Millipede 088 Access Catheter

{0}------------------------------------------------ September 19, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION". Perfuze Ltd. Anne-Marie Gannon Director of Regulatory Affairs Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland Re: K231802 Trade/Device Name: Millipede 088 Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: August 25, 2023 Received: August 25, 2023 Dear Anne-Marie Gannon: 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}------------------------------------------------ 2 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 -S Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. #### 510(k) Number (if known) K231802 RZ51802 Device Name Millipede 088 Access Catheter Indications for Use (Describe) The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. 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." FORM FDA 3881 (6/20) {3}------------------------------------------------ ## 510(k) Summary K231802 #### Submitter Information Submitter's Name: Address: Contact Person: Telephone: Date Prepared: ### Subject Device Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Requlation: Product Code: #### Predicate Device Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Regulation: Product Code: Manufacturer: 510(k) Number: Perfuze Ltd. Unit 6, Galway Business Park, Dangan. Galway, H91 W7CP, Ireland Anne-Marie Gannon +353 91 428083 September 19, 2023 Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature ll 21 CFR 870.1250 QJP Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature . 21 CFR 870.1250 QJP Perfuze Ltd. K214048 ## Device Description The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO). The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter. ### Indications for Use The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. The Indications for Use statement for the modified Millipede 088 Access Catheter is identical to the predicate device. {4}------------------------------------------------ ## Comparison to the Predicate Device The intended use of the subject device is identical to the predicate device. The subject and predicate devices have similar technological characteristics as shown in the following table. | Attribute | Predicate Device<br>Millipede 088 Access Catheter (K214048) | Subject Device<br>Millipede 088 Access Catheter<br>(K231802) | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Regulation<br>Number | 21 CFR 870.1250 | Same | | Regulation Name | Percutaneous catheter | Same | | Classification | Class II | Same | | Product Code | QJP | Same | | Indications for<br>Use | The Millipede 088 Access Catheter is<br>indicated for use in facilitating the insertion<br>and guidance of microcatheters into a<br>selected blood vessel in the<br>neurovasculature. | Same | | Prescription/Over-<br>the-Counter Use | Prescription | Same | | Device<br>Description | Single-use, variable stiffness, wire-<br>reinforced catheter with a single lumen.<br>The catheter is comprised of a hollow<br>cylindrical tube bonded at the proximal end<br>to a standard luer fitting. The wall of the<br>tube is constructed using metals and<br>polymers. A radiopaque marker provides<br>visual confirmation of the distal tip location<br>under fluoroscopy. | Same | | Principle of<br>Operation | May be used with support catheters to<br>assist in accessing the target<br>neurovasculature. | Same | | Techniques for<br>Use | Standard percutaneous interventional<br>techniques, including access site<br>preparation, introduction of the catheter<br>into the access vessel, advancing the<br>catheter under fluoroscopy, withdrawing<br>the catheter and closing the access site. | Same | | Materials | Polymers and metals commonly used in<br>the manufacture of medical devices. | Same | | Distal Tip | Soft, flexible, and atraumatic | Same | | Catheter Wall<br>Construction | Coil-reinforced with ribbed surface at distal<br>section | Coil and braid reinforced, with<br>ribbed surface at distal section | | Coating | Hydrophilic Coating | Same | | Catheter Profile | 8 Fr | Same | | Inner Diameter | Distal: 0.088"<br>Proximal: 0.087 | | | Attribute | Predicate Device<br>Millipede 088 Access Catheter (K214048) | Subject Device<br>Millipede 088 Access Catheter<br>(K231802) | | Packaging<br>Configuration | The catheters are placed in a protective<br>polyethylene tube, mounted with accessory<br>RHV and valve crossing tool onto a<br>cardboard packaging card, placed into a<br>pouch, sealed, and labeled. The sealed<br>pouch and IFU (Instructions for Use) are<br>placed in a labeled shelf carton box. | Same, with dimensional<br>changes to protective tube and<br>packaging card. | {5}------------------------------------------------ ## Performance Testing (Bench) The design of both the subject and predicate devices are identical at the distal end and transitions, but there are some differences in the design at the proximal end. The successful completion of the performance testing listed in the table below demonstrates that the modified Millipede 088 Access Catheter is suitable for its intended use. | Test | Test Method | Conclusions | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Dimensional<br>Inspection | The device dimensions were measured to<br>confirm conformance to the specifications. | The device met established<br>specifications. | | Visual Inspection | The device surface characteristics were<br>assessed to confirm freedom from defects. | The device surface<br>characteristics are suitable for<br>its intended use. | | Simulated Use<br>Testing | The deliverability and compatibility with<br>accessory devices were evaluated in a<br>neurovascular model. | The device performs as<br>intended under simulated use<br>conditions. | | Hydrophilic<br>Coating Integrity | The integrity of the hydrophilic coating was<br>evaluated after multiple insertion and<br>withdrawal cycles. | The hydrophilic coating<br>integrity is suitable for its<br>intended use. | | Particulate<br>Recovery | The purpose of this test was to quantify<br>the particulate size and count generated<br>during simulated use of the test article. | The particulate size and count<br>was similar to control devices. | | Kink Resistance | Test specimen segments were formed into<br>a defined bend diameter to evaluate kink<br>resistance. | The device met established<br>specifications. | | Air Leakage | Tested per ISO 10555-1:2013 Annex D. | The device integrity is suitable<br>for its intended use. | | Liquid Leakage | Tested as per ISO 10555-1:2013 Annex C. | The device integrity is suitable<br>for its intended use. | | Static Burst | Tested as per ISO 10555-1 Annex F. | The device integrity is suitable<br>for its intended use. | | Catheter Joint<br>Tensile Testing | The tensile strength was evaluated for the<br>bonds between sections of the catheter. | The device met established<br>specifications. | | Torque<br>Strength | The test specimens were rotated in a<br>simulated use model to evaluate integrity<br>after rotation. | The device met established<br>specifications. | | Flow Rate<br>Characterization | The flow rate of saline and a contrast-<br>saline solution was characterized when<br>injected through the catheter. | The flow rate was<br>characterized. | {6}------------------------------------------------ ### Biocompatibility The materials, formulation and suppliers of the materials used in the Millipede 088 Access Catheter in the subject and predicate devices are identical. The product-contacting packaging materials in both devices are also identical, therefore no further biocompatibility testing was required for these components of the subject device. Biocompatibility testing was completed on the accessories provided with the modified Millipede 088 Access Catheter. The Rotating Hemostasis Valve (RHV) and Valve Crossing Tool (VCT) to be provided with the subject device include changes in material and design when compared with those provided with the predicate. The modified accessories were evaluated in accordance with ISO 10993-1:2018. A summary of the biocompatibility testing is outlined below. | Test | Results | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Cytotoxicity - ISO MEM Elution | The test article is non-cytotoxic. | | Sensitization – ISO Guinea Pig<br>Maximization Sensitization Test | The test article did not elicit a sensitization response. | | Irritation - ISO Intracutaneous<br>Reactivity | Requirements of the ISO intracutaneous reactivity test<br>were met for the test article. | | Acute Systemic Toxicity - ISO Acute<br>Systemic Injection | Requirements of the ISO acute systemic injection test<br>were met for the test article. | | Material-Medicated Pyrogenicity | The test article is non-pyrogenic. | | Hemocompatibility – ASTM Hemolysis | The test article is considered non-hemolytic. | #### Shelf Life and Packaging The labeled shelf life is identical for the subject and predicate devices. The sterile barrier is also identical for the subject and predicate devices. Dimensional changes were made to the protective tube and packaging card to accommodate a longer catheter and modified accessories. Packaging validation testing was completed to assess these changes. #### Sterilization The sterilization method is identical for the subject and predicate devices. Confirmatory EO residual testing was repeated on the modified Millipede 088 Access Catheter to confirm that the design differences did not impact residual EO levels of the testing confirmed that EO residuals were within the limits specified in ISO 10993-7. ### Animal Testing No animal testing was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices. ### Clinical Testing No clinical data was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices. #### Conclusion The intended use and indications for use of the Millipede 088 Access Catheter are identical to the intended use and indications for use of the predicate device. The subject modified Millipede 088 Access Catheter and the predicate device use the same operating principles and have a similar design. The differences identified in this submission do not raise different or new questions of safety or effectiveness. The successful completion of performance testing and biocompatibility testing demonstrates that the modified Millipede 088 Access Catheter is substantially equivalent to the predicate device.