Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (microcatheter) and its construction, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
The device is described as a microcatheter intended for the introduction of embolic devices and infusion of diagnostic agents. It acts as a delivery system rather than directly providing a therapeutic effect.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section states that the device is intended for the "infusion of diagnostic agents". Although it also mentions the introduction of embolic devices (therapeutic), the explicit mention of diagnostic agents confirms its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with specific material components (stainless-steel braid, Platinum/Tungsten coil, hydrophilic coating) and a defined physical structure (3-zone construction, single lumen). This indicates a hardware medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature." This describes a device used within the body for therapeutic and diagnostic procedures, not a device used to test samples outside the body (which is the definition of an IVD).
Device Description: The description details a catheter designed to be inserted into blood vessels. This aligns with an in-vivo medical device, not an in-vitro diagnostic.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in-vitro diagnostics.

Therefore, the PROWLER SELECT LP ES and PROWLER XS Microcatheters are medical devices used for interventional procedures, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

KRA, DQY, QJP

Device Description

The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-zone construction that enables smoother transitions to enhance the stability of the microcatheter. The microcatheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. The maximum outer diameter of a guidewire 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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and neuro vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
No clinical studies were required to support the minor changes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K021591

Reference Device(s)

K210838, K965181

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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

1

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 SÀRL
Chemin-Blanc 38
2400 Le Locle, Switzerland |

--------------	---------------------------------------------------------------------------

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 Proprietary
Name	PROWLER SELECT LP ES Microcatheter;
PROWLER XS Microcatheter
Common or Usual
Name	Catheter, Percutaneous
Classification Name	Class II - 21 CFR 870.1210 – Continuous flush
catheter
Class 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.

	Table 2. Predicate and Reference Devices
Type	510(k) #	Date
Cleared	Name	Manufacturer
Primary
Predicate	K021591	22 May
2002	PROWLER SELECT (10,
14, and PLUS) Infusion
Catheters with and
without pre-shaped tips
Reference	K210838	25 Aug
2021	PROWLER SELECT
PLUS Microcatheter;
PROWLER EX
Microcatheter	Medos
International
SÀRL
	K965181	21 Mar
1997	CES Infusion
Catheters

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| IV. Device
Description | The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-
zone construction that enables smoother transitions to enhance the stability of the
microcatheter. The microcatheters are variable stiffness, single lumen catheters
designed to access small, tortuous vasculature. The maximum outer diameter of a
guidewire 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. 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. |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| V. Indications for
Use | 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. |
| 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. |

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Table 3. Predicate Comparison
Description	Subject Devices	Primary Predicate
	PROWLER SELECT LP ES
Microcatheter; PROWLER XS
Microcatheter (K214025)	PROWLER SELECT (10, 14, and PLUS)
Infusion Catheters with and without pre-shaped tips (K021591)
Indications for Use	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.

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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