The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, 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, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

Device Description

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).

The catheter is a single lumen, 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 RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede 070 Aspiration Catheter.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connects to the hub of a Millipede 070 Aspiration Catheter. The suction connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

AI/ML Overview

This document is a 510(k) summary for the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set. It states that the subject device is substantially equivalent to a previously cleared predicate device (K242504), also from Perfuze Ltd.

The key takeaway is that no new acceptance criteria, new studies, or performance data were generated or provided for this 510(k) submission (K250012) to prove the device meets acceptance criteria.

The reasoning presented in the document is that the subject device has identical indications for use, operating principle, and design to the predicate device. The only noted difference for the subject device (K250012) compared to the predicate device (K242504) is a different sterilization cycle for the Perfuze Aspiration Tube Set.

Therefore, the document argues that:

Non-clinical bench testing was not required because "There are no changes to technological characteristics."
Biocompatibility testing was not required because "The materials, formulation, and suppliers... are identical in the subject and predicate devices."
Sterilization validation was performed only for the new sterilization cycle of the Perfuze Aspiration Tube Set to ensure it meets ISO 11135 standards, not to establish new performance criteria for the device itself.
Shelf life and packaging testing was done to ensure the integrity of the sterile barrier with the new sterilization cycle, not to prove new performance.
No animal or clinical studies were deemed necessary because of the substantial equivalence to the predicate device.

In summary, the document asserts substantial equivalence based on the device being functionally identical to an already cleared device, with only a change in a manufacturing process (sterilization of one component) that was validated to ensure it does not negatively impact existing performance.

Therefore, I cannot provide the requested information about acceptance criteria or specific study results for this 510(k) submission (K250012) because the document explicitly states that such studies were not performed for this submission due to perceived substantial equivalence.

The information requested, such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, and ground truth establishment, would have been part of the original K242504 submission that established the predicate device's safety and effectiveness. This current 510(k) (K250012) relies on the previous clearance rather than generating new performance data.

Summary

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February 26, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Perfuze Ltd. Anne-Marie Gannon Director of Regulatory Affairs Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland

Re: K250012

Trade/Device Name: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: January 30, 2025 Received: January 30, 2025

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 (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.

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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 medical devices and radiation-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

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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,

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

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Indications for Use

510(k) Number (if known) K250012

Device Name Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Indications for Use (Describe)

Millipede 070 Aspiration Catheter

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

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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510(k) Summary - K250012

Submitter Information

Submitter's Name: Address:

Contact Person: Telephone: Date Prepared:

Subject Device

Proprietary Name:

Common/Usual Name: Classification Name: Regulatory Class: Regulation: 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 17th February 2025

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Percutaneous Catheter Catheter, Thrombus Retriever 21 CFR 870.1250 NRY

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Percutaneous Catheter Catheter, Thrombus Retriever ll 21 CFR 870.1250 NRY Perfuze Ltd. K242504

Device Description

The Millipede 070 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).

For the aspiration source, the Millipede 070 Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is

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connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

Indications for Use

Millipede 070 Aspiration Catheter

The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, 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, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.

Attribute	Predicate DeviceMillipede 070 Aspiration Catheter;Perfuze Aspiration Tube Set(K242504)	Subject DeviceMillipede 070 Aspiration Catheter;Perfuze Aspiration Tube Set(K250012)
RegulationNumber	21 CFR 870.1250	Same
Regulation Name	Percutaneous Catheter	Same
Classification	Class II	Same
Product Code	NRY	Same
Indications foruse	The Millipede 070 AspirationCatheter, with the Perfuze AspirationTube Set and a compatibleaspiration pump, is indicated for usein the revascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (within theinternal carotid, middle cerebral -M1 and M2 segments, basilar, andvertebral arteries) within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) orwho fail IV t-PA therapy arecandidates for treatment.	The Millipede 070 AspirationCatheter, with the Perfuze AspirationTube Set and a compatibleaspiration pump, is indicated for usein the revascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (within theinternal carotid, middle cerebral -M1 and M2 segments, basilar, andvertebral arteries) within 8 hours ofsymptom onset. Patients who areineligible for intravenousthrombolytic drug therapy or whohave not responded to thrombolyticdrug therapy are candidates fortreatment.
	The Perfuze Aspiration Tube Set isindicated to connect the Millipede070 Aspiration Catheter to acompatible aspiration pump.	The Perfuze Aspiration Tube Set isindicated to connect the Millipede070 Aspiration Catheter to acompatible aspiration pump.
DeviceDescription	Single lumen catheter designed tobe introduced over a steerableguidewire to access theneurovasculature. The semi-rigidproximal section transitions to aflexible distal tip to facilitateadvancement through vessels. A	Same
Attribute	Predicate DeviceMillipede 070 Aspiration Catheter;Perfuze Aspiration Tube Set(K242504)	Subject DeviceMillipede 070 Aspiration Catheter;Perfuze Aspiration Tube Set(K250012)
	single radiopaque marker at thedistal end facilitates fluoroscopicvisualization. The outer surface ofthe catheter is coated with ahydrophilic coating to reduce frictionduring navigation in the vasculature.A luer fitting on the catheter hub isused for the attachment ofaccessories. A strain relief at the hubprovides kink resistance for theproximal end.
Principle ofOperation	Designed to remove thrombus fromthe neurovasculature using directaspiration.	Same
Techniques forUse	Standard percutaneous,intravascular techniques.	Same
Materials	Polymers and metals commonlyused in the manufacture of medicaldevices.	Same
Distal Tip	Tapered, soft, flexible.	Same
Catheter WallConstruction	Braid and coil reinforcement, withribbed internal surface at distal end.	Same
Coating	Hydrophilic coating	Same
Catheter Profile	6 Fr	Same
Inner Diameter	Distal: 0.070 inProximal: 0.069 in	Same
Outer Diameter	Distal: 0.0835 inProximal: 0.0865 in	Same
Working Length /Effective length	136 cm	Same
PackagedAccessories	Rotating Hemostasis Valve	Same
ConditionSupplied	Sterile and single use	Same
SterilizationMethod	Ethylene Oxide (EO)	Same
PackagingConfiguration	Polyethylene terephthalate Tyvek®pouch, polyethylene tube,paperboard packaging card,cardboard carton.	Same
PerfuzeAspiration Tubing	100 in lengthTubing ID = 0.110 inPinch clamp valve for vacuumcontrol	Same

Comparison to the Predicate Device

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Non-Clinical Testing

Performance Testing (Bench)

The subject and predicate devices have indications for use, operating principle, and design. There are no changes to technological characteristics. Therefore, non-clinical bench testing was not required for the subject Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set.

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Biocompatibility

The materials, formulation, and suppliers of the materials used in the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are identical in the subject and predicate devices. The product-contacting packaging materials in the subject and predicate devices are also identical. Therefore, no biocompatibility testing was required for the subject Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set.

Sterilization

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are sterilized using a validated EO process with a sterility assurance level of 1x10 °. There is no change to the sterilization method used for the subject Millipede 070 Aspiration Catheter compared to the predicate device. Therefore, no additional sterilization data was required for the subject Millipede 070 Aspiration Catheter.

A different sterilization cycle will be used for the subject Perfuze Aspiration Tube Set compared to the predicate device. A validation was conducted for this cycle using the overkill method according to ISO 11135, "Sterilization of Health-Care Products - Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices".

Shelf Life and Packaging

The subject and predicate devices have an identical shelf life and packaging configuration. To ensure that the new sterilization cycle for the Perfuze Aspiration Tube Set does not impact integrity of the sterile barrier, packaging testing was conducted following sterilization with the new process. The device packaging met established specifications.

Animal Study

No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.

Clinical Data

No clinical study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.

Conclusion

The subject and predicate devices have the same indications for use, operating principle, and design. The different sterilization cycle used for the Perfuze Aspiration Tube Set does not raise different questions of safety or effectiveness. The successful completion of sterilization and packaging validation demonstrates that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).