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

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.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Zipline Access Catheter." It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, it does not describe a study proving a device meets acceptance criteria for an AI/ML product, nor does it contain information about expert ground truth, adjudication methods, MRMC studies, or training data.

The document details the device's technical specifications, its comparison to a predicate device, and the non-clinical testing performed to establish its safety and effectiveness.

Here's why the requested information cannot be extracted from this document:

This is a 510(k) for a physical medical device (catheter), not an AI/ML-driven diagnostic or therapeutic device. The acceptance criteria and testing described relate to the physical and functional performance of the catheter (e.g., buckling force, torque strength, biocompatibility, kink resistance, radiopacity), not to the performance of an algorithm.
The document explicitly states "no clinical study was conducted" because "The non-clinical performance testing was determined to be sufficient to support the substantial equivalence of the subject device to the predicate." This means there was no human-in-the-loop or standalone performance evaluation against a clinical ground truth, which would be typical for AI/ML devices.

To directly answer your request based on the provided text, but with the understanding that the product is a physical medical device:

A table of acceptance criteria and the reported device performance:
The document presents several tables summarizing testing. I will consolidate the "Test" and "Conclusions" columns from the "Performance Testing - Bench" section as they effectively serve as acceptance criteria (the test performed) and reported performance (the conclusion, e.g., "met established specifications" or "suitable for its intended use").

Acceptance Criteria (Test)	Reported Device Performance (Conclusions)
Visual Inspection	The device surface characteristics are suitable for its intended use.
Dimensional Inspection	The device met established specifications.
Buckling Force Test	The device met established specifications.
Simulated Use Testing	The device performs as intended under simulated use conditions.
Torque Strength	The device met established specifications.
Torque to Failure	Resistance to torque failure was similar to control devices.
Hydrophilic Coating Integrity	The hydrophilic coating integrity is suitable for its intended use.
Tensile Strength	The device met established specifications.
Air Leakage (per ISO 10555-1:2013 Annex D)	The device integrity is suitable for its intended use.
Liquid Leakage (per ISO 10555-1:2013 Annex C)	The device integrity is suitable for its intended use.
Luer Dimensions and Performance (per ISO	The device met established specifications.
80369-7:2021 and ISO 80369-20:2015)
Kink Resistance	The device met established specifications.
Radiopacity	The radiopacity was similar to a control device.
Particulate Recovery	The particulate generation was similar to control devices.
Biocompatibility: Cytotoxicity	The test article is non-cytotoxic.
Biocompatibility: Sensitization	The test article did not elicit a sensitization response.
Biocompatibility: Irritation	Requirements of the ISO intracutaneous reactivity test were met for the test article.
Biocompatibility: Acute Systemic Toxicity	Requirements of the ISO acute systemic injection test were met for the test article.
Biocompatibility: Material-Mediated Pyrogenicity	The test article is non-pyrogenic.
Biocompatibility: Hemocompatibility (SC5b-9)	The test article is not considered to be a potential activator of the complement system.
Biocompatibility: Hemocompatibility (PTT)	The test article is not considered to be an activator of the intrinsic coagulation pathway.
Biocompatibility: Hemocompatibility (Hemolysis)	The test article is considered non-hemolytic.
Biocompatibility: Hemocompatibility (Thromboresistance)	The test articles have similar thromboresistance characteristics as the control devices.
Animal Testing (In vivo performance & safety)	Demonstrated acceptable results; histologic evaluations concluded comparable tissue response to control device.
Sterilization (Ethylene Oxide)	Validated using the overkill method according to ISO-11135, achieved 1x10-6 sterility assurance level.
Shelf Life and Packaging	12-month shelf life verified by accelerated aging (ASTM F1980) and functional/performance testing on aged devices.

Sample size used for the test set and the data provenance:
- Bench Testing: The document does not specify exact sample sizes for each bench test, but implies that "test specimens" and "catheters" were used. It signifies that multiple samples were tested to demonstrate conformity to specifications.
- Animal Testing: "Suitably sized branches of the carotid arteries in a porcine model." The number of animals or specific vessels tested is not provided, but it was "in comparison to a control device."
- Data Provenance: The testing was conducted internally by Perfuze Ltd. (Ireland) or by their contractors, as typically expected for device manufacturers. It is non-clinical laboratory data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is not an AI/ML device requiring human expert label ground truth. The "ground truth" for the physical device performance is established by standardized test methods (e.g., ISO, ASTM) and engineering specifications. For the animal study, histological evaluation would have been performed by qualified pathologists, but specific numbers or qualifications are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This relates to consensus for human interpretation, not physical device testing.
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 for AI/ML devices, not a physical medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for AI/ML devices, not a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For physical and chemical attributes, the "ground truth" is defined by engineering specifications, validated test methods (e.g., ISO, ASTM), and established biocompatibility standards (e.g., ISO 10993). For the animal study, the ground truth was histological evaluations and angiographic assessments, which would typically be performed by veterinary pathologists and imaging specialists.
The sample size for the training set:
Not applicable. There is no AI/ML algorithm or training set for this physical device.
How the ground truth for the training set was established:
Not applicable. There is no AI/ML algorithm or training set for this physical device.

Summary

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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 (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

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 +353 91 428083 11 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

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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 DeviceRoute 92 Medical Delivery Catheter(K182512)	Subject DeviceZipline Access Catheter(K240711)
RegulationNumber	21 CFR 870.1250	Same
Regulation Name	Percutaneous catheter	Same
Classification	Class II	Same
Product Code	DQY	QJP
Indications forUse	The Route 92 Medical DeliveryCatheter is indicated for use withcompatible catheters in facilitating theinsertion and guidance of cathetersinto a selected blood vessel in theneurovascular system.	The Zipline Access Catheter isindicated to facilitate the insertionand guidance of catheters into aselected blood vessel in theneurovascular system.
DeviceDescription	The Delivery Catheter is a sterile,single-use, single-lumen,hydrophilically coated, variablestiffness catheter with a flexible,tapered tip.	Same
Principle ofOperation	During use, a neurovascularguidewire may be inserted throughthe Delivery Catheter. The DeliveryCatheter is advanced over theguidewire to the target location underfluoroscopy using standardendovascular techniques.	Same
Materials	Biocompatible polymers and metalscommonly used in the manufacture ofmedical devices.Catheter shaft: PTFE, Stainless steel(proximal), and varying durometers ofPebax (distal).Luer: PolycarbonateMarker bands: Tungsten/Pebax	Biocompatible polymers and metalscommonly used in the manufactureof medical devices.Catheter shaft: Varying durometersof Pebax, Polyurethane, and Nylon.Luer: NylonRadiopaque features: Tungsten/Polyurethane and Platinum/Iridium
HydrophilicCoating	Present on polymer section of theDelivery Catheter.	Present on distal section of theZipline Access Catheter.
Inner Diameter	0.019 in.	0.021 in.
Outer Diameterat Bulb Section	0.062 in.	Zipline 070: 0.061 inZipline 088: 0.080 in
Proximal OuterDiameter	0.028 in.	Zipline 070: 0.063 in.Zipline 088: 0.063 in
Maximum OuterDiameter	0.062 in.	Zipline 070: 0.064 inZipline 088: 0.080 in
Working Length /Effective length	143 cm	Zipline 070: 158 cmZipline 088: 147 cm
PackagedAccessories	No accessories included	Same
Attribute	Predicate DeviceRoute 92 Medical Delivery Catheter(K182512)	Subject DeviceZipline Access Catheter(K240711)
SterilizationMethod	Ethylene Oxide (EO)	Same
Packaging	Nylon/Tyvek pouch inside of an SBSshelf carton.	Polyester/Polyethylene/Tyvekpouch inside of an SBS shelfcarton.
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 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.
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.

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 hubwith the distal end constrained until devicefailure.	Resistance to torque failurewas similar to controldevices.
HydrophilicCoating Integrity	The integrity of the hydrophilic coating wasevaluated after multiple insertion andwithdrawal cycles.	The hydrophilic coatingintegrity is suitable for itsintended use.
Tensile Strength	The tensile strength was evaluated for thebonds between sections of the catheter andat the distal tip.	The device met establishedspecifications.
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	The device integrity issuitable for its intended use.
Liquid Leakage	Tested per ISO 10555-1:2013 Annex C.	The device integrity issuitable for its intended use.
Luer Dimensionsand Performance	The luer was evaluated per ISO 80369-7:2021 and ISO 80369-20:2015.	The device met establishedspecifications.
Kink Resistance	Test specimen segments were formed intoa defined bend diameter to evaluate kinkresistance.	The device met establishedspecifications.
Radiopacity	Radiopacity of the device was evaluated inan animal model under fluoroscopy.	The radiopacity was similarto a control device.
ParticulateRecovery	The purpose of this test was to quantify theparticulate sizes and counts generatedduring simulated use of the test article.	The particulate generationwas similar to controldevices.

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.

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).