Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 2, 2024 Micro Therapeutics Inc. d/b/a ev3 Neurovascular Tony Rizzardi Principal Regulatory Specialist 9775 Toledo Way Irvine, California 92618 Re: K243418 Trade/Device Name: Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: November 1, 2024 Received: November 4, 2024 Dear Tonv Rizzardi: 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/cdrb/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 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-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, Digitally signed by Long H. Chen Long H. Chen -S-s Date: 2024.12.02 09:42:22 -05'00' Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K243418 Device Name Riptide TM Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing ndications for Use (Describe) The Riptide™ Aspiration Pump is intended as a vacuum source for Medtronic aspiration devices or systems for use in hospitals or clinics. Refer to the Instructions for Use included with the accessory aspiration device for indications related to the procedure for which this device will be used. 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." {4}------------------------------------------------ # 510(k) Summary | 510(k) Owner | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618, USA<br>Establishment Registration: 2029214 | |----------------|-------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Tony Rizzardi<br>Principal Regulatory Affairs Specialist<br>Telephone: (763) 505-3017<br>Email: tony.rizzardi@medtronic.com | | Date Summary Prepared | 31 October 2024 | |-----------------------|----------------------------------------------------| | Trade Name of Device | Riptide™ Aspiration Pump | | Common Name of Device | Apparatus, suction, ward use, portable, ac-powered | | Review Panel | General & Plastic Surgery | | Medical Specialty | General & Plastic Surgery | | Product Code | JCX | | Regulation Number | 21 CFR 878.4780 | | Regulation Name | Apparatus, suction, ward use, portable, ac-powered | | Device Classification | Class II | | Predicate Device | Penumbra Pump MAX™ (K122756) | | Reference Device | Riptide™ Aspiration System (K172448) | ### Device Description #### Riptide™ Aspiration Pump The Riptide™ Aspiration Pump is an externally powered electromechanical device capable of generating a vacuum designed for drawing fluids and thrombus into the Riptide™ Collection Canister during interventional procedures. It is intended for general suction use in hospitals or clinics and is not intended for transport or field applications. The Riptide™ Aspiration Pump includes a receptacle that holds the Riptide™ Collection Canister with Intermediate Tubing in place. The intermediate tubing is connected to the vacuum inlet port. The Riptide™ Aspiration Pump package includes the following: - Riptide™ Aspiration Pump (LMT-RAP) ● - Region specific power cord for connection to earthed receptacle. - . Riptide™ Aspiration Pump User's Manual The following item is required for use with Riptide™ Aspiration Pump (packaged separately): - Riptide™ Collection Canister with Intermediate Tubing (LMT-RCT) {5}------------------------------------------------ Image /page/5/Figure/1 description: The image shows a diagram of a vacuum pump with labels pointing to different parts. The labels include vacuum control knob, vacuum inlet, vacuum gauge, on/off button, and canister holder. The vacuum pump has a canister holder on the bottom and a vacuum control knob and gauge on the top. The vacuum inlet is on the side of the pump. Figure 1. Riptide™ Aspiration Pump (Front) Image /page/5/Figure/3 description: The image shows the back of a machine with labels pointing to different parts. The top of the machine has a "COOLING AIR INTAKE". The bottom of the machine has a "POWER CORD CONNECTION" on the left and a "POTENTIAL EQUALIZATION PLUG" on the right. Figure 2. Riptide™ Aspiration Pump (Back) Riptide™ Collection Canister with Intermediate Tubing The Riptide™ Collection Canister is provided non-sterile and is pre-assembled with the Intermediate Tubing. The Riptide™ Collection Canister with Intermediate Tubing is single use. The Riptide™ Collection Canister is the repository for aspirated material. The Riptide™ Canister is placed into the receptacle of the Riptide™ Aspiration Pump as shown in Figure 3. The Intermediate Tubing is then connected to the vacuum inlet port. Image /page/5/Picture/7 description: The image shows two medical suction devices. The device on the left has a Riptide Collection Canister connected to the top of the machine via tubing. The device on the right has Intermediate Tubing connected to the top of the machine. Both devices have a gauge on the top and a collection canister on the side. Figure 3. Riptide™ Collection Canister with Intermediate Tubing {6}------------------------------------------------ # Indications for Use The Riptide™ Aspiration Pump is intended as a vacuum source for Medtronic aspiration devices or systems for use in hospitals or clinics. Refer to the Instructions for Use included with the accessory aspiration device for indications related to the procedure for which this device will be used. # Comparison of Technological Characteristics | Attribute | Predicate Device:<br>Penumbra Pump MAX™<br>(PMX110 - K122756) | Reference Device:<br>Riptide™ Aspiration System<br>(MAP-1000 - K172448) | Subject Device:<br>Riptide™ Aspiration Pump<br>(LMT-RAP) | |--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | | Product Code/<br>Regulation | JCX (21 CFR 878.4780) | NRY (21 CFR 870.1250) | Same as Predicate (K122756) | | Classification | Class II | Class II | Same as Predicate (K122756) | | Components<br>Comprising the<br>System | Pump, collection canister with filter, intermediate tubing | Pump, collection canister with filter, intermediate tubing | Same as Predicate (K122756) | | Pump User Manual Characteristics | | | | | Indications for<br>Use | The Penumbra Pump MAX™ is<br>intended for general suction use in<br>hospitals or clinics. | The Riptide™ Aspiration System is<br>intended for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive<br>disease (within the internal carotid,<br>middle cerebral M1 and M2<br>segments, basilar, and vertebral<br>arteries) within 8 hours of symptom<br>onset. Patients who are ineligible for<br>intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA<br>therapy are candidates for treatment. | The Riptide™ Aspiration Pump is<br>intended as a vacuum source for<br>Medtronic aspiration devices or<br>systems for use in hospitals or clinics.<br>Refer to the Instructions for Use<br>included with the accessory<br>aspiration device for indications<br>related to the procedure for which<br>this device will be used. | | User Manual | User manual with safety information<br>and directions for the Penumbra<br>Pump MAX™ for general suction use. | User manual with safety information<br>and directions for the Riptide™<br>Aspiration Pump for neurovascular<br>use. | User manual with safety information<br>and directions for the Riptide™<br>Aspiration Pump for general suction<br>use. | | Pump Characteristics | | | | | Vacuum Range | 0-29 inHg | Same as Predicate (K122756) | Same as Predicate (K122756) | | Flow Rate | 60 Hz (US):<br>0-0.8 SCFM (0-23 LPM) | Same as Predicate (K122756) | Same as Predicate (K122756) | | Voltage | 100-115 Vac | 110-115 Vac | 110-115 Vac | | Frequency | 60 Hz (US) | Same as Predicate (K122756) | Same as Predicate (K122756) | | Duty Cycle | Non-continuous<br>97.8% (45 minutes on, 1 minute<br>off) | Non-continuous<br>97% (58.2 minutes on, 1.8<br>minutes off) | Non-continuous<br>97% (58.2 minutes on, 1.8<br>minutes off) | | Applied Part<br>Classification | Type CF | Type BF | Same as Predicate (K122756) | | IEC 60601-1<br>and<br>IEC 60601-1-2<br>Compliance | Yes:<br>IEC 60601-1 and<br>IEC 60601-1-2 | Yes:<br>IEC 60601-1 (Edition 3.1) and<br>IEC 60601-1-2 (Edition 4.0) | Yes:<br>IEC 60601-1 (Edition 3.2 2020-08)<br>and IEC 60601-1-2 (Edition 4.1<br>2020-09) | | Attribute | Predicate Device:<br>Penumbra Pump MAX™<br>(PMX110 - K122756) | Reference Device:<br>Riptide™ Aspiration System<br>(MAP-1000 - K172448) | Subject Device:<br>Riptide™ Aspiration Pump<br>(LMT-RAP) | | ISO 10079-1<br>and<br>ISO 10079-4<br>Compliance | Yes:<br>EN ISO 10079-1 | No | Design changes to meet IEC<br>60601-1 (Edition 3.2 2020-08)<br>compared to the Reference<br>Device required displaying dual<br>scale units for pressure as inHg<br>and kPa and included addition of<br>a new component:<br>• Vacuum gauge (P/N 140643-<br>01)<br><br>Yes:<br>ISO 10079-1 (Fourth edition<br>2022-03) and ISO 10079-4 (First<br>edition 2021-08)<br><br>Design changes to meet IP22<br>ingress protection requirement of<br>ISO 10079-1 (Fourth edition<br>2022-03) required addition of<br>new components including:<br>• Sealing washer (P/N 12130-<br>0003) for pressure regulator<br>• Silicon seal (P/N 12130-0001)<br>under power button<br>• Silicon seal inside (P/N<br>12130-0002)<br>• O-ring (P/N 12130-0004) to<br>aid in sealing around gauge<br>• SS plate (P/N 05131-0001) to<br>stop plastic deformation<br>from point loading at clamp<br>and apply even pressure to<br>seal and O-ring<br>• Ring clamp (P/N 08130-0001)<br>• Epoxy (P/N 140518-01)<br>applied to seal handle screws<br>(existing component) to<br>improve sealing around<br>interfaces | | Physical<br>Dimensions | Length: 15.5"<br>Depth: 11.2"<br>Height: 13.2" | Length: 16.1"<br>Depth: 13.2"<br>Height: 12.3" | Length: 16.1"<br>Depth: 13.2"<br>Height: 12.3" | | Weight | 22.3 lbs (10.1 kg) | Approximately 24 lbs (11 kg) | Approximately 24 lbs (11 kg) | | Noise | <60 dBa | 60.5 dBa | <70 dBa | | Internal<br>Components | Commonly used electrical<br>components, fittings, and tubing. | Same as Predicate (K122756) | Same as Predicate (K122756) | | Sterilization | Non-sterile | Same as Predicate (K122756) | Same as Predicate (K122756) | | Operating Life | 500 hours | Same as Predicate (K122756) | Same as Predicate (K122756) | | Attribute | Predicate Device:<br>Penumbra Pump MAX™<br>(PMX110 - K122756) | Reference Device:<br>Riptide™ Aspiration System<br>(MAP-1000 - K172448) | Subject Device:<br>Riptide™ Aspiration Pump<br>(LMT-RAP) | | Collection Canister with Intermediate Tubing Characteristics | | | | | Materials of Construction | Commonly used medical grade plastics | Same as Predicate (K122756) | Same as Predicate (K122756) | | Volume | 1000 mL | 1200 mL | 1200 mL | | Shelf Life | Unknown | 3 years | 3 years | {7}------------------------------------------------ {8}------------------------------------------------ ## Biocompatibility There is no impact to the biocompatibility of the Riptide™ Aspiration Pump associated with the proposed changes. ## Performance Data - Bench The following non-clinical bench tests were conducted for the Riptide™ Aspiration Pump: | Test | Test Method Summary | Results | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Riptide™ Aspiration Pump | | | | Electrical Safety<br>(IEC 60601-1) | Electrical safety testing conducted per IEC 60601-1<br>Edition 3.2 2020-08. | Pass | | Electromagnetic Compatibility<br>(IEC 60601-1-2) | Electromagnetic compatibility (EMC) testing conducted<br>per IEC 60601-1-2 Edition 4.1 2020-09. | Pass | | User Manual Design Validation<br>(for general suction use) | The subject device was evaluated per FDA guidance<br>"Applying Human Factors and Usability Engineering to<br>Medical Devices, Guidance for Industry and Food and<br>Drug Administration Staff" (February 2016) and per FDA<br>recognized consensus standards ISO 14971 (Third Edition<br>2019-12) and ANSI/AAMI HE75:2009/(R)2018 Human<br>Factors Engineering - Design of Medical Devices. | Pass | | Riptide™ Aspiration Pump and Riptide™ Collection Canister with Intermediate Tubing | | | | Medical Suction Equipment<br>(ISO 10079-1/10079-4) | Medical suction equipment testing conducted per ISO<br>10079-1 Fourth Edition 2022-03 and ISO 10079-4 First<br>Edition 2021-08. | Pass | ## Performance Data – Animal The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction. # Performance Data - Clinical The determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the intended use, fundamental scientific technology, or materials of construction. {9}------------------------------------------------ # Conclusion There is no change to the intended use, fundamental scientific technology, principle of operation, and materials of construction of the subject Riptide™ Aspiration Pump (LMT-RAP) in comparison to the legally marketed predicate Penumbra Pump MAX™ (K122756). The design and labeling changes for Type CF applied part classification, meeting latest electrical safety and medical suction equipment standards (including IEC 60601-1, IEC 60601-1-2, ISO 10079-1, and ISO 10079-4), and updated indications for general use in hospitals or clinics under product code JCX do not raise different questions of safety and effectiveness and have been tested through non-clinical bench testing using established scientific methods. The information provided in this submission supports a determination of substantial equivalence for the subject Riptide™ Aspiration Pump.