(51 days)
The ProtekDuo Veno-Venous Cannula is a single use dual lumen cannula, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult patients with acute requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.
Each ProtekDuo Veno-Venous Cannula Set includes a dual lumen cannula and an introducer. The introducer is designed to accept a standard 0.038-inch guidewire. The ProtekDuo Veno-Venous Cannula Sets are intended as single patient, single use, sterile devices.
Each ProtekDuo Veno-Venous Cannula consists of two (2) distinct lumens, each made of polyurethane with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.
The distal section (inner lumen/cannula) of the cannula body is the smaller diameter lumen with six (6) side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during set-up and removal of the cannula from the extracorporeal circulatory support equipment. A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8-inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The cannula has two suture wings that can be used for securing the cannula in place to the patient. The cannulas also have printed insertion depth markings measured from the distal tip.
Each introducer consists of a tube and hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque polyvinyl chloride material for visualization under fluoroscopy.
This document describes the premarket notification (510(k)) for the ProtekDuo Veno-Venous Cannula Sets, asserting their substantial equivalence to legally marketed predicate devices. The information provided outlines the device's technical characteristics, its intended use, and the non-clinical testing performed to demonstrate its performance.
However, the provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in the context of an AI/human reader performance study. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to existing devices, primarily through non-clinical testing and an in vivo animal study. It does not mention any AI component or human reader performance evaluation.
Therefore, I cannot fulfill the request to provide information based on the input about:
- A table of acceptance criteria and reported device performance (in the context of AI/human reader performance)
- Sample sized used for the test set and data provenance (for an AI/human reader study)
- Number of experts used to establish ground truth and qualifications (for an AI/human reader study)
- Adjudication method (for an AI/human reader study)
- MRMC comparative effectiveness study, effect size
- Standalone (algorithm only) performance study
- Type of ground truth used (for an AI/human reader study)
- Sample size for the training set (for an AI)
- How ground truth for the training set was established (for an AI)
The document's "acceptance criteria" are related to regulatory conformity (e.g., biocompatibility, sterility, mechanical integrity) and "performance" refers to the device's physical and functional characteristics (e.g., flow rates, tensile strength) demonstrated through non-clinical bench testing and an animal study, not human or AI diagnostic performance.
Based on the provided document, here's what can be extracted regarding the device's acceptance criteria and proof of performance:
The acceptance criteria for the ProtekDuo Veno-Venous Cannula Sets are primarily defined by the Special Controls outlined in 21 CFR 870.4100 for Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure. The study proving the device meets these criteria is a series of non-clinical tests (bench tests) and an in vivo animal study.
1. Table of Acceptance Criteria (Special Controls) and Reported Device Performance:
| Acceptance Criteria (Special Controls) | Reported Device Performance (Summary) |
|---|---|
| #1: Technological Characteristics (geometry, design, compatibility) | Established through use in ECMO procedures. Designed to be compatible with other extracorporeal circuit devices and accessories. |
| #2: Biocompatibility | Demonstrated to be biocompatible for prolonged (24 hours to 30 days) contact with circulating blood in accordance with ISO 10993-1. |
| #3: Sterility and Shelf-Life | Testing demonstrates sterility as provided and maintenance of sterility, integrity, durability, and reliability over the stated shelf-life. |
| #4: Non-clinical Performance Evaluation (bench, mechanical integrity, EMC, software, durability, reliability) | Substantial equivalence demonstrated by performance characteristics assessed through: Simulated Use/Reliability (30 days), Hemolysis, Pressure/Flow Characteristics, Tensile Strength, Leak, Deflection/Stiffness (Cannula, Introducer, Assembly), Kink Resistance, and Recirculation. |
| #5: In vivo Evaluation (performance over intended duration, clinical evaluation summary) | A 14-day in vivo evaluation demonstrated performance over a long-term duration of use in a biologic test system. (Note: This is an animal study, not a human clinical trial for this 510(k)). |
| #6: Labeling (non-clinical/in vivo summaries, instructions, compatibility, maintenance) | The Directions for Use contain the information detailed in this Special Control. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-Clinical/Bench Testing): Specific sample sizes for each non-clinical test (e.g., number of cannulas tested for tensile strength, number of setups for pressure/flow) are not detailed in this summary. However, these would be standard engineering test sample sizes to ensure statistical validity for the specific tests performed (e.g., according to ISO standards or internal validation protocols).
- Test Set (In Vivo): The summary mentions a "14-day in vivo evaluation" in a "biologic test system." The specific number of animals used for this study is not provided in this document.
- Data Provenance: The testing appears to be conducted by the manufacturer or contract research organizations as part of their regulatory submission for the device. The country of origin for the data is implied to be related to the applicant's location (Pittsburgh, PA, USA) or its testing facilities. It is a prospective set of tests and studies specifically performed for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as this submission is for a medical device (cannula) based on physical and biological performance, not an AI or diagnostic imaging device requiring expert reader ground truth.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Not applicable.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by physical measurement standards, engineering specifications, and established biological/material compatibility protocols (e.g., ISO standards for biocompatibility, flow dynamics equations for pressure/flow).
For the in vivo animal study, the "ground truth" would be the observed physiological function and integrity of the device within the biologic system over the 14-day period.
8. The Sample Size for the Training Set: Not applicable, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established: Not applicable.
§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.