(178 days)
Not Found
No
The document describes a mechanical aspiration system for removing blood clots. There is no mention of AI, ML, image processing for analysis, or any other computational elements that would suggest the use of AI/ML. The performance studies are limited to bench testing, further indicating a lack of complex algorithmic components.
Yes.
The device is indicated for use in the revascularization of patients with acute ischemic stroke, which is a therapeutic intervention.
No
The device is indicated for revascularization and thrombus removal in patients with acute ischemic stroke, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines multiple hardware components including catheters, pumps, tubing, and a revascularization device, all designed for physical interaction within the body. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The description clearly states that the Penumbra System is used to physically remove thrombus (blood clots) from within the patient's blood vessels. It is a mechanical device used for intervention, not for analyzing biological samples like blood, urine, or tissue.
- The intended use is therapeutic. The primary indication is "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic intervention to restore blood flow.
- The device description focuses on mechanical components and their function. The description details catheters, pumps, tubing, and separators, all of which are physical tools used within the body.
- There is no mention of analyzing biological samples or providing diagnostic information. The device's purpose is to treat a condition, not to diagnose it or provide information about the patient's biological state through sample analysis.
Therefore, the Penumbra System, as described, is a medical device used for interventional treatment, not an In Vitro Diagnostic device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
NRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial large vessel occlusive disease (within the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
- Design Verification
- Biocompatibility
- Shelf Life
- Sterilization
- Packaging Validation
The subject device met all established requirements.
Design Verification Testing:
- 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)
- Fluoroscopy Test: Confirms the marker band is fluoroscopically visible. (Acceptance Criteria Met)
- Simulated Use Test: Confirms the functionality of units using clinically relevant benchtop model. (Acceptance Criteria Met)
- Particulate Test: Particulates generated during simulated use (including multiple deployment cycling) were evaluated. (Acceptance Criteria Met)
- Hub Air Test: Confirms units have no leaks when tested. (Acceptance Criteria Met)
- Tensile Test: Confirms units meet product specification related to tensile 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 appropriate distal tip stiffness. (Acceptance Criteria Met)
- Shelf-Life: Confirms expiration date based on accelerated aging test studies. (Acceptance Criteria Met)
- Packaging Validation Test: Confirms the packaging of the units meet all product specifications (Acceptance Criteria Met)
- Sterilization Test: Confirms the units are sterilized in accordance with ISO 11135 and ISO 10993-7. (Acceptance Criteria Met)
Biocompatibility evaluation:
- Cytotoxicity (MEM Elution): No evidence of cell lysis or toxicity (Grade = 0, Reactivity None). (Pass)
- Sensitization (Magnusson-Kligman Method): Both Test Group & Control Group Grade = 0. None of the treated or negative control animals exhibited any reaction at the challenge. The positive control article elicited discrete reactions in all animals. (Pass)
- Irritation (Intracutaneous Reactivity): None of the animals exhibited overt signs of toxicity at any of the observation points. The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. (Pass)
- Systemic Toxicity (Acute Systemic Injection): No evidence of systemic toxicity from sample extracts. (Pass)
- Systemic Toxicity (Material Mediated Pyrogen): Non-pyrogenic: no single animal had an individual rise in body temperature ≥ 0.5 °C. (Pass)
- Hemocompatibility (In-vitro Thrombogenicity): Device non-thrombogenic in vitro when compared to a predicate device. (Pass)
- Hemocompatibility (Partial Thromboplastin Time (PTT)): Test article coagulation times are statistically similar to predicate. (Pass)
- Hemocompatibility (Complement Activation): Test article concentrations of Sc5b-9 are statistically similar to predicate. (Pass)
- Hemocompatibility (Hemolysis, indirect contact): Hemolytic Index = 0.00%. (Pass)
- Hemocompatibility (Hemolysis, direct contact): Hemolytic Index = 0.00%. (Pass)
Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements.
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
May 20, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Penumbra, Inc. Aditi Kolla Regulatory Affairs Program Manager One Penumbra Place Alameda, California 94502
Re: K203440
Trade/Device Name: Penumbra System (Reperfusion Catheter RED 62) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 14, 2021 Received: April 15, 2021
Dear Aditi Kolla:
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 (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
2
Indications for Use
510(k) Number (if known) K203440
Device Name Penumbra System (Reperfusion Catheter RED 62)
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The "P" is stylized with a line through the middle. The logo is simple and modern. The text is clear and easy to read.
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™ 62).
1.1 Submitter
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Person: Aditi Kolla Regulatory Affairs Program Manager Tel: (510) 995-2010 Fax: (510) 217-6414 E-mail: akolla@penumbrainc.com
Date of Preparation: May 19, 2021
Subject Device 1.2
Penumbra System® (Reperfusion Catheter RED™ 62)
Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Code: NRY
1.3 Predicate Devices
| 510(k) Number | Name of Device | Name of
Manufacturer |
|---------------|---------------------------------------------|-------------------------|
| K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra,
Inc. |
| K162901 | Penumbra 3D Revascularization Device | Penumbra,
Inc. |
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Image /page/4/Picture/0 description: The image shows the logo for Penumbra, a healthcare company. The word "Penumbra" is written in red, with a stylized "P" in a circle to the right. The logo is simple and modern, with a focus on the company's name.
Device Description 1.4
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.
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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 line going through the middle. The logo is simple and modern.
Indications For Use ાં રે
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 Catheter | Penumbra System (Reperfusion | |
| Catheter RED 62) | ||
| FDA Product | ||
| Classification | Class II, NRY, 21 CFR 870.1250 | SAME |
| 510(k) Number | K161640 | K203440 |
| Indications for Use | Penumbra Reperfusion Catheters and | |
| Separators | ||
| As part of the Penumbra System, the | ||
| Reperfusion Catheters and Separators | Same as Predicate Device with | |
| K162901 | ||
| Device Attribute | Predicate Device | Subject Device |
| 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. | ||
| 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 Pump MAX. | ||
| Penumbra Pump MAX | ||
| The Penumbra Pump MAX 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 | SAME | |
| ID Band Color | Yellow [black text] | Black [white text] |
| Coating | Hydrophilic coating (proprietary) | Equivalent |
| Min. ID | 0.068 in. (1.73 mm) | 0.062 in. (1.57 mm) |
| Max. OD | 0.084 in. (2.13 mm) | 0.076 in. (1.93 mm) |
| Distal Flex Length | 30 cm | SAME |
| Coating Length | 30 cm | SAME |
| Effective Lengths | 115, 120, 125, 127, 132 cm | 115, 120, 125, 127, 132, 138, |
| 160 cm | ||
| Accessories | Peelable Sheath, Shaping Mandrel, | |
| RHV | SAME | |
| Packaging | ||
| Materials | Polyester/Polyethylene/Tyvek, | |
| Polystyrene, SBS Paperboard | SAME | |
| Condition Supplied | Sterile and Single Use | SAME |
| Sterilization | ||
| Method | EO | SAME |
| Device | ||
| Attribute | Predicate Device | Subject Device |
| Trade Name | Penumbra 3D Revascularization Device | Penumbra System |
| (Reperfusion | ||
| Catheter RED 62) | ||
| FDA Product | ||
| Classification | Class II, NRY, 21 CFR 870.1250 | SAME |
| 510(k) | ||
| Number | K162901 | K203440 |
| Indications | ||
| For Use | Penumbra Reperfusion Catheters and Separators | |
| As part of the Penumbra System, the Reperfusion | ||
| Catheters and Separators are indicated for use in the | ||
| revascularization of patients with acute ischemic stroke | ||
| secondary to intracranial large vessel occlusive disease | ||
| (within the internal carotid, middle cerebral - M1 and | ||
| M2 segments, basilar, and vertebral arteries) within 8 | ||
| hours of symptom onset. Patients who are ineligible for | ||
| intravenous tissue plasminogen activator (IV t-PA) or | ||
| who fail IV t-PA therapy are candidates for treatment. | ||
| Penumbra 3D Revascularization Device | ||
| As part of the Penumbra System, the Penumbra 3D | ||
| Revascularization Device is indicated for use in the | ||
| revascularization of patients with acute ischemic stroke | ||
| secondary to intracranial large vessel occlusive disease | ||
| (within the internal carotid, middle cerebral - M1 and | ||
| M2 segments) within 8 hours of symptom onset. Patients | ||
| who are ineligible for intravenous tissue plasminogen | ||
| activator (IV t-PA) or who fail IV t-PA therapy are | ||
| candidates for treatment. | ||
| Penumbra Aspiration Tubing | ||
| As part of the Penumbra System, the Penumbra Sterile | ||
| Aspiration Tubing is indicated to connect the Penumbra | ||
| Reperfusion Catheters to the Penumbra Aspiration | ||
| Pump. | SAME | |
| Device | ||
| Attribute | Predicate Device | Subject Device |
| Penumbra Aspiration Pump | ||
| The Penumbra Aspiration Pump is indicated as a | ||
| vacuum source for Penumbra Aspiration Systems. |
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Image /page/6/Picture/1 description: The image shows the logo for Penumbra, Inc., a healthcare company. The word "Penumbra" is written 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, and the red color gives it a sense of energy and urgency.
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Image /page/7/Picture/0 description: The image shows 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 appears to be for a company or organization called Penumbra.
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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 .
- . Sterilization
- Packaging 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 specifications. | Acceptance Criteria Met | |
| Friction Test | Confirms units meet product specification related to | |
| friction. | Acceptance Criteria Met | |
| Fluoroscopy Test | Confirms the marker band is fluoroscopically visible. | Acceptance Criteria Met |
| Simulated Use Test | Confirms the functionality of units using clinically | |
| relevant benchtop model. | Acceptance Criteria Met | |
| Particulate Test | Particulates generated during simulated use (including | |
| multiple deployment cycling) were evaluated. | Acceptance Criteria Met | |
| Hub Air Test | Confirms units have no leaks when tested. | Acceptance Criteria Met |
| Tensile Test | Confirms units meet product specification related to | |
| tensile 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 appropriate distal tip stiffness. | Acceptance Criteria Met |
| Shelf-Life | Confirms expiration date based on accelerated aging | |
| test studies. | Acceptance Criteria Met | |
| Packaging Validation | ||
| Test | Confirms the packaging of the units meet all product | |
| specifications | Acceptance Criteria Met |
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Image /page/9/Picture/0 description: The image contains the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside of it. The "P" is stylized with a white line going through the middle of it. The image is a logo for the company Penumbra.
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Sterilization Test | Confirms the units are sterilized in accordance with | |
| ISO 11135 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 FDA Good Laboratory Practices (GLP) as recognized by FDA. The battery of testing included the following tests:
| Tests | Results | Conclusion |
|---|---|---|
| Cytotoxicity: | ||
| MEM Elution | ||
| (ISO 10993-5) | No evidence of cell lysis or toxicity (Grade = 0, | |
| Reactivity None). | Pass | |
| Sensitization: | ||
| Magnusson-Kligman | ||
| Method | ||
| (ISO 10993-10) | Both Test Group & Control Group Grade = 0 | |
| None of the treated or negative control animals exhibited | ||
| any reaction at the challenge. The positive control article | ||
| elicited discrete reactions in all animals. | Pass | |
| Irritation: | ||
| Intracutaneous | ||
| Reactivity | ||
| (ISO 10993-10) | None of the animals exhibited overt signs of toxicity at | |
| any of the observation points. The test article sites did not | ||
| show a significantly greater biological reaction than the | ||
| sites injected with the control article. | Pass | |
| Systemic Toxicity: | ||
| Acute Systemic Injection | ||
| (ISO 10993-11) | No evidence of systemic toxicity from sample extracts. | |
| That is: | ||
| ● | ||
| No deaths; | ||
| No signs consistent with toxicity; | ||
| ● | ||
| No weight loss > 10%. | ||
| ● | Pass | |
| Systemic Toxicity: | ||
| Material Mediated | ||
| Pyrogen | ||
| (ISO 10993-11) | Non-pyrogenic: no single animal had an individual rise in | |
| body temperature ≥ 0.5 °C. | Pass | |
| Hemocompatibility: | ||
| In-vitro | ||
| Thrombogenicity | ||
| (ISO 10993-4) | Device non-thrombogenic in vitro when compared to a | |
| predicate device. | Pass | |
| Hemocompatibility: | ||
| Partial Thromboplastin | ||
| Time (PTT) | ||
| (ISO 10993-4) | Test article coagulation times are statistically similar to | |
| predicate. | Pass | |
| Hemocompatibility: | ||
| Complement Activation | ||
| (ISO 10993-4) | Test article concentrations of Sc5b-9 are statistically | |
| similar to predicate. | Pass | |
| Hemocompatibility: | ||
| Hemolysis, indirect | ||
| contact (ISO 10993-4) | Hemolytic Index = 0.00%. | Pass |
10
Image /page/10/Picture/0 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a bold, sans-serif font. The "P" in the circle is also in a sans-serif font and is slightly offset to the right. The overall design is simple and modern.
| Tests | Results | Conclusion |
|---|---|---|
| Hemocompatibility: | ||
| Hemolysis, direct | ||
| contact (ISO 10993-4) | Hemolytic Index = 0.00%. | Pass |
Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements.
1.7.3 Performance Data – Animal, Clinical
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Conclusions 1.8
The subject Penumbra System® (Reperfusion Catheter RED™ 62) is substantially equivalent to the predicate devices Penumbra System ACE 68 Reperfusion Catheter and Penumbra 3D Revascularization Device. The subject device has the same 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.