Penumbra System (Reperfusion Catheter RED 72)

K242104 · Penumbra, Inc. · NRY · Feb 13, 2025 · Cardiovascular

Device Facts

• Record ID: K242104
• Device Name: Penumbra System (Reperfusion Catheter RED 72)
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Feb 13, 2025
• 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 thrombolytic drug therapy or who failed thrombolytic drug 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 thrombolytic drug therapy or who failed thrombolytic drug 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 is a neurovascular aspiration device designed to remove thrombus and restore blood flow in patients with acute ischemic stroke. The system consists of a reperfusion catheter, 3D revascularization device, aspiration pump, tubing, and separator. The reperfusion catheter is introduced via guide catheter or femoral sheath, navigated over a guidewire to the occlusion site under fluoroscopic guidance. The aspiration pump provides vacuum pressure, transmitted through the tubing to the catheter, to aspirate the clot. The 3D revascularization device or separator may be used to facilitate clot removal or clear the catheter lumen if blocked. The device is operated by physicians in a clinical setting. By removing the thrombus, the system aims to restore cerebral perfusion, potentially improving patient outcomes in acute stroke cases.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including dimensional/visual verification, friction, radiopacity, simulated use, particulate/coating integrity, hub/air leak, tensile, pressure, elongation, corrosion, torque, burst, distal tip stiffness, kink resistance, and shelf life/packaging/sterilization validation. Biocompatibility testing followed ISO 10993 and USP standards, confirming the device is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, and hemocompatible.

Technological Characteristics

Materials: Stainless steel, PTFE, polyurethane, polyether block amide, nylon 12, nitinol, platinum/iridium. Features: Hydrophilic coating, fluoroscopic visibility, distal flex length 30 cm. Connectivity: Standalone aspiration system. Sterilization: Ethylene Oxide (EO). Software: None.

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or who failed thrombolytic drug 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 72) (K211654)

Reference Devices

• Penumbra System (Reperfusion Catheter JET 7) (K173761)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 13, 2025

Penumbra, Inc. Sindokht (Sisi) Soltanzadeh Sr. Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502

Re: K242104

Trade/Device Name: Penumbra System (Reperfusion Catheter RED 72) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: January 8, 2025 Received: January 10, 2025

Dear Sindokht (Sisi) Soltanzadeh:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242104

Device Name

Penumbra System (Reperfusion Catheter RED 72)

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 thrombolytic drug therapy or who failed thrombolytic drug 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 thrombolytic drug therapy or who failed thrombolytic drug 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# K242104

### 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 72).

#### 1.1 Submitter

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

Contact Person: Sindokht (Sisi) Soltanzadeh Sr. Regulatory Affairs Specialist Tel: [phone] E-mail: ssoltanzadeh(@penumbrainc.com

Date of Preparation:

February 10, 2025

### 1.2 Subject Device

Penumbra System (Reperfusion Catheter RED 72)

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

#### Predicate and Reference Devices 1.3

| 510(k) Number | Name of Device | Name of Manufacturer |
|------------------|-----------------------------------------------|----------------------|
| Predicate Device | | |
| K211654 | Penumbra System (Reperfusion Catheter RED 72) | Penumbra, Inc. |
| Reference Device | | |
| K173761 | Penumbra System (Reperfusion Catheter JET 7) | Penumbra, Inc. |

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Image /page/5/Picture/0 description: The image shows the Penumbra logo. The word "Penumbra" is written in red, with a stylized red circle and a white line through it to the right of the word. The logo is simple and modern.

#### 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/Tubing
- Penumbra Aspiration Tubing ●
- Penumbra Separator .

The Penumbra System is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The Reperfusion Catheter delivers aspiration from the pump directly to the site of occlusion to remove the clot. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. Alternatively, a Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. 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 Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. The Penumbra Reperfusion Catheter is connected to the Penumbra Aspiration Pump using the Penumbra Aspiration Tubing and the Penumbra Aspiration Pump Canister. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel, rotating hemostasis valve (RHV), peelable sheath, and optionally, SENDit Technology (cleared under K191946). The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.

#### Indications For Use 1.5

### 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

### Penumbra 3D Revascularization Device

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Image /page/6/Picture/0 description: The image contains 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 logo is simple and modern.

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 thrombolytic drug therapy or who failed thrombolytic drug 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<br>Attribute | Predicate Device | Subject Device |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Penumbra System<br>(Reperfusion Catheter RED 72) | Penumbra System<br>(Reperfusion Catheter RED 72) |
| FDA Product<br>Classification | Class II, NRY, 21 CFR 870.1250 | SAME |
| 510(k)<br>Number | K211654 | K242104 |
| Indications<br>for Use | Penumbra Reperfusion Catheters and<br>Separators<br>As part of the Penumbra System, the<br>Reperfusion Catheters and Separators are<br>indicated for use in the revascularization of<br>patients with acute ischemic stroke<br>secondary to intracranial large vessel<br>occlusive disease (within the internal<br>carotid, middle cerebral – M1 and M2<br>segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. Patients<br>who are ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or who fail<br>IV t-PA therapy are candidates for<br>treatment.<br><br>Penumbra 3D Revascularization Device<br>As part of the Penumbra System, the<br>Penumbra 3D Revascularization Device is<br>indicated for use in the revascularization of | Penumbra Reperfusion<br>Catheters and Separators<br>As part of the Penumbra<br>System, the Reperfusion<br>Catheters and Separators are<br>indicated for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral – M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of<br>symptom onset. Patients who<br>are ineligible for thrombolytic<br>drug therapy or who failed<br>thrombolytic drug therapy are<br>candidates for treatment. |
| Device<br>Attribute | Predicate Device | Subject Device |
| Trade Name | Penumbra System<br>(Reperfusion Catheter RED 72) | Penumbra System<br>(Reperfusion Catheter RED 72) |
| | patients with acute ischemic stroke<br>secondary to intracranial large vessel<br>occlusive disease (within the internal<br>carotid, middle cerebral – M1 and M2<br>segments) within 8 hours of symptom<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen activator<br>(IV t-PA) or who fail IV t-PA therapy are<br>candidates for treatment.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the<br>Penumbra Sterile Aspiration Tubing is<br>indicated to connect the Penumbra<br>Reperfusion 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 Penumbra<br>Aspiration Systems. | Penumbra 3D<br>Revascularization Device<br>As part of the Penumbra<br>System, the Penumbra 3D<br>Revascularization Device is<br>indicated for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral - M1 and M2<br>segments) within 8 hours of<br>symptom onset. Patients who<br>are ineligible for thrombolytic<br>drug therapy or who failed<br>thrombolytic drug therapy are<br>candidates for treatment.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra<br>System, the Penumbra Sterile<br>Aspiration Tubing is indicated<br>to connect the Penumbra<br>Reperfusion Catheters to the<br>Penumbra Aspiration Pump.<br><br>Penumbra Aspiration Pump<br>The Penumbra Aspiration<br>Pump is indicated as a vacuum<br>source for Penumbra Aspiration<br>Systems. |
| Principles of<br>Operation | See Section 1.4 | SAME |
| Device<br>Materials | Stainless Steel, PTFE, Polyurethane,<br>Polyether Block Amide, Nylon 12, Nitinol,<br>Platinum/Iridium | Stainless Steel, PTFE,<br>Polyurethane, differing Polyether<br>Block Amide, Nylon 12, Nitinol,<br>Platinum/Iridium |
| ID Band<br>Color | Polyolefin, PET black [white foil] | SAME |
| Coating | Hydrophilic coating (proprietary) | SAME |
| Min. ID | 0.072 in. (1.83 mm) | SAME |
| Max. OD | 0.085 in. (2.16 mm) | SAME |
| Device<br>Attribute | Predicate Device | Subject Device |
| Trade Name | Penumbra System<br>(Reperfusion Catheter RED 72) | Penumbra System<br>(Reperfusion Catheter RED 72) |
| Distal Flex<br>Length | 30 cm | SAME |
| Coating<br>Length | 30 cm | SAME |
| Effective<br>Lengths | 115, 120, 125, 127, 132 cm | SAME |
| Accessories | Peelable Sheath, Shaping Mandrel, RHV | Peelable Sheath, Shaping<br>Mandrel, RHV, SENDit<br>Technology (Optional, K191946) |
| Packaging<br>Materials | Polyester/Polyethylene/Tyvek, Polystyrene,<br>SBS Paperboard | SAME |
| Condition<br>Supplied | Sterile and Single Use | SAME |
| Sterilization<br>Method | Ethylene Oxide (EO) | SAME |

#### Comparison of Technological Characteristics with the Predicate Device 1.6

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### Performance Data 1.7

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

- Design Verification .
- Biocompatibility ●
- Shelf Life .
- Packaging Validation o
- Sterilization

The subject device met all established requirements.

### Design Verification Testing 1.7.1

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

| Test | Test Method Summary | Conclusion |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Dimensional/Visual 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 |
| Radiopacity 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 and Coating<br>Integrity Test | Particulates generated during simulated use and coating<br>integrity after simulated use (including multiple deployment<br>cycles) were evaluated. | Acceptance Criteria Met |
| Hub/Air Test | Confirms units have no leaks when tested. | Acceptance Criteria Met |

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Image /page/9/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white stylized "P" inside, which is the company's symbol.

| Test | Test Method Summary | Conclusion |
|-------------------------------------------|---------------------------------------------------------------------------------------|-------------------------|
| 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 distal tip stiffness comparable to the<br>reference device. | Acceptance Criteria Met |
| Kink Resistance Test | Confirms units meet product specification related to kink<br>resistance. | Acceptance Criteria Met |
| Simulated Use Physician<br>Usability Test | Confirms the usability of units in clinically relevant benchtop<br>model. | 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 meets 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 |

#### 1.7.2 Biocompatibility

The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1, USP standards, and 21 CFR, Part 58, Good Laboratory Practices (GLP). The battery of testing included the following tests:

| Tests | Acceptance Criteria | Conclusion |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Cytotoxicity:<br>MEM Elution | Sample extracts must have a cytotoxic reactivity<br>score of Grade 2 or lower. | Pass<br>Non-cytotoxic |
| Sensitization:<br>Magnusson-Kligman Method | Test group shall yield Grade $< 1$ score on<br>Magnusson and Kligman scale (provided control<br>group yields Grade $< 1$ ). | Pass<br>Non-sensitizing |
| Irritation:<br>Intracutaneous Reactivity | The difference between the average scores for<br>the extract of the test article and the control is $\leq$<br>1.0. | Pass<br>Non-irritating |
| Systemic Toxicity:<br>Acute Systemic Injection | Sample extracts must not cause significant<br>biological reaction greater than control. That is:<br>Death in 2 or more animals. Signs of toxicity in 2 or more animals (i.e.<br>convulsions, prostration). Weight loss $> 10%$ in 3 or more animals. | Pass<br>Non-toxic |
| Systemic Toxicity: Material-<br>Mediated Pyrogen | Sample extracts must not cause a total rise in<br>body temperature of $\geq 0.5$ °C. | Pass<br>Non-pyrogenic |

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Image /page/10/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The logo consists of the word "Penumbra" in a bold, red font, followed by a stylized "P" symbol enclosed in a red circle. The "P" symbol is formed by a white line that creates the shape of the letter within the circle. The logo is clean and modern, reflecting the company's focus on innovation and technology in the healthcare industry.

| Tests | Acceptance Criteria | Conclusion |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Hemocompatibility:<br>In-vitro Thrombogenicity | Device must not be thrombogenic in vitro when<br>compared to a predicate device. | Pass<br>Comparable to the<br>predicate |
| Hemocompatibility: Partial<br>Thromboplastin Time (PTT) | Clotting times of test article must be similar to<br>predicate values. | Pass<br>Comparable to the<br>predicate |
| Hemocompatibility:<br>Complement Activation | The concentration of SC5b-9 of test article must<br>be similar to predicate values. | Pass<br>Non-activator of the<br>complement system |
| Hemocompatibility:<br>Hemolysis (indirect contact) | Sample extracts must be non-hemolytic (≤ 2%<br>hemolytic index). | Pass<br>Non-hemolytic |
| Hemocompatibility:<br>Hemolysis (direct contact) | Sample must be non-hemolytic (≤ 2% hemolytic<br>index). | Pass<br>Non-hemolytic |
| Hemocompatibility: Platelet<br>and Leukocyte Count | Sample must meet the requirements of ASTM<br>F2888-19, Standard Practice for Platelet<br>Leukocyte Count. | Pass<br>Similar to the<br>predicate |

Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements.

### Performance Data - Animal, Clinical 1.7.3

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

#### 1.8 Conclusions

The subject Penumbra System (Reperfusion Catheter RED 72) is substantially equivalent to the predicate Penumbra System (Reperfusion Catheter RED 72). The subject device has the identical intended use and similar operating principle, design concept, fundamental technology as the predicate. The differences between the subject and predicate devices do not raise new or different questions of safety or effectiveness. The device testing described in this 510(k) Summary demonstrates the subject device performs as intended.