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 arterial and venous systems, and for the treatment of pulmonary embolism.

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.

Device Description

The INDIGO® Aspiration System is comprised of several devices:

INDIGO Aspiration Catheter ●
Penumbra Aspiration Pump ●
INDIGO Aspiration Pump Canister
INDIGO Aspiration Tubing ●
. INDIGO SeparatorTM

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical 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 INDIGO Aspiration Catheter is introduced through a guide catheter or vascular 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 Penumbra 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. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.

AI/ML Overview

This document outlines the substantial equivalence of the "Indigo Aspiration System Lightning Aspiration Tubing" (subject device) to a predicate device (K193244) and a reference device (K192833). The review primarily focuses on demonstrating that the subject device is identical to the predicate device and that prior performance data for similar devices within the Indigo Aspiration System remain applicable.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." This implies that the acceptance criteria for the subject device are met by virtue of it being identical to a previously cleared predicate device that had already satisfied those criteria.

Acceptance Criteria Category	Reported Device Performance (Subject Device)	Supporting Evidence
Biocompatibility	No changes to previously provided biocompatibility data from K193244 (predicate device).	Implicitly, the subject device meets the biocompatibility criteria established for K193244.
Bench-Top Performance	No changes to previously provided bench-top data from K193244 (predicate device).	Implicitly, the subject device meets the bench-top performance criteria established for K193244.
Clinical Performance	No additional clinical data required or performed for these devices. Met by the EXTRACT-PE trial (from K192833, reference device) which demonstrated substantial equivalence for acute PE. Primary efficacy and safety endpoints were met.	Clinical study EXTRACT-PE, associated with reference device K192833.
Shelf-Life	No changes to previously provided shelf-life data from K193244 (predicate device). The shelf-life for the subject device is "SAME as Predicate Device (K193244)", which is 12 Months.	Implicitly, the subject device meets the shelf-life criteria established for K193244.
Packaging	No changes to the packaging material listing or the packaging process for the devices cleared in K193244 (predicate device).	Implicitly, the subject device meets the packaging integrity criteria established for K193244.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility & Bench-Top Performance: Not explicitly stated for the subject device, as these tests were not re-performed. The document refers to data from the predicate device (K193244). The specific sample sizes and provenance for those original tests are not detailed in this document.
Clinical Performance (EXTRACT-PE Trial): The sample size for the clinical study (EXTRACT-PE) is not specified in this document. The data provenance is also not specified (e.g., country of origin). It is stated as a "clinical study" and "trial," suggesting it was prospective. The document refers to the data from the reference device (K192833).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not available in the provided document. The document refers to previous clearances (K193244 and K192833) for performance data, but does not detail how ground truth was established for those studies.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not mentioned or implied. The clinical data cited (EXTRACT-PE) appears to focus on device efficacy and safety outcomes rather than reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device (Indigo Aspiration System Lightning Aspiration Tubing) is a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant here.

7. The Type of Ground Truth Used

For the clinical study (EXTRACT-PE) related to the reference device, the document states it "demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met." This implies that the ground truth was based on clinical outcomes data related to the efficacy of thrombus removal and patient safety in acute pulmonary embolism settings. Specific methods for establishing definitive "ground truth" for patient outcomes (e.g., imaging confirmation, pathology reports, adjudicated clinical events) are not detailed.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable. The device is a physical medical device, not an AI model.

Summary

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April 22, 2020

Penumbra, Inc. Micaela Victoria Regulatory Specialist III One Penumbra Place Alameda, California 94502

Re: K200771

Trade/Device Name: Indigo Aspiration System Lightning Aspiration Tubing Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: March 24, 2020 Received: March 25, 2020

Dear Ms. Victoria:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200771

Device Name

Indigo Aspiration System Lightning Aspiration Tubing

Indications for Use (Describe)

INDIGO Aspiration Catheters and Separators:

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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 1

(as required by 21 CFR 807.92)

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra, Inc. is providing the summary of Substantial Equivalence for the Indigo® System - Lightning Aspiration Tubing.

1.1 Sponsor/Applicant Name and Address

Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA

1.2 Sponsor Contact Information

Micaela Victoria Regulatory Affairs Specialist III Phone: (510) 995-2082 FAX: (510) 217-6414 Email: mvictoria2(@penumbrainc.com

Date of Preparation of 510(k) Summary 1.3

April 16, 2020

1.4 Device Trade or Proprietary Name

Indigo® Aspiration System Lightning Aspiration Tubing

Device Classification 1.5

Regulatory Class:	II
Classification Panel:	Cardiovascular
Classification Name:	Catheter, Embolectomy
Regulation Number:	21 CFR §870.5150
Product Code:	QEW

1.6 Predicate and Reference Devices

510(k) Number/Clearance Date	Name of Device	Name of Manufacture
Predicate Device
K193244 cleared on March 13, 2020	Indigo System – LightningAspiration Tubing	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA
Reference Device
K192833 cleared on December 20, 2019	Indigo AspirationSystem	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA

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Predicate Comparison 1.7

System Name	Indigo Aspiration System
	Predicate Device	Reference Device	Subject Device
510(k) No.	K193244	K192833	To be determined
Classification	QEW	SAME	SAME
Indication forUse	INDIGO Aspiration Cathetersand Separators:As part of the INDIGOAspiration System, theINDIGO Aspiration Cathetersand Separators are indicatedfor the removal of fresh, softemboli and thrombi fromvessels of the peripheralarterial and venous systems.INDIGO Aspiration Tubing:As part of the INDIGOAspiration System, theINDIGO Sterile AspirationTubing is indicated to connectthe INDIGO AspirationCatheters to the PenumbraAspiration Pump.Penumbra Aspiration Pump:The Penumbra AspirationPump is indicated as a vacuumsource for the PenumbraAspiration Systems.	INDIGO Aspiration Catheters andSeparators:As part of the INDIGO AspirationSystem, the INDIGO AspirationCatheters and Separators areindicated for the removal of fresh,soft emboli and thrombi fromvessels of the peripheral arterial andvenous systems, and for thetreatment of pulmonary embolism.INDIGO Aspiration Tubing:As part of the INDIGO AspirationSystem, the INDIGO SterileAspiration Tubing is indicated toconnect the INDIGO AspirationCatheters to the PenumbraAspiration Pump.Penumbra Aspiration Pump:The Penumbra Aspiration Pump isindicated as a vacuum source forthe Penumbra Aspiration Systems.	Same as Reference Device (K192833)

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System Name			Indigo Aspiration System
	Predicate Device	Reference Device	Subject Device
Packaging,Materials &Configurations	Commonly utilized forinterventional devices	SAME	SAME
AspirationSource	Penumbra Aspiration Pump	SAME	SAME
Sterilization	EO	SAME	SAME
Shelf-Life	12 Months	36 Months	SAME as Predicate Device (K193244)

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Device Description 1.8

The INDIGO® Aspiration System is comprised of several devices:

INDIGO Aspiration Catheter ●
Penumbra Aspiration Pump ●
INDIGO Aspiration Pump Canister
INDIGO Aspiration Tubing ●
. INDIGO SeparatorTM

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Indications for Use 1.9

INDIGO Aspiration Catheters and Separators:

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.

1.10 Summary of Non-Clinical Data

The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged.

1.10.1 Summary of Biocompatibility

There are no changes to the previously provided biocompatibility data of the Indigo System Lightning Aspiration Tubing sterile device materials cleared in K193244 (predicate device).

1.10.2 Summary of Performance Testing - Bench-Top

There are no changes to the previously provided bench-top data of the devices cleared in K193244 (predicate device).

1.11 Summary of Performance Data - Clinical

The predicate, Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). The EXTRACT-PE trial demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met. No additional clinical data is required or was performed for these devices.

1.12 Summary of Shelf-Life

There are no changes to the previously provided shelf-life data of the devices cleared in K193244 (predicate device).

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1.13 Summary of Packaging

There are no changes to the packaging material listing or the packaging process for the devices cleared in K193244 (predicate device).

1.14 Summary of Substantial Equivalence

The subject device is substantially equivalent to the predicate and reference devices, as provided in Section 1.7, with regard to indications, intended use, design, performance, materials, sterilization and packaging.

Regulation Number and Section

§ 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).