "Not Applicable" for clinical performance data. Therefore, questions related to human reader studies, ground truth establishment for a test set of clinical images, and training set details are not directly addressed in this document.

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

• Test Set Sample Size:
  • Bench Testing: The document does not specify the exact sample sizes (number of units tested) for each individual bench test. The nature of these tests often involves a batch of devices or components.
  • Animal Testing: The document mentions "a porcine model" but does not specify the number of animals used for the animal testing.
• Data Provenance:
  • Bench Testing: Conducted by the manufacturer, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, as part of their R&D and regulatory submission process. Location not specified, but the company is based in Irvine, California, USA.
  • Animal Testing: Conducted "in a porcine model." Location not specified.
  • Retrospective/Prospective: These are non-clinical studies (bench and animal), so the terms retrospective/prospective in the context of human data acquisition do not directly apply. They are inherently prospective in the sense that the tests were designed and executed to evaluate this specific device for its regulatory submission.

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)

• Not Applicable. The studies described are non-clinical (bench and animal). There is no mention of human expert-established ground truth for a test set of clinical images or data. The "ground truth" for these tests comes from objective measurements against defined standards (e.g., ISO, ASTM, USP standards, or internal specifications) and observations in animal models.

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

• Not Applicable. As no human expert evaluation of clinical data for ground truth establishment is described, adjudication methods are not relevant to this submission.

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. The document explicitly states "Performance Data - Clinical: Not Applicable." This means no human reader studies (MRMC or otherwise) were conducted or submitted as part of this 510(k). The device is not an AI-powered system that assists human readers.

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

• No. This device is a medical instrument (aspiration system for stroke), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

• Bench Testing: Ground truth is established by objective measurements against pre-defined engineering specifications, international standards (ISO, ASTM, USP), and validated test methods. For example, "The Arc™ Catheter met the acceptance criteria for EO Residual" means the measured residual levels were below the established safe limits per ISO 10993-7.
• Animal Testing: Ground truth is established through direct observation and measurement in a controlled porcine model, in accordance with "21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies". The goal was to evaluate "safety, efficacy, and usability" and compare it to the predicate device.

8. The sample size for the training set

• Not Applicable. No AI/machine learning component is described for this device, so there is no concept of a "training set" in the context of algorithm development.

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

• Not Applicable. As there is no training set for an AI algorithm mentioned, this question is not relevant.

Ask a specific question about this device

Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Penumbra Aspiration Tubing: As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in [1.37mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.

The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the KIT configuration, as that's where new testing was performed:

1. Table of Acceptance Criteria and Reported Device Performance (KIT Configuration)

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

The document does not explicitly state the numerical sample size for the "Design Verification testing" for the KIT configuration. It only mentions "units used in this Design Verification testing" for Visual Inspection, and implicitly for Simulated Use, Catheter Coating, and Gross Leak tests as they all report 100% Pass.

• Sample Size: Not explicitly stated as a number, but all tested units passed.
• Data Provenance: The tests are described as "additional testing performed for the KIT configuration packaging," suggesting these are prospective, benchtop tests conducted by Penumbra, Inc. The country of origin for the data generation would logically be the USA, given the company's location.

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

There is no mention of experts or clinicians being used to establish a ground truth for these non-clinical tests. The tests are focused on physical and mechanical properties and simulated use in anatomical models.

4. Adjudication Method for the Test Set

Not applicable, as these are non-clinical, objective tests and not based on expert review or consensus.

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 document describes a medical device (Penumbra System and Penumbra Pump MAX) for treating acute ischemic stroke, not an AI-based diagnostic or treatment guidance system that would involve human readers or AI assistance.

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

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

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is based on:
* Defined specifications and performance expectations: For Visual Inspection, Catheter Coating, and Gross Leak, the "ground truth" is adherence to predefined quality and integrity standards.
* Simulated physiological conditions and objective performance: For Simulated Use, the "ground truth" is the effective removal of clots and prevention of catheter collapse in an anatomical model that mimics neurovasculature.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable.

Ask a specific question about this device

The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for test sets, where applicable)

• Biocompatibility Testing:

  • In Vitro Cytotoxicity: Not specified in terms of sample size for the test itself, but implies multiple samples for extract testing.
  • Sensitization: "Test Group" - size not specified.
  • Acute Intracutaneous Reactivity: "mean test article and mean control score" - implies multiple samples, size not specified.
  • Acute Systemic Toxicity: "3 or more test animals" (for weight loss criteria), "2 or more test animals" (for morality/behavior) - implies at least 3 animals for each extract/test (likely mice or rats, as common for this test).
  • Rabbit Pyrogen Study: "No single animal" suggests multiple rabbits, specific number not stated.
  • Hemocompatibility In Vitro Hemolysis: Sample extracts, size not specified.
  • Complement Activation: "test samples" compared to "predicate (Exposure Control & Ref Material) control" and "positive control" at "all three exposure times." Specific number of samples not stated.
  • Dog Thrombogenicity: "2 out of 2 test site and 2 out of 2 control sites" - suggests at least two test animals (dogs) for the in-vivo evaluation.
  • Data Provenance: Retrospective, conducted by the manufacturer, or by external labs following GLP. Country of origin not specified, but following EN ISO 10993 guidelines.

• Bench-top Testing:

  • Sample sizes are not explicitly stated for all individual tests, but most indicate "100% Pass," which suggests the testing was performed on a sample of devices and all met the criteria. For particulate testing, the maximum number suggests a specific measurement from a sample.
  • Data Provenance: Retrospective, conducted by the manufacturer.

• Animal Study:

  • Sample Size: A "swine model" was used. The number of individual animals (swine) is not explicitly stated, but the conclusions "No vessel injury was noted on the final angiograms following the vessel response procedure," "No abnormal gross or histology findings were noted in test vessel segments," and "The use of the Penumbra System ACE devices resulted in no significant vascular response in these experimental conditions," suggest sufficient animal subjects were used to support the claim.
  • Data Provenance: Prospective, animal study (GLP Animal Testing).

3. Number of Experts Used and Qualifications (for ground truth establishment)

• Biocompatibility Testing: Experts in toxicology, microbiology, and animal studies would have been involved in the design and interpretation of these studies. Their specific number and qualifications are not detailed in this summary.
• Bench-top Testing: Engineers and material scientists within the manufacturer's R&D and Quality departments would have developed the specifications and assessed the results.
• Animal Study: Veterinarians, interventionalists (to perform the procedures), pathologists (for gross and histology findings), and researchers expert in animal models for vascular devices.
• Note: This document does not pertain to AI/ML or image data, so the concept of experts establishing ground truth for a test set (e.g., radiologist for image interpretation) as typically understood in AI studies is not directly applicable here. The "ground truth" here is physical/biological measurements and observations.

4. Adjudication Method (for the test set)

• Not applicable in the context of this device's non-clinical testing. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation where there is subjective assessment by multiple human readers (e.g., radiologists) that needs to be reconciled to establish a ground truth. The tests described are objective physical, chemical, or biological measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This document describes the pre-market non-clinical testing of a physical medical device (catheter), not an AI/ML algorithm for diagnostic imaging or similar applications where human reader performance is augmented.

6. Standalone (Algorithm Only) Performance Study

• No, this is not an AI/ML device. Therefore, a standalone algorithm performance study was not performed.

7. Type of Ground Truth Used

• Biocompatibility Testing: The ground truth is objective biological and chemical reactions/measurements (e.g., cell lysis grade, inflammation scores, weight changes, temperature changes, hemolytic index, C3a/SC5b-9 concentrations, histopathology for thrombogenicity).
• Bench-top Testing: The ground truth is objective physical and mechanical measurements against technical specifications (e.g., dimensions, force measurements, flow rates, visual integrity, particulate counts).
• Animal Study: The ground truth is direct in-vivo observation and pathological assessment (e.g., angiographic evidence of injury, gross pathology findings, histological examination of vessel segments).

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices involves engineering design, material selection, and iterative prototyping based on established engineering principles and prior knowledge.

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

• Not applicable, as there is no "training set" in the AI/ML sense for this device. The development process relies on engineering specifications, material science data, and established test methods, rather than a labeled dataset for algorithm training.

Ask a specific question about this device