Penumbra System (Reperfusion Catheter RED 43)

K222808 · Penumbra, Inc. · NRY · Dec 20, 2022 · Cardiovascular

Device Facts

• Record ID: K222808
• Device Name: Penumbra System (Reperfusion Catheter RED 43)
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Dec 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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

Penumbra System (RED 43) is a neurovascular aspiration device; removes thrombus to restore blood flow in intracranial large vessel occlusive disease. System components: Reperfusion Catheter, 3D Revascularization Device, Aspiration Pump, Aspiration Tubing, and Separator. Physician introduces catheter through guide catheter/femoral sheath into intracranial vasculature; navigates over guidewire to occlusion site. Pump provides continuous vacuum aspiration; catheter targets thrombus directly. Separator may be deployed to clear catheter lumen if blocked. Device visible under fluoroscopy. Used in clinical settings by neurointerventionalists. Output is physical removal of thrombus; benefits patient by restoring cerebral perfusion in acute stroke.

Clinical Evidence

Bench testing only. No clinical or animal studies were conducted. Design verification included dimensional/visual inspection, friction, fluoroscopy, simulated use, particulate, hub/air, tensile, pressure, elongation, corrosion, torque, burst, and distal tip stiffness testing. All acceptance criteria were met.

Technological Characteristics

Materials: Stainless steel, PTFE, polyurethane, polyether block amide, nylon 12, nitinol, platinum/iridium. Hydrophilic coating. Sterilization: EO (ISO 11135+A1, ISO 10993-7). Form factor: Catheter with steam shaping mandrel, rotating hemostasis valve, and peelable sheath. Connectivity: None (mechanical aspiration system).

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or failing IV t-PA therapy.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Penumbra System (Reperfusion Catheter RED 62) (K203440)

Reference Devices

• Penumbra System (K072718)

Submission Summary (Full Text)

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December 20, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

Penumbra, Inc. Micaela Victoria Regulatory Affairs Program Manager One Penumbra Place Alameda, California 94502

Re: K222808

Trade/Device Name: Penumbra System (Reperfusion Catheter RED 43) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 14, 2022 Received: November 15, 2022

Dear Micaela 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

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

Sincerely,

# Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K22808

### Device Name

Penumbra System® (Reperfusion Catheter RED™ 43)

### Indications for Use (Describe)

Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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)

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Image /page/3/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 is simple and clean. The font is sans-serif.

#### 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 Penumbra System (Reperfusion Catheter RED 43).

#### 1.1 Submitter

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

Contact Person: Micaela Victoria Regulatory Affairs Program Manager Tel: [phone] Fax: [phone] E-mail: [e-mail]

Date of Preparation:

December 19, 2022

#### 1.2 Subject Device

Penumbra System (Reperfusion Catheter RED 43)

Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY

#### 1.3 Predicate/References Devices

| 510(k) Number | Name of Device | Name of<br>Manufacturer |
|------------------|-----------------------------------------------|-------------------------|
| Predicate Device | | |
| K203440 | Penumbra System (Reperfusion Catheter RED 62) | Penumbra, Inc. |
| Reference Device | | |
| K072718 | Penumbra System | Penumbra, Inc. |

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Image /page/4/Picture/1 description: The image shows the Penumbra logo. The word "Penumbra" is written in red, with a stylized red circle containing a white "P" to the right of the word. The logo is simple and modern, with a focus on the company name and a distinctive symbol.

#### 1.4 Device Description

The Penumbra System is comprised of the following devices:

- Penumbra Reperfusion Catheter ●
- Penumbra 3D Revascularization Device .
- Penumbra Aspiration Pump
- Penumbra Aspiration Pump Canister ●
- Penumbra Aspiration Tubing
- Penumbra Separator .

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an ID of 0.054 in. [1.37 mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.

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Image /page/5/Picture/0 description: The image shows the word "Penumbra" in a red sans-serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line running through it. The logo is simple and modern, with a focus on the company name and a distinctive symbol.

#### 1.5 Indications For Use

# Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

# Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

# Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

# Penumbra Aspiration Pump

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

| Device Attribute | Predicate Device | Reference Device | Subject Device |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Trade Name | Penumbra System<br>(Reperfusion Catheter RED 62) | Penumbra System<br>[Reperfusion Catheter 041] | Penumbra System<br>(Reperfusion Catheter RED 43) |
| FDA Product<br>Classification | Class II, NRY, 21 CFR 870.1250 | SAME | SAME |
| 510(k) Number | K203440 | K072718 | K222808 |
| Indications for<br>Use | Penumbra Reperfusion Catheters<br>and Separators<br>As part of the Penumbra System,<br>the Reperfusion Catheters and<br>Separators are indicated for use in<br>the revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large | The Penumbra System™ is<br>intended for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial<br>large vessel occlusive<br>disease (in the internal | SAME as Predicate |
| Device Attribute | Predicate Device | Reference Device | Subject Device |
| Trade Name | Penumbra System<br>(Reperfusion Catheter RED 62) | Penumbra System<br>[Reperfusion Catheter 041] | Penumbra System<br>(Reperfusion Catheter<br>RED 43) |
| | vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral - M1 and M2 segments,<br>basilar, and vertebral arteries)<br>within 8 hours of symptom onset.<br>Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV<br>t-PA therapy are candidates for<br>treatment. | carotid, middle cerebral -<br>M1 and M2 segments,<br>basilar, and vertebral<br>arteries) within 8 hours of<br>symptom onset. | |
| | Penumbra 3D Revascularization<br>Device<br>As part of the Penumbra System,<br>the Penumbra 3D<br>Revascularization Device is<br>indicated for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary<br>to intracranial large vessel<br>occlusive disease (within the<br>internal carotid, middle cerebral -<br>M1 and M2 segments) within 8<br>hours of symptom onset. Patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV<br>t-PA) or who fail IV t-PA therapy<br>are candidates for treatment. | | |
| | Penumbra Aspiration Tubing<br>As part of the Penumbra System,<br>the Penumbra Sterile Aspiration<br>Tubing is indicated to connect the<br>Penumbra Reperfusion Catheters<br>to the Penumbra Aspiration<br>Pump. | | |
| | Penumbra Aspiration Pump<br>The Penumbra Aspiration Pump<br>is indicated as a vacuum source<br>for Penumbra Aspiration<br>Systems. | | |
| Principles of<br>Operation | See Section 1.4 | SAME | SAME |
| Device Attribute | Predicate Device | Reference Device | Subject Device |
| Trade Name | Penumbra System<br>(Reperfusion Catheter RED 62) | Penumbra System<br>[Reperfusion Catheter 041] | Penumbra System<br>(Reperfusion Catheter<br>RED 43) |
| Device Materials | Stainless Steel, PTFE,<br>Polyurethane, Polyether Block<br>Amide, Nylon 12, Nitinol,<br>Platinum/Iridium | Stainless Steel, PTFE,<br>Polyurethane, Polyether<br>Block Amide, Nylon 12,<br>Platinum/Iridium | SAME as Predicate |
| ID Band Color | Polyolefin, black [white text] | Polyolefin, PET green<br>[white text] | SAME as Predicate |
| Coating | Hydrophilic coating (proprietary) | Similar to Predicate | SAME as Predicate |
| Dimensions | | | |
| Proximal OD | 0.076 in. (1.93 mm) Max | 0.056 in. (1.42 mm) Max | 0.060 in. (1.52 mm) Max |
| Proximal ID | 0.062 in. (1.57 mm) Min | 0.041 in. (1.04 mm) Min | 0.043 in. (1.09 mm) Min |
| Distal OD | 0.076 in. (1.93 mm) Max | 0.056 in. (1.42 mm) Max | SAME as Reference |
| Distal ID | 0.062 in. (1.57 mm) Min | 0.041 in. (1.04 mm) Min | 0.043 in. (1.09 mm) Min |
| Distal Flex<br>Length | 30 cm | SAME | SAME |
| Coating Length | 30 cm | 60 cm | SAME as Reference |
| Effective Lengths | 115, 120, 125, 127, 132, 138,<br>and 160 cm | 137 cm | 115, 120, 125, 127, 132,<br>136, 138, 145, 150, 153,<br>155, 160, 162, and 167 cm |
| Accessories | Peelable Sheath, Shaping<br>Mandrel, RHV | Shaping Mandrel, RHV | SAME as Predicate |
| Packaging<br>Materials | Polyester/Polyethylene/Tyvek,<br>Polystyrene, SBS Paperboard | SAME | SAME |
| Condition<br>Supplied | Sterile and Single Use | SAME | SAME |
| Sterilization<br>Method | EO | SAME | SAME |

### 1.6 Comparison of Technological Characteristics with the Predicate and Reference Devices

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Image /page/6/Picture/1 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The font is sans-serif and the word is written in a simple, clean style. The logo is simple and modern, and the colors are bold and eye-catching. The logo is likely for a company or organization called Penumbra.

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Image /page/7/Picture/0 description: The image shows the word "Penumbra" in a red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a sans-serif font. The "P" in the circle is also in a sans-serif font. The circle is slightly offset to the right of the word "Penumbra".

#### 1.7 Performance Data

The following performance data were provided in support of the substantial equivalence determination:

- . Design Verification
- . Shelf-Life
- Packaging Validation .
- Sterilization .

The subject device met all established requirements.

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Image /page/8/Picture/1 description: The image contains the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern. The word "Penumbra" is written in a sans-serif font.

#### Design Verification Testing 1.7.1

The following design verification tests were performed on the subject device:

| Test | Test Method Summary | Conclusion |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Dimensional/Visual<br>Inspection Test | Confirms the units meet all dimensional and visual product<br>specifications. | Acceptance Criteria Met |
| Friction Test | Confirms units meet product specification related to<br>friction. | Acceptance Criteria Met |
| Fluoroscopy Test | Confirms the markerband is fluoroscopically visible. | Acceptance Criteria Met |
| Simulated Use Test | Confirms the functionality of units using clinically<br>relevant benchtop model. | Acceptance Criteria Met |
| Particulate Test | Particulates generated and coating integrity during simulated<br>use (including multiple deployment cycling) were evaluated. | Acceptance Criteria Met |
| Hub/Air Test | Confirms units have no leaks when tested. | Acceptance Criteria Met |
| Tensile Test | Confirms units meet product specification related to tensile<br>strength. | Acceptance Criteria Met |
| Pressure Test | Confirms units meet product specification related to<br>pressure. | Acceptance Criteria Met |
| Elongation Test | Confirms units meet product specification related to<br>elongation. | Acceptance Criteria Met |
| Corrosion Resistance<br>Test | Confirms there is no visible corrosion on the units when<br>tested. | Acceptance Criteria Met |
| Torque Strength Test | Confirms units have sufficient torque strength. | Acceptance Criteria Met |
| Burst Pressure Test | Confirms units can withstand sufficient pressure. | Acceptance Criteria Met |
| Distal Tip Stiffness Test | Confirms units have appropriate distal tip stiffness. | Acceptance Criteria Met |
| Shelf-Life | Confirms expiration date based on accelerated aging test<br>studies. | Acceptance Criteria Met |
| Packaging Validation | Confirms the packaging of the units meet all product<br>specifications. | Acceptance Criteria Met |
| Sterilization Test | Confirms the units are sterilized in accordance with ISO<br>11135+A1 and ISO 10993-7 | Acceptance Criteria Met |

#### Biocompatibility 1.7.2

There are no changes to materials compared to the predicate device. Therefore, testing in support of the predicate device applies to the subject device and additional biocompatibility testing was not required.

#### 1.7.3 Performance Data – Animal, Clinical

No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.

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Image /page/9/Picture/0 description: The image shows the word "Penumbra" in a red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and clean, with the wordmark and symbol working together to create a recognizable brand identity. The red color is bold and eye-catching.

#### Conclusions 1.8

The subject Penumbra System (Reperfusion Catheter RED 43) is substantially equivalent to the predicate Penumbra System (Reperfusion Catheter RED 62) and reference Penumbra System. The subject device has the identical intended use as the predicate device. The device testing described in the 510(k) Summary demonstrates the subject device is substantially equivalent to the predicate and reference devices in regard to intended use, operating principle, design concept, fundamental technology and device performance.