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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Penumbra System (RED 68 Reperfusion Catheter):

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Test Method Summary	Acceptance Criteria	Reported Device Performance
Dimensional/Visual Test	Confirms the units meet all dimensional and visual product specifications.	Not explicitly stated in terms of specific dimensions/visuals, but implied as meeting product specifications.	Acceptance Criteria Met
Kink Resistance Test	Confirms units meet product specification related to kink resistance when formed in a defined radius.	Implied as meeting product specifications related to kink resistance.	Acceptance Criteria Met
Friction Test	Confirms units meet product specification related to friction.	Implied as meeting product specifications related to friction.	Acceptance Criteria Met
Fluoroscopy Test	Confirms the markerband is fluoroscopically visible.	Implied: Markerband is fluoroscopically visible.	Acceptance Criteria Met
Simulated Use Test	Confirms the functionality of units using clinically relevant benchtop model.	Implied: Functionality of units confirmed in a clinically relevant benchtop model.	Acceptance Criteria Met
Particulate Test	Particulates generated during simulated use (including multiple deployment cycling) were evaluated.	Implied: Particulates generated during simulated use are within acceptable limits or deemed safe.	Acceptance Criteria Met
Hub/Air Test	Confirms units have no leaks when tested.	Implied: No leaks when tested.	Acceptance Criteria Met
Tensile Test	Confirms units meet product specification related to tensile strength.	Implied as meeting product specifications related to tensile strength.	Acceptance Criteria Met
Pressure Test	Confirms units meet product specification related to pressure.	Implied as meeting product specifications related to pressure.	Acceptance Criteria Met
Elongation Test	Confirms units meet product specification related to elongation.	Implied as meeting product specifications related to elongation.	Acceptance Criteria Met
Corrosion Resistance Test	Confirms there is no visible corrosion on the units when tested.	No visible corrosion on the units when tested.	Acceptance Criteria Met
Torque Strength Test	Confirms units have sufficient torque strength.	Implied: Sufficient torque strength.	Acceptance Criteria Met
Burst Pressure Test	Confirms units can withstand sufficient pressure.	Implied: Can withstand sufficient pressure.	Acceptance Criteria Met
Shelf-Life	Confirms expiration date based on accelerated aging test studies.	Implied: Expiration date confirmed based on accelerated aging test studies.	Acceptance Criteria Met
Sterilization Test	Confirms the units are sterilized in accordance with ISO 11135 and ISO 10993-7.	Units are sterilized in accordance with ISO 11135 and ISO 10993-7.	Acceptance Criteria Met
Biocompatibility Tests
Cytotoxicity (MEM Elution)	Sample extracts must have a cytotoxic reactivity score of grade 2 or lower.	Pass (Non-cytotoxic)
Sensitization (Magnusson-Kligman Method)	Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided Control Group yields Grade < 1).	Pass (Non-sensitizing)
Irritation (Intracutaneous Toxicity)	The difference between the average scores for the extract of the test article and the control is ≤ 1.0.	Pass (Non-irritating)
Systemic Toxicity (Acute Systemic Injection)	Sample extracts must not cause significant biological reaction greater than control: • Death in 2 or more animals • Signs of toxicity in 2 or more animals (i.e. convulsions, prostration) • Weight loss > 10% in 3 or more animals.	Pass (Non-toxic)
Systemic Toxicity (Material Mediated Pyrogen)	Sample extracts must not cause a total rise in body temperature of ≥ 0.5°C.	Pass (Non-pyrogenic)
Hemocompatibility (Thrombogenicity)	The test article must have similar or less thrombus formation compared to predicate device.	Pass (Non-thrombogenic)
Hemocompatibility (Partial Thromboplastin Time - PTT)	Clotting times of test article must be similar to predicate values.	Pass (Hemocompatible)
Hemocompatibility (Complement Activation)	The concentration of SC5b-9 of test article must be similar to predicate values.	Pass (Hemocompatible)
Hemocompatibility (Hemolysis, indirect contact)	Sample extracts must be non-hemolytic (≤ 2% hemolytic index).	Pass (Non-hemolytic)
Hemocompatibility (Hemolysis, direct contact)	Sample must be non-hemolytic (≤ 2% hemolytic index).	Pass (Non-hemolytic)

2. Sample Size Used for the Test Set and Data Provenance

Design Verification Testing: The document does not specify a quantitative sample size for each individual design verification test. It states "the units" were tested.
Biocompatibility Testing: The sample sizes for animal tests (e.g., systemic toxicity, irritation, sensitization) are not explicitly stated in this document but are implied to be sufficient for GLP compliance.
Data Provenance: Not explicitly stated for each test, but the tests were performed by Penumbra, Inc. as part of their 510(k) submission. For biocompatibility, it states "previous biocompatibility testing on the predicate and reference devices applies to the subject device" and "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." This suggests a mix of historical data from predicate/reference devices and possibly new testing. The country of origin is not mentioned, but is likely the USA, given the FDA submission. All data appears to be retrospective in the sense that the studies were already completed for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "experts" being used to establish ground truth in the context of the design verification or biocompatibility testing described. These tests rely on predefined engineering specifications, standardized test methods (e.g., ISO standards), and laboratory procedures, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, measurable physical and biological tests against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance?

Not applicable. This device is a medical catheter and does not involve AI or human readers for diagnostic interpretation. The studies are for physical and biological performance of the device itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?

Not applicable, as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Design Verification Tests: The "ground truth" for these tests is based on engineering specifications and performance requirements defined for the device. For example, a catheter must not kink at a certain radius, or it must withstand a certain pressure.
Biocompatibility Tests: The "ground truth" is based on established biological safety standards and criteria (e.g., ISO 10993 guidelines, USP requirements). These standards define what constitutes non-cytotoxic, non-sensitizing, non-irritating, etc.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set mentioned or implied.

Summary

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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: 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

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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 (1-800-638-2041 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

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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

Penumbra 3D Revascularization Device

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)

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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: (510) 995-2082 Fax: (510) 217-6414 E-mail: mvictoria@penumbrainc.com

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 ofManufacturer
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.

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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 .

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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 ReperfusionCatheter	Penumbra System (RED68 Reperfusion Catheter)
510(k) Number	K161640	K211411
FDA ProductClassification	Class II, NRY,21 CFR 870.1250	SAME
Indications forUse	Penumbra Reperfusion Catheters andSeparatorsAs part of the Penumbra System, theReperfusion Catheters and Separators areindicated for use in the revascularization ofpatients with acute ischemic stroke	SAME as PredicateDevice with K162901
Device Attribute	Predicate Device	Subject Device
	secondary to intracranial large vesselocclusive disease (within the internalcarotid, middle cerebral – M1 and M2segments, basilar, and vertebral arteries)within 8 hours of symptom onset.
	Penumbra Aspiration TubingAs part of the Penumbra System, thePenumbra Sterile Aspiration Tubing isindicated to connect the PenumbraReperfusion Catheters to the PenumbraPump MAX.
	Penumbra Pump MAXThe Penumbra Pump MAX is indicated as avacuum source for Penumbra AspirationSystems.
Principles ofOperation	See Section 1.4	SAME
Device Materials	Stainless Steel, PTFE, Polyurethane,Polyether Block Amide, Nylon 12, Nitinol,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 FlexLength	30 cm	SAME
Coating Length	30 cm	SAME
Effective Lengths	115, 120, 125, 127, 132 cm	SAME
Accessories	Peelable Sheath, Shaping Mandrel, RHV	SAME
PackagingMaterials	Polyester/Polyethylene/Tyvek,Polystyrene, SBS Paperboard	SAME
ConditionSupplied	Sterile and Single Use	SAME
SterilizationMethod	EO	SAME
Device Attribute	Predicate Device	Subject Device
Trade Name	Penumbra 3D Revascularization Device	Penumbra System(RED 68 ReperfusionCatheter)
FDA ProductClassification	Class II, NRY, 21 CFR 870.1250	SAME
510(k) Number	K162901	K211411
Indications ForUse	Penumbra Reperfusion Catheters andSeparatorsAs part of the Penumbra System, theReperfusion Catheters and Separators areindicated for use in the revascularization ofpatients with acute ischemic stroke secondaryto intracranial large vessel occlusive disease(within the internal carotid, middle cerebral –M1 and M2 segments, basilar, and vertebralarteries) within 8 hours of symptom onset.Patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or whofail IV t-PA therapy are candidates fortreatment.Penumbra 3D Revascularization DeviceAs part of the Penumbra System, the Penumbra3D Revascularization Device is indicated foruse in the revascularization of patients withacute ischemic stroke secondary to intracraniallarge vessel occlusive disease (within theinternal carotid, middle cerebral – M1 and M2segments) within 8 hours of symptom onset.Patients who are ineligible for intravenoustissue plasminogen activator (IV t-PA) or whofail IV t-PA therapy are candidates fortreatment.Penumbra Aspiration TubingAs part of the Penumbra System, the PenumbraSterile Aspiration Tubing is indicated toconnect the Penumbra Reperfusion Cathetersto the Penumbra Aspiration Pump.Penumbra Aspiration PumpThe Penumbra Aspiration Pump is indicated asa vacuum source for Penumbra AspirationSystems.	SAME

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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.

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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".

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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 productspecifications.	Acceptance Criteria Met
Kink Resistance Test	Confirms units meet product specification related to kinkresistance 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 clinicallyrelevant benchtop model.	Acceptance Criteria Met
Particulate Test	Particulates generated during simulated use (including multipledeployment 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 tensilestrength.	Acceptance Criteria Met
Pressure Test	Confirms units meet product specification related to pressure.	Acceptance Criteria Met
Elongation Test	Confirms units meet product specification related toelongation.	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 teststudies.	Acceptance Criteria Met
Sterilization Test	Confirms the units are sterilized in accordance with ISO 11135and 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

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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:MEM Elution(ISO 10993-5)	Sample extracts must have a cytotoxic reactivityscore of grade 2 or lower.	PassNon-cytotoxic
Sensitization:Magnusson-Kligman Method(ISO 10993-10)	Test Group shall yield Grade < 1 score onMagnusson and Kligman scale (providedControl Group yields Grade < 1).	PassNon-sensitizing
Irritation:Intracutaneous Toxicity(ISO 10993-10)	The difference between the average scores forthe extract of the test article and the control is≤ 1.0.	PassNon-irritating
Systemic Toxicity:Acute Systemic Injection(ISO 10993-11)	Sample extracts must not cause significantbiological reaction greater than control. That is:• Death in 2 or more animals• Signs of toxicity in 2 or more animals (i.e.convulsions, prostration)• Weight loss > 10% in 3 or more animals.	PassNon-toxic
Systemic Toxicity: MaterialMediated Pyrogen(ISO 10993-11)	Sample extracts must not cause a total rise inbody temperature of ≥ 0.5°C.	PassNon-pyrogenic
Hemocompatibility:Thrombogenicity(ISO 10993-4)	The test article must have similar or lessthrombus formation compared to predicatedevice.	PassNon-thrombogenic
Hemocompatibility: PartialThromboplastin Time (PTT)(ISO 10993-4)	Clotting times of test article must be similar topredicate values.	PassHemocompatible
Hemocompatibility:Complement Activation(ISO 10993-4)	The concentration of SC5b-9 of test article mustbe similar to predicate values.	PassHemocompatible
Hemocompatibility:Hemolysis, indirect contact(ISO 10993-4)	Sample extracts must be non-hemolytic(≤ 2% hemolytic index).	PassNon-hemolytic
Hemocompatibility:Hemolysis, direct contact(ISO 10993-4)	Sample must be non-hemolytic(≤ 2% hemolytic index).	PassNon-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.

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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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).