K Number

Device Name

PROWLER SELECT PLUS; PROWLER EX

Manufacturer

Medos International SARL

Date Cleared

2021-08-25

(156 days)

Product Code

KRA DQY QJP

Regulation Number

870.1210

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K021591

Reference Devices

K162563, K191237, K131437

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical microcatheter and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as a microcatheter intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents, not as a therapeutic device itself.

Diagnostic

The device is intended for the introduction of interventional devices, delivery of therapeutic devices, and infusion of diagnostic agents. While it can introduce diagnostic agents, its primary function is not to diagnose, but rather to facilitate other procedures.

SaMD (Software as a Medical Device)

The device description clearly describes a physical catheter with specific material properties, coatings, and radiopaque markers, indicating it is a hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The PROWLER SELECT PLUS and PROWLER EX Microcatheters are designed to be inserted into the body (specifically the peripheral and neuro vasculature) to deliver other devices or agents. They are used in vivo (within a living organism), not in vitro (in a lab setting).
Intended Use: The intended use clearly states the introduction and delivery of devices and agents into the vasculature, not the analysis of samples taken from the body.

Therefore, based on the provided information, this device falls under the category of an interventional medical device used within the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

KRA, DQY, QJP

Device Description

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)

Simulated Use Testing in a tortuous anatomical model
Test Method Summary: 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.
Results: 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
Test Method Summary: 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.
Results: Particle generation from baseline and aged subject devices were comparable with the reference device (K131437).

Static Burst Pressure Testing
Test Method Summary: 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.
Results: 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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K021591

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K162563, K191237, K131437

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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 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.

III. Predicate and Reference Devices

	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	Medos
International
SÀRL
Reference	K162563	5 Jan 2017	YOGA Microcatheter
	K191237	8 Nov 2019	CERENOVUS Large Bore
Catheter
	K131437	11 Oct 2013	MODIFIED CONCENTRIC
MICROCATHETER	Concentric
Medical, Inc.

IV. Device Description

Continued next page

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 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.	The PROWLER
SELECT (10, 14, and
PLUS) Infusion
Catheters with and
without pre-shaped tips
are intended to be used
as a mechanism for the
infusion of various
diagnostic, embolic,
and therapeutic agents
into the vascular
systems (Neuro,
Peripheral, Coronary),
for Guidewire
Exchange/Support, and
for superselective
angiography of the
peripheral and
coronary vasculatures.

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	PROWLER
SELECT®PLUS	PROWLER®EX	PROWLER
SELECT® (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 the
shaft.
Shaft Braid	Stainless-steel
Distal Tip
Radiopaque
Marker	1 or 2 Pt-W coils
Accessories	Shaping mandrel
Packaging	HDPE Hoop or PETG Tray, Tyvek pouch sealed to PET/PE film, SBS
paperboard carton
Sterilization
Method	Ethylene Oxide
Shelf Life	27 Months		36 Months (3 Years)

Continued next page

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 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.

Continued next page

K210838: 510(k) Summary, continued

| VII. Non-Clinical
Performance

Testing, continued	Shelf-Life
	Comparison testing of baseline and real-time aged samples supports a product shelf-life of
27 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. Clinical
Performance Data	No clinical studies were required as appropriate verification and validation of the catheter
modifications were achieved based on the similarities of the proposed device to the primary
predicate device, and from results of bench testing.
IX. Conclusion	The selective non-clinical tests performed support the substantial equivalence of the subject
devices for the proposed indications for use, with a shelf-life of 27 months. 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