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.

Device Description

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.

AI/ML Overview

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.

Summary

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March 8, 2018

Penumbra, Inc. Mr. Richard Kimura Regulatory Specialist One Penumbra Place Alameda, California 94502

Re: K180105

Trade/Device Name: Indigo Aspiration System - Penumbra Engine Pump and Canister Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: January 15, 2018 Received: January 16, 2018

Dear Mr. Kimura:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Mr. Richard Kimura

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180105

Device Name

Indigo Aspiration System-Penumbra Engine Pump and Canister

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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® - Penumbra Engine™ Pump and Canister.

1.1 Sponsor/Applicant Name and Address

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

1.2 Sponsor Contact Information

Richard Kimura Regulatory Affairs Specialist Phone: (510) 995-2034 FAX: (510) 217-6414 Email: rkimura@penumbrainc.com

1.3 Date of Preparation of 510(k) Summary

January 12, 2018

1.4 Device Trade or Proprietary Name

Indigo Aspiration System® - Penumbra Engine™ Pump and Canister

1.5 Device Classification

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

1.6 Predicate and Reference Devices

510(k) Number / Clearance Date	Name of Device	Name of Manufacturer
Predicate Device
K161523 cleared on July 1, 2016	Indigo Aspiration System	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA
Reference Device
K122756 cleared on October 2, 2012	Penumbra Pump MAX	Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA

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Predicate Comparison 1.7

	Predicate Device	Subject Device
Trade Name	Indigo System (with Penumbra Pump MAXand Canister)	Indigo System (with Penumbra EnginePump and Canister)
510(k) No.	K161523	To Be Determined
Classification	Class II, DXE	SAME
Indication for Use	INDIGO Aspiration Catheters andSeparatorsAs part of the INDIGO Aspiration System,the INDIGO Aspiration Catheters andSeparators are indicated for the removal offresh, soft emboli and thrombi from vesselsof the peripheral arterial and venoussystems.INDIGO Aspiration TubingAs part of the INDIGO Aspiration System,the INDIGO Sterile Aspiration Tubing isindicated to connect the INDIGO AspirationCatheters to the Penumbra AspirationPump.Penumbra Aspiration PumpThe Penumbra Aspiration Pump is indicatedas a vacuum source for PenumbraAspiration Systems.	SAME
Aspiration Pump
Trade Name	Penumbra Pump MAX and Canister	Penumbra Engine Pump and Canister
IEC 60601-1Compliance	Yes	SAME
IEC 60601-1-2Compliance	Yes	SAME
Voltage	100-115 Vac/230 Vac	100-240 Vac
Frequency	50 Hz/60 Hz	SAME
Sterilization	Non sterile	SAME
Shelf Life	N/A	SAME
The Aspiration Catheters, Separators, and Aspiration Tubings are unchanged and remain identical tothose of the currently cleared Indigo System (K161523).

1.8 Device Description

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Aspiration Pump. The Indigo System was most recently cleared under K161523.

The Penumbra Engine Pump and Canister

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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 to the Engine Pump and Canister) which substantiates the performance of the subject Indigo System with Engine Pump and Canister as well as its substantial equivalence to the predicate device:

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

The subject Indigo System with Engine Pump and Canister met all established requirements.

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1.10.1 Biocompatibility

The subject and predicate Indigo System sterile devices are identical. There are no changes to the previously provided biocompatibility data of the Indigo System materials sterile devices, which were reviewed and cleared under K161523. No additional biocompatibility testing is required or was performed for the Indigo System sterile devices.

The Indigo System Engine Pump is a non-sterile reusable piece of capital equipment. The pump does not contact the patient, nor is it introduced into the sterile field. As such, biocompatibility testing is not required and was not performed for the pump. The Indigo System Engine Pump Canister also does not contact the patient, nor is it introduced into the sterile field. Furthermore, blood or body fluids collected in the canister are not reintroduced to the patient. As such, biocompatibility testing is not required and was not performed for the Canister.

1.10.2 Design Verification (Bench-top Testing and Electrical Safety/EMC Testing)

The subject and predicate Indigo System sterile devices are identical. There are no changes to the design specifications and performance characteristics of the Indigo System sterile devices. Therefore, all previous bench-top testing data which were reviewed and cleared under K161523 continue to support the subject Indigo System sterile devices. No additional bench-top testing is required or was performed for the Indigo System sterile devices.

Bench-top testing was conducted to evaluate the physical and mechanical properties of the subject Indigo System Engine Pump and Canister. All bench-top studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. Performance testing was based on the design specifications, risk analysis, performance standards, and guidance documents.

The Indigo System Engine Pump and Canister also underwent electrical safety and EMC testing in accordance with the requirements of IEC 60601-1 and IEC 60601-1-2. Testing was performed by Intertek, a nationally recognized test laboratory. The Engine Pump and Canister passed all tests and met all acceptance criteria.

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Attribute	SampleSize	Specification	Acceptance Criteria	Results
Pump - ElectricalSafety	N=1	The Pump conforms to IEC 60601-1and IEC 60601-1-2 requirementsincluding international worldwidevariants (CB Scheme). The Pump iscompliant with EN ISO 10079-1.	100% Pass	100% Pass
Pump - EnvironmentalTesting	N=5	Pump performance specificationsunder environmental conditions	100% Pass	100% Pass
Pump - DimensionalInspection	N=5	Dimensional specifications perProduct Specification	100% Pass	100% Pass
Pump - Inspection ofDesign Features	N=5	Design specifications per ProductSpecification	100% Pass	100% Pass
Pump - Performance	N=5	Performance specifications perProduct Specification	100% Pass	100% Pass
Pump - Performance atvariable voltage andfrequency	N=5	Performance specifications perProduct Specification	100% Pass	100% Pass
Pump and Canister -500 hour Use Testing	N=5	Performance specifications after 500hour use	100% Pass	100% Pass
Pump Canister -Inspection of DesignFeatures	N=5	Design specifications per ProductSpecification	100% Pass	100% Pass
Pump Canister -Performance	N=5	Performance specifications perProduct Specification	100% Pass	100% Pass
Pump and Canister -Simulated Use	N=5	Pump and Canister usespecifications	100% Pass	100% Pass

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1.10.3 Shelf Life

The subject and predicate Indigo System sterile devices are identical. There are no changes to the previously provided shelf life data for the sterile devices which were reviewed and cleared under K161523. No additional shelf life testing is required or was performed for the Indigo System sterile devices.

The proposed Indigo System Engine Pump is a reusable piece of capital equipment that is provided non-sterile. Therefore, shelf life testing is not applicable to the Engine Pump and shelf life testing was not performed. The Engine Pump is established for 500 hours of use based on completed life (reliability) testing. The Engine Pump Canister does not have an established shelf life.

1.10.4 Sterilization

The subject and predicate Indigo System sterile devices are identical. There are no changes to the previously provided sterilization data of the devices, which were reviewed and cleared under K161523. No additional sterilization testing is required or was performed for these devices.

Sterilization testing is not applicable to the proposed Indigo System Engine Pump and Canister. Both are supplied non-sterile and are not intended to be sterilized.

1.10.5 Packaging

The packaging materials and process of the subject and predicate Indigo System sterile devices are identical. There are no changes to the previously provided packaging material listing or the packaging process for these devices, which were reviewed and cleared under K161523. No additional packaging testing is required or was performed for the Indigo System sterile devices.

The packaging materials for the proposed Indigo System Engine Pump and Canister are similar to those used for the predicate Indigo System Penumbra Pump MAX and Canister. The Engine Pump and Canister are packaged to ensure that damage does not occur during shipping. The Engine Pump is packaged in a protective, corrugated, cardboard 275 B/C Flute Double Wall RSC shipping container with custom shaped foam inserts. Pumps used for Design Verification and Packaging Validation testing first underwent transportation conditioning per ASTM D4169, Distribution Cycle 3,

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Assurance Level 3 to ensure packaging integrity. The Canister is packaged individual in 200 pound E-Flute container product boxes. The Canister box is then packaged in protective, corrugated, cardboard 275 B/C Flute Double Wall RSC shipping containers (8 canister boxes per shipper).

1.11 Summary of Substantial Equivalence

The subject Indigo System disposable devices are unchanged and remain identical to those of the predicate Indigo System with regard to indications, function, design, materials, biocompatibility, packaging, and sterilization. The subject Indigo System Engine Pump and Canister are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, and packaging processes.

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).