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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Millipede 088 Access Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a standalone clinical study to prove the device meets those criteria.

Therefore, the document does not contain the information requested in points 2, 3, 4, 5, 8, and 9, and only partially addresses points 1, 6, and 7.

Here's a breakdown of what can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their conclusions, indicating that the device met "established specifications" or was "suitable for its intended use." However, the specific quantitative acceptance criteria for each test are not provided. The reported device performance is qualitative rather than quantitative in most cases.

Test	Test Method	Reported Device Performance (Conclusions)
Dimensional Inspection	Device dimensions were measured to confirm conformance to the specifications.	The device met established specifications.
Tip Stiffness	Test specimens were tested for tip flexibility and compared to predicate and reference devices.	The device met established specifications.
Visual Inspection	Device surface characteristics were assessed to confirm freedom from defects.	The device surface characteristics are suitable for its intended use.
Simulated Use Testing	Deliverability and compatibility with accessory devices were evaluated in a neurovascular model.	The device performs as intended under simulated use conditions.
Hydrophilic Coating Integrity	The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles.	The hydrophilic coating integrity is suitable for its intended use.
Particulate Recovery	Quantify the particulate size and count generated by simulated use of the test article.	The particulate size and count were similar to control devices.
Tensile Strength	The tensile strength was evaluated for the bonds between sections of the catheter.	The device met established specifications.
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	The device integrity is suitable for its intended use.
Liquid Leakage	Tested per ISO 10555-1:2013 Annex C.	The device integrity is suitable for its intended use.
Static Burst	Tested per ISO 10555-1:2013 Annex F.	The device integrity is suitable for its intended use.
Luer Integrity	The luers were evaluated for compliance to relevant standards.	The luers on the device are suitable for their intended use.
Kink Resistance	Test specimen segments were formed into a defined bend diameter to evaluate kink resistance.	The device met established specifications.
Torque Strength	The test specimens were rotated in a simulated use model to evaluate integrity after rotation.	The device met established specifications.
Flow Rate Characterization	The flow rate of saline and a contrast-saline solution was characterized when injected through the catheter.	The flow rate was characterized.
Radiopacity	Radiopacity of the device was evaluated in an animal model under fluoroscopy.	The radiopacity of the Millipede 088 Access Catheter was similar to a control device.
Biocompatibility (various tests)	ISO 10993-1, 10993-4 (Hemocompatibility), 10993-5 (Cytotoxicity), 10993-10 (Irritation, Sensitization), 10993-11 (Systemic Toxicity, Pyrogenicity)	Non-cytotoxic, no sensitization response, met intracutaneous reactivity, met acute systemic injection, non-pyrogenic, not a complement activator, not an intrinsic coagulation pathway activator, non-hemolytic, similar thromboresistance to controls.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the individual performance tests beyond implicitly suggesting multiple samples were tested (e.g., "test specimens," "test articles"). For the Animal Testing, it states "two studies in a porcine model."

The data provenance for the in vitro and animal studies isn't explicitly stated beyond "Good Laboratory Practices" for the animal studies, which is a standard of conduct rather than a geographic origin. No human data is presented.

3. 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)

This information is not provided as the submission relies on objective performance testing, biocompatibility studies, and animal studies rather than expert-derived ground truth from human data for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The evaluation methods described are objective performance tests and animal studies, not human data requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

Yes, the performance testing described (mechanical, dimensional, coating integrity, etc.) and the animal studies represent "standalone" evaluations of the device's physical and functional properties without human interpretation of data in a clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance and biocompatibility tests, the "ground truth" is defined by the established specifications, relevant ISO standards, and comparison to control devices or predicate devices. For example:

"The device met established specifications."
"The test article is non-cytotoxic."
"The particulate size and count were similar to control devices."
"The radiopacity of the Millipede 088 Access Catheter was similar to a control device."
For animal testing, "Usability, radiopacity, thromboresistance, and vessel injury were assessed," and "The results for the subject device were comparable to a control device."

8. The sample size for the training set

Not applicable. This device is a medical catheter and does not involve a "training set" in the context of machine learning or AI. Its performance is evaluated through engineering and biological testing.

9. How the ground truth for the training set was established

Not applicable (as above).

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 +353 91 428083 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)Number	ProductCode	Name of Device	Device Manufacturer
K190010	NRY	Penumbra System ReperfusionCatheter JET 7	Penumbra Inc.
K161152	DQY	Navien Intracranial SupportCatheter	Micro Therapeutics Inc. d/b/aev3 Neurovascular
K152541	NRY	Penumbra System ACE 64Reperfusion Catheter	Penumbra Inc.
K193034	DQY	AXS Infinity LS Plus LongSheath	Stryker Neurovascular
K203840	QJP, DQY	BOSS 8F Balloon GuideCatheter	Marblehead Medical LLC
K182097	DQY	React 71 Catheter	Micro Therapeutics Inc. d/b/aev3 Neurovascular

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510(k)Number	ProductCode	Name of Device	Device Manufacturer
K183464	NRY	AXS Catalyst 7 Distal AccessCatheter	Stryker Neurovascular
K133177	DQY, DQO	Modified HD Guide Catheter	Concentric Medical Inc.
K090752	NRY	Penumbra ReperfusionCatheter 054	Penumbra Inc.

Device Description

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 DeviceTracStar™ Large Distal PlatformZoom™ 88 Large Distal PlatformZoom™ 88-T Large Distal Platform(K203764)	Subject DeviceMillipede 088 Access Catheter
RegulationNumber	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 PlatformZoom™ 88 Large Distal PlatformZoom™ 88-T Large Distal Platform(K203764)	Millipede 088 Access Catheter
Indications for use	The TracStar Large Distal Platform is indicated for the introduction ofinterventional devices into theperipheral, coronary, and neurovasculature.The ZOOM 88 and ZOOM 88-TLarge Distal Platform are indicatedfor the introduction of interventionaldevices into the peripheral, coronary,and neuro vasculature.	The Millipede 088 Access Catheteris indicated for use in facilitatingthe insertion and guidance ofmicrocatheters into a selectedblood vessel in theneurovasculature.
Prescription/over-the-counter use	Prescription	Same
Device Description	Single-use, variable stiffness, wire-reinforced catheters with a singlelumen. The catheters are comprisedof a hollow cylindrical tube bonded atthe proximal end to a standard luerfitting. The wall of the tube isconstructed using metals andpolymers. A radiopaque markerprovides visual confirmation of thedistal tip location under fluoroscopy.	Same
Principle ofOperation	May be used with support cathetersto assist in accessing the targetvasculature.	Same
Techniques forUse	Standard percutaneous interventionaltechniques, including access sitepreparation, introduction of thecatheter into the access vessel,advancing the catheter underfluoroscopy, withdrawing thecatheter, and closing the access site.	Same
Materials	Polymers and metals commonly usedin the manufacture of medicaldevices.	Same
Distal Tip	Beveled edge, soft, flexible, andatraumatic	Square edge, soft, flexible, andatraumatic
Catheter WallConstruction	Coil-reinforced	Coil-reinforced with ribbed surfaceat distal section
Coating	Hydrophilic Coating	Same
Catheter Profile	8 Fr	Same
Inner Diameter	Distal: 0.088"Proximal: 0.088"	Distal: 0.088"Proximal: 0.087"
Outer Diameter	Distal: 0.106"Proximal: 0.108"	Distal: 0.104"Proximal: 0.108"
Effective Length	80cm -110cm	115cm
PackagedAccessories	RHV	RHV and Valve Crossing Tool
Condition	Sterile and Single Use	Same
Attribute	Predicate DeviceTracStarTM Large Distal PlatformZoomTM 88 Large Distal PlatformZoomTM 88-T Large Distal Platform(K203764)	Subject DeviceMillipede 088 Access Catheter
Sterilization Method	Ethylene Oxide (EO), SterilityAssurance Level 10-6	Same
Packaging Configuration	The catheters are placed in aprotective polyethylene tube,mounted with accessory RHV onto apolyethylene packaging card, placedinto a pouch, sealed, and labeled.The sealed pouch and IFU areplaced in a labeled shelf carton box.	The catheters are placed in aprotective polyethylene tube,mounted with accessory RHV andvalve crossing tool onto acardboard packaging card, placedinto a pouch, sealed, and labeled.The sealed pouch and IFU areplaced in a labeled shelf cartonbox.

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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 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

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
DimensionalInspection	Device dimensions were measured toconfirm conformance to thespecifications.	The device met establishedspecifications.
Tip Stiffness	Test specimens were tested for tipflexibility and compared to predicate andreference devices.	The device met establishedspecifications.

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Test	Test Method	Conclusions
Visual Inspection	Device surface characteristics wereassessed to confirm freedom fromdefects.	The device surfacecharacteristics are suitablefor its intended use.
Simulated UseTesting	Deliverability and compatibility withaccessory devices were evaluated in aneurovascular model.	The device performs asintended under simulated useconditions.
Hydrophilic CoatingIntegrity	The integrity of the hydrophilic coatingwas evaluated after multiple insertion andwithdrawal cycles.	The hydrophilic coatingintegrity is suitable for itsintended use.
ParticulateRecovery	The purpose of this test was to quantifythe particulate size and count generatedby simulated use of the test article.	The particulate size and countwere similar to controldevices.
Tensile Strength	The tensile strength was evaluated forthe bonds between sections of thecatheter.	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.
Static Burst	Tested per ISO 10555-1:2013 Annex F.	The device integrity issuitable for its intended use.
Luer Integrity	The luers were evaluated for complianceto relevant standards.	The luers on the device aresuitable for their intendeduse.
Kink Resistance	Test specimen segments were formedinto a defined bend diameter to evaluatekink resistance.	The device met establishedspecifications.
Torque Strength	The test specimens were rotated in asimulated use model to evaluate integrityafter rotation.	The device met establishedspecifications.
Flow RateCharacterization	The flow rate of saline and a contrast-saline solution was characterized wheninjected through the catheter.	The flow rate wascharacterized.
Radiopacity	Radiopacity of the device was evaluatedin an animal model under fluoroscopy.	The radiopacity of theMillipede 088 AccessCatheter was similar to acontrol 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.

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).