Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical components and their physical properties, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.

Therapeutic

Yes
The device is used to remove emboli and thrombi from blood vessels to restore normal blood flow, which is a therapeutic intervention.

Diagnostic

No

The device is indicated for the removal of emboli and thrombi (treatment), not for identifying or diagnosing them.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including catheters, separators, tubing, and a pump, which are physical medical devices used in a procedure.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for the "removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems." This is a therapeutic intervention performed directly on the patient's body.
Device Description: The description details a system of catheters, separators, and a pump used to physically remove blockages from blood vessels. This is an invasive procedure.
Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.

Therefore, the INDIGO Aspiration System is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 Pump MAX.

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

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

DXE

Device Description

The INDIGO Aspiration System is comprised of several devices:

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

The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used in parallel with the INDIGO Separator and an aspiration source to separate the embolus or thrombus and aspirate it from the occluded vessel. The INDIGO Separator is deployed from the INDIGO Aspiration Catheter. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion. This facilitates aspiration and debulking of the thrombus and reduces or eliminates the endovascular clot burden. 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 devices are visible under fluoroscopy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

fluoroscopy

Anatomical Site

peripheral arterial and venous systems

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Design Verification (Bench-Top Testing), Shelf-life. The subject Separator 8 met all predetermined requirements.

Bench-top testing was based on the design specifications, risk analysis and available guidance documents. The physical and mechanical properties of subject Separator 8 devices were assessed using standard test methods and pre-determined acceptance criteria. Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle. All established acceptance criteria were met.
Summary of the testing performed on subject Separator 8:

Dimensional/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. Acceptance Criteria: 100% Pass. Results: 100% Pass.
Simulated Use (Peripheral Access, Vessel Access Entry Performance & Clot Removal): Simulated use testing of the Aspiration Catheter and Separator was performed with accessory devices in an anatomical Vascular Flow model which simulated the tortuosity of the peripheral vasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Aspiration Catheter does not collapse under vacuum. Acceptance Criteria: 100% Pass. Results: 100% Pass.
Separator Shape: Must be diamond shaped. Acceptance Criteria: 100% Must meet Specification. Results: 100% Pass.
Advanced Separator 8 and Wire Joint Break Force: >= 0.67 lb. Acceptance Criteria: 100% Must meet Specification. Results: 100% Pass.
Core Wire PTFE Coating Integrity: Coating has not delaminated, peeled, or flaked after simulated use. Acceptance Criteria: 100% Must meet Specification. Results: 100% Pass.
Particulate Testing with Heparinized Saline (Separator): The maximum number of particles: >= 10 um will be = 25 um will be = 75 um & >= 125 um.

All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the subject Separator 8 devices are acceptable for the intended use and substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160533

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K100826, K082290

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.

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

July 1, 2016

Penumbra, Inc. Ms. Aditi Kolla Regulatory Affairs Manager One Penumbra Place Alameda. CA 94502

Re: K161523

Trade/Device Name: INDIGO™ Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: June 1, 2016 Received: June 2, 2016

Dear Ms. Kolla:

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 devicerelated 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.

1

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/ResourcesforYou/Industry/default.htm. 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.

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,

Brian D. Pullin -S

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

Enclosure

2

Indications for Use

510(k) Number (if known) K161523

Device Name INDIGO™ Aspiration System

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 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 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)
-------------------------------------------------

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 subject Separator 8.

1.1 Sponsor/Applicant Name and Address

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

1.2 Sponsor Contact Information

Aditi Kolla Regulatory Affairs Specialist Phone: (510) 995-2010 Fax: (510) 217-6414 Email: akolla@penumbrainc.com

1.3 Date of Preparation of 510(k) Summary

June 24, 2016

Device Trade or Proprietary Name 1.4

INDIGO™ Aspiration System

Device Classification 1.5

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

4

Image /page/4/Picture/0 description: The image shows the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. The logo appears to be for a company or organization called Penumbra.

Predicate and Reference Devices 1.6

Predicate Device
510(k) Number	Clearance Date	Name of Predicate Device	Name of
Manufacturer
K160533	May 24, 2016	Separator 8	Penumbra, Inc.
Reference Devices
510(k) Number	Clearance Date	Name of Predicate Device	Name of
Manufacturer
K100826	13 July 2010	PX 400 Microcatheter	Penumbra, Inc.
K082290	31 October 2008	Neuron 6F Delivery
Catheters 053 and 070	Penumbra, Inc.

1.7 Predicate Comparison

Common Device Name	Penumbra Embolectomy Aspiration System
Trade Name	INDIGO™ Aspiration System
510(k) No.	K160533	K161523
Classification	Class II, DXE	Class II, DXE
Intended Use	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.

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.

5

Image /page/5/Picture/0 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a sans-serif font and is the main focus of the image. The red circle with the white "P" is located to the right of the word "Penumbra" and serves as a logo for the company.

Common Device Name	Penumbra Embolectomy Aspiration System
Trade Name	INDIGO™ Aspiration System
510(k) No.	K160533	K161523
Proximal Coil	Stainless Steel 304	Pebax 63D - colorant (green for 90 cm
length/orange for 150 cm length)
Solder Joint	Gold Solder [Au/Sn] & Silver
Solder [SN/Ag]	Same
Separator Cone Tip	Pebax 40D, Transparent Blue
(or)
Pebax 35D with 40% Alldyne
Tungsten and 5% Titanium Oxide
(TiO2)	Same
Dimensions
Total Length	150 cm	90 cm, 150 cm
Working Length	96cm	50cm, 96cm
Flex Length	30 cm	20 cm
Cone Shape	teardrop	diamond
Distal Cone OD	0.068" (1.73mm)	0.072" (1.83mm)
Center Section OD	0.021" (0.533mm)	Same
Cone Length	5mm	7mm
Accessories	Torque Device & Introducer
Sheath	Same
Packaging Materials
& Configuration	Commonly utilized for
interventional devices	Same
Aspiration Source	Aspiration Pump	Same
Sterilization	EO	Same
Shelf-Life	36 Months	Same

Device Description 1.8

The INDIGO Aspiration System is comprised of several devices:

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

The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used in parallel with the INDIGO Separator and an aspiration source to separate the embolus or thrombus and aspirate it from the occluded vessel. The INDIGO Separator is deployed from the INDIGO Aspiration Catheter. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion. This facilitates aspiration and debulking of the thrombus and reduces or eliminates the endovascular clot burden. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO

6

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 devices are visible under fluoroscopy.

1.9 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 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 Pump MAX.

Penumbra Pump MAX

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

1.10 Summary of Non-Clinical Data

Included in this section is a description of the testing, which substantiates the substantial equivalence of subject Separator 8 to the predicate device:

Design Verification (Bench-Top Testing) .
Shelf-life .

The subject Separator 8 met all predetermined requirements.

1.10.1 Biocompatibility Testing

Biocompatibility testing previously performed on the predicate and reference devices listed in Section 1.6 substantiate the biocompatibility of the subject Separator 8. Studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.

7

1.10.2 Bench-top Testing

Testing was based on the design specifications, risk analysis and available guidance documents. These guidance documents include:

Guidance on Premarket Notification [510(k)] Submission for Short-Term and . Long-Term Intravascular Catheters (FDA - 1995)
EN ISO 10555-1:2013 Sterile, single-use intravascular catheters Part 1: ● General Requirements

The physical and mechanical properties of subject Separator 8 devices were assessed using standard test methods and pre-determined acceptance criteria. Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle. All established acceptance criteria were met. The summary of the testing performed on subject Separator 8 is listed below:

| Attribute | Specification | Acceptance
Criteria | Results |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------|
| Dimensional/
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. | | 100% Pass |
| Simulated Use
(Peripheral Access,
Vessel Access Entry
Performance & Clot
Removal) | Simulated use testing of the Aspiration
Catheter and Separator was performed with
accessory devices in an anatomical
Vascular Flow model which simulated the
tortuosity of the peripheral vasculature.
Devices were delivered through the tortuous
anatomical model to evaluate the
effectiveness of the devices to remove clots
and that the Aspiration Catheter does not
collapse under vacuum. | | 100% Pass |
| Separator Shape | Must be diamond
shaped | 100% Must
meet
Specification | 100% Pass |
| Advanced Separator
8 and Wire Joint
Break Force | $\ge$ 0.67 lb | 100% Must
meet
Specification | 100% Pass |
| Core Wire PTFE
Coating Integrity | Coating has not
delaminated,
peeled, or flaked | 100% Must
meet
Specification | 100% Pass |

8

Image /page/8/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending beyond the circle.

| Attribute | Specification | Acceptance
Criteria | Results |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------|
| | after simulated use | | |
| Particulate Testing
with Heparinized
Saline (Separator) | The maximum
number of particles:
$\geq$ 10 μm will be $\leq$
6000 particles
$\geq$ 25 μm will be $\leq$
600 particles. | 100% Must meet
Specification | 10μm
100% Pass

All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the subject Separator 8 devices are acceptable for the intended use and substantially equivalent to the predicate device.

1.11 Sterilization

The sterilization data from previous pre-market notification listed in Section 1.6 are directly applicable to the subject devices and no additional testing was required or performed. The subject devices were adopted into the existing validated Ethylene Oxide (EO) sterilization cycle as per TIR28, Annex A. Therefore, the subject Separator 8 has proved to be sterile in accordance with EN ISO 11135:2014.

1.12 Shelf-life

The subject Separator 8 has proved to have a 36 month shelf-life.

1.13 Summary of Substantial Equivalence

The subject Separator 8 device is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.