Indigo Aspiration System Lightning Aspiration Tubing

K200771 · Penumbra, Inc. · QEW · Apr 22, 2020 · Cardiovascular

Device Facts

• Record ID: K200771
• Device Name: Indigo Aspiration System Lightning Aspiration Tubing
• Applicant: Penumbra, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Apr 22, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

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, and for the treatment of pulmonary embolism. 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 Story

Indigo Aspiration System Lightning Aspiration Tubing connects Indigo Aspiration Catheters to Penumbra Aspiration Pump; facilitates mechanical aspiration of thrombus from peripheral vasculature and pulmonary arteries. System components include aspiration catheter, separator, pump, canister, and tubing. Physician introduces catheter through guide catheter/sheath over guidewire to occlusion site; uses pump to create vacuum for thrombus removal. Separator may be deployed through catheter to clear lumen blockages. Devices are fluoroscopically visible. System provides clinical benefit by restoring blood flow in occluded vessels. Used in clinical settings by physicians.

Clinical Evidence

No new clinical data performed. Relies on EXTRACT-PE clinical study data from reference device (K192833), which demonstrated safety and effectiveness for acute pulmonary embolism.

Technological Characteristics

Mechanical aspiration system. Components include aspiration catheter, separator, pump, canister, and tubing. Materials are identical to predicate (K193244). Sterilization via ethylene oxide (EO). Fluoroscopically visible. No software or electronic algorithms integral to the tubing function.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous vessels and treatment of pulmonary embolism in patients requiring mechanical aspiration.

Regulatory Classification

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.

Predicate Devices

• Indigo System – Lightning Aspiration Tubing (K193244)

Reference Devices

• Indigo Aspiration System (K192833)

Submission Summary (Full Text)

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April 22, 2020

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

Re: K200771

Trade/Device Name: Indigo Aspiration System Lightning Aspiration Tubing Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: March 24, 2020 Received: March 25, 2020

Dear Ms. Victoria:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200771

Device Name

Indigo Aspiration System Lightning Aspiration Tubing

Indications for Use (Describe)

INDIGO Aspiration Catheters and Separators:

As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism.

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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Image /page/3/Picture/1 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red serif font. To the right of the word is a red circle with a white "P" inside of it. A thin white line connects the word "Penumbra" to the "P" in the circle.

#### 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® System - Lightning Aspiration Tubing.

#### 1.1 Sponsor/Applicant Name and Address

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

#### 1.2 Sponsor Contact Information

Micaela Victoria Regulatory Affairs Specialist III Phone: [phone] FAX: [phone] Email: mvictoria2(@penumbrainc.com

#### Date of Preparation of 510(k) Summary 1.3

April 16, 2020

#### 1.4 Device Trade or Proprietary Name

Indigo® Aspiration System Lightning Aspiration Tubing

#### Device Classification 1.5

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

#### 1.6 Predicate and Reference Devices

| 510(k) Number/Clearance Date | Name of Device | Name of Manufacture |
|--------------------------------------|------------------------------------------------|---------------------------------------------------------------|
| Predicate Device | | |
| K193244 cleared on March 13, 2020 | Indigo System – Lightning<br>Aspiration Tubing | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
| Reference Device | | |
| K192833 cleared on December 20, 2019 | Indigo Aspiration<br>System | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |

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Image /page/4/Picture/0 description: The image shows the logo for Penumbra, a healthcare company. The word "Penumbra" is written in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside of it.

#### Predicate Comparison 1.7

| System Name | Indigo Aspiration System | | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | Predicate Device | Reference Device | Subject Device |
| 510(k) No. | K193244 | K192833 | To be determined |
| Classification | QEW | SAME | SAME |
| Indication for<br>Use | INDIGO Aspiration Catheters<br>and Separators:<br>As part of the INDIGO<br>Aspiration System, the<br>INDIGO Aspiration Catheters<br>and Separators are indicated<br>for the removal of fresh, soft<br>emboli and thrombi from<br>vessels of the peripheral<br>arterial and venous systems.<br><br>INDIGO Aspiration Tubing:<br>As part of the INDIGO<br>Aspiration System, the<br>INDIGO Sterile Aspiration<br>Tubing is indicated to connect<br>the INDIGO Aspiration<br>Catheters to the Penumbra<br>Aspiration Pump.<br><br>Penumbra Aspiration Pump:<br>The Penumbra Aspiration<br>Pump is indicated as a vacuum<br>source for the Penumbra<br>Aspiration Systems. | INDIGO Aspiration Catheters and<br>Separators:<br>As part of the INDIGO Aspiration<br>System, the INDIGO Aspiration<br>Catheters and Separators are<br>indicated for the removal of fresh,<br>soft emboli and thrombi from<br>vessels of the peripheral arterial and<br>venous systems, and for the<br>treatment of pulmonary embolism.<br><br>INDIGO Aspiration Tubing:<br>As part of the INDIGO Aspiration<br>System, the INDIGO Sterile<br>Aspiration Tubing is indicated to<br>connect the INDIGO Aspiration<br>Catheters to the Penumbra<br>Aspiration Pump.<br><br>Penumbra Aspiration Pump:<br>The Penumbra Aspiration Pump is<br>indicated as a vacuum source for<br>the Penumbra Aspiration Systems. | Same as Reference Device (K192833) |

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Image /page/5/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 from the right side of the "P" to the edge of the circle.

| System Name | | | Indigo Aspiration System | | |
|---------------------------------------------|-------------------------------------------------|------------------|------------------------------------|--|--|
| | Predicate Device | Reference Device | Subject Device | | |
| Packaging,<br>Materials &<br>Configurations | Commonly utilized for<br>interventional devices | SAME | SAME | | |
| Aspiration<br>Source | Penumbra Aspiration Pump | SAME | SAME | | |
| Sterilization | EO | SAME | SAME | | |
| Shelf-Life | 12 Months | 36 Months | SAME as Predicate Device (K193244) | | |

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Image /page/6/Picture/1 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red serif font. To the right of the word is a red circle with a white "P" inside of it. A white line extends from the right side of the word "Penumbra" to the left side of the "P".

#### Device Description 1.8

The INDIGO® Aspiration System is comprised of several devices:

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

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 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 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.

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Image /page/7/Picture/1 description: The image shows the Penumbra company logo. The word "Penumbra" is written 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 from the right side of the "P" to the edge of the circle.

#### Indications for Use 1.9

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, and for the treatment of pulmonary embolism.

## 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

The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged.

### 1.10.1 Summary of Biocompatibility

There are no changes to the previously provided biocompatibility data of the Indigo System Lightning Aspiration Tubing sterile device materials cleared in K193244 (predicate device).

## 1.10.2 Summary of Performance Testing - Bench-Top

There are no changes to the previously provided bench-top data of the devices cleared in K193244 (predicate device).

### 1.11 Summary of Performance Data - Clinical

The predicate, Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). The EXTRACT-PE trial demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met. No additional clinical data is required or was performed for these devices.

## 1.12 Summary of Shelf-Life

There are no changes to the previously provided shelf-life data of the devices cleared in K193244 (predicate device).

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Image /page/8/Picture/1 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, and the colors are eye-catching.

# 1.13 Summary of Packaging

There are no changes to the packaging material listing or the packaging process for the devices cleared in K193244 (predicate device).

# 1.14 Summary of Substantial Equivalence

The subject device is substantially equivalent to the predicate and reference devices, as provided in Section 1.7, with regard to indications, intended use, design, performance, materials, sterilization and packaging.