(96 days)
INDIGO Aspiration Catheters and Separators: As part of the Penumbra Embolectomy Aspiration System (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 arterial and venous systems. Not for use in the coronaries or the neurovasculature.
INDIGO Aspiration Tubing: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.
The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial and venous systems. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for the Aspiration Catheters with Aspiration Tubing is available. Intended users for this device are physicians who have received appropriate training in interventional radiology.
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The use of the INDIGO Separator may not be necessary when using an INDIGO Aspiration Catheter with an I.D. of 0.054in [1.37mm] or larger. The INDIGO Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The INDIGO Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.
The Penumbra Pump MAX is the aspiration source for the INDIGO 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 inHz. The pump is available in both 110Vac and 230Vac versions.
The front face of the Penumbra Pump MAX has a display panel with a vacuum gauge, suction regulating valve, and power switch. The Penumbra Pump MAX 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System).
It's important to note that this document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of all validation studies. Therefore, some information requested might not be explicitly present or might be referenced by prior clearances.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | These evaluations confirm that the units used in this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Simulated Use (Vessel Access Entry Performance & Clot Removal) | Simulated use testing of the Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the vasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Catheter does not collapse under vacuum. | 100% Pass |
| Catheter Coating | Coating has not delaminated, peeled, or flaked after simulated use. | 100% Pass |
| Gross Leak | Pouch seals, pouch front, and pouch back material do not leak. | 100% Pass |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "Visual Inspection," "Catheter Coating," and "Gross Leak" tests. For the "Simulated Use" test, it states that "Devices were delivered through the tortuous anatomical model..." but doesn't provide a specific number of devices or trials.
Data Provenance: The studies described in Section 1.11 Non-Clinical Data – KIT Configuration are benchtop or laboratory studies, not directly involving human or animal data for this specific submission. The original provenance for the predicate device and leveraged data (as mentioned in Sections 1.10 and 1.12) would be from previous submissions (K142870, K121917, K122756), which are not detailed in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The described tests (Packaging Validation) are physical and mechanical property assessments. These typically do not involve human expert adjudication for ground truth, but rather engineering or quality control personnel assessing against defined specifications. Therefore, information about experts and their qualifications (like radiologists) is not applicable to these specific tests.
4. Adjudication Method for the Test Set
Not applicable for these types of engineering/benchtop tests. The results are binary (Pass/Fail) based on objective measurements against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document describes a 510(k) submission primarily based on demonstrating substantial equivalence to a predicate device through non-clinical (benchtop) testing and leveraging data from prior clearances. It does not include an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a mechanical system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device is a mechanical aspiration system, not an algorithm.
7. The Type of Ground Truth Used
For the Packaging Validation tests, the "ground truth" is defined by the technical specifications and performance criteria established for the device's physical and mechanical properties. This is typically determined through engineering design documents and quality control standards.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a mechanical device.
§ 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).