Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

K232524 · Perfuze, Ltd. · NRY · Oct 18, 2023 · Cardiovascular

Device Facts

• Record ID: K232524
• Device Name: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
• Applicant: Perfuze, Ltd.
• Product Code: NRY · Cardiovascular
• Decision Date: Oct 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Millipede 070 Aspiration Catheter is a sterile, single-use, single-lumen, reinforced catheter with variable stiffness and hydrophilic coating; includes rotating hemostasis valve (RHV). Perfuze Aspiration Tube Set is a flexible braided tube with luer-lock and suction connectors; includes pinch clamp for vacuum control. Used in neurointerventional procedures by physicians to remove thrombus from intracranial vasculature via direct aspiration. Device is navigated through vasculature under fluoroscopic guidance using radiopaque distal marker. Connected to compatible aspiration pump via tube set to apply vacuum. Output is thrombus removal; benefits include revascularization of occluded vessels in acute ischemic stroke patients. Performance verified via bench testing and porcine animal models comparing clot aspiration and vessel wall interaction against predicate systems.

Clinical Evidence

No clinical data. Evidence consists of bench performance testing (dimensional, tensile, kink resistance, flow rate, clot retrieval, simulated use) and comparative porcine animal studies (subacute and chronic) against Penumbra JET 7 and AXS Vecta systems. Animal studies confirmed comparable angiographic and histological outcomes.

Technological Characteristics

Single-lumen, reinforced catheter (braid/coil) with variable stiffness and hydrophilic coating. Distal ID 0.070 in. Sterilized via Ethylene Oxide (ISO 11135). Biocompatibility per ISO 10993-1. Aspiration tubing includes pinch clamp for vacuum control. No software or electronic components.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or failing IV t-PA therapy.

Regulatory Classification

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.

Predicate Devices

• SOFIA Plus Aspiration Catheter (K173200)

Submission Summary (Full Text)

{0}------------------------------------------------

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).

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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

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.

| 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)

## 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."

{3}------------------------------------------------

# 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 [phone]th 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

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.

{4}------------------------------------------------

## 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<br>(K173200) | Millipede 070 Aspiration Catheter;<br>Perfuze Aspiration Tube Set (K232524) |
| Regulation<br>Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Indications for<br>Use | 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.<br>The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump. |
| Prescription/over-<br>the-counter use | Prescription | Same |
| Attribute | Predicate Device | Subject Device |
| | SOFIA Plus Aspiration Catheter<br>(K173200) | Millipede 070 Aspiration Catheter;<br>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 in<br>Proximal: 0.069 in |
| Outer Diameter | Distal: 0.082 in<br>Proximal: 0.083 in | Distal: 0.0835 in<br>Proximal: 0.0865 in |
| Effective Length /<br>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 length<br>Tubing ID = 0.110 in<br>Integrated valve for vacuum control | 100 in length<br>Tubing ID = 0.110 in<br>Pinch clamp valve for vacuum control |

## Comparison to the Predicate Device

{5}------------------------------------------------

{6}------------------------------------------------

# 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 Pig<br>Maximization Sensitization Test | The test article did not elicit a sensitization<br>response. |
| Irritation - ISO Intracutaneous Reactivity | Requirements of the ISO intracutaneous reactivity<br>test were met for the test article. |
| Acute Systemic Toxicity – ISO Acute<br>Systemic Injection | Requirements of the ISO acute systemic injection<br>test were met for the test article. |
| Material-Mediated Pyrogenicity | The test article is non-pyrogenic. |
| Hemocompatibility - Complement<br>Activation (SC5b-9) | The test article is not considered to be a potential<br>activator of the complement system. |
| Hemocompatibility - Partial<br>Thromboplastin Time | The test article is not considered to be an activator<br>of the intrinsic coagulation pathway. |
| Hemocompatibility – ASTM Hemolysis | The test article is considered non-hemolytic. |
| Hemocompatibility - Thromboresistance | The test articles have similar thromboresistance<br>characteristics 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 Pig<br>Maximization Sensitization Test | The test article did not elicit a sensitization response. |
| Irritation - ISO Intracutaneous Reactivity | Requirements of the ISO intracutaneous reactivity<br>test 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 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Dimensional<br>Inspection | Device dimensions were measured to confirm<br>conformance to the specifications. | The device met<br>established<br>specifications. |
| Tip Stiffness | Test specimens were tested for tip flexibility. | The device met<br>established<br>specifications. |
| Test | Test Method | Conclusions |
| Visual Inspection | Device surface characteristics were assessed to<br>confirm freedom from defects that could cause<br>injury. | The device surface<br>characteristics are<br>suitable for its intended<br>use. |
| Simulated Use<br>Testing | Deliverability and compatibility with accessory<br>devices were evaluated in a neurovascular model. | The device performs as<br>intended under<br>simulated use<br>conditions. |
| Stent-retriever<br>Compatibility | Durability of the catheter was evaluated after a<br>stent-retriever was deployed and retrieved through<br>it such that the stent-retriever engages the catheter<br>tip. | The device met<br>established<br>specifications. |
| Hydrophilic<br>Coating Integrity | The integrity of the hydrophilic coating was<br>evaluated after multiple insertion and withdrawal<br>cycles. | The hydrophilic coating<br>integrity is suitable for its<br>intended use. |
| Particulate<br>Recovery | The purpose of this test was to quantify the<br>particulate sizes and counts generated during<br>simulated use of the test article. | The particulate<br>generation was similar to<br>control devices. |
| Tensile Strength | The tensile strength was evaluated for the bonds<br>between sections of the catheter. | The device met<br>established<br>specifications. |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | The device integrity is<br>suitable for its intended<br>use. |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | The device integrity is<br>suitable for its intended<br>use. |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | The device integrity is<br>suitable for its intended<br>use. |
| Luer Integrity | The luers were evaluated for compliance to<br>relevant standards. | The luers on the device<br>are suitable for their<br>intended use. |
| Kink Resistance | Test specimen segments were formed into a<br>defined bend diameter to evaluate kink resistance. | The device met<br>established<br>specifications. |
| Torque Strength | The test specimens were rotated with the distal end<br>constrained from movement to evaluate integrity<br>after rotation. | The device met<br>established<br>specifications. |
| Flow Rate<br>Characterization | The flow rate of saline and a contrast-saline<br>solution was characterized when injected through<br>the catheter. The aspiration flow rate of<br>saline through the catheter was also characterized. | The flow rate was<br>characterized. |
| Radiopacity | Radiopacity of the device was evaluated in an<br>animal model under fluoroscopy. | The radiopacity was<br>similar to a control<br>device. |
| Clot Retrieval<br>Testing | Clot retrieval performance was evaluated in a<br>neurovascular model. | The device met<br>established<br>specifications. |
| 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. |

{7}------------------------------------------------

{8}------------------------------------------------

## 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.

{9}------------------------------------------------

# 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.