(56 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing for decision support or image analysis.
Yes
The Penumbra System, including components like the Reperfusion Catheters, Separators, and 3D Revascularization Device, is indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusion, which is a therapeutic intervention aimed at restoring blood flow and treating a medical condition.
No
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including catheters, pumps, tubing, and separators, which are physical medical devices used in a procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Penumbra System is a medical device designed for the mechanical removal of thrombus (blood clots) from blood vessels in patients experiencing acute ischemic stroke. It is an interventional device used directly within the patient's body.
- Intended Use: The intended use clearly describes a therapeutic procedure to revascularize patients by removing blockages in their arteries. This is a treatment, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details catheters, pumps, and tubing used to physically interact with and remove the thrombus from the vasculature. This aligns with an interventional therapeutic device.
Therefore, the Penumbra System falls under the category of a therapeutic medical device, 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 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
Fluoroscopy
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)
Design Verification Testing:
Dimensional/Visual Test: Confirms the units meet all dimensional and visual product specifications. Acceptance Criteria Met.
Kink Resistance Test: Confirms units meet product specification related to kink resistance when formed in a defined radius. Acceptance Criteria Met.
Friction Test: Confirms units meet product specification related to friction. Acceptance Criteria Met.
Fluoroscopy Test: Confirms the markerband is fluoroscopically visible. Acceptance Criteria Met.
Simulated Use Test: Confirms the functionality of units using clinically 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.
Shelf-Life: Confirms expiration date 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. Acceptance Criteria Met.
Biocompatibility Testing:
The biocompatibility of the subject device is supported by the biocompatibility testing of the predicate and reference devices. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
Cytotoxicity (MEM Elution, ISO 10993-5): Sample extracts must have a cytotoxic reactivity score of grade 2 or lower. Conclusion: Pass, Non-cytotoxic.
Sensitization (Magnusson-Kligman Method, ISO 10993-10): Test Group shall yield Grade 10% in 3 or more animals. Conclusion: Pass, Non-toxic.
Systemic Toxicity (Material Mediated Pyrogen, ISO 10993-11): Sample extracts must not cause a total rise in body temperature of >= 0.5°C. Conclusion: Pass, Non-pyrogenic.
Hemocompatibility (Thrombogenicity, ISO 10993-4): The test article must have similar or less thrombus formation compared to predicate device. Conclusion: Pass, Non-thrombogenic.
Hemocompatibility (Partial Thromboplastin Time (PTT), ISO 10993-4): Clotting times of test article must be similar to predicate values. Conclusion: Pass, Hemocompatible.
Hemocompatibility (Complement Activation, ISO 10993-4): The concentration of SC5b-9 of test article must be similar to predicate values. Conclusion: Pass, Hemocompatible.
Hemocompatibility (Hemolysis, indirect contact, ISO 10993-4): Sample extracts must be non-hemolytic (
§ 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).
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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
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) K211411
Device Name
Penumbra System® (RED™ 68 Reperfusion Catheter)
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 of
Manufacturer |
|------------------|----------------------------------------------|-------------------------|
| Predicate Device | | |
| K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. |
| K162901 | Penumbra 3D Revascularization Device | Penumbra, Inc. |
| Reference Device | | |
| K190010 | Penumbra System (Reperfusion Catheter JET 7) | Penumbra, Inc. |
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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 .
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 "P" inside. The "P" is stylized with a white outline and a horizontal line extending from the top right of the "P" to the right edge of the word "Penumbra".
Indications For Use 1.5
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra Aspiration Tubing
As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
1.6 Comparison of Indications for Use and Technological Characteristics with the Predicate Devices
| Device Attribute | Predicate Device | Subject Device |
|---|---|---|
| Trade Name | Penumbra System ACE 68 Reperfusion | |
| Catheter | Penumbra System (RED | |
| 68 Reperfusion Catheter) | ||
| 510(k) Number | K161640 | K211411 |
| FDA Product | ||
| Classification | Class II, NRY, | |
| 21 CFR 870.1250 | SAME | |
| 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 | SAME as Predicate | |
| Device with K162901 | ||
| Device Attribute | Predicate Device | Subject Device |
| 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 |
| Accessories | Peelable Sheath, RHV, Shaping Mandrel | SAME |
| Min. ID | 0.068 in. (1.73 mm) | SAME |
| Max. OD | 0.084 in. (2.13 mm) | SAME |
| Distal Flex | ||
| Length | 30 cm | SAME |
| Coating Length | 30 cm | SAME |
| Effective Lengths | 115, 120, 125, 127, 132 cm | SAME |
| Accessories | Peelable Sheath, Shaping Mandrel, RHV | SAME |
| Packaging | ||
| 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 |
| (RED 68 Reperfusion | ||
| Catheter) | ||
| FDA Product | ||
| Classification | Class II, NRY, 21 CFR 870.1250 | SAME |
| 510(k) Number | K162901 | K211411 |
| 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. | 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 product | |
| specifications. | Acceptance Criteria Met | |
| Kink Resistance Test | Confirms units meet product specification related to kink | |
| resistance when formed in a defined radius. | Acceptance Criteria Met | |
| Friction Test | Confirms units meet product specification related to friction. | Acceptance Criteria Met |
| Fluoroscopy Test | Confirms the markerband is fluoroscopically visible. | Acceptance Criteria Met |
| Simulated Use Test | Confirms the functionality of units using clinically | |
| 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 |
| Shelf-Life | Confirms expiration date 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. | 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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Image /page/9/Picture/0 description: The image shows the word "Penumbra" in a red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern.
and additional testing is not required. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure ( 10% in 3 or more animals. | Pass
Non-toxic |
| Systemic Toxicity: Material
Mediated Pyrogen
(ISO 10993-11) | Sample extracts must not cause a total rise in
body temperature of ≥ 0.5°C. | Pass
Non-pyrogenic |
| Hemocompatibility:
Thrombogenicity
(ISO 10993-4) | The test article must have similar or less
thrombus formation compared to predicate
device. | Pass
Non-thrombogenic |
| Hemocompatibility: Partial
Thromboplastin Time (PTT)
(ISO 10993-4) | Clotting times of test article must be similar to
predicate values. | Pass
Hemocompatible |
| Hemocompatibility:
Complement Activation
(ISO 10993-4) | The concentration of SC5b-9 of test article must
be similar to predicate values. | Pass
Hemocompatible |
| Hemocompatibility:
Hemolysis, indirect contact
(ISO 10993-4) | Sample extracts must be non-hemolytic
(≤ 2% hemolytic index). | Pass
Non-hemolytic |
| Hemocompatibility:
Hemolysis, direct contact
(ISO 10993-4) | Sample must be non-hemolytic
(≤ 2% hemolytic index). | Pass
Non-hemolytic |
Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements.
Performance Data – Animal, Clinical 1.7.3
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
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Image /page/10/Picture/0 description: The image shows the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. A thin white line extends from the right side of the word "Penumbra" to the left side of the circle.
Conclusions 1.8
The subject Penumbra System® (RED™ 68 Reperfusion Catheter) is substantially equivalent to the predicate device Penumbra System ACE 68 Reperfusion Catheter and Penumbra 3D Revascularization Device. The subject device has identical intended use as the predicate devices. The device testing described in the 510(k) Summary demonstrates the subject device is substantially equivalent to the predicate devices in regard to intended use, operating principle, design concept, fundamental technology and device performance.