(23 days)
INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.
INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO 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 Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180105.
The Indigo System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the Aspiration 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 0.054in or larger. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a 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 Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Aspiration Catheter may be provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy.
The Indigo Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Indigo Aspiration Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for IST1, 0.088 in [2.24mm] for IST2, and 0.110 in [2.79mm] for IST3 and IST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices.
Here's an analysis of the acceptance criteria and supporting study for the Penumbra Indigo Aspiration System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are primarily found in Section 1.10, "Summary of Non-Clinical Data," specifically subsections 1.10.1 (Biocompatibility) and 1.10.2 (Design Verification - Bench-top Testing).
| Test / Test Subject | Attribute | Acceptance Criteria | Result |
|---|---|---|---|
| Biocompatibility (Modified 110 Aspiration Tubing) | |||
| Cytotoxicity (MEM Elution) / EN ISO 10993-5 | n/a | Sample extracts must yield a cell lysis grade of 2 or lower | Grade 2: Mild |
| Sensitization / EN ISO 10993-10 | n/a | Test Group shall yield Grade 1 score on Magnusson and Kligman scale (provided Control Grade |
§ 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).