Zipline Access Catheter

K240711 · Perfuze, Ltd. · QJP · Oct 17, 2024 · Cardiovascular

Device Facts

• Record ID: K240711
• Device Name: Zipline Access Catheter
• Applicant: Perfuze, Ltd.
• Product Code: QJP · Cardiovascular
• Decision Date: Oct 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

Device Story

Zipline Access Catheter is a single-use, single-lumen, variable-stiffness catheter; designed to deliver large-bore catheters to neurovasculature. Input: manual advancement over guidewire (up to 0.018") under fluoroscopic guidance. Operation: advanced to target vessel; outer catheter then tracked over Zipline. Features: tapered flexible tip, radiopaque marker/coil for visualization, hydrophilic coating on distal end for tracking, luer fitting for ancillary devices. Used in clinical neurovascular procedures by physicians. Output: provides access path for secondary catheters. Benefit: facilitates navigation of large-bore catheters through complex neurovascular anatomy.

Clinical Evidence

No clinical data. Evidence provided via bench testing (biocompatibility, mechanical integrity, simulated use) and animal study (porcine carotid artery model, n=not specified, 3-day survival). Animal study demonstrated comparable tissue response and performance to control device.

Technological Characteristics

Single-lumen, variable-stiffness catheter. Materials: Pebax, Polyurethane, Nylon, Tungsten/Polyurethane, Platinum/Iridium. Hydrophilic coating on distal end. Dimensions: 0.021" ID; 0.061"-0.080" OD at bulb. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 10993-1 (biocompatibility), ISO 10555-1 (leakage), ISO 80369-7/20 (luer), ASTM F1980 (shelf life).

Indications for Use

Indicated for facilitating insertion and guidance of catheters into selected blood vessels in the neurovascular system.

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

• Route 92 Medical Delivery Catheter (K182512)

Reference Devices

• Scout Introducer (used in animal study)

Submission Summary (Full Text)

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October 17, 2024

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

Re: K240711

Trade/Device Name: Zipline Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: September 17, 2024 Received: September 17, 2024

Dear Anne-Marie Gannon:

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

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

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([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

Enclosure

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## Indications for Use

Submission Number (if known)

K240711

Device Name

Zipline Access Catheter

Indications for Use (Describe)

The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

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)

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## 510(k) Summary K240711

#### Submitter Information

Submitter's Name: Address:

Contact Person: Telephone: Date Prepared:

### Subject Device

Proprietary Name: Common/Usual Name: Classification Name: Requlatory Class: Requlation: Product Code:

## Predicate Device

Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Requlation: Product Code: Manufacturer: 510(k) Number:

Perfuze Ltd. Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland Anne-Marie Gannon [phone] October 2024

Zipline Access Catheter Percutaneous Catheter Catheter, Percutaneous, Neurovasculature . 21 CFR 870.1250 QJP

Route 92 Medical Delivery Catheter Percutaneous Catheter Catheter, Percutaneous . 21 CFR 870.1250 DQY Route 92 Medical Inc. K182512

## Device Description

The Zipline Access Catheter is a single-use device designed to deliver large-bore catheters to the neurovasculature using standard endovascular techniques. It is supplied sterile and nonpyrogenic. It is available in two sizes: Zipline 070. Zipline 070. Zipline 088 is designed for use with outer catheters with 0.088" or larger internal diameter, and Zipline 070 is designed for use with outer catheters with 0.070" or larger internal diameter.

During use, the Zipline Access Catheter is advanced over a guidewire to the desired location in the neurovasculature. An outer catheter is then advanced over the Zipline Access Catheter to the desired location.

The Zipline Access Catheter is a single lumen, variable stiffness catheter. It has a tapered flexible tip and a radiopague marker at its distal end. Proximal to the tapered section is a "bulb" and a radiopaque coil to facilitate bulb visualization under fluoroscopy. The outer of the bulb is designed to closely match the inner diameter of outer catheters, thereby minimizing the gap between the two catheters during navigation.

The Zipline Access Catheter has a hydrophilic coating on the outer surface of the distal end to enhance tracking through the vasculature. A luer fitting located on the catheter hub is used for attachment of ancillary devices. A continuous internal lumen spanning from the distal tip to the proximal hub accommodates guidewires up to 0.018" in diameter.

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## Indications for Use

The Zipline Access Catheter is indicated to facilitate the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

| Attribute | Predicate Device<br>Route 92 Medical Delivery Catheter<br>(K182512) | Subject Device<br>Zipline Access Catheter<br>(K240711) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | DQY | QJP |
| Indications for<br>Use | The Route 92 Medical Delivery<br>Catheter is indicated for use with<br>compatible catheters in facilitating the<br>insertion and guidance of catheters<br>into a selected blood vessel in the<br>neurovascular system. | The Zipline Access Catheter is<br>indicated to facilitate the insertion<br>and guidance of catheters into a<br>selected blood vessel in the<br>neurovascular system. |
| Device<br>Description | The Delivery Catheter is a sterile,<br>single-use, single-lumen,<br>hydrophilically coated, variable<br>stiffness catheter with a flexible,<br>tapered tip. | Same |
| Principle of<br>Operation | During use, a neurovascular<br>guidewire may be inserted through<br>the Delivery Catheter. The Delivery<br>Catheter is advanced over the<br>guidewire to the target location under<br>fluoroscopy using standard<br>endovascular techniques. | Same |
| Materials | Biocompatible polymers and metals<br>commonly used in the manufacture of<br>medical devices.<br><br>Catheter shaft: PTFE, Stainless steel<br>(proximal), and varying durometers of<br>Pebax (distal).<br><br>Luer: Polycarbonate<br><br>Marker bands: Tungsten/Pebax | Biocompatible polymers and metals<br>commonly used in the manufacture<br>of medical devices.<br><br>Catheter shaft: Varying durometers<br>of Pebax, Polyurethane, and Nylon.<br><br>Luer: Nylon<br><br>Radiopaque features: Tungsten/<br>Polyurethane and Platinum/Iridium |
| Hydrophilic<br>Coating | Present on polymer section of the<br>Delivery Catheter. | Present on distal section of the<br>Zipline Access Catheter. |
| Inner Diameter | 0.019 in. | 0.021 in. |
| Outer Diameter<br>at Bulb Section | 0.062 in. | Zipline 070: 0.061 in<br>Zipline 088: 0.080 in |
| Proximal Outer<br>Diameter | 0.028 in. | Zipline 070: 0.063 in.<br>Zipline 088: 0.063 in |
| Maximum Outer<br>Diameter | 0.062 in. | Zipline 070: 0.064 in<br>Zipline 088: 0.080 in |
| Working Length /<br>Effective length | 143 cm | Zipline 070: 158 cm<br>Zipline 088: 147 cm |
| Packaged<br>Accessories | No accessories included | Same |
| Attribute | Predicate Device<br>Route 92 Medical Delivery Catheter<br>(K182512) | Subject Device<br>Zipline Access Catheter<br>(K240711) |
| Sterilization<br>Method | Ethylene Oxide (EO) | Same |
| Packaging | Nylon/Tyvek pouch inside of an SBS<br>shelf carton. | Polyester/Polyethylene/Tyvek<br>pouch inside of an SBS shelf<br>carton. |
| Shelf Life | 8 months | 12 months |

## Comparison to the Predicate Device

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## Non-Clinical Testing

#### Biocompatibility Testing

The Zipline 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 Zipline Access Catheter has been 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 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. |
| 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 - Bench

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

| Test | Test Method | Conclusions |
|------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Visual Inspection | Device surface characteristics were assessed to confirm freedom from defects that could cause injury. | 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. |
| Buckling Force Test | Test specimens were tested for buckling force at the distal tip. | The device met established specifications. |
| Simulated Use Testing | Deliverability and compatibility with ancillary devices were evaluated in a neurovascular model. | The device performs as intended under simulated use conditions. |
| Torque Strength | The test specimens were rotated with the distal end constrained from movement to evaluate integrity after rotation. | The device met established specifications. |

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| Test | Test Method | Conclusions |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Torque to Failure | Catheters were rotated at the proximal hub<br>with the distal end constrained until device<br>failure. | Resistance to torque failure<br>was similar to control<br>devices. |
| Hydrophilic<br>Coating Integrity | The integrity of the hydrophilic coating was<br>evaluated after multiple insertion and<br>withdrawal cycles. | The hydrophilic coating<br>integrity is suitable for its<br>intended use. |
| Tensile Strength | The tensile strength was evaluated for the<br>bonds between sections of the catheter and<br>at the distal tip. | 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. |
| Luer Dimensions<br>and Performance | The luer was evaluated per ISO 80369-<br>7:2021 and ISO 80369-20:2015. | The device met established<br>specifications. |
| Kink Resistance | Test specimen segments were formed into<br>a defined bend diameter to evaluate kink<br>resistance. | The device met established<br>specifications. |
| Radiopacity | Radiopacity of the device was evaluated in<br>an animal model under fluoroscopy. | The radiopacity was similar<br>to a control device. |
| Particulate<br>Recovery | The purpose of this test was to quantify the<br>particulate sizes and counts generated<br>during simulated use of the test article. | The particulate generation<br>was similar to control<br>devices. |

#### Animal Testing

The in vivo performance and safety of the subject device was assessed in suitably sized branches of the carotid arteries in a porcine model in comparison to a control device (Scout Introducer, provided with the AXS Vecta Intermediate Catheter). The study was conducted under Good Laboratory Practices. Assessments included the maximum number of delivery and retrieval attempts expected during a clinical procedure with the Zipline Access Catheter. Angiographic assessments during the procedure and prior to necropsy demonstrated acceptable results. Animals were survived to a subacute (3-day) time point to evaluate the vascular response to device use. Histological evaluations concluded that artery segments in which the subject and control devices were used exhibited a comparable tissue response.

#### Sterilization

The Zipline Access Catheter is sterilized using a validated EO process with a sterility assurance level of 1x106. 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 Zipline Access Catheter has a 12-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.

### Clinical Data

The non-clinical performance testing was determined to be sufficient to support the substantial equivalence of the subject device to the predicate. Therefore, no clinical study was conducted.

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## Conclusion

The intended use of the Zipline Access Catheter is the same as that of the predicate device. The Zipline Access Catheter 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. The successful completion of biocompatibility, bench performance, and animal testing demonstrates that the Zipline Access Catheter is substantially equivalent to the predicate device.