The PROWLER SELECT LP ES Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER XS Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.

Device Description

The proximal shaft is reinforced with a stainless-steel braid to aid in pushability. The distal shafts are reinforced with a Platinum/Tungsten coil to provide flexibility. To provide lubricity, the distal 30 cm of the catheter is coated with a hydrophilic coating.

AI/ML Overview

This document is a 510(k) clearance letter for medical microcatheters (PROWLER SELECT LP ES Microcatheter and PROWLER XS Microcatheter). It focuses on demonstrating substantial equivalence to existing predicate devices, not on proving device performance against specific de novo clinical performance acceptance criteria.

Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not present in this type of FDA submission.

Here's why and what can be inferred:

Substantial Equivalence (510(k)) vs. De Novo Clearance/PMA:
- A 510(k) submission, like this one, aims to show that a new device is as safe and effective as a legally marketed predicate device. This often relies on design comparisons, bench testing (non-clinical performance), and sometimes clinical data if there are new indications or significant technological differences that raise new questions of safety and effectiveness.
- The prompt's questions are typically relevant for novel devices seeking de novo classification or high-risk devices requiring a Premarket Approval (PMA) application, where the device must prove its safety and effectiveness against defined clinical endpoints and acceptance criteria. This usually involves robust clinical trials, often with AI-based devices needing specific performance metrics like AUC, sensitivity, specificity, and comparison to human performance (MRMC studies).
What this document does state regarding "performance":
- Non-Clinical Performance Testing (Section VII): "No new testing was conducted to support the minor changes subject to this submission, because all relevant testing has been previously submitted to and reviewed by the FDA." This means the manufacturer relied on existing data, presumably from the original clearance of the predicate device or prior versions. They emphasize that minor design changes "do not raise different questions of safety and effectiveness."
- Clinical Performance Data (Section VIII): "No clinical studies were required to support the minor changes." This explicitly states that clinical trials (which would involve human participants, test sets, ground truth establishment, etc.) were not necessary for this specific submission.
- Ground Truth: The concept of "ground truth" as it pertains to AI/diagnostic performance (expert consensus, pathology, outcomes data) is not applicable here because this is a physical medical device (microcatheter) and the submission doesn't involve an AI component or complex diagnostic performance evaluation. The "ground truth" for a microcatheter's performance is typically established through engineering bench testing (e.g., burst pressure, material integrity, flexibility, guidewire compatibility) and often in vivo animal studies or ex vivo models for more complex functional aspects like navigability, not human clinical consensus on images or diagnoses.

In summary, based on the provided document:

Acceptance Criteria Table: Not applicable. The "acceptance" is substantial equivalence to a predicate device, demonstrated through non-clinical data already on file. Performance criteria would be engineering specifications (e.g., burst pressure, tensile strength, lubricity), but these specific values are not detailed in this public summary.
Study that proves the device meets acceptance criteria: The document states "No new testing was conducted" and "No clinical studies were required." The "proof" relies on the existing non-clinical data for the predicate and the manufacturer's assertion that minor changes do not impact safety or effectiveness.
Sample size for test set / Data provenance: Not applicable for a typical clinical trial. Non-clinical testing would have sample sizes for different mechanical tests, but these are not disclosed.
Number of experts / Qualifications / Adjudication: Not applicable, as no human expert review for establishing ground truth on a diagnostic test set was performed or required.
MRMC comparative effectiveness study: No.
Standalone performance: No.
Type of ground truth used: Not applicable in the context of diagnostic performance. For physical device performance, ground truth would be established through engineering metrology and standardized test methods.
Training set sample size / Ground truth for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring training data.

This 510(k) clearance is for a conventional medical device, not an AI/ML device or one requiring de novo clinical validation against complex diagnostic endpoints.

Summary

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April 12, 2022

Image /page/0/Picture/1 description: The image contains 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Medos International SÀRL Ivenette Guzman Senior Regulatory Affairs Program Lead 6303 Blue Lagoon Drive, Suite 315 Miami. Florida 33126

Re: K214025

Trade/Device Name: PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, DQY, QJP Dated: March 11, 2022 Received: March 14, 2022

Dear Ivenette Guzman:

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 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-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) K214025

Device Name PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter

Indications for Use (Describe)

The PROWLER SELECT LP ES Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.

The PROWLER XS Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.

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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I. Submitter	Medos International SÀRLChemin-Blanc 382400 Le Locle, Switzerland
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Contact Person: Ivenette Guzman Email of Contact Person: iguzma1@its.jnj.com Telephone of Contact Person: +1 (954) 415-7177

Date Prepared: 07 April 2022

II. Device

III. Predicate

and Reference Devices

Table 1. Device
Device ProprietaryName	PROWLER SELECT LP ES Microcatheter;PROWLER XS Microcatheter
Common or UsualName	Catheter, Percutaneous
Classification Name	Class II - 21 CFR 870.1210 – Continuous flushcatheterClass II - 21 CFR 870.1250 - Catheter,Percutaneous
RegulatoryClassification	II
Product Code	KRA, DQY, QJP

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

	Table 2. Predicate and Reference Devices
Type	510(k) #	DateCleared	Name	Manufacturer
PrimaryPredicate	K021591	22 May2002	PROWLER SELECT (10,14, and PLUS) InfusionCatheters with andwithout pre-shaped tips
Reference	K210838	25 Aug2021	PROWLER SELECTPLUS Microcatheter;PROWLER EXMicrocatheter	MedosInternationalSÀRL
	K965181	21 Mar1997	CES InfusionCatheters

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IV. DeviceDescription	The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-zone construction that enables smoother transitions to enhance the stability of themicrocatheter. The microcatheters are variable stiffness, single lumen cathetersdesigned to access small, tortuous vasculature. The maximum outer diameter of aguidewire that is allowed inside the subject microcatheter is 0.014 in.The proximal shaft is reinforced with a stainless-steel braid to aid in pushability. Thedistal shafts are reinforced with a Platinum/Tungsten coil to provide flexibility. Toprovide lubricity, the distal 30 cm of the catheter is coated with a hydrophiliccoating.
V. Indications forUse	The PROWLER SELECT LP ES Microcatheter is intended for the introduction ofembolic devices and infusion of diagnostic agents into the peripheral and neurovasculature.The PROWLER XS Microcatheter is intended for the introduction of embolicdevices and infusion of diagnostic agents into the peripheral and neuro vasculature.
VI. Comparisonof TechnologicalCharacteristicswith PredicateDevice	Table 3 provides comparison of technological characteristics with the predicatedevice. Based on design verification and validation testing, the minor differences incharacteristics do not raise different questions of safety and effectiveness.

IV. DeviceDescription

The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-zone construction that enables smoother transitions to enhance the stability of themicrocatheter. The microcatheters are variable stiffness, single lumen cathetersdesigned to access small, tortuous vasculature. The maximum outer diameter of aguidewire that is allowed inside the subject microcatheter is 0.014 in.The proximal shaft is reinforced with a stainless-steel braid to aid in pushability. Thedistal shafts are reinforced with a Platinum/Tungsten coil to provide flexibility. Toprovide lubricity, the distal 30 cm of the catheter is coated with a hydrophiliccoating.

V. Indications forUse

The PROWLER SELECT LP ES Microcatheter is intended for the introduction ofembolic devices and infusion of diagnostic agents into the peripheral and neurovasculature.The PROWLER XS Microcatheter is intended for the introduction of embolicdevices and infusion of diagnostic agents into the peripheral and neuro vasculature.

VI. Comparisonof TechnologicalCharacteristicswith PredicateDevice

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

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Table 3. Predicate Comparison
Description	Subject Devices	Primary Predicate
	PROWLER SELECT LP ESMicrocatheter; PROWLER XSMicrocatheter (K214025)	PROWLER SELECT (10, 14, and PLUS)Infusion Catheters with and without pre-shaped tips (K021591)
Indications for Use	The PROWLER SELECT LP ESMicrocatheter is intended for theintroduction of embolic devices andinfusion of diagnostic agents into theperipheral and neuro vasculature.The PROWLER XS Microcatheter isintended for the introduction of embolicdevices and infusion of diagnosticagents into the peripheral and neurovasculature.	The PROWLER SELECT (10, 14, and PLUS)Infusion Catheters with and without pre-shaped tips are intended to be used as amechanism for the infusion of variousdiagnostic, embolic, and therapeutic agentsinto the vascular systems (Neuro, Peripheral,Coronary), for Guidewire Exchange/Support,and for superselective angiography of theperipheral and coronary vasculatures.
Useable Length (cm)	150	150
Tip Shapes		Straight, J, 45-, and 90-degree
Inner Diameter	0.0165"	0.021" (PLUS)0.0165" (14)0.015" (10)
OuterDiameter	2.3F /1.9F	2.8F / 2.3F (PLUS)2.3F / 1.9 F (14)2.3F / 1.7F (10)
Hub Material	Grilamid	Grilamid
Shaft Material		Nylon and Pellethane
Inner Lining		PTFE
OuterCoating		Hydrophilic coating on distal-most 30 cm of the outside surfaceof the shaft
Shaft Braid		Stainless-steel
Distal TipRadiopaque Marker		1 or 2 Pt-W coils
Accessories		Shaping mandrel
Packaging		HDPE Hoop or PETG Tray, Tyvek pouch sealed to PET/PEfilm, SBS paperboard carton
SterilizationMethod		Ethylene Oxide
Shelf Life	27 months	36 months (3-years)

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VII. Non-Clinical Performance Testing	No new testing was conducted to support the minor changes subject to this submission, because all relevant testing has been previously submitted to and reviewed by the FDA.
Shelf-Life	Referenced comparison testing of baseline and real-time aged samples supports a product shelf- life of 27 months.
Packaging	N/A - Changes did not impact packaging design.
Biocompatibility	N/A - Changes did not impact biocompatibility.
Sterilization Validation	N/A - Changes did not impact sterilization.
VIII. Clinical Performance Data	No clinical studies were required to support the minor changes.
IX. Conclusion	The selective non-clinical tests referenced support the substantial equivalence of the subject devices for the proposed indications for use, with a shelf-life of 27 months. The comparison of the technological characteristics and the intended use of the subject device and the predicate does not raise 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).