The Millipede70 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 Millipede70 Aspiration Catheter to a compatible aspiration pump.

Device Description

The Millipede70 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 Millipede70 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 connector connects to the hub of a Millipede70 Aspiration Catheter. The suction connector 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 Millipede70 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

The provided FDA 510(k) clearance letter and summary for the Perfuze Ltd. Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set do not contain information about an AI/ML-based device or a comparative effectiveness study involving human readers with and without AI assistance.

This submission focuses on demonstrating substantial equivalence of a physical medical device (catheter and aspiration tube set) to a previously cleared predicate device. The primary change is a minor modification to the outer diameter of the distal end of the catheter.

Therefore, many of the requested criteria regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for AI models are not applicable to this specific 510(k) submission.

However, I can still extract information about the acceptance criteria and the study that proves the physical device meets these criteria based on the provided document.

Acceptance Criteria and Device Performance for the Physical Device

The acceptance criteria for this physical device are primarily demonstrated through performance testing (bench testing), confirming its mechanical properties and functionality meet defined specifications and are comparable to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

Test Method (Acceptance Criteria)	Reported Device Performance (Conclusion)
Dimensional Verification: Conformance to specifications (specifically the outer diameter of the distal end)	The device met established specifications. (Outer diameter increased from 0.0835" to 0.0837").
Simulated Use Testing: Deliverability and compatibility with accessory devices in a neurovascular model	The device performs as intended under simulated use conditions.
Visual Inspection: Device surface characteristics assessed after simulated use testing for freedom from defects	The device surface characteristics are suitable for its intended use.
Hydrophilic Coating Integrity: Evaluated after multiple insertion and withdrawal cycles	The hydrophilic coating integrity is suitable for its intended use.
Kink Resistance: Specimen segments formed into a defined bend diameter to evaluate kink resistance	The device met established specifications.
Tip Stiffness: Bending stiffness of the tip measured to confirm conformance to specification	The device met established specifications.
Torque Strength: Test specimens rotated with distal end constrained to evaluate integrity post-rotation	The device met established specifications.
Biocompatibility: Materials, formulation, and suppliers identical to predicate.	No biocompatibility testing required.
Sterilization: EO process with 1x10-6 sterility assurance level, identical to predicate.	No new sterilization testing required; method is identical and validated.
Shelf Life and Packaging: Identical to predicate.	No shelf-life testing or packaging validation required.

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: The document does not specify exact sample sizes (N-values) for each bench test (e.g., how many catheters were subjected to kink resistance or torque strength testing). It broadly states "test specimen segments" or "test specimens."
Data Provenance: The studies are bench (laboratory) tests conducted by the manufacturer, Perfuze Ltd., in Ireland. They are inherently prospective in the sense that they are designed and executed specifically for this regulatory submission. Country of origin of the data would be Ireland (where Perfuze Ltd. is based).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is not an AI/ML device where expert consensus would establish ground truth for image interpretation or diagnosis. The "ground truth" for this physical device's performance is established by engineering specifications and physical measurements, and its functionality evaluated against predefined criteria in simulated environments.

4. Adjudication method for the test set:

Not Applicable. As this is not a study involving human-in-the-loop assessment or expert review of clinical cases. Bench testing results are typically evaluated against pre-defined engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study was not conducted as this is a physical medical device (catheter) and not an AI/ML diagnostic or assistive software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical device, not a standalone algorithm.

7. The type of ground truth used:

For the physical device, the "ground truth" is defined by engineering specifications, performance standards, and functional demonstration in controlled laboratory environments (e.g., neurovascular models). The goal is to demonstrate that the device performs according to its design, is safe, and is substantially equivalent to a previously cleared device.

8. The sample size for the training set:

Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. There is no training set. The device's design and manufacturing are based on established engineering principles and material science, verified through the bench testing described.

Summary of the Device and Study:

The Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set are physical devices indicated for the revascularization of patients with acute ischemic stroke. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device (Millipede 070 Aspiration Catheter; K250012) due to a minor change in the distal outer diameter (from 0.0835" to 0.0837").

The study to prove the device meets acceptance criteria was non-clinical bench (laboratory) testing. This testing confirmed that the slightly modified device still met all relevant engineering specifications for dimensions, simulated use performance, coating integrity, kink resistance, tip stiffness, and torque strength. No new biocompatibility, sterilization, shelf-life, animal, or clinical studies were deemed necessary because the materials, fundamental design, indications for use, and operating principle remained the same as the predicate device. The change was determined not to raise different questions of safety or effectiveness.

Summary

FDA 510(k) Clearance Letter - K252392

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 29, 2025

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

Re: K252392
Trade/Device Name: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: NRY
Dated: July 31, 2025
Received: July 31, 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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K252392 - Anne-Marie Gannon
Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252392 - Anne-Marie Gannon
Page 3

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, PhD
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

Page 4

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252392

Device Name: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

Indications for Use (Describe)

Millipede70 Aspiration Catheter

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.

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:

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Page 5

510(k) Summary – K252392

Submitter Information

Submitter's Name: Perfuze Ltd.
Address: Unit 6, Galway Business Park,
Dangan,
Galway, H91 W7CP,
Ireland
Contact Person: Anne-Marie Gannon
Telephone: +353 91 428083
Date Prepared: 31 July 2025

Subject Device

Proprietary Name: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
Common/Usual Name: Percutaneous Catheter
Classification Name: Catheter, Thrombus Retriever
Regulatory Class: II
Regulation: 21 CFR 870.1250
Product Code: NRY

Predicate Device

Proprietary Name: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Common/Usual Name: Percutaneous Catheter
Classification Name: Catheter, Thrombus Retriever
Regulatory Class: II
Regulation: 21 CFR 870.1250
Product Code: NRY
Manufacturer: Perfuze Ltd.
510(k) Number: K250012

Device Description

The Millipede70 Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).

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Indications for Use

Millipede70 Aspiration Catheter

The Millipede70 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 Millipede70 Aspiration Catheter to a compatible aspiration pump.

Comparison to the Predicate Device

Attribute	Predicate DeviceMillipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012)	Subject DeviceMillipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392)
Regulation Number	21 CFR 870.1250	Same
Regulation Name	Percutaneous Catheter	Same
Classification	Class II	Same
Product Code	NRY	Same
Indications for use	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.The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.	The Millipede70 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.The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump.
Device Description	Single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during	Same

Page 7

Attribute	Predicate DeviceMillipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012)	Subject DeviceMillipede70 Aspiration Catheter; Perfuze Aspiration Tube Set (K252392)
	navigation in the vasculature. A luer fitting on the catheter hub is used for the attachment of accessories. A strain relief at the hub provides kink resistance for the proximal end.
Principle of Operation	Designed to remove thrombus from the neurovasculature using direct aspiration.	Same
Techniques for Use	Standard percutaneous, intravascular techniques.	Same
Materials	Polymers and metals commonly used in the manufacture of medical devices.	Same
Distal Tip	Tapered, soft, flexible.	Same
Catheter Wall Construct	Braid and coil reinforcement, with ribbed 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	Distal: 0.0837 inProximal: Same
Working Length / Effective length	136 cm	Same
Packaged Accessories	Rotating Hemostasis Valve	Same
Condition Supplied	Sterile and single use	Same
Sterilization Method	Ethylene Oxide (EO)	Same
Packaging Configuration	Polyethylene terephthalate Tyvek® pouch, polyethylene tube, paperboard packaging card, cardboard carton.	Same
Perfuze Aspiration Tubing	100 in lengthTubing ID = 0.110 inPinch clamp valve for vacuum control	Same

Non-Clinical Testing

Performance Testing (Bench)

The subject and predicate devices have the same indications for use, fundamental design, and operating principle.

The subject Millipede70 Aspiration Catheter has the same materials as the predicate device. The only difference in design is a change to the maximum outer diameter at the distal end of the subject device, which is increasing from 0.0835" to 0.0837".

The successful completion of the performance testing listed in the table below demonstrates that the subject Millipede70 Aspiration Catheter meets the defined design specifications and is suitable for its intended use.

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Test	Test Method	Conclusions
Dimensional Verification	The outer diameter of the distal end was measured to confirm conformance to specifications.	The device met established specifications.
Simulated Use Testing	Deliverability and compatibility with accessory devices were evaluated in a neurovascular model.	The device performs as intended under simulated use conditions.
Visual Inspection	Device surface characteristics were assessed after simulated use testing to confirm freedom from defects that could cause injury.	The device surface characteristics are suitable for its intended use.
Hydrophilic Coating Integrity	The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles.	The hydrophilic coating integrity is suitable for its intended use.
Kink Resistance	Test specimen segments were formed into a defined bend diameter to evaluate kink resistance.	The device met established specifications.
Tip Stiffness	The bending stiffness of the tip was measured to confirm conformance to the specification.	The device met established specifications.
Torque Strength	The test specimens were rotated with the distal end constrained from movement to evaluate integrity after rotation.	The device met established specifications.

The design of the Perfuze Aspiration Tube Set is identical for the subject and predicate devices. Therefore, non-clinical bench testing was not required for the subject Perfuze Aspiration Tube Set.

Biocompatibility

The materials, formulation, and suppliers of the materials used in the Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set are identical in the subject and predicate devices. Therefore, no biocompatibility testing was required for the subject device.

Sterilization

The Millipede70 Aspiration Catheter and Perfuze Aspiration Tube Set are sterilized using a validated EO process with a sterility assurance level of 1x10-6. The sterilization method is identical for the subject and predicate devices.

Shelf Life and Packaging

The subject device's shelf life and packaging configuration remain the same as that of the predicate device. Therefore, no shelf-life testing or packaging validation was required to demonstrate substantial equivalence between the subject and predicate devices.

Animal Study

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

Clinical Data

The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the subject and predicate devices. Therefore, no clinical study was conducted.

Conclusion

The subject and predicate devices have the same indications for use, fundamental design, operating principle, and materials. The change to the outer diameter at the distal end of the subject Millipede70

Page 9

Aspiration Catheter does not raise different questions of safety or effectiveness. The successful completion of bench testing 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).