Indigo Aspiration System - Lightning Flash

K222358 · Penumbra, Inc. · QEW · Dec 20, 2022 · Cardiovascular

Device Facts

• Record ID: K222358
• Device Name: Indigo Aspiration System - Lightning Flash
• Applicant: Penumbra, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Dec 20, 2022
• Decision: SESE
• Submission Type: Traditional
• 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 the Penumbra Aspiration Systems.

Device Story

Indigo Aspiration System - Lightning Flash is a mechanical aspiration device for removing thrombus from peripheral vasculature. System components include aspiration catheter, separator, aspiration tubing, and vacuum pump. Physician guides catheter through sheath/guide catheter over guidewire to occlusion site under fluoroscopy. Separator clears catheter lumen if blocked. Tubing connects catheter to pump, which provides vacuum source. Device enables direct aspiration of thrombus. Used in clinical settings by trained physicians. Output is physical removal of emboli/thrombi, improving vessel patency and patient outcomes.

Clinical Evidence

No clinical study conducted. Substantial equivalence supported by bench-top testing and literature review of clinical outcomes for technologically equivalent devices.

Technological Characteristics

System includes aspiration catheter, separator, and tubing. Materials are biocompatible interventional polymers (e.g., Grilamid, Polycarbonate, Silicone, PTFE, Polyolefin). Features hydrophilic coating. Sterilization via Ethylene Oxide (EO). Connectivity: physical tubing connection to vacuum pump. Software: Minor Level of Concern.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous systems 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 Aspiration System – Lightning Aspiration Tubing (K210323)
• Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (K192981)
• Neuron MAX System (K111380)

Reference Devices

• Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (K202821)
• FlowTriever Retrieval/Aspiration System (K180466)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger font and is placed inside a blue square.

January 30, 2023

Penumbra, Inc. Deanna Kimlinger Senior Regulatory Specialist One Penumbra Place Alameda, California 95132

Re: K222358

Trade/Device Name: Indigo® Aspiration System - Lightning® Flash Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW

Dear Deanna Kimlinger:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 20, 2022. Specifically, FDA is updating this SE Letter to correct a typo in the device trade name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, by phone [phone]), or email (gregory.oconnell(@fda.hhs.gov).

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.01.30
12:06:11 -05'00'

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

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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2022

Penumbra, Inc. Deanna Kimlinger Senior Regulatory Specialist One Penumbra Place Alameda, California 95132

Re: K222358

Trade/Device Name: Indigo® Aspiration System - Lighting® Flash Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: November 17, 2022 Received: November 18, 2022

Dear Deanna Kimlinger:

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/ofdocs/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

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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 (OS) 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 mediation-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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/2/Picture/6 description: The image shows a digital signature. The signature is for Gregory W. O'connell. The date of the signature is 2022.12.20, and the time is 15:45:58 -05'00'.

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

Enclosure

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# Indications for Use

510(k) Number (if known) K222358

Device Name Indigo® Aspiration System - Lightning® Flash

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 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)

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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 - Lightning" Flash.

#### 1.1 Sponsor/Applicant Name and Address

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

#### 1.2 Sponsor Contact Information

Deanna Kimlinger Senior Regulatory Affairs Specialist Phone: [phone] FAX: [phone] Email: [e-mail]

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

December 20, 2022

#### 1.4 Device Trade or Proprietary Name

Indigo

#### 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 - Lightning Flash

| 510(k) Number | | Name of Device |
|-----------------------------------|---------|--------------------------------------------------------------------|
| Lightning Flash Aspiration Tubing | | |
| Predicate | K210323 | Indigo Aspiration System – Lightning Aspiration Tubing |
| Reference | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
| Flash Aspiration Catheter | | |
| Predicate | K192981 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
| Reference | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
| Reference | K180466 | FlowTriever Retrieval/Aspiration System |
| Select Catheter (Accessory) | | |
| Predicate | K111380 | Neuron MAX System |

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#### 1.7 Predicate Comparison

| System Name | Indigo® Aspiration System | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | Lightning Aspiration Tubing<br>[Predicate] | CAT12 & SEP12<br>[Predicate] | CAT12 & SEP12 with<br>PE Treatment Indication<br>[Reference] | Lightning Flash<br>[Subject] |
| Classification | Class II, QEW | Class II, QEW | Class II, QEW | SAME |
| 510(k) no. | K210323 | K192981 | K202821 | K222358 |
| Indication | INDIGO Aspiration Catheters<br>and Separators:<br>As part of the INDIGO™<br>Aspiration System, the INDIGO<br>Aspiration Catheters and<br>Separators are indicated for the<br>removal of fresh, soft emboli<br>and thrombi from vessels of the<br>peripheral arterial and venous<br>systems, and for the treatment<br>of pulmonary embolism.<br><br>INDIGO Aspiration Tubing:<br>As part of the INDIGO™<br>Aspiration System, the INDIGO<br>Sterile Aspiration Tubing is<br>indicated to connect the<br>INDIGO Aspiration Catheters to<br>the Penumbra Aspiration Pump.<br><br>Penumbra Aspiration Pump:<br>The Penumbra Aspiration Pump<br>is indicated as a vacuum source<br>for the Penumbra Aspiration | 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<br>fresh, soft emboli and thrombi<br>from vessels of the peripheral<br>arterial and venous systems.<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<br>is indicated as a vacuum source<br>for Penumbra Aspiration<br>Systems. | INDIGO Aspiration Catheters<br>and Separators:<br>As part of the INDIGO™<br>Aspiration System, the INDIGO<br>Aspiration Catheters and<br>Separators are indicated for the<br>removal of fresh, soft emboli<br>and thrombi from vessels of the<br>peripheral arterial and venous<br>systems, and for the treatment<br>of pulmonary embolism.<br><br>INDIGO Aspiration Tubing:<br>As part of the INDIGO™<br>Aspiration System, the INDIGO<br>Sterile Aspiration Tubing is<br>indicated to connect the INDIGO<br>Aspiration Catheters to the<br>Penumbra Aspiration Pump.<br><br>Penumbra Aspiration Pump:<br>The Penumbra Aspiration Pump<br>is indicated as a vacuum source<br>for the Penumbra Aspiration<br>Systems. | SAME AS PREDICATE<br>K210323 and<br>REFERENCE K202821 |
| Aspiration Tubing | Lightning Aspiration Tubing<br>[Predicate] | Lightning Flash Aspiration Tubing<br>[Subject] | | |
| 510(k) No. | | K210323 | K222358 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for<br>interventional devices | SAME | |
| Dimensions | | | | |
| Proximal OD | | Appropriately sized for the Aspiration<br>Catheter | SAME plus larger diameters | |
| Proximal ID | | | | |
| Distal OD | | | | |
| Distal ID | | | | |
| Effective Length | | | | |
| Aspiration Catheter | | Indigo System – CAT12<br>[Predicate] | Indigo System – Flash Aspiration<br>Catheter<br>[Subject] | |
| 510(k) No. | | K192981 | K222358 | |
| Materials | | | | |
| Materials | | Biocompatible, commonly utilized for<br>interventional devices | SAME with subset of colorants | |
| 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 | | | | |
| | | Sheath: Grilamid | SAME | |
| Introducer | | ID Band: Polyolefin | SAME | |
| Rotating<br>Hemostasis | Materials | Polycarbonate/Silicone/PTFE | Polycarbonate/Silicone/PVC/PTFE/<br>Polyolefin with foil/Loctite/<br>Thermoplastic Polymer | |
| Valve<br>(RHV) | French<br>Size | 10F | 13F | |
| Select Catheter<br>(Accessory) | | Neuron MAX - 6F Select Catheter<br>[Predicate]…