Millipede 088 Access Catheter

K214048 · Perfuze, Ltd. · QJP · Sep 20, 2022 · Cardiovascular

Device Facts

• Record ID: K214048
• Device Name: Millipede 088 Access Catheter
• Applicant: Perfuze, Ltd.
• Product Code: QJP · Cardiovascular
• Decision Date: Sep 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

Device Story

Single-lumen, coil-reinforced, variable-stiffness catheter; includes rotating hemostasis valve (RHV) and valve crossing tool. Used in neurovasculature to facilitate microcatheter insertion/guidance. Operated by clinicians under fluoroscopic guidance. Distal segment features hydrophilic coating; radiopaque marker at distal tip for visualization. RHV maintains hemostasis during saline/contrast infusion and device insertion. Valve crossing tool protects access sheath valve during catheter introduction. Device provides access to target vasculature; enables subsequent interventional procedures. Benefits include atraumatic navigation and reliable access to neurovascular sites.

Clinical Evidence

No clinical data. Evidence consists of bench testing (dimensional, tip stiffness, tensile strength, leak, burst, kink, torque, flow rate, coating integrity, particulate recovery) and in vivo porcine model studies (3-day and 30-day) assessing usability, radiopacity, thromboresistance, and vessel injury. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Coil-reinforced catheter; variable stiffness; hydrophilic coating; radiopaque marker. Materials: medical-grade polymers and metals. Dimensions: 8 Fr profile, 115 cm length. Sterilization: Ethylene Oxide (ISO 11135). Packaging: polyethylene tube, cardboard card, pouch. Standards: ISO 10993-1 (biocompatibility), ISO 10555-1 (leak/burst), ASTM F1980 (shelf life).

Indications for Use

Indicated for facilitating insertion and guidance of microcatheters into selected blood vessels in the neurovasculature.

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

• TracStar Large Distal Platform, Zoom 88 Large Distal Platform, Zoom 88-T Large Distal Platform (K203764)

Reference Devices

• Penumbra System Reperfusion Catheter JET 7 (K190010)
• Navien Intracranial Support Catheter (K161152)
• Penumbra System ACE 64 Reperfusion Catheter (K152541)
• AXS Infinity LS Plus Long Sheath (K193034)
• BOSS 8F Balloon Guide Catheter (K203840)
• React 71 Catheter (K182097)
• AXS Catalyst 7 Distal Access Catheter (K183464)
• Modified HD Guide Catheter (K133177)
• Penumbra Reperfusion Catheter 054 (K090752)

Submission Summary (Full Text)

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September 20, 2022

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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

#### Re: K214048

Trade/Device Name: Millipede 088 Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: August 18, 2022 Received: August 22, 2022

#### Dear Anne-Marie Gannon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K214048

Device Name Millipede 088 Access Catheter

Indications for Use (Describe)

The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K214048 - 510(k) Summary

#### 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 [phone] September 20, 2022

Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature = 21 CFR 870.1250 QJP

TracStar™ Large Distal Platform Zoom™ 88 Large Distal Platform Zoom™ 88-T Large Distal Platform Guide Catheter Catheter, Percutaneous, Neurovasculature . 21 CFR 870.1250 QJP DQY Imperative Care K203764

# Reference Devices

The following table lists the reference devices that were used to support the substantial equivalence determination in this submission.

| 510(k)<br>Number | Product<br>Code | Name of Device | Device Manufacturer |
|------------------|-----------------|------------------------------------------------|----------------------------------------------------|
| K190010 | NRY | Penumbra System Reperfusion<br>Catheter JET 7 | Penumbra Inc. |
| K161152 | DQY | Navien Intracranial Support<br>Catheter | Micro Therapeutics Inc. d/b/a<br>ev3 Neurovascular |
| K152541 | NRY | Penumbra System ACE 64<br>Reperfusion Catheter | Penumbra Inc. |
| K193034 | DQY | AXS Infinity LS Plus Long<br>Sheath | Stryker Neurovascular |
| K203840 | QJP, DQY | BOSS 8F Balloon Guide<br>Catheter | Marblehead Medical LLC |
| K182097 | DQY | React 71 Catheter | Micro Therapeutics Inc. d/b/a<br>ev3 Neurovascular |

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| 510(k)<br>Number | Product<br>Code | Name of Device | Device Manufacturer |
|------------------|-----------------|------------------------------------------|-------------------------|
| K183464 | NRY | AXS Catalyst 7 Distal Access<br>Catheter | Stryker Neurovascular |
| K133177 | DQY, DQO | Modified HD Guide Catheter | Concentric Medical Inc. |
| K090752 | NRY | Penumbra Reperfusion<br>Catheter 054 | Penumbra Inc. |

#### Device Description

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

#### Indications for Use

The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Indications for Use statement for the Millipede 088 Access Catheter is not identical to the predicate device. However, both the Millipede 088 Access Catheter and the predicate device can be used to facilitate insertion and guidance of microcatheters into the neurovasculature. The differences in the Indications for Use statement do not raise new questions of safety and effectiveness for the Millipede 088 Access Catheter relative to the predicate device.

#### Comparison to the Predicate Device

The subject and predicate devices have similar technological characteristics as shown in the following table.

| Attribute | Predicate Device<br>TracStar™ Large Distal Platform<br>Zoom™ 88 Large Distal Platform<br>Zoom™ 88-T Large Distal Platform<br>(K203764) | Subject Device<br>Millipede 088 Access Catheter |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | QJP, DQY | QJP |
| Attribute | Predicate Device | Subject Device |
| | TracStar™ Large Distal Platform<br>Zoom™ 88 Large Distal Platform<br>Zoom™ 88-T Large Distal Platform<br>(K203764) | Millipede 088 Access Catheter |
| Indications for use | The TracStar Large Distal Platform is indicated for the introduction of<br>interventional devices into the<br>peripheral, coronary, and neuro<br>vasculature.<br><br>The ZOOM 88 and ZOOM 88-T<br>Large Distal Platform are indicated<br>for the introduction of interventional<br>devices into the peripheral, coronary,<br>and neuro vasculature. | The Millipede 088 Access Catheter<br>is indicated for use in facilitating<br>the insertion and guidance of<br>microcatheters into a selected<br>blood vessel in the<br>neurovasculature. |
| Prescription/over-<br>the-counter use | Prescription | Same |
| Device Description | Single-use, variable stiffness, wire-<br>reinforced catheters with a single<br>lumen. The catheters are comprised<br>of a hollow cylindrical tube bonded at<br>the proximal end to a standard luer<br>fitting. The wall of the tube is<br>constructed using metals and<br>polymers. A radiopaque marker<br>provides visual confirmation of the<br>distal tip location under fluoroscopy. | Same |
| Principle of<br>Operation | May be used with support catheters<br>to assist in accessing the target<br>vasculature. | Same |
| Techniques for<br>Use | Standard percutaneous interventional<br>techniques, including access site<br>preparation, introduction of the<br>catheter into the access vessel,<br>advancing the catheter under<br>fluoroscopy, withdrawing the<br>catheter, and closing the access site. | Same |
| Materials | Polymers and metals commonly used<br>in the manufacture of medical<br>devices. | Same |
| Distal Tip | Beveled edge, soft, flexible, and<br>atraumatic | Square edge, soft, flexible, and<br>atraumatic |
| Catheter Wall<br>Construction | Coil-reinforced | Coil-reinforced with ribbed surface<br>at distal section |
| Coating | Hydrophilic Coating | Same |
| Catheter Profile | 8 Fr | Same |
| Inner Diameter | Distal: 0.088"<br>Proximal: 0.088" | Distal: 0.088"<br>Proximal: 0.087" |
| Outer Diameter | Distal: 0.106"<br>Proximal: 0.108" | Distal: 0.104"<br>Proximal: 0.108" |
| Effective Length | 80cm -110cm | 115cm |
| Packaged<br>Accessories | RHV | RHV and Valve Crossing Tool |
| Condition | Sterile and Single Use | Same |
| Attribute | Predicate Device<br>TracStarTM Large Distal Platform<br>ZoomTM 88 Large Distal Platform<br>ZoomTM 88-T Large Distal Platform<br>(K203764) | Subject Device<br>Millipede 088 Access Catheter |
| Sterilization Method | Ethylene Oxide (EO), Sterility<br>Assurance Level 10-6 | Same |
| Packaging Configuration | The catheters are placed in a<br>protective polyethylene tube,<br>mounted with accessory RHV onto a<br>polyethylene packaging card, placed<br>into a pouch, sealed, and labeled.<br>The sealed pouch and IFU are<br>placed in a labeled shelf carton box. | The catheters are placed in a<br>protective polyethylene tube,<br>mounted with accessory RHV and<br>valve crossing tool onto a<br>cardboard packaging card, placed<br>into a pouch, sealed, and labeled.<br>The sealed pouch and IFU are<br>placed in a labeled shelf carton<br>box. |

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# Biocompatibility Testing

The Millipede 088 Access 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 088 Access 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 MEM Elution | The test article is non-cytotoxic. |
| Sensitization - ISO Guinea Pig<br>Maximization Sensitization Test | The test article did not elicit a sensitization response. |
| Irritation - ISO Intracutaneous 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. |

# Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Millipede 088 Access Catheter is suitable for its intended use.

| Test | Test Method | Conclusions |
|---------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Dimensional<br>Inspection | Device dimensions were measured to<br>confirm conformance to the<br>specifications. | The device met established<br>specifications. |
| Tip Stiffness | Test specimens were tested for tip<br>flexibility and compared to predicate and<br>reference devices. | The device met established<br>specifications. |

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| Test | Test Method | Conclusions |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Visual Inspection | Device surface characteristics were<br>assessed to confirm freedom from<br>defects. | The device surface<br>characteristics are suitable<br>for its intended use. |
| Simulated Use<br>Testing | Deliverability and compatibility with<br>accessory devices were evaluated in a<br>neurovascular model. | The device performs as<br>intended under simulated use<br>conditions. |
| Hydrophilic Coating<br>Integrity | The integrity of the hydrophilic coating<br>was evaluated after multiple insertion and<br>withdrawal cycles. | The hydrophilic coating<br>integrity is suitable for its<br>intended use. |
| Particulate<br>Recovery | The purpose of this test was to quantify<br>the particulate size and count generated<br>by simulated use of the test article. | The particulate size and count<br>were similar to control<br>devices. |
| Tensile Strength | The tensile strength was evaluated for<br>the bonds between sections of the<br>catheter. | The device met established<br>specifications. |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | The device integrity is<br>suitable for its intended use. |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | The device integrity is<br>suitable for its intended use. |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | The device integrity is<br>suitable for its intended use. |
| Luer Integrity | The luers were evaluated for compliance<br>to relevant standards. | The luers on the device are<br>suitable for their intended<br>use. |
| Kink Resistance | Test specimen segments were formed<br>into a defined bend diameter to evaluate<br>kink resistance. | The device met established<br>specifications. |
| Torque Strength | The test specimens were rotated in a<br>simulated use model to evaluate integrity<br>after rotation. | The device met established<br>specifications. |
| Flow Rate<br>Characterization | The flow rate of saline and a contrast-<br>saline solution was characterized when<br>injected through the catheter. | The flow rate was<br>characterized. |
| Radiopacity | Radiopacity of the device was evaluated<br>in an animal model under fluoroscopy. | The radiopacity of the<br>Millipede 088 Access<br>Catheter was similar to a<br>control device. |

# Animal Testing

The in vivo performance and safety of the device was assessed in two studies in a porcine model at 3-day and 30-day time points. Studies were conducted under Good Laboratory Practices. Usability, radiopacity, thromboresistance, and vessel injury were assessed. The results for the subject device were comparable to a control device, demonstrating acceptable results.

#### Sterilization

The Millipede 088 Access Catheter is sterilized using a validated EO process with a sterility assurance level of 1x10-9. 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 Packaqinq

Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance. A real time aging equivalent of 8 months was used to support an 8-month shelf-life claim. Device performance was verified by functional and performance testing.

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# Substantial Equivalence

The intended use of the Millipede 088 Access Catheter is similar to the intended use of the predicate device. The Millipede 088 Access Catheter and the predicate device use the same operating principles and have a similar design. The minor technological differences identified do not raise different questions of safety or effectiveness for the two devices. The successful completion of biocompatibility testing and performance testing demonstrates that the Millipede 088 Access Catheter is substantially equivalent to the predicate device.