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

This document is a 510(k) Summary for a medical device called the Millipede 088 Access Catheter. It's a submission to the FDA for market clearance, asserting that the "subject device" (new version) is substantially equivalent to a "predicate device" (previously cleared version).

Here's the breakdown of acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document describes a medical device, not an AI/Software as a Medical Device (SaMD). Therefore, questions related to AI-specific metrics like human reader improvement with AI assistance, training sets, and expert qualifications for ground truth establishment for AI models are not applicable in this context. The "acceptance criteria" here refer to engineering and performance specifications for the physical catheter and its accessories.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" column with specific numerical targets. Instead, it lists various performance tests and then states whether the device "met established specifications" or if the characteristics are "suitable for its intended use." I will infer the acceptance criteria from these conclusions.

Test / Attribute	Acceptance Criteria (Inferred from Conclusion)	Reported Device Performance
Bench Testing
Dimensional Inspection	Conformance to specifications.	The device met established specifications.
Visual Inspection	Freedom from defects; surface characteristics suitable for intended use.	The device surface characteristics are suitable for its intended use.
Simulated Use Testing	Deliverability and compatibility with accessory devices in a neurovascular model.	The device performs as intended under simulated use conditions.
Hydrophilic Coating Integrity	Coating integrity suitable for intended use after multiple cycles.	The hydrophilic coating integrity is suitable for its intended use.
Particulate Recovery	Particulate size and count similar to control devices.	The particulate size and count was similar to control devices.
Kink Resistance	Met established specifications when formed into a defined bend diameter.	The device met established specifications.
Air Leakage	Device integrity suitable for intended use (per ISO 10555-1:2013 Annex D).	The device integrity is suitable for its intended use.
Liquid Leakage	Device integrity suitable for intended use (per ISO 10555-1:2013 Annex C).	The device integrity is suitable for its intended use.
Static Burst	Device integrity suitable for intended use (per ISO 10555-1 Annex F).	The device integrity is suitable for its intended use.
Catheter Joint Tensile Testing	Tensile strength of bonds between catheter sections met specifications.	The device met established specifications.
Torque Strength	Integrity maintained after rotation in a simulated use model.	The device met established specifications.
Flow Rate Characterization	Flow rate characterized for saline and contrast-saline solution.	The flow rate was characterized.
Biocompatibility
Cytotoxicity (ISO MEM Elution)	Non-cytotoxic.	The test article is non-cytotoxic.
Sensitization (ISO Guinea Pig Maximization)	No sensitization response.	The test article did not elicit a sensitization response.
Irritation (ISO Intracutaneous Reactivity)	Requirements of ISO intracutaneous reactivity test met.	Requirements of the ISO intracutaneous reactivity test were met for the test article.
Acute Systemic Toxicity (ISO Acute Systemic Injection)	Requirements of ISO acute systemic injection test met.	Requirements of the ISO acute systemic injection test were met for the test article.
Material-Medicated Pyrogenicity	Non-pyrogenic.	The test article is non-pyrogenic.
Hemocompatibility (ASTM Hemolysis)	Non-hemolytic.	The test article is considered non-hemolytic.
Sterilization
EO Residual Testing	EO residuals within limits specified in ISO 10993-7.	Confirmed that EO residuals were within the limits specified in ISO 10993-7.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for each test in the "Performance Testing (Bench)" section. For bench tests, it typically involves a certain number of devices tested to ensure reproducibility and statistical significance. However, this specific summary does not offer those details. The testing is bench-top testing, meaning it's performed in a laboratory setting, not on patient data. There is no 'data provenance' in terms of country of origin or retrospective/prospective for this type of physical device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable. This is a physical medical device. "Ground truth" in the context of expert review is for evaluating the performance of diagnostic algorithms or imaging interpretations, which is not what this document is about. The "ground truth" for the device's performance is established by standardized engineering measurements and tests.

4. Adjudication Method for the Test Set

This question is not applicable. As stated above, this is about physical device performance, not interpretive tasks 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

This question is not applicable. This is not an AI-assisted diagnostic device.

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

This question is not applicable. This is not an algorithm or software device.

7. The type of ground truth used

For the performance testing, the "ground truth" is derived from established engineering specifications, industry standards (e.g., ISO, ASTM), and simulated use conditions designed to mimic real-world scenarios. For biocompatibility, the ground truth is defined by the Pass/Fail criteria outlined in the relevant ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This question is not applicable, as there is no training set for this type of device.

Summary

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September 19, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a stylized image of a human figure. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

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

Re: K231802

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 25, 2023 Received: August 25, 2023

Dear Anne-Marie Gannon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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

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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 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 (OS) 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 -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K231802

RZ51802

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (6/20)

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510(k) Summary K231802

Submitter Information

Submitter's Name: Address:

Contact Person: Telephone: Date Prepared:

Subject Device

Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Requlation: 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 19, 2023

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

Millipede 088 Access Catheter Guide Catheter Catheter, Percutaneous, Neurovasculature . 21 CFR 870.1250 QJP Perfuze Ltd. K214048

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 modified Millipede 088 Access Catheter is identical to the predicate device.

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Comparison to the Predicate Device

The intended use of the subject device is identical to the predicate device. The subject and predicate devices have similar technological characteristics as shown in the following table.

Attribute	Predicate DeviceMillipede 088 Access Catheter (K214048)	Subject DeviceMillipede 088 Access Catheter(K231802)
RegulationNumber	21 CFR 870.1250	Same
Regulation Name	Percutaneous catheter	Same
Classification	Class II	Same
Product Code	QJP	Same
Indications forUse	The Millipede 088 Access Catheter isindicated for use in facilitating the insertionand guidance of microcatheters into aselected blood vessel in theneurovasculature.	Same
Prescription/Over-the-Counter Use	Prescription	Same
DeviceDescription	Single-use, variable stiffness, wire-reinforced catheter with a single lumen.The catheter is comprised of a hollowcylindrical tube bonded at the proximal endto a standard luer fitting. The wall of thetube is constructed using metals andpolymers. A radiopaque marker providesvisual confirmation of the distal tip locationunder fluoroscopy.	Same
Principle ofOperation	May be used with support catheters toassist in accessing the targetneurovasculature.	Same
Techniques forUse	Standard percutaneous interventionaltechniques, including access sitepreparation, introduction of the catheterinto the access vessel, advancing thecatheter under fluoroscopy, withdrawingthe catheter and closing the access site.	Same
Materials	Polymers and metals commonly used inthe manufacture of medical devices.	Same
Distal Tip	Soft, flexible, and atraumatic	Same
Catheter WallConstruction	Coil-reinforced with ribbed surface at distalsection	Coil and braid reinforced, withribbed surface at distal section
Coating	Hydrophilic Coating	Same
Catheter Profile	8 Fr	Same
Inner Diameter	Distal: 0.088"Proximal: 0.087
Attribute	Predicate DeviceMillipede 088 Access Catheter (K214048)	Subject DeviceMillipede 088 Access Catheter(K231802)
PackagingConfiguration	The catheters are placed in a protectivepolyethylene tube, mounted with accessoryRHV and valve crossing tool onto acardboard packaging card, placed into apouch, sealed, and labeled. The sealedpouch and IFU (Instructions for Use) areplaced in a labeled shelf carton box.	Same, with dimensionalchanges to protective tube andpackaging card.

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Performance Testing (Bench)

The design of both the subject and predicate devices are identical at the distal end and transitions, but there are some differences in the design at the proximal end. The successful completion of the performance testing listed in the table below demonstrates that the modified Millipede 088 Access Catheter is suitable for its intended use.

Test	Test Method	Conclusions
DimensionalInspection	The device dimensions were measured toconfirm conformance to the specifications.	The device met establishedspecifications.
Visual Inspection	The device surface characteristics wereassessed to confirm freedom from defects.	The device surfacecharacteristics are suitable forits intended use.
Simulated UseTesting	The deliverability and compatibility withaccessory devices were evaluated in aneurovascular model.	The device performs asintended under simulated useconditions.
HydrophilicCoating Integrity	The integrity of the hydrophilic coating wasevaluated 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 generatedduring simulated use of the test article.	The particulate size and countwas similar to control devices.
Kink Resistance	Test specimen segments were formed intoa defined bend diameter to evaluate kinkresistance.	The device met establishedspecifications.
Air Leakage	Tested per ISO 10555-1:2013 Annex D.	The device integrity is suitablefor its intended use.
Liquid Leakage	Tested as per ISO 10555-1:2013 Annex C.	The device integrity is suitablefor its intended use.
Static Burst	Tested as per ISO 10555-1 Annex F.	The device integrity is suitablefor its intended use.
Catheter JointTensile Testing	The tensile strength was evaluated for thebonds between sections of the catheter.	The device met establishedspecifications.
TorqueStrength	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.

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Biocompatibility

The materials, formulation and suppliers of the materials used in the Millipede 088 Access Catheter in the subject and predicate devices are identical. The product-contacting packaging materials in both devices are also identical, therefore no further biocompatibility testing was required for these components of the subject device.

Biocompatibility testing was completed on the accessories provided with the modified Millipede 088 Access Catheter. The Rotating Hemostasis Valve (RHV) and Valve Crossing Tool (VCT) to be provided with the subject device include changes in material and design when compared with those provided with the predicate. The modified accessories were evaluated in accordance with ISO 10993-1:2018. 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 IntracutaneousReactivity	Requirements of the ISO intracutaneous reactivity testwere met for the test article.
Acute Systemic Toxicity - ISO AcuteSystemic Injection	Requirements of the ISO acute systemic injection testwere met for the test article.
Material-Medicated Pyrogenicity	The test article is non-pyrogenic.
Hemocompatibility – ASTM Hemolysis	The test article is considered non-hemolytic.

Shelf Life and Packaging

The labeled shelf life is identical for the subject and predicate devices. The sterile barrier is also identical for the subject and predicate devices. Dimensional changes were made to the protective tube and packaging card to accommodate a longer catheter and modified accessories. Packaging validation testing was completed to assess these changes.

Sterilization

The sterilization method is identical for the subject and predicate devices. Confirmatory EO residual testing was repeated on the modified Millipede 088 Access Catheter to confirm that the design differences did not impact residual EO levels of the testing confirmed that EO residuals were within the limits specified in ISO 10993-7.

Animal Testing

No animal testing was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.

Clinical Testing

No clinical data was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.

Conclusion

The intended use and indications for use of the Millipede 088 Access Catheter are identical to the intended use and indications for use of the predicate device. The subject modified Millipede 088 Access Catheter and the predicate device use the same operating principles and have a similar design. The differences identified in this submission do not raise different or new questions of safety or effectiveness. The successful completion of performance testing and biocompatibility testing demonstrates that the modified 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).