Penumbra System (RED 68 Reperfusion Catheter)

K211411 · Penumbra, Inc. · NRY · Jul 1, 2021 · Cardiovascular

Device Facts

• Record ID: K211411
• Device Name: Penumbra System (RED 68 Reperfusion Catheter)
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Jul 1, 2021
• 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 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 68 Reperfusion Catheter) removes thrombus from intracranial vasculature via continuous aspiration. System components: Reperfusion Catheter, Aspiration Pump, Aspiration Tubing, Separator, 3D Revascularization Device. Catheter introduced via guide catheter/sheath into intracranial vasculature; guided over neurovascular guidewire to occlusion site. Aspiration Pump provides vacuum source; Separator may be deployed through catheter to clear lumen of thrombus. Used in clinical setting by physicians; visible under fluoroscopy. Output is thrombus removal; benefits patient by restoring blood flow in acute ischemic stroke.

Clinical Evidence

Bench testing only. No clinical or animal studies conducted. Verification testing included dimensional/visual, kink resistance, friction, fluoroscopy, simulated use, particulate, hub/air, tensile, pressure, elongation, corrosion, torque, burst, shelf-life, and sterilization. Biocompatibility supported by predicate/reference device data and ISO 10993 testing.

Technological Characteristics

Materials: Stainless Steel, PTFE, Polyurethane, Polyether Block Amide, Nylon 12, Nitinol, Platinum/Iridium. Sensing/Actuation: Mechanical aspiration. Form factor: Catheter with 0.068 in. min ID, 0.084 in. max OD, 30 cm distal flex length. Sterilization: EO. Connectivity: None.

Indications for Use

Indicated for revascularization of 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 patients 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 ACE 68 Reperfusion Catheter (K161640)
• Penumbra 3D Revascularization Device (K162901)

Reference Devices

• Penumbra System (Reperfusion Catheter JET 7) (K190010)

Submission Summary (Full Text)

{0}------------------------------------------------

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 1, 2021

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

Re: K211411

Trade/Device Name: Penumbra System (RED 68 Reperfusion Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: Mav 4, 2021 Received: May 6, 2021

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

{1}------------------------------------------------

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, 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

{2}------------------------------------------------

# Indications for Use

## 510(k) Number (if known) K211411

### Device Name

Penumbra System® (RED™ 68 Reperfusion Catheter)

### 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 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) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

{3}------------------------------------------------

Image /page/3/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. A thin gray line extends from the right of the word "Penumbra" to the left side of the red circle, visually connecting the text and the symbol.

# 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® (RED™ 68 Reperfusion Catheter).

#### 1.1 Submitter

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

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

Date of Preparation:

June 25, 2021

#### Subject Device 1.2

Penumbra System® (RED™ 68 Reperfusion Catheter)

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

#### 1.3 Predicate & Reference Devices

| 510(k) Number | Name of Device | Name of<br>Manufacturer |
|------------------|----------------------------------------------|-------------------------|
| Predicate Device | | |
| K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. |
| K162901 | Penumbra 3D Revascularization Device | Penumbra, Inc. |
| Reference Device | | |
| K190010 | Penumbra System (Reperfusion Catheter JET 7) | Penumbra, Inc. |

{4}------------------------------------------------

Image /page/4/Picture/1 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 "P" is stylized with a horizontal line extending from the right side of the "P" to the edge of the circle. The logo is simple and modern.

#### 1.4 Device Description

The Penumbra System® is comprised of the following devices:

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

The Penumbra System is designed to remove thrombus from the vasculature 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. 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 Pump/Canister Tubing. 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.

{5}------------------------------------------------

Image /page/5/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 "P" is stylized with a white outline and a horizontal line extending from the top right of the "P" to the right edge of the word "Penumbra".

#### 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 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.

### 1.6 Comparison of Indications for Use and Technological Characteristics with the Predicate Devices

| Device Attribute | Predicate Device | Subject Device |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Trade Name | Penumbra System ACE 68 Reperfusion<br>Catheter | Penumbra System (RED<br>68 Reperfusion Catheter) |
| 510(k) Number | K161640 | K211411 |
| FDA Product<br>Classification | Class II, NRY,<br>21 CFR 870.1250 | SAME |
| Indications for<br>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 | SAME as Predicate<br>Device with K162901 |
| Device Attribute | Predicate Device | Subject Device |
| | 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. | |
| | 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>Pump MAX. | |
| | Penumbra Pump MAX<br>The Penumbra Pump MAX is indicated as a<br>vacuum source for Penumbra Aspiration<br>Systems. | |
| Principles of<br>Operation | See Section 1.4 | SAME |
| Device Materials | Stainless Steel, PTFE, Polyurethane,<br>Polyether Block Amide, Nylon 12, Nitinol,<br>Platinum/Iridium | SAME |
| ID Band Color | Yellow [black text] | Black [white text] |
| Coating | Hydrophilic Coating (proprietary) | Equivalent |
| Accessories | Peelable Sheath, RHV, Shaping Mandrel | SAME |
| Min. ID | 0.068 in. (1.73 mm) | SAME |
| Max. OD | 0.084 in. (2.13 mm) | SAME |
| Distal Flex<br>Length | 30 cm | SAME |
| Coating Length | 30 cm | SAME |
| Effective Lengths | 115, 120, 125, 127, 132 cm | SAME |
| Accessories | Peelable Sheath, Shaping Mandrel, RHV | SAME |
| Packaging<br>Materials | Polyester/Polyethylene/Tyvek,<br>Polystyrene, SBS Paperboard | SAME |
| Condition<br>Supplied | Sterile and Single Use | SAME |
| Sterilization<br>Method | EO | SAME |
| Device Attribute | Predicate Device | Subject Device |
| Trade Name | Penumbra 3D Revascularization Device | Penumbra System<br>(RED 68 Reperfusion<br>Catheter) |
| FDA Product<br>Classification | Class II, NRY, 21 CFR 870.1250 | SAME |
| 510(k) Number | K162901 | K211411 |
| Indications For<br>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 secondary<br>to intracranial large vessel occlusive disease<br>(within the internal carotid, middle cerebral –<br>M1 and M2 segments, basilar, and vertebral<br>arteries) within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who<br>fail IV t-PA therapy are candidates for<br>treatment.<br><br>Penumbra 3D Revascularization Device<br>As part of the Penumbra System, the Penumbra<br>3D Revascularization Device is indicated for<br>use in the revascularization of patients with<br>acute ischemic stroke secondary to intracranial<br>large vessel occlusive disease (within the<br>internal carotid, middle cerebral – M1 and M2<br>segments) within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous<br>tissue plasminogen activator (IV t-PA) or who<br>fail IV t-PA therapy are candidates for<br>treatment.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra System, the Penumbra<br>Sterile Aspiration Tubing is indicated to<br>connect the Penumbra Reperfusion Catheters<br>to the Penumbra Aspiration Pump.<br><br>Penumbra Aspiration Pump<br>The Penumbra Aspiration Pump is indicated as<br>a vacuum source for Penumbra Aspiration<br>Systems. | SAME |

{6}------------------------------------------------

Image /page/6/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. A white line extends from the right side of the word "Penumbra" to the left side of the "P" in the circle.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The word "Penumbra" is written in a bold, red font. To the right of the word is a red circle with a white "P" inside, with a horizontal line extending from the left side of the "P" to the end of the word "Penumbra".

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image features the word "Penumbra" in a bold, red font. To the right of the word is a circular logo, also in red, with a white "P" inside. A thin white line extends from the right of the word "Penumbra" to the left side of the "P" in the logo, connecting the text and the symbol.

#### Performance Data 1.7

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

- Design Verification ●
- Biocompatibility ●
- . Shelf Life
- Sterilization LAL Validation .

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 |
| Kink Resistance Test | Confirms units meet product specification related to kink<br>resistance when formed in a defined radius. | Acceptance Criteria Met |
| Friction Test | Confirms units meet product specification related to 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 during simulated use (including multiple<br>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 pressure. | Acceptance Criteria Met |
| Elongation Test | Confirms units meet product specification related to<br>elongation. | Acceptance Criteria Met |
| Corrosion Resistance Test | Confirms there is no visible corrosion on the units when 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 |
| Shelf-Life | Confirms expiration date based on accelerated aging test<br>studies. | Acceptance Criteria Met |
| Sterilization Test | Confirms the units are sterilized in accordance with ISO 11135<br>and ISO 10993-7. | Acceptance Criteria Met |

#### Biocompatibility 1.7.2

Biocompatibility of the subject device is supported by the biocompatibility testing of the predicate and reference devices. Compared with the predicate device (K161640), all materials are the same, aside from the ID band colorant and hydrophilic coating, which are identical to those in the reference device (K190010). Therefore, the previous biocompatibility testing on the predicate and reference devices applies to the subject device

{9}------------------------------------------------

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 modern.

and additional testing is not required. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), externally communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).

| Tests | Acceptance Criteria | Conclusion |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Cytotoxicity:<br>MEM Elution<br>(ISO 10993-5) | Sample extracts must have a cytotoxic reactivity<br>score of grade 2 or lower. | Pass<br>Non-cytotoxic |
| Sensitization:<br>Magnusson-Kligman Method<br>(ISO 10993-10) | Test Group shall yield Grade < 1 score on<br>Magnusson and Kligman scale (provided<br>Control Group yields Grade < 1). | Pass<br>Non-sensitizing |
| Irritation:<br>Intracutaneous Toxicity<br>(ISO 10993-10) | The difference between the average scores for<br>the extract of the test article and the control is<br>≤ 1.0. | Pass<br>Non-irritating |
| Systemic Toxicity:<br>Acute Systemic Injection<br>(ISO 10993-11) | Sample extracts must not cause significant<br>biological reaction greater than control. That is:<br>• Death in 2 or more animals<br>• Signs of toxicity in 2 or more animals (i.e.<br>convulsions, prostration)<br>• Weight loss > 10% in 3 or more animals. | Pass<br>Non-toxic |
| Systemic Toxicity: Material<br>Mediated Pyrogen<br>(ISO 10993-11) | Sample extracts must not cause a total rise in<br>body temperature of ≥ 0.5°C. | Pass<br>Non-pyrogenic |
| Hemocompatibility:<br>Thrombogenicity<br>(ISO 10993-4) | The test article must have similar or less<br>thrombus formation compared to predicate<br>device. | Pass<br>Non-thrombogenic |
| Hemocompatibility: Partial<br>Thromboplastin Time (PTT)<br>(ISO 10993-4) | Clotting times of test article must be similar to<br>predicate values. | Pass<br>Hemocompatible |
| Hemocompatibility:<br>Complement Activation<br>(ISO 10993-4) | The concentration of SC5b-9 of test article must<br>be similar to predicate values. | Pass<br>Hemocompatible |
| Hemocompatibility:<br>Hemolysis, indirect contact<br>(ISO 10993-4) | Sample extracts must be non-hemolytic<br>(≤ 2% hemolytic index). | Pass<br>Non-hemolytic |
| Hemocompatibility:<br>Hemolysis, direct contact<br>(ISO 10993-4) | Sample must be non-hemolytic<br>(≤ 2% hemolytic index). | Pass<br>Non-hemolytic |

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 testing was determined sufficient for verification and validation purposes.

{10}------------------------------------------------

Image /page/10/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. A thin white line extends from the right side of the word "Penumbra" to the left side of the circle.

#### Conclusions 1.8

The subject Penumbra System® (RED™ 68 Reperfusion Catheter) is substantially equivalent to the predicate device Penumbra System ACE 68 Reperfusion Catheter and Penumbra 3D Revascularization Device. The subject device has identical intended use as the predicate devices. The device testing described in the 510(k) Summary demonstrates the subject device is substantially equivalent to the predicate devices in regard to intended use, operating principle, design concept, fundamental technology and device performance.