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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

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

AI/ML Overview

The document you provided is a 510(k) premarket notification for a medical device (Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical study data often seen for novel devices that might require a PMA (Premarket Approval) or de novo classification.

Therefore, the information typically requested in your prompt (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, training set size for AI, etc.) is not present in this document because it is not a study assessing the performance of an AI/ML-driven device or an imaging diagnostic tool. Instead, this is a clearance for a physical medical catheter and tubing set.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biological performance testing, not AI/ML model validation.

Here's a breakdown based on the document, addressing what is present and explaining why other points are absent:

Device: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Regulatory Classification: Class II Percutaneous Catheter (Product Code: NRY)

Purpose of Submission: Demonstrate substantial equivalence to the SOFIA Plus Aspiration Catheter (K173200).

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various performance tests and their conclusions, acting as the "acceptance criteria" and "reported device performance." Since this is not an AI/ML device, the criteria are physical and functional, rather than diagnostic accuracy metrics.

Test Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance (Conclusion)
Biocompatibility	Cytotoxicity	Non-cytotoxic	The test article is non-cytotoxic.
	Sensitization	No sensitization response	The test article did not elicit a sensitization response.
	Irritation (Intracutaneous Reactivity)	Requirements met	Requirements of the ISO intracutaneous reactivity test were met for the test article.
	Acute Systemic Toxicity	Requirements met	Requirements of the ISO acute systemic injection test were met for the test article.
	Material-Mediated Pyrogenicity	Non-pyrogenic	The test article is non-pyrogenic.
	Hemocompatibility (Complement Act.)	Not a potential activator of complement system	The test article is not considered to be a potential activator of the complement system.
	Hemocompatibility (Partial Thrombo.)	Not an activator of intrinsic coagulation pathway	The test article is not considered to be an activator of the intrinsic coagulation pathway.
	Hemocompatibility (Hemolysis)	Non-hemolytic	The test article is considered non-hemolytic.
	Hemocompatibility (Thromboresistance)	Similar to control devices	The test articles have similar thromboresistance characteristics as the control devices.
Millipede Catheter Performance	Dimensional Inspection	Conformance to specifications	The device met established specifications.
	Tip Stiffness	Conformance to specifications	The device met established specifications.
	Visual Inspection	Freedom from defects, suitable surface characteristics	The device surface characteristics are suitable for its intended use.
	Simulated Use Testing	Performs as intended under simulated use conditions	The device performs as intended under simulated use conditions.
	Stent-retriever Compatibility	Durability maintained after deployment/retrieval	The device met established specifications.
	Hydrophilic Coating Integrity	Integrity maintained after multiple cycles, suitable for use	The hydrophilic coating integrity is suitable for its intended use.
	Particulate Recovery	Similar particulate generation to control devices	The particulate generation was similar to control devices.
	Tensile Strength (bonds)	Conformance to specifications	The device met established specifications.
	Air Leakage	Integrity suitable for intended use	The device integrity is suitable for its intended use.
	Liquid Leakage	Integrity suitable for intended use	The device integrity is suitable for its intended use.
	Static Burst	Integrity suitable for intended use	The device integrity is suitable for its intended use.
	Luer Integrity	Compliance to relevant standards, suitable for intended use	The luers on the device are suitable for their intended use.
	Kink Resistance	Conformance to specifications	The device met established specifications.
	Torque Strength	Conformance to specifications	The device met established specifications.
	Flow Rate Characterization	Characterized flow rate data available (implied acceptable)	The flow rate was characterized.
	Radiopacity	Similar to control device	The radiopacity was similar to a control device.
	Clot Retrieval Testing	Conformance to specifications	The device met established specifications.
Perfuze Tube Set Performance	Visual Inspection	Freedom from defects, suitable surface characteristics	The device surface characteristics are suitable for its intended use.
	Dimensional Inspection	Conformance to specifications	The device met established specifications.
	Luer & Suction Connectors Comp.	Conformance to specifications	The device met established specifications.
	Luer Integrity	Compliance to relevant standards, suitable for intended use	The luer on the device is suitable for its intended use.
	Kink Resistance & Collapse	No kinks/visible collapse under vacuum pressure, Conformance to specs	The device met established specifications.
	Vacuum Decay	Conformance to specifications	The device met established specifications.
	Pinch Clamp Functionality	Ability to enable/disable suction, Conformance to specs	The device met established specifications.
	Tensile Testing (bonds)	Conformance to specifications	The device met established specifications.
Animal Study	Performance vs. Controls	Comparable results to controls (Penumbra, AXS Vecta)	Wedge assessment and clot aspiration assessment results were comparable between the test and control systems. Angiographic and histological evaluations concluded the devices were comparable at all time points.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of catheters tested for kink resistance). However, for the animal study, it mentions "two comparative animal studies conducted under Good Laboratory Practices in a porcine model." The exact number of animals is not provided.
Data Provenance:
- Country of Origin: Not explicitly stated for bench testing, but Perfuze Ltd. is based in Galway, Ireland, suggesting testing likely occurred there or at contracted labs.
- Retrospective/Prospective: All described tests and the animal study are prospective design, as they were specifically conducted to support this premarket notification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable for this type of device. This device is a physical catheter and tube set, not a diagnostic AI/ML system. There is no "ground truth" to be established by human experts in the context of image interpretation or disease diagnosis. The "ground truth" here is the physical measurement, functional performance (e.g., flow rate), or biological response (e.g., non-cytotoxic).

4. Adjudication Method for the Test Set

Not applicable. As there are no human expert readers establishing a diagnostic "ground truth," there is no need for an adjudication method. The test results are objective measurements or observations during laboratory testing.

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

Not applicable. This is not an AI-assisted diagnostic device. Its function is direct mechanical aspiration. No MRMC study was conducted or is relevant.

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

Not applicable. This is not an algorithm or software device. Its performance is evaluated through bench testing and animal studies as described.

7. The Type of Ground Truth Used:

For Biocompatibility: Laboratory assays and histological/pathological evaluation (e.g., for pyrogenicity, cytotoxicity, systemic toxicity, sensitization, irritation, hemocompatibility in vitro/in vivo, and animal tissue analysis).
For Performance Testing: Objective measurements (e.g., dimensions, flow rates, tensile strength), functional assessments (e.g., kink resistance, leakage), and simulated use observations against pre-defined engineering specifications.
For Animal Study: Angiographic and histological evaluations of the porcine model.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set for an AI/ML model is involved.

Summary regarding AI/ML related questions: The questions about experts, adjudication, MRMC studies, standalone algorithms, and training sets are relevant for submissions of Artificial Intelligence / Machine Learning (AI/ML) enabled diagnostic devices or software as a medical device (SaMD). The provided document is for a traditional, physical interventional device (catheter and tube set), and therefore, the testing described focuses on its physical, mechanical, and biological properties, as well as its functional similarity to predicate devices.

Summary

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October 18, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K232524

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: August 18, 2023 Received: August 18, 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 (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).

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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.

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

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Indications for Use

510(k) Number (if known) K232524

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 - K232524

Submitter Information

Submitter's Name: Address:

Contact Person: Telephone: Date Prepared:

Subject Device

Proprietary Name:

Common/Usual Name: Classification Name: Requlatory Class: Regulation: Product Code:

Predicate Device

Proprietary Name: Common/Usual Name: Classification Name: Requlatory Class: Requlation: Product Code: Manufacturer: 510(k) Number:
Perfuze Ltd. Unit 6. Galway Business Park, Dangan. Galway, H91 W7CP, Ireland Anne-Marie Gannon +353 91 428083 12th October 2023

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

SOFIA Plus Aspiration Catheter Percutaneous Catheter Catheter, Thrombus Retriever . 21 CFR 870.1250 NRY MicroVention, Inc. K173200

Device Description

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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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA 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 Device	Subject Device
Device	SOFIA Plus Aspiration Catheter(K173200)	Millipede 070 Aspiration Catheter;Perfuze Aspiration Tube Set (K232524)
RegulationNumber	21 CFR 870.1250	Same
Regulation Name	Percutaneous Catheter	Same
Classification	Class II	Same
Product Code	NRY	Same
Indications forUse	The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVention Tubing Kit is intended 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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.	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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump.
Prescription/over-the-counter use	Prescription	Same
Attribute	Predicate Device	Subject Device
	SOFIA Plus Aspiration Catheter(K173200)	Millipede 070 Aspiration Catheter;Perfuze Aspiration Tube Set (K232524)
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 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 at the proximal end.	Same
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	Straight - steam shapeable by user.	Tapered, soft, flexible.
Catheter Wall Construction	Braid and coil reinforcement.	Braid and coil reinforcement, with ribbed internal surface at distal end.
Coating	Hydrophilic coating	Same
Catheter Profile	6 Fr	Same
Inner Diameter	0.070 in	Distal: 0.070 inProximal: 0.069 in
Outer Diameter	Distal: 0.082 inProximal: 0.083 in	Distal: 0.0835 inProximal: 0.0865 in
Effective Length /Working Length	125 - 131 cm	136 cm
Packaged Accessories	Introducer sheath and shaping mandrel	Rotating Hemostasis Valve
Condition Supplied	Sterile and single use	Same
Sterilization Method	Ethylene Oxide (EO)	Same
Packaging Configuration	Polyester/polyethylene/Tyvek® pouch, polyethylene tube, polyethylene card, paperboard carton.	Polyethylene terephthalate Tyvek® pouch, polyethylene tube, paperboard packaging card, cardboard carton.
Aspiration Tubing	112 in lengthTubing ID = 0.110 inIntegrated valve for vacuum control	100 in lengthTubing ID = 0.110 inPinch clamp valve for vacuum control

Comparison to the Predicate Device

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Biocompatibility Testing

Millipede 070 Aspiration Catheter

The Millipede 070 Aspiration Catheter is constructed using materials that are commonly used in the medical device industry. All patient-contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process". The Millipede 070 Aspiration Catheter is classified per ISO 10993-1 as an externally communicating device that contacts circulating blood for a limited (< 24 hours) duration. A summary of the biocompatibility testing is outlined below.

Test	Results
Cytotoxicity - ISO MTS Cytotoxicity Test	The test article is non-cytotoxic.
Sensitization - ISO Guinea PigMaximization Sensitization Test	The test article did not elicit a sensitizationresponse.
Irritation - ISO Intracutaneous Reactivity	Requirements of the ISO intracutaneous reactivitytest were met for the test article.
Acute Systemic Toxicity – ISO AcuteSystemic Injection	Requirements of the ISO acute systemic injectiontest were met for the test article.
Material-Mediated Pyrogenicity	The test article is non-pyrogenic.
Hemocompatibility - ComplementActivation (SC5b-9)	The test article is not considered to be a potentialactivator of the complement system.
Hemocompatibility - PartialThromboplastin Time	The test article is not considered to be an activatorof the intrinsic coagulation pathway.
Hemocompatibility – ASTM Hemolysis	The test article is considered non-hemolytic.
Hemocompatibility - Thromboresistance	The test articles have similar thromboresistancecharacteristics as the control devices.

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is categorized according to ISO 10993-1 as a surface-contacting medical device that contacts intact skin surfaces for a limited (< 24 hours) duration. A summary of the biocompatibility testing is outlined below.

Test	Results
Cytotoxicity - ISO Elution Method	The test article is non-cytotoxic.
Sensitization – ISO Guinea PigMaximization Sensitization Test	The test article did not elicit a sensitization response.
Irritation - ISO Intracutaneous Reactivity	Requirements of the ISO intracutaneous reactivitytest were met for the test article.

Performance Testing

The successful completion of the performance testing listed in the following tables demonstrates that the Millipede 070 Aspiration Catheter and the Perfuze Aspiration Tube Set meet their design specifications and are suitable for their intended use.

Millipede 070 Aspiration Catheter

Test	Test Method	Conclusions
DimensionalInspection	Device dimensions were measured to confirmconformance to the specifications.	The device metestablishedspecifications.
Tip Stiffness	Test specimens were tested for tip flexibility.	The device metestablishedspecifications.
Test	Test Method	Conclusions
Visual Inspection	Device surface characteristics were assessed toconfirm freedom from defects that could causeinjury.	The device surfacecharacteristics aresuitable for its intendeduse.
Simulated UseTesting	Deliverability and compatibility with accessorydevices were evaluated in a neurovascular model.	The device performs asintended undersimulated useconditions.
Stent-retrieverCompatibility	Durability of the catheter was evaluated after astent-retriever was deployed and retrieved throughit such that the stent-retriever engages the cathetertip.	The device metestablishedspecifications.
HydrophilicCoating Integrity	The integrity of the hydrophilic coating wasevaluated after multiple insertion and withdrawalcycles.	The hydrophilic coatingintegrity is suitable for itsintended use.
ParticulateRecovery	The purpose of this test was to quantify theparticulate sizes and counts generated duringsimulated use of the test article.	The particulategeneration was similar tocontrol devices.
Tensile Strength	The tensile strength was evaluated for the bondsbetween sections of the catheter.	The device metestablishedspecifications.
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	The device integrity issuitable for its intendeduse.
Liquid Leakage	Tested per ISO 10555-1:2013 Annex C.	The device integrity issuitable for its intendeduse.
Static Burst	Tested per ISO 10555-1:2013 Annex F.	The device integrity issuitable for its intendeduse.
Luer Integrity	The luers were evaluated for compliance torelevant standards.	The luers on the deviceare suitable for theirintended use.
Kink Resistance	Test specimen segments were formed into adefined bend diameter to evaluate kink resistance.	The device metestablishedspecifications.
Torque Strength	The test specimens were rotated with the distal endconstrained from movement to evaluate integrityafter rotation.	The device metestablishedspecifications.
Flow RateCharacterization	The flow rate of saline and a contrast-salinesolution was characterized when injected throughthe catheter. The aspiration flow rate ofsaline through the catheter was also characterized.	The flow rate wascharacterized.
Radiopacity	Radiopacity of the device was evaluated in ananimal model under fluoroscopy.	The radiopacity wassimilar to a controldevice.
Clot RetrievalTesting	Clot retrieval performance was evaluated in aneurovascular model.	The device metestablishedspecifications.
Test	Test Method	Conclusions
Visual Inspection	Device surface characteristics were assessed to confirm freedom from defects that could affect clinical use.	The device surface characteristics are suitable for its intended use.
Dimensional Inspection	Device dimensions were measured to confirm conformance to the specifications.	The device met established specifications.
Luer and Suction Connector Compatibility	Compatibility of device connectors to Millipede 070 Aspiration Catheter hub and aspiration pump canister was assessed.	The device met established specifications.
Luer Integrity	The luer was evaluated for compliance to relevant standards.	The luer on the device is suitable for its intended use
Kink Resistance and Collapse under Aspiration	Device was inspected for kinks or visible collapse after application of vacuum pressure.	The device met established specifications.
Vacuum Decay	Device was assessed for air leakage when under vacuum.	The device met established specifications.
Pinch Clamp Functionality	Ability to enable and disable suction using the pinch clamp was assessed.	The device met established specifications.
Tensile Testing	Tensile strength was evaluated for the bonds between tube and connectors.	The device met established specifications.

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Perfuze Aspiration Tube Set

Animal Study

The safety and effectiveness of the subject device was evaluated in two comparative animal studies conducted under Good Laboratory Practices in a porcine model against two controls (Penumbra System with JET 7 Reperfusion Catheter and AXS Vecta Aspiration System with Vecta 71 Aspiration Catheter). Assessments included aspiration of experimental soft and application of maximum vacuum with the device in a wedged position against the vessel wall. Both the subject and control devices were evaluated at subacute (3 day) and chronic (30 day) time points. Wedge assessment and clot aspiration assessment results were comparable between the test and control systems. Angiographic and histological evaluations concluded the devices were comparable at all time points.

Clinical Data

The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set. Therefore, no clinical study was conducted.

Sterilization

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are sterillized using a validated EO process with a sterility assurance level of 1x10-6. The validation was conducted 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 Millipede 070 Aspiration Catheter has a 12-month shelf life, and the Perfuze Aspiration Tube Set has a 24-month shelf life. Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance. Device performance was also verified by functional and performance testing on devices conditioned by accelerated aging.

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Conclusion

The intended use of the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set is the same as the predicate device. The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set and the predicate device use the same operating principles and have a similar design. The technological differences identified do not raise different questions of safety or effectiveness for the two devices. The successful completion of biocompatibility and performance testing demonstrates that the Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are 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).