Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12

• K Number: K192981
• Device Name: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
• Manufacturer: Penumbra, Inc
• Date Cleared: 2020-05-28 ( 217 days)
• Product Code: QEW
• Regulation Number: 870.5150

Intended Use

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.

Device Description

The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques. The INDIGO® Aspiration System is comprised of several devices: - INDIGO Aspiration Catheter . - Penumbra Aspiration Pump . - INDIGO Aspiration Pump Canister ● - 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.

Predicate Devices

K142870

Reference Devices

K161523, K180939, K180466

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical aspiration and physical components, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes
The device is clearly indicated for the "removal of fresh, soft emboli and thrombi," which is a direct treatment of a medical condition.

Diagnostic

No

The device is indicated for the removal of fresh, soft emboli and thrombi, which is a therapeutic function, not a diagnostic one. While fluoroscopy is mentioned, it is for guiding the device, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and a canister. The performance studies also focus on the physical and mechanical properties of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The device is indicated for the removal of emboli and thrombi from vessels. This is a therapeutic intervention performed directly on the patient's body.
• Device Description: The description details a system designed for mechanical aspiration within the vasculature. This is an invasive procedure.
• Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is used to physically remove material from within the body.

The device is clearly intended for a therapeutic, interventional procedure, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The INDIGO Aspiration Catheters and Separators, as part of the INDIGO Aspiration System, are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.

The INDIGO Sterile Aspiration Tubing, as part of the INDIGO Aspiration System, is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.

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

Product codes (comma separated list FDA assigned to the subject device)

QEW

Device Description

The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.

The INDIGO® Aspiration System is comprised of several devices:

• INDIGO Aspiration Catheter .
• Penumbra Aspiration Pump .
• INDIGO Aspiration Pump Canister ●
• 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral arterial and venous systems

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians who have received appropriate training in interventional techniques.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Data:

• Biocompatibility: Conducted on the subject Indigo Aspiration Catheter 12 and Separator 12 in accordance with ISO 10993-1 guidelines for a limited exposure (

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).

Summary

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May 28, 2020

Penumbra, Inc Teri Nguyen Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502

Re: K192981

Trade/Device Name: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW Dated: May 15, 2020 Received: May 18, 2020

Dear Teri Nguyen:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K192981

Device Name

Indigo Aspiration System - Aspiration Catheter 12 and Separator 12

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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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® Aspiration System - Aspiration Catheter 12 and Separator 12.

1.1 Sponsor/Applicant Name and Address

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

1.2 Sponsor Contact Information

Teri Nguyen Regulatory Affairs Specialist II Phone: [phone] FAX: [phone] Email: [e-mail]

1.3 Date of Preparation of 510(k) Summary

May 22, 2020

1.4 Device Trade or Proprietary Name

Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12

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	Name of Device	Name of Manufacture
Predicate Device
K142870	Indigo Aspiration System – Aspiration Catheter 8 and
Separator 8	Penumbra, Inc.
Reference Device
K161523	Indigo Aspiration System – Advanced Separator 8	Penumbra, Inc.
K180939	Indigo Aspiration System - Modified Aspiration Tubing
K180466	FlowTriever Retrieval/Aspiration System	Inari Medical, Inc.

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Predicate Comparison 1.7

System Name			Indigo® Aspiration System
	Predicate	Reference		Subject
Classification		Class II, DXE		QEW
510(k) no.	K142870	K161523	K180939	K192981
Indication	The Penumbra Embolectomy
Aspiration System (INDIGOTM
Aspiration System) is intended
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
Catheters and Separators:
As part of the INDIGOTM
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 INDIGOTM
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.	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.	SAME AS REFERENCE
K180939

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| Catheter | | CAT8
[Predicate] | CAT12
[Subject] | |
|--------------------------------------------|-------------|---------------------------------------------------------------------------------------------|-----------------------------------------------|--|
| 510(k) No. | | K142870 | K192981 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for
interventional devices | SAME plus additional material
compositions | |
| Coating | | Hydrophilic | SAME | |
| Dimensions | | | | |
| Proximal OD | | | | |
| Proximal ID | | | SAME plus larger diameters | |
| Distal OD | | Appropriately sized for the target vessel | | |
| Distal ID | | | | |
| Effective Length | | | | |
| Accessories | | | | |
| Introducer | | PTFE | Sheath: Grilamid
ID Band: Polyolefin | |
| Rotating | Materials | Polycarbonate/Silicone/PTFE | SAME | |
| Hemostasis
Valve | French Size | 7.5F | 10F | |
| Kit Packaging
Configuration | | Pouch/Tray Retainer/Tray Base/Tray
Cover/Aspiration Tubing Kit/Ruler
Card/Product Box | SAME | |
| Packaging Materials (Kit
Configuration) | | Commonly used materials for medical
devices | SAME | |
| Separator | | Advanced SEP8
[Reference] | SEP12
[Subject] | |
| 510(k) No. | | K161523 | K192981 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for
interventional devices | SAME plus additional material
compositions | |
| Dimensions | | | | |
| Wire | | | | |
| OD Center Section | | | | |
| OD Proximal | | | SAME | |
| Proximal Length | | Appropriately sized for the target vessel | | |
| Working Length | | | | |
| Total Length | | | | |
| Cone | | | | |
| Cone OD | | 0.072 in (1.82 mm) | 0.110 in (2.79 mm) | |
| Cone Shape | | Diamond | SAME | |
| Accessories | | | | |
| Torque Device | | Polycarbonate/Brass/Polypropylene | SAME | |
| Introducer Sheath | | Stainless Steel with Grilamid | N/A | |

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| Packaging Materials | Commonly used materials for medical
devices | SAME |
|---------------------|------------------------------------------------|-----------|
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |

1.8 Device Description

The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.

The INDIGO® Aspiration System is comprised of several devices:

• INDIGO Aspiration Catheter .
• Penumbra Aspiration Pump .
• INDIGO Aspiration Pump Canister ●
• 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

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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.

1.9 Indications for Use

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.

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 Catheter 12 and Separator 12 as well as its substantial equivalence to the predicate device:

• Biocompatibility .
• Design Verification (Bench-Top Testing) ●
• . Shelf Life
• Sterilization ●
• Packaging

The subject Indigo Aspiration Catheter 12 and Separator 12 met all established requirements.

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1.10.1 Biocompatibility

Biocompatibility was conducted on the subject Indigo Aspiration Catheter 12 and Separator 12. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (