The PROWLER SELECT PLUS Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

Device Description

The PROWLER SELECT PLUS Microcatheter and PROWLER EX Microcatheter are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal sections of the catheter bodies are radiopaque to aid visualization under fluoroscopy, and the distal tips are clearly distinguished by a radiopaque marker.

AI/ML Overview

The provided FDA 510(k) summary (K210838) is for a medical device, specifically a microcatheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The document does not describe studies proving an AI/ML powered device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria, performance tables, sample sizes, expert involvement, or MRMC studies from the provided text, as those concepts are not applicable to the device described (a physical microcatheter).

The document details performance testing for this physical device as follows:

Acceptance Criteria and Device Performance (Not applicable to AI/ML):

The document describes non-clinical performance testing for the PROWLER SELECT PLUS Microcatheter and PROWLER EX Microcatheter. The acceptance criteria are implicit in the "Test Method Summary" and the "Results" sections.

Test	Test Method Summary	Results (Device Performance)
Simulated Use Testing in a tortuous anatomical model	To provide evidence that the subject devices can safely and effectively deliver interventional devices to the peripheral and neurovasculature. The test method and anatomical model were the same established for reference devices K162563 and K191237.	Test sample microcatheters successfully delivered interventional devices, including vascular stents, stent retrievers, and aneurysm coils. Results demonstrated substantial equivalence for delivery of interventional devices.
Particulate Testing	To evaluate and compare the quantity of particles generated by the subject device during simulated device delivery in a tortuous anatomical model versus particles generated by an applicable reference device (K131437). The test method and anatomical model were the same established for reference devices K162563 and K191237.	Particle generation from baseline and aged subject devices were comparable with the reference device (K131437).
Static Burst Pressure Testing	This test verified that the subject devices meet the established static burst pressure specification, after simulating the delivery of an interventional device. Static burst pressure specifications were the same as those established for predicate K021591. The test method was the same established for reference devices K162563 and K191237.	All tested baseline and aged samples met the minimum static burst pressure acceptance criteria with a demonstrated 95% confidence and 99% reliability and substantial equivalence for delivery of interventional devices.

Regarding the specific questions asked for an AI/ML device:

A table of acceptance criteria and the reported device performance: Provided above for the physical device.
Sample sized used for the test set and the data provenance: Not explicitly stated (e.g., number of microcatheters tested in "test sample microcatheters" or "all tested baseline and aged samples"). The data is from non-clinical bench testing, not patient data (so no country of origin, retrospective/prospective information).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical microcatheter's performance is based on direct measurement and observation of physical properties and simulated use, not expert interpretation of AI output.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a physical medical device, not an AI-powered diagnostic/analytic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on established engineering specifications, physical testing standards, and direct observation of mechanical performance (e.g., successful delivery, particle generation counts, burst pressure measurements).
The sample size for the training set: Not applicable (no AI model).
How the ground truth for the training set was established: Not applicable (no AI model).

Summary

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August 25, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medos International SARL Samuel K. Shimp Senior Regulatory Affairs Program Lead 6303 Blue Lagoon Drive, Suite 315 Miami. Florida 33126

Re: K210838

Trade/Device Name: PROWLER SELECT PLUS Microcatheter; PROWLER EX Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY, QJP Dated: July 23, 2021 Received: July 26, 2021

Dear Dr. Samuel Shimp:

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,

Xiaolin Zheng, Ph.D. 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) K210838

Device Name PROWLER SELECT PLUS Microcatheter; PROWLER EX Microcatheter

Indications for Use (Describe)

The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

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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K210838: 510(K) SUMMARY

I. Submitter Medos International SÀRL Chemin-Blanc 38 2400 Le Locle, Switzerland

Tel: +1 (757) 790-9275

Contact Person: Samuel Shimp Email of Contact Person: sshimp@its.jnj.com Date Prepared: 23 Aug 2021

II. Device

Table 1. Device
Device Proprietary Name	PROWLER SELECT PLUS Microcatheter;PROWLER EX Microcatheter
Common or Usual Name	Catheter, Percutaneous
Classification Name	Class II - 21 CFR 870.1210 – Continuous flush catheterClass II - 21 CFR 870.1250 – Catheter, Percutaneous
Regulatory Classification	II
Product Code	KRA, DQY, QJP

The predicate and reference devices are listed below in Table 2.

III. Predicate and Reference Devices

	Table 2. Predicate and Reference Devices
Type	510(k) #	Date Cleared	Name	Manufacturer
PrimaryPredicate	K021591	22 May 2002	PROWLER SELECT (10, 14,AND PLUS) INFUSIONCATHETERS WITH ANDWITHOUT PRE-SHAPED TIPS	MedosInternationalSÀRL
Reference	K162563	5 Jan 2017	YOGA Microcatheter
	K191237	8 Nov 2019	CERENOVUS Large BoreCatheter
	K131437	11 Oct 2013	MODIFIED CONCENTRICMICROCATHETER	ConcentricMedical, Inc.

IV. Device Description

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K210838: 510(k) Summary, continued

V. Indications for The PROWLER SELECT PLUS Microcatheter is intended for the introduction of interventional Use devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER EX Microcatheter is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents into the peripheral and neuro vasculature.

VI. Comparison of Technological Characteristics with Predicate Device

Table 3 provides comparison of technological characteristics with the predicate device. Based on design verification and validation testing, the minor differences in characteristics do not raise different questions of safety and effectiveness.

Table 3. Predicate Comparison
	Subject Devices		Primary Predicate
Description	PROWLER SELECT®PLUS	PROWLER®EX	PROWLER SELECT® (K021591)
Indications	The PROWLERSELECT PLUSMicrocatheter isintended for theintroduction ofinterventional devices,delivery of therapeuticdevices, and infusion ofdiagnostic agents intothe peripheral andneuro vasculature.	The PROWLER EXMicrocatheter isintended for theintroduction ofinterventional devices,delivery of therapeuticdevices, and infusion ofdiagnostic agents intothe peripheral andneuro vasculature.	The PROWLERSELECT (10, 14, andPLUS) InfusionCatheters with andwithout pre-shaped tipsare intended to be usedas a mechanism for theinfusion of variousdiagnostic, embolic,and therapeutic agentsinto the vascularsystems (Neuro,Peripheral, Coronary),for GuidewireExchange/Support, andfor superselectiveangiography of theperipheral andcoronary vasculatures.

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K210838: 510(k) Summary, continued

VI. Comparison of Technological Characteristics with Predicate Device, continued

Table 3. Predicate Comparison, continued
Description	Subject Devices		Primary Predicate
Description	PROWLERSELECT®PLUS	PROWLER®EX	PROWLERSELECT® (K021591)
Useable Length(cm)	110, 135, 150, 160, 170	110, 135, 150, 160, 170	110, 135, 150, 170
Tip Shapes	Straight, J, 45-, and 90-degree
Inner Diameter	0.021”
Outer Diameter	2.8/ 2.3F
Hub Material	Girlamid
Shaft Material	Nylon and Pellethane
Inner Lining	PTFE
Outer Coating	Hydrophilic coating on distal-most 30 cm of the outside surface of theshaft.
Shaft Braid	Stainless-steel
Distal TipRadiopaqueMarker	1 or 2 Pt-W coils
Accessories	Shaping mandrel
Packaging	HDPE Hoop or PETG Tray, Tyvek pouch sealed to PET/PE film, SBSpaperboard carton
SterilizationMethod	Ethylene Oxide
Shelf Life	27 Months		36 Months (3 Years)

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K210838: 510(k) Summary, continued

VII. Non-Clinical Performance Testing

Performance Testing

Testing was conducted according to existing design controls and protocols / test methods previously reviewed by FDA in relevant prior submissions. Table 4 provides a description of each performance test used to support substantial equivalence determination.

Table 4. Performance Testing
Test	Test Method Summary	Results
Simulated UseTesting in atortuousanatomicalmodel	To provide evidence that the subjectdevices can safely and effectivelydeliver interventional devices to theperipheral and neurovasculature.The test method and anatomicalmodel were the same established forreference devices K162563 andK191237.	Testsample microcatheterssuccessfully delivered interventionaldevices, including vascular stents,stent retrievers, and aneurysm coils.Results demonstrated substantialequivalence for deliveryofinterventional devices.
ParticulateTesting	To evaluate and compare thequantity of particles generated by thesubject device during simulateddevice delivery in a tortuousanatomical model versus particlesgenerated by an applicable referencedevice (K131437). The test methodand anatomical model were the sameestablished for reference devicesK162563 and K191237.	Particle generation from baseline andaged subject devices werecomparable with the reference device(K131437).
StaticBurstPressureTesting	This test verified that the subjectdevices meet the established staticburst pressure specification, aftersimulating the delivery of aninterventional device. Static burstpressure specifications were thesame as those establishedforpredicate K021591. The test methodwas the same established forreference devices K162563 andK191237.	All tested baseline and aged samplesmet the minimum static burstpressure acceptance criteria with ademonstrated 95% confidence and99% reliability and substantialequivalence for deliveryofinterventional devices.

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K210838: 510(k) Summary, continued

VII. Non-ClinicalPerformanceTesting, continued	Shelf-Life
	Comparison testing of baseline and real-time aged samples supports a product shelf-life of27 months.
	Biocompatibility
	N/A - Changes did not impact biocompatibility.
	Packaging
	N/A - Changes did not impact packaging design.
	Sterilization Validation
	N/A - Changes did not impact sterilization.
VIII. ClinicalPerformance Data	No clinical studies were required as appropriate verification and validation of the cathetermodifications were achieved based on the similarities of the proposed device to the primarypredicate device, and from results of bench testing.
IX. Conclusion	The selective non-clinical tests performed support the substantial equivalence of the subjectdevices for the proposed indications for use, with a shelf-life of 27 months. Comparison of thetechnological characteristics and the intended use of the subject device and the predicate does notraise new questions of safety and effectiveness.

End of 510(k) Summary

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).