(210 days)
No
The device description and performance studies focus on mechanical aspiration and physical components, with no mention of AI/ML, image processing, or data analysis that would typically indicate AI/ML involvement.
Yes
The device is used for revascularization and thrombus removal in patients with acute ischemic stroke, which are therapeutic medical interventions.
No
Explanation: The device is indicated for revascularization and thrombus removal in acute ischemic stroke, which are therapeutic interventions rather than diagnostic functions.
No
The device description clearly outlines multiple hardware components including catheters, a revascularization device, an aspiration pump, tubing, and a canister, all designed for physical interaction within the body.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the revascularization of patients with acute ischemic stroke by removing thrombus from blood vessels. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device description details a system of catheters, pumps, and tubing designed to physically remove blood clots from the neurovasculature. This is a mechanical process, not a diagnostic test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis. The device's function is to treat a condition, not diagnose it.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for 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.
Product codes
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
intracranial (internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination:
- Design Verification
- Biocompatibility
- Shelf Life
- Packaging Validation
- Sterilization
No animal or clinical study was conducted as bench and biocompatibility testing were determined sufficient for verification and validation purposes.
The following design verification tests were performed on the subject device:
- Dimensional/Visual Test: Confirms the units meet all dimensional and visual product specifications. Conclusion: Acceptance Criteria Met
- Friction Test: Confirms units meet product specification related to friction. Conclusion: Acceptance Criteria Met
- Radiopacity Test: Confirms the markerband is fluoroscopically visible. Conclusion: Acceptance Criteria Met
- Simulated Use Test: Confirms the functionality of units using clinically relevant benchtop model. Conclusion: Acceptance Criteria Met
- Particulate and Coating Integrity Test: Particulates generated during simulated use and coating integrity after simulated use (including multiple deployment cycles) were evaluated. Conclusion: Acceptance Criteria Met
- Hub/Air Test: Confirms units have no leaks when tested. Conclusion: Acceptance Criteria Met
- Tensile Test: Confirms units meet product specification related to tensile strength. Conclusion: Acceptance Criteria Met
- Pressure Test: Confirms units meet product specification related to pressure. Conclusion: Acceptance Criteria Met
- Elongation Test: Confirms units meet product specification related to elongation. Conclusion: Acceptance Criteria Met
- Corrosion Resistance Test: Confirms there is no visible corrosion on the units when tested. Conclusion: Acceptance Criteria Met
- Torque Strength Test: Confirms units have sufficient torque strength. Conclusion: Acceptance Criteria Met
- Burst Pressure Test: Confirms units can withstand sufficient pressure. Conclusion: Acceptance Criteria Met
- Distal Tip Stiffness Test: Confirms units have distal tip stiffness comparable to the reference device. Conclusion: Acceptance Criteria Met
- Kink Resistance Test: Confirms units meet product specification related to kink resistance. Conclusion: Acceptance Criteria Met
- Simulated Use Physician Usability Test: Confirms the usability of units in clinically relevant benchtop model. Conclusion: Acceptance Criteria Met
- Shelf Life: Confirms expiration date based on accelerated aging test studies. Conclusion: Acceptance Criteria Met
- Packaging Validation: Confirms the packaging of the units meets all product specifications. Conclusion: Acceptance Criteria Met
- Sterilization Test: Confirms the units are sterilized in accordance with ISO 11135+A1 and ISO 10993-7. Conclusion: Acceptance Criteria Met
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:
- Cytotoxicity: MEM Elution: Sample extracts must have a cytotoxic reactivity score of Grade 2 or lower. Conclusion: Pass Non-cytotoxic
- Sensitization: Magnusson-Kligman Method: Test group shall yield Grade 10% in 3 or more animals. Conclusion: Pass Non-toxic
- Systemic Toxicity: Material-Mediated Pyrogen: Sample extracts must not cause a total rise in body temperature of ≥ 0.5 °C. Conclusion: Pass Non-pyrogenic
- Hemocompatibility: In-vitro Thrombogenicity: Device must not be thrombogenic in vitro when compared to a predicate device. Conclusion: Pass Comparable to the predicate
- Hemocompatibility: Partial Thromboplastin Time (PTT): Clotting times of test article must be similar to predicate values. Conclusion: Pass Comparable to the predicate
- Hemocompatibility: Complement Activation: The concentration of SC5b-9 of test article must be similar to predicate values. Conclusion: Pass Non-activator of the complement system
- Hemocompatibility: Hemolysis (indirect contact): Sample extracts must be non-hemolytic (≤ 2% hemolytic index). Conclusion: Pass Non-hemolytic
- Hemocompatibility: Hemolysis (direct contact): Sample must be non-hemolytic (≤ 2% hemolytic index). Conclusion: Pass Non-hemolytic
- Hemocompatibility: Platelet and Leukocyte Count: Sample must meet the requirements of ASTM F2888-19, Standard Practice for Platelet Leukocyte Count. Conclusion: Pass Similar to the predicate
Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements.
The subject device met all established requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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: 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.
1
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
2
assistance/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 -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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
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."
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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: (510) 995-9792 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
6
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
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Trade Name | Penumbra System | |
| (Reperfusion Catheter RED 72) | Penumbra System | |
| (Reperfusion Catheter RED 72) | ||
| FDA Product | ||
| Classification | Class II, NRY, 21 CFR 870.1250 | SAME |
| 510(k) | ||
| Number | K211654 | K242104 |
| Indications | ||
| for Use | Penumbra Reperfusion Catheters and | |
| Separators | ||
| As part of the Penumbra System, the | ||
| Reperfusion Catheters and Separators are | ||
| indicated for use in the revascularization of | ||
| patients with acute ischemic stroke | ||
| secondary to intracranial large vessel | ||
| occlusive disease (within the internal | ||
| carotid, middle cerebral – M1 and M2 | ||
| segments, basilar, and vertebral arteries) | ||
| within 8 hours of symptom onset. Patients | ||
| who are ineligible for intravenous tissue | ||
| plasminogen activator (IV t-PA) or who fail | ||
| IV t-PA therapy are candidates for | ||
| treatment. |
Penumbra 3D Revascularization Device
As part of the Penumbra System, the
Penumbra 3D Revascularization Device is
indicated for use in the revascularization of | 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. |
| Device
Attribute | Predicate Device | Subject Device |
| Trade Name | Penumbra System
(Reperfusion Catheter RED 72) | Penumbra System
(Reperfusion Catheter RED 72) |
| | 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. | 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. |
| Principles of
Operation | See Section 1.4 | SAME |
| Device
Materials | Stainless Steel, PTFE, Polyurethane,
Polyether Block Amide, Nylon 12, Nitinol,
Platinum/Iridium | Stainless Steel, PTFE,
Polyurethane, differing Polyether
Block Amide, Nylon 12, Nitinol,
Platinum/Iridium |
| ID Band
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
Attribute | Predicate Device | Subject Device |
| Trade Name | Penumbra System
(Reperfusion Catheter RED 72) | Penumbra System
(Reperfusion Catheter RED 72) |
| Distal Flex
Length | 30 cm | SAME |
| Coating
Length | 30 cm | SAME |
| Effective
Lengths | 115, 120, 125, 127, 132 cm | SAME |
| Accessories | Peelable Sheath, Shaping Mandrel, RHV | Peelable Sheath, Shaping
Mandrel, RHV, SENDit
Technology (Optional, K191946) |
| Packaging
Materials | Polyester/Polyethylene/Tyvek, Polystyrene,
SBS Paperboard | SAME |
| Condition
Supplied | Sterile and Single Use | SAME |
| Sterilization
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 | |
| specifications. | Acceptance Criteria Met | |
| Friction Test | Confirms units meet product specification related to | |
| 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 | |
| relevant benchtop model. | Acceptance Criteria Met | |
| Particulate and Coating | ||
| Integrity Test | Particulates generated during simulated use and coating | |
| integrity after simulated use (including multiple deployment | ||
| cycles) were evaluated. | Acceptance Criteria Met | |
| Hub/Air Test | Confirms units have no leaks when tested. | Acceptance Criteria Met |
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| Test | Test Method Summary | Conclusion |
|---|---|---|
| Tensile Test | Confirms units meet product specification related to tensile | |
| 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 | |
| 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 |
| Distal Tip Stiffness Test | Confirms units have distal tip stiffness comparable to the | |
| reference device. | Acceptance Criteria Met | |
| Kink Resistance Test | Confirms units meet product specification related to kink | |
| resistance. | Acceptance Criteria Met | |
| Simulated Use Physician | ||
| Usability Test | Confirms the usability of units in clinically relevant benchtop | |
| model. | Acceptance Criteria Met | |
| Shelf Life | Confirms expiration date based on accelerated aging test | |
| studies. | Acceptance Criteria Met | |
| Packaging Validation | Confirms the packaging of the units meets all product | |
| specifications. | Acceptance Criteria Met | |
| Sterilization Test | Confirms the units are sterilized in accordance with ISO | |
| 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: | ||
| 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 $ 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 $\geq 0.5$ °C. | Pass | |
| Non-pyrogenic |
10
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: | ||
| In-vitro Thrombogenicity | Device must not be thrombogenic in vitro when | |
| compared to a predicate device. | Pass | |
| Comparable to the | ||
| predicate | ||
| Hemocompatibility: Partial | ||
| Thromboplastin Time (PTT) | Clotting times of test article must be similar to | |
| predicate values. | Pass | |
| Comparable to the | ||
| predicate | ||
| Hemocompatibility: | ||
| Complement Activation | The concentration of SC5b-9 of test article must | |
| be similar to predicate values. | Pass | |
| Non-activator of the | ||
| complement system | ||
| 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 | ||
| Hemocompatibility: Platelet | ||
| and Leukocyte Count | Sample must meet the requirements of ASTM | |
| F2888-19, Standard Practice for Platelet | ||
| Leukocyte Count. | Pass | |
| Similar to the | ||
| 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.