MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)

{0}------------------------------------------------ March 27, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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. Sheina Rajkumar Regulatory Affairs Specialist II One Penumbra Place Alameda. California 94502 #### Re: K233201 Trade/Device Name: MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: February 21, 2024 Received: February 22, 2024 Dear Sheina Rajkumar: 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. 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). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) 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. 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 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 -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 2 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233201 Device Name MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Indications for Use (Describe) The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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One Penumbra Place Alameda, CA 94502 USA Contact Person: Sheina Rajkumar Regulatory Affairs Specialist II Tel: (510) 995-2426 E-mail: srajkumar(@penumbrainc.com Date of Preparation: March 26, 2024 #### 2. Subject Device MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Classification Name: Catheter, Percutaneous, Neurovasculature Regulation Number: 21 CFR 870.1250 - Class II Product Code: QJP, DQY #### 3. Predicate/Reference Devices | MIDWAY 43 Delivery Catheter | | | |-----------------------------|---------|-----------------------------------------------| | Predicate | K070970 | Neuron Intracranial Access System | | Reference | K222808 | Penumbra System (Reperfusion Catheter RED 43) | | MIDWAY 62 Delivery Catheter | | | | Predicate | K142321 | Benchmark Intracranial Access System | | Reference | K203440 | Penumbra System (Reperfusion Catheter RED 62) | #### 4. Device Description The MIDWAY Delivery Catheters are single lumen percutaneous catheters designed to provide a conduit for introduction of interventional devices to the peripheral, coronary, and neuro vasculature. The MIDWAY Delivery Catheters include the following: - MIDWAY 43 Delivery Catheter - · MIDWAY 62 Delivery Catheter {4}------------------------------------------------ Image /page/4/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 connected to the word "Penumbra" by a thin white line. The logo is simple and modern, and the colors are eye-catching. The MIDWAY Delivery Catheter is a single lumen, coil-reinforced, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The MIDWAY Delivery Catheter is compatible with sheaths and guide catheters appropriately sized for the outer diameter of the MIDWAY Delivery Catheter. The MIDWAY Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft. ### 5. Indications For Use The MIDWAY Delivery Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. ## 6. Comparison of Technological Characteristics with the Predicate and Reference Devices | Device Name | Neuron Intracranial<br>Access System<br>[Predicate] | Penumbra System<br>(Reperfusion Catheter<br>RED 43)<br>[Reference] | MIDWAY 43<br>Delivery Catheter<br>[Subject] | Comparison | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Classification | Class II, DQY | Class II, NRY | Class II, QJP, DQY | N/A | | 510(k)<br>Number | K070970 | K222808 | K233201 | N/A | | Indications<br>for Use | The Neuron™<br>Intracranial Access<br>System is indicated for<br>the introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | Penumbra Reperfusion<br>Catheters and Separators<br>As part of the Penumbra<br>System, the Reperfusion<br>Catheters and Separators are<br>indicated for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral - M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of<br>symptom onset. Patients who<br>are ineligible for intravenous<br>tissue plasminogen activator<br>(IV t-PA) or who fail IV t-PA<br>therapy are candidates for<br>treatment.<br>Penumbra 3D<br>Revascularization Device<br>As part of the Penumbra<br>System, the Penumbra 3D<br>Revascularization Device is | The MIDWAY<br>Delivery Catheter is<br>indicated for the<br>introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | SAME as<br>Predicate Device<br>[K070970] | | Device Name | Neuron Intracranial<br>Access System<br>[Predicate] | Penumbra System<br>(Reperfusion Catheter<br>RED 43)<br>[Reference] | MIDWAY 43<br>Delivery Catheter<br>[Subject] | Comparison | | | | indicated for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease (within<br>the internal carotid, middle<br>cerebral – M1 and M2<br>segments) within 8 hours of<br>symptom onset. Patients who<br>are ineligible for intravenous<br>tissue plasminogen activator<br>(IV t-PA) or who fail IV t-PA<br>therapy are candidates for<br>treatment.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra<br>System, the Penumbra Sterile<br>Aspiration Tubing is indicated<br>to connect the Penumbra<br>Reperfusion Catheters to the<br>Penumbra Aspiration Pump.<br><br>Penumbra Aspiration Pump<br>The Penumbra Aspiration<br>Pump is indicated as a vacuum<br>source for Penumbra<br>Aspiration Systems. | | | | Materials | Stainless Steel, PTFE,<br>Polyurethane, Polyether<br>Block Amide, Nylon,<br>Platinum/Iridium | Stainless Steel, PTFE,<br>Polyurethane, Polyether Block<br>Amide, Nylon 12, Nitinol,<br>Platinum/Iridium | Stainless Steel, PTFE,<br>Polyurethane, Polyether<br>Block Amide, Nylon 12,<br>Nitinol, Platinum/Iridium | SAME as<br>Reference<br>Device<br>[K222808] | | Coating | Hydrophilic<br>(proprietary) | Hydrophilic<br>(proprietary) | Hydrophilic<br>(proprietary) | SAME as<br>Reference<br>Device<br>[K222808] | | Distal Inner<br>Diameter (ID) | 0.053 in Min | 0.043 in Min | 0.043 in Min | SAME as<br>Reference<br>Device<br>[K222808] | | Proximal ID | 0.053 in Min | 0.043 in Min | 0.043 in Min | SAME as<br>Reference<br>Device<br>[K222808] | | Distal Outer<br>Diameter (OD) | 0.072 in Max | 0.056 in Max | 0.056 in Max | SAME as<br>Reference<br>Device<br>[K222808] | | Proximal OD | 0.083 in Max | 0.060 in Max | 0.060 in Max | SAME as<br>Reference<br>Device<br>[K222808] | | Device Name | Neuron Intracranial<br>Access System<br>[Predicate] | Penumbra System<br>(Reperfusion Catheter<br>RED 43)<br>[Reference] | MIDWAY 43<br>Delivery Catheter<br>[Subject] | Comparison | | Effective<br>Lengths | 105, 115 cm | 115, 120, 125, 127, 132, 136, 138,<br>145, 150, 153, 155, 160, 162, 167 cm | 115, 120, 125, 127, 136,<br>138, 160, 162, 167 cm | SAME | | Packaging<br>Materials | Polyester/Polyethylene/<br>Tyvek, Polyethylene,<br>SBS Paperboard. | Polyester/Polyethylene/Tyvek,<br>Polystyrene, SBS Paperboard | Polyester/Polyethylene/Tyvek,<br>SBS Paperboard | SAME | | Sterilization | Ethylene Oxide (EO) | EO | EO | SAME | | Shelf-Life | 36 Months | 36 Months | 36 Months | SAME | | Single Use | Single use | Single use | Single use | SAME | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in red, with a stylized "P" in a red circle to the right of the word. A thin white line runs horizontally through the "P" in the circle. K233201 {6}------------------------------------------------ Image /page/6/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 "P" is stylized with a horizontal line extending from the top of the "P" to the edge of the circle. | Device Name | Benchmark<br>Intracranial Access<br>System [Predicate] | Penumbra System<br>(Reperfusion Catheter RED<br>62)<br>[Reference] | MIDWAY 62<br>Delivery Catheter<br>[Subject] | Comparison | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Classification | Class II, DQY | Class II, NRY | Class II, QJP, DQY | N/A | | 510(k)<br>Number | K142321 | K203440 | K233201 | N/A | | Indications for<br>Use | The Benchmark™<br>Intracranial Access<br>System is indicated for<br>the introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | Penumbra Reperfusion<br>Catheters and Separators<br>As part of the Penumbra<br>System, the Reperfusion<br>Catheters and Separators<br>are indicated for use in the<br>revascularization of<br>patients with acute<br>ischemic stroke secondary<br>to intracranial large vessel<br>occlusive disease (within<br>the internal carotid,<br>middle cerebral - M1 and<br>M2 segments, basilar, and<br>vertebral arteries) within 8<br>hours of symptom onset.<br>Patients who are ineligible<br>for intravenous tissue<br>plasminogen activator (IV<br>t-PA) or who fail IV t-PA<br>therapy are candidates for<br>treatment.<br><br>Penumbra 3D<br>Revascularization Device<br>As part of the Penumbra<br>System, the Penumbra 3D<br>Revascularization Device is<br>indicated for use in the<br>revascularization of patients<br>with acute ischemic stroke<br>secondary to intracranial large<br>vessel occlusive disease<br>(within the internal carotid, | The MIDWAY<br>Delivery Catheter is<br>indicated for the<br>introduction of<br>interventional devices<br>into the peripheral,<br>coronary, and neuro<br>vasculature. | SAME as<br>Predicate<br>Device<br>[K142321] | | Device Name | Benchmark<br>Intracranial Access<br>System [Predicate] | Penumbra System<br>(Reperfusion Catheter RED<br>62)<br>[Reference] | MIDWAY 62<br>Delivery Catheter<br>[Subject] | Comparison | | | | middle cerebral – M1 and M2<br>segments) within 8 hours of<br>symptom onset. Patients who<br>are ineligible for intravenous<br>tissue plasminogen activator<br>(IV t- PA) or who fail IV t-PA<br>therapy are candidates for<br>treatment.<br><br>Penumbra Aspiration Tubing<br>As part of the Penumbra<br>System, the Penumbra Sterile<br>Aspiration Tubing is<br>indicated to connect the<br>Penumbra Reperfusion<br>Catheters to the Penumbra<br>Aspiration Pump.<br><br>Penumbra Aspiration Pump<br>The Penumbra Aspiration Pump<br>is indicated as a vacuum source<br>for Penumbra Aspiration<br>Systems. | | | | Materials | Stainless Steel, PTFE,<br>Polyurethane,<br>Polyether Block<br>Amide, Nylon,<br>Platinum/Tungsten | Stainless Steel, PTFE,<br>Polyurethane, Polyether Block<br>Amide, Nylon 12, Nitinol,<br>Platinum/Iridium | Stainless Steel, PTFE,<br>Polyurethane, Polyether<br>Block Amide, Nylon<br>12, Nitinol,<br>Platinum/Iridium | SAME as<br>Reference<br>Device<br>[K203440] | | Coating | Hydrophilic<br>(proprietary) | Hydrophilic<br>(proprietary) | Hydrophilic<br>(proprietary) | SAME as<br>Reference<br>Device<br>[K203440] | | Distal ID | 0.070 in Min | 0.062 in Min | 0.062 in Min | SAME as<br>Reference<br>Device<br>[K203440] | | Proximal ID | 0.070 in Min | 0.062 in Min | 0.062 in Min | SAME as<br>Reference<br>Device<br>[K203440] | | Distal OD | 0.083 in Max | 0.076 in Max | 0.076 in Max | SAME as<br>Reference<br>Device<br>[K203440] | | Proximal OD | 0.083 in Max | 0.076 in Max | 0.076 in Max | SAME as<br>Reference<br>Device<br>[K203440] | | Effective<br>Lengths | 95, 105, 115 cm | 115, 120, 125, 127, 132, 138,<br>160 cm | 115, 120, 125, 132, 138,<br>160 cm | SAME | | Packaging<br>Materials | Polyester/Polyethylene | Polyester/Polyethylene/ | Polyester/Polyethylene/<br>Tyvek, SBS Paperboard | SAME | | Device Name | Benchmark<br>Intracranial Access<br>System [Predicate] | Penumbra System<br>(Reperfusion Catheter RED<br>62)<br>[Reference] | MIDWAY 62<br>Delivery Catheter<br>[Subject] | Comparison | | | SBS Paperboard | Tyvek, Polystyrene, SBS<br>Paperboard | | | | Sterilization | EO | EO | EO | SAME | | Shelf-Life | 36 Months | 36 Months | 36 Months | SAME | | Single Use | Single use | Single use | Single use | SAME | {7}------------------------------------------------ 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. A thin white line extends from the right side of the word "Penumbra" to the left side of the "P". K233201 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Penumbra, 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. A white line extends from the right side of the word "Penumbra" to the left side of the "P" in the circle. #### 7. Bench Performance Testing The subject MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter have the same design, materials, and manufacturing as the respective reference devices: Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440). Bench performance testing of the reference devices was used in support of the subject device. The following additional bench performance testing was conducted to support the new indication of the subject catheters: | Test | Test Method Summary | Conclusion | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Simulated Use Test | Confirms the functionality of MIDWAY Delivery<br>Catheters using clinically relevant benchtop model,<br>including testing with a marketed stent-retriever. | Acceptance Criteria Met | | Compatibility Test | Confirms compatibility of MIDWAY Delivery Catheters<br>with a marketed introducer sheath, guidewire,<br>microcatheter, and stent-retriever. | Acceptance Criteria Met | | Particulate Test | Particulates generated during simulated use were<br>evaluated. | Acceptance Criteria Met | | Coating Integrity Test | Confirms that coating of MIDWAY Delivery Catheters<br>has not delaminated, peeled, or flaked before or after<br>simulated use. | Acceptance Criteria Met | | Surface Integrity | The MIDWAY Delivery Catheter surface is inspected for<br>defects. | Acceptance Criteria Met | | Tensile Strength Test | Confirms MIDWAY Delivery Catheters meet product<br>specification related to tensile strength after simulated use. | Acceptance Criteria Met | | Burst Pressure Test | Confirms MIDWAY Delivery Catheters can withstand<br>sufficient pressure after simulated use. | Acceptance Criteria Met | {9}------------------------------------------------ Image /page/9/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 of it. The "P" is connected to the word "Penumbra" by a thin white line. #### 8. Other Performance Data The subject MIDWAY 43 Delivery Catheter and MIDWAY 62 Delivery Catheter have the same design, materials, and manufacturing as the respective reference devices: Reperfusion Catheter RED 43 (K222808) and Reperfusion Catheter RED 62 (K203440). The following testing of the reference devices was used in support of the subject device: - Biocompatibility ● - Shelf Life . - Sterilization ● - Packaging ● #### 9. Animal and Clinical Data No animal or clinical studies were deemed necessary to support the substantial equivalence of the MIDWAY Delivery Catheters. #### 10. Conclusions The subject MIDWAY Delivery Catheters are substantially equivalent to the respective predicate devices (K070970 and K142321). The subject device has the same intended use as the predicate devices. The non-clinical testing demonstrates that the subject device performs as intended and is substantially equivalent to the predicate devices. The differences in technological characteristics of the subject and predicate devices do not raise new questions of safety or effectiveness.