(117 days)
Penumbra Aspiration Catheters and Separators: As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing: As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
The Penumbra Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology. The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using an Aspiration Catheter with an I.D. of 0.054 in or larger. The Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy. The Penumbra Pump MAX is the aspiration source for the Penumbra Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHg. The pump is available in both 110Vac and 230Vac versions. The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.
The provided document is a 510(k) premarket notification for the Penumbra Aspiration System. It details the device's indications for use, its classification, and a comparison to predicate and reference devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical (benchtop) and animal study data, largely leveraging existing data from previously cleared similar devices.
Crucially, this document does NOT contain information about specific "acceptance criteria" or "device performance" in terms of clinical outcomes, nor does it describe a study involving human subjects or experts for establishing ground truth for AI/algorithm performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the specified sub-points (table of acceptance criteria/performance, sample size, experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details) because this information is not present in the provided text.
The document discusses:
- Leveraged Non-Clinical Data (Section 1.10): This section lists benchtop tests (Friction, Visual & Dimensional, Pouch Seal Strength, Flow Rate, Tensile, Elongation, Bond Strength, Hub Air Aspiration, Torsion, Burst, Simulated Use, Particulate, Flexibility, Packaging, Corrosion). It states that "all established requirements and acceptance criteria were met," but it does not specify what those acceptance criteria were in measurable terms (e.g., "flow rate X L/min," "tensile strength Y N"). It also does not define "device performance" in the way requested (e.g., diagnostic accuracy, sensitivity, specificity).
- Leveraged Animal Studies (Section 1.11): This section summarizes findings from design validation in GLP animal testing, noting "No vessel injury," "No abnormal gross or histology findings," and "no significant vascular response." This is performance data in an animal model, but not clinical performance in humans, nor does it relate to acceptance criteria for an AI/algorithm-driven device.
In summary, the provided text describes the regulatory clearance process for a medical device (an aspiration system) based on substantial equivalence to existing devices, supported by benchtop testing and animal studies. It does not contain the kind of information typically found in a study proving an AI/algorithm-driven device meets specific clinical acceptance criteria, which would involve human data, expert review, and metrics like accuracy, sensitivity, or specificity.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).