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 arterial 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.

Device Description

The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial 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 K180939.
The INDIGO® Aspiration System is comprised of the several devices:

· INDIGO Aspiration Catheter
Penumbra Aspiration Pump
INDIGO Pump/Canister Tubing
INDIGO Aspiration Tubing
INDIGO Separator
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 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.
Lightning Aspiration Tubing: The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device (Indigo Aspiration System - Lightning Aspiration Tubing) and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a comparative effectiveness study with human readers assisting AI or an AI standalone system. The concepts of AI assistance, multi-reader multi-case studies, and specific performance metrics like sensitivity/specificity for AI are not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing conducted to ensure the new device functions as intended and is equivalent to the predicate device. The prompt's request for information largely aligns with the type of evaluation performed for an AI-powered diagnostic device, which is not what this document describes.

Therefore, providing a direct answer to all points of the prompt as though the document describes an AI diagnostic or assistive device study would be factually incorrect and misleading.

However, I can extract the relevant information regarding the engineering/performance acceptance criteria and the supporting studies from the provided document as it pertains to the device's substantial equivalence.

Here's how the information can be broken down based on the document's content, focusing on what is present:

Device: Indigo Aspiration System - Lightning Aspiration Tubing

Regulatory Class: Class II

Product Code: QEW (Embolectomy Catheter)

Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K180939, 110 Aspiration Tubing, modified).

1. Table of Acceptance Criteria and Reported Device Performance

The document details various non-clinical tests performed to demonstrate the device meets its design specifications and is substantially equivalent to the predicate. These are more akin to engineering and material acceptance criteria rather than diagnostic performance metrics.

Acceptance Criteria (Attribute/Specification)	Reported Device Performance (Results)
Biocompatibility:
In Vitro Cytotoxicity (ISO Elution Test) - Non-Toxic	Pass - Non-Toxic
Sensitization (ISO Maximization Test) - Non-Sensitizing	Pass - Non-Sensitizing
Irritation (ISO Intracutaneous Reactivity) - Non-Irritant	Pass - Non-Irritant
Design Verification (Bench-Top Testing):
Dimensional/Visual Inspection (Units meet all product specifications)	Pass
Simulated Use (Units meet specifications)	Pass
Tensile Strength (Minimum value per specification)	Pass
Indigo Aspiration System Compatibility (Must meet specification)	Pass
Lightning Aspiration Tubing Valve Sense Testing (Must meet specification)	Pass
Shelf Life:
Support a 12-month shelf life (based on accelerated aging)	Shelf life supported
Sterilization:
Ethylene Oxide (EO) gas exposure in accordance with BS EN ISO 11135	Device provided sterile
Packaging:
Packaging Validation Testing - Met all acceptance criteria	Met all acceptance criteria
Software Verification and Validation:
Complies with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Minor Level of Concern)	Complies
Electrical Safety/EMC Testing:
Complies with IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, and IEC/EN 62366-1	Complies

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

Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI study. The "test sets" for each specific engineering/performance test (e.g., biocompatibility, tensile strength, simulated use) would vary, but the document does not provide the exact sample sizes for each. It generally states that "units" or "the subject device" were tested.
Data Provenance: The tests are non-clinical (bench-top, laboratory testing) and focused on device performance, not clinical patient data. The provenance is internal to Penumbra, Inc. (Alameda, CA, USA). The document does not specify if any retrospective or prospective patient data was used, as it explicitly states "Clinical Testing was not required".

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

This concept is not applicable to this 510(k) submission. "Ground truth" in the context of AI diagnostic performance is typically established by medical experts (e.g., radiologists, pathologists). Here, the "ground truth" for each test is its defined engineering specification or a generally accepted laboratory standard (e.g., ISO guidelines for biocompatibility). The experts would be engineers, chemists, and quality control professionals, but their number and specific qualifications are not detailed in this regulatory summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1 consensus) are used for resolving disagreements among human readers or between human readers and AI outputs in diagnostic studies. For engineering tests, results are typically binary (pass/fail) based on objective measurements against pre-defined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers. It's a medical device (aspiration tubing) used in a non-AI surgical/interventional procedure. Therefore, no MRMC study with human readers and AI assistance was conducted or described.

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

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various non-clinical tests were:

Pre-defined engineering specifications (e.g., dimensional requirements, tensile strength minimums).
International and national standards (e.g., ISO 10993-1 for biocompatibility, IEC/EN 60601 series for electrical safety).
Results from previously cleared predicate devices for comparison.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable, as no training set exists for this device.

Summary

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March 13, 2020

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

Re: K193244

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: February 11, 2020 Received: February 12, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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.

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) K193244

Device Name

Indigo Aspiration System - Lightning Aspiration Tubing

Indications for Use (Describe)

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.

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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1 510(k) Summary

(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® Aspiration 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: mvictoria@penumbrainc.com

1.3 Date of Preparation of 510(k) Summary

January 14, 2020

1.4 Device Trade or Proprietary Name

Indigo® Aspiration System – Lightning Aspiration Tubing

1.5 Device Classification

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 Manufacturer	System Name	INDIGO® Aspiration System
Predicate Device			Device Name	110 Aspiration Tubing (modified)[Predicate Device]	110 Aspiration Tubing[Reference Device]	Lightning AspirationTubingSubject Device
K180939 cleared on May 3, 2018	110 Aspiration Tubing(Modified) – INDIGOAspiration System	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA	510(k) Number	K180939	K142870	TBD
Reference Device			Classification	DXE	SAME	QEW
K142870 cleared on May 26, 2015	110 Aspiration Tubing –INDIGO AspirationSystem	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA	Indication for Use	INDIGO Aspiration Catheters and SeparatorsAs part of the INDIGO Aspiration System, theINDIGO Aspiration Catheters and Separators areindicated for the removal of fresh, soft emboliand thrombi from vessels of the peripheral arterialand venous systems.INDIGO Aspiration TubingAs part of the INDIGO Aspiration System, theINDIGO Sterile Aspiration Tubing is indicated toconnect the INDIGO Aspiration Catheters to thePenumbra Aspiration Pump.Penumbra Aspiration PumpThe Penumbra Aspiration Pump is indicated as avacuum source for Penumbra Aspiration Systems.	The Penumbra EmbolectomyAspiration System isintended for the removal offresh, soft emboli andthrombi from vessels of theperipheral arterial andvenous systems.Not for use in the coronariesor the neurovasculature.	SAME as PredicateDevice
Materials	Biocompatible, commonly utilized forinterventional devices	SAME	SAME
Dimensions
Tubing inner diameter(ID)	0.110 in	SAME as Predicate Device	0.131 in

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1.7 Predicate Comparison

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Tubing outer diameter(OD)	0.188 in	SAME as Predicate Device	0.237 in
Overall Length	100.0 in	112.0 in	SAME as PredicateDevice
Distal length	N/A (Single piece construction)	7.9 in	8 in
PackagingConfigurations	Individual and Kit	SAME as Predicate Device	Kit only
Packaging Materials	Commonly utilized for interventional devices	SAME	SAME
Aspiration Source	Penumbra Aspiration Pump	SAME	SAME
Sterilization	EO	SAME	SAME
Shelf Life	36 months	SAME as Predicate Device	12 months

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1.8 Device Description

The INDIGO® Aspiration System is comprised of the several devices:

· INDIGO Aspiration Catheter
Penumbra Aspiration Pump
INDIGO Pump/Canister Tubing
INDIGO Aspiration Tubing
INDIGO Separator

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 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.

Lightning Aspiration Tubing

The Lightning Aspiration Tubing is a component to the currently available Indigo Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing

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aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.

1.9 Indications for Use

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

As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows.

Included in this section are summary descriptions of the testing (or rationale for not testing if not applicable) which substantiates the performance of the subject Indigo Aspiration System - Lightning Aspiration Tubing as well as its substantial equivalence to the predicate device:

Biocompatibility (Leveraged) ●
Design Verification (Bench-Top Testing) .
Shelf Life .
Sterilization
Packaging ●
Software .
Electrical/EMC ●

The subject Lightning Aspiration Tubing met all established requirements.

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1.10.1 Biocompatibility (Leveraged)

Biocompatibility was leveraged for the subject Lightning Aspiration Tubing. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), externally communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).

Biocompatibility Test Summary
Test	Method	Results
In Vitro Cytotoxicity	ISO Elution Test (MEMElution)	PassNon-Toxic
Sensitization	ISO Maximization Test(Magnusson and KligmanMethod)	PassNon-Sensitizing
Irritation	ISO Intracutaneous Reactivity	PassNon-Irritant

1.10.2 Design Verification (Bench-Top Testing)

The physical and mechanical properties of the subject Lightning Aspiration Tubing was assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:

Attribute	Specification	Results
Dimensional/VisualInspection	These evaluations confirm that the units used in thisDesign Verification testing meet all productspecification.	Pass
Simulated Use	Simulated use testing of the Aspiration Tubing wasconducted to verify units met specifications	Pass
Tensile Strength	Minimum value per specification	Pass
Indigo Aspiration SystemCompatibility	Must meet specification	Pass
Lightning AspirationTubing Valve SenseTesting	Must meet specification	Pass

Lightning Aspiration Tubing Design Verification Test Results Summary

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1.10.3 Shelf Life

Testing was performed on the subject Lightning Aspiration Tubing to support a 12-month shelf life based on accelerated aging.

1.10.4 Sterilization

The subject Lightning Aspiration Tubing is provided sterile and intended to be single-use. Ethylene Oxide (EO) gas exposure is used to sterilize the subject Lightning Aspiration Tubing accordance with BS EN ISO 11135.

1.10.5 Packaging

Packaging Validation Testing has been completed for the subject Lightning Aspiration Tubing. The subject device met all acceptance criteria.

1.10.6 Software Verification and Validation

Software verification and validation testing and documentation for the Lightning Aspiration Tubing was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005). The software for this device was considered as a Minor Level of Concern.

1.10.7 Electrical Safety/EMC Testing

Electrical Safety and EMC testing were conducted on the Lightning Aspiration Tubing. The subject device complies with the requirements of IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, and IEC/EN 62366-1

1.10.8 Animal Testing

Animal testing was not required for the determination of substantial equivalence.

1.10.9 Clinical Testing

Clinical testing was not required for the determination of substantial equivalence.

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1.11 Summary of Substantial Equivalence

The subject Lightning Aspiration Tubing is substantially equivalent to the predicate device. The subject device has an identical intended use as the predicate device. The subject and the predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology. However, these differences do not raise different questions of safety and effectiveness.

The device testing described in the 510(k) Summary demonstrate the subject devices are substantially equivalent to the predicate device in regard to intended use, fundamental technology and device performance.

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).