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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2016

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

Re: K160533

Trade/Device Name: Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 25, 2016 Received: April 29, 2016

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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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) K160533

Device Name

Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System)

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
× 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 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

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

May 19, 2016

1.4 Device Trade or Proprietary Name

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

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 ofManufacturer
Predicate Device
K142870[26May2015]	Penumbra Embolectomy Aspiration System(INDIGOTM Aspiration System)	Penumbra, Inc.
Reference Devices
K121917[19Sep2012]	Penumbra Embolectomy Aspiration System(INDIGOTM Aspiration System)	Penumbra, Inc.
K122756[02Oct2012]	Penumbra Pump MAX	Penumbra, Inc.

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1.7 Predicate Comparison

	Predicate Device	Subject Device
Trade Name	Penumbra Embolectomy AspirationSystem (INDIGO™ AspirationSystem)	Penumbra Embolectomy AspirationSystem (INDIGO™ AspirationSystem) (including Penumbra PumpMAX)
Predicate 510(k) No.	INDIGO Aspiration System : K142870	K160533
Reference 510(k) No.	INDIGO Aspiration System: K121917Penumbra Pump MAX: K122756
Classification	INDIGO Aspiration System: Class II,DXEPenumbra Pump MAX: Class II, JCX	Class II, DXE
Indication for Use	INDIGO™ Aspiration SystemThe INDIGO™ Aspiration System isintended for the removal of fresh, softemboli and thrombi from vessels of theperipheral arterial and venous systems.Not for use in the coronaries or theneurovasculature.Penumbra Aspiration PumpThe Penumbra Pump MAX is intendedfor general suction use in hospitals orclinics.	INDIGO Aspiration Catheters andSeparatorsAs part of the PenumbraEmbolectomy Aspiration System(INDIGOTM Aspiration System), theINDIGO Aspiration Catheters andSeparators are indicated for theremoval of fresh, soft emboli andthrombi from vessels of theperipheral arterial and venoussystems. Not for use in the coronariesor the neurovasculature.INDIGO Aspiration TubingAs part of the PenumbraEmbolectomy Aspiration System(INDIGOTM Aspiration System), theINDIGO Sterile Aspiration Tubing isindicated to connect the INDIGOAspiration Catheters to the PenumbraPump MAX.Penumbra Pump MAXThe Penumbra Pump MAX isindicated as a vacuum source forPenumbra Aspiration Systems.
Aspiration Catheter
Materials	Biocompatible, commonly utilized forinterventional devices	SAME
Coating	Hydrophilic	SAME
Markerband	Radiopaque	SAME
Guidewire compatible	Yes	SAME
Dimensions
- OD [Maximum]	0.051" - 0.080"[1.295mm - 2.030mm]	SAME
- Working Length	125cm - 153cm	SAME
Separator
	Predicate Device	Subject Device
Trade Name	Penumbra Embolectomy AspirationSystem (INDIGO™ AspirationSystem)	Penumbra Embolectomy AspirationSystem (INDIGO™ AspirationSystem) (including Penumbra PumpMAX)
Predicate 510(k) No.	INDIGO Aspiration System : K142870	K160533
Reference 510(k) No.	INDIGO Aspiration System: K121917Penumbra Pump MAX: K122756
Classification	INDIGO Aspiration System: Class II,DXEPenumbra Pump MAX: Class II, JCX	Class II, DXE
Materials	Biocompatible, commonly utilized forinterventional devices	SAME
Dimensions
- Distal OD	0.022" – 0.045"[0.56mm – 1.14mm]	SAME
- Working Length	135cm – 155cm	SAME
Aspiration Tubing
Materials	Biocompatible, commonly utilized forinterventional devices	SAME
Dimensions
- ID	0.071" – 0.110 " [1.8mm – 2.8mm]	SAME
- Length	112.0" [284.5cm]	SAME
Sterilization	EO	SAME
Shelf-Life	36-Months	SAME
Aspiration Pump
IEC 60601-1Compliance	Yes	SAME
IEC 60601-1-2Compliance	Yes	SAME
Voltage	100-115 Vac/230 Vac	SAME
Frequency	50 Hz/60 Hz	SAME
Sterilization	Non sterile	SAME
Shelf Life	N/A	SAME

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Device Description 1.8

The Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

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Catheters with Aspiration Tubing is available. Intended users for this device are physicians who have received appropriate training in interventional radiology.

The Penumbra Pump MAX

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The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.

Indications for Use 1.9

INDIGO Aspiration Catheters and Separators

INDIGO Aspiration Tubing

Penumbra Pump MAX

The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

1.10 Leveraged Non-Clinical Data - Individual Packaged Devices

The subject and predicate devices are identical. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods. Therefore, biocompatibility data, bench top data, sterilization data, and stability data from previous pre-market notifications listed in Section 1.6 are directly applicable and no additional testing was required or was performed to support the consolidation of the INDIGO Aspiration System and Penumbra Pump MAX under the same product code (DXE), clarifications of the Indications for Use statements, and Instructions for Use (IFU) and Operation, Maintenance, and Service Manual revisions.

1.11 Non-Clinical Data – KIT Configuration

Included in this section is a brief summary of additional testing performed for the KIT configuration packaging:

. Packaging Validation Testing
The KIT configuration met all established requirements.

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1.11.1 Packaging Validation

The physical and mechanical properties of the KIT configuration were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:

Attribute	Specification	Results
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 EntryPerformance &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

The results of the tests appropriately address the physical and mechanical performance expectations of the KIT configuration. Based on these overall results, the physical and mechanical properties of the KIT configuration devices are acceptable for the intended use and substantially equivalent to the predicate device.

1.12 Leveraged Animal Study – Individual Packaged Devices and KIT Configuration

The subject and predicate devices are identical. Therefore, Animal Testing data from previous pre-market notifications listed in Section 1.6 are directly applicable and no further Animal Testing was required or was performed to support the consolidation of the INDIGO Aspiration System and Penumbra Pump MAX under the same product code (DXE), clarifications in the Indications for Use statements, and IFU and Operation, Maintenance, and Service Manual revisions.

1.13 Summary of Substantial Equivalence

The subject INDIGO Aspiration System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelflife, packaging and sterilization 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).