(51 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 K161523.
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 is 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 Penumbra Engine Pump and Canister
The Penumbra Engine Pump ("Engine Pump") is an electromechanical device designed to create vacuum pressure for use with the Indigo System. The Engine Pump maintains vacuum pressure for 3 hours of continuous use and has an operating life of ≥ 500 hours. The pump can be used in environments with 100 - 240 Vac and 50/60 Hz. The Engine Pump is intended for use in operating rooms or interventional catheterizations laboratories. The Engine Pump and Canister do not come into contact with the patient. The Engine Pump Canister is a 1000 mL minimum volume reservoir which is an accessory to the Engine Pump. The Canister has a lid with a stop-flow filter to prevent excess fluid from entering the pump. The patient port on the lid is sized to accept the Suction Connector on the Indigo Aspiration Tubing.
The provided document describes the Indigo Aspiration System - Penumbra Engine Pump and Canister. It is a 510(k) premarket notification for a medical device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K161523 cleared on July 1, 2016, also called Indigo Aspiration System, and a reference device K122756 Penumbra Pump MAX).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table for the "Design Verification (Bench-top Testing and Electrical Safety/EMC Testing)" of the Penumbra Engine Pump and Canister.
| Attribute | Specification | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Pump - Electrical Safety | The Pump conforms to IEC 60601-1 and IEC 60601-1-2 requirements including international worldwide variants (CB Scheme). The Pump is compliant with EN ISO 10079-1. | 100% Pass | 100% Pass |
| Pump - Environmental Testing | Pump performance specifications under environmental conditions | 100% Pass | 100% Pass |
| Pump - Dimensional Inspection | Dimensional specifications per Product Specification | 100% Pass | 100% Pass |
| Pump - Inspection of Design Features | Design specifications per Product Specification | 100% Pass | 100% Pass |
| Pump - Performance | Performance specifications per Product Specification | 100% Pass | 100% Pass |
| Pump - Performance at variable voltage and frequency | Performance specifications per Product Specification | 100% Pass | 100% Pass |
| Pump and Canister - 500 hour Use Testing | Performance specifications after 500 hour use | 100% Pass | 100% Pass |
| Pump Canister - Inspection of Design Features | Design specifications per Product Specification | 100% Pass | 100% Pass |
| Pump Canister - Performance | Performance specifications per Product Specification | 100% Pass | 100% Pass |
| Pump and Canister - Simulated Use | Pump and Canister use specifications | 100% Pass | 100% Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The sample size for the test set is indicated in the "Sample Size" column of the table above:
- For "Pump - Electrical Safety": N=1
- For all other tests related to the Pump and Canister: N=5
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the tests are described as "Bench-top testing" and "Electrical safety and EMC testing," performed by "Intertek, a nationally recognized test laboratory." This implies laboratory-based testing rather than clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The tests described are engineering and performance verification tests for a mechanical/electrical device, not diagnostic or interpretive tasks where human experts would establish ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are objective engineering performance measures, not subjective interpretations requiring adjudication. The "100% Pass" acceptance criteria suggest direct measurement against specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. This device is a pump and canister, which are components of an aspiration system, not a diagnostic imaging device or an AI algorithm intended to assist human readers. The clinical performance of the entire Indigo Aspiration System (catheters and separators) for removing emboli and thrombi is separate from the performance of the vacuum pump itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone study was done, but it refers to the standalone performance of the device (pump and canister) itself, not an algorithm. The tests listed in the table demonstrate the performance of the Penumbra Engine Pump and Canister without human intervention for the specific parameters being tested (e.g., electrical safety, dimensional inspection, performance specs, 500-hour use). This is a technical performance assessment, not an AI algorithm assessment.
7. Type of Ground Truth Used:
For the tests described, the "ground truth" is based on engineering specifications, performance standards (e.g., IEC 60601-1, EN ISO 10079-1), and product design specifications. These are objective, measurable criteria, not expert consensus, pathology, or outcomes data typically associated with diagnostic or therapeutic device efficacy.
8. Sample Size for the Training Set:
This information is not applicable. The device is an electromechanical pump and canister, not an artificial intelligence or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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).