PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter

K214025 · Medos International SARL · KRA · Apr 12, 2022 · Cardiovascular

Device Facts

• Record ID: K214025
• Device Name: PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
• Applicant: Medos International SARL
• Product Code: KRA · Cardiovascular
• Decision Date: Apr 12, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Variable stiffness, single-lumen microcatheters designed for access to small, tortuous vasculature. Proximal shaft reinforced with stainless-steel braid for pushability; distal shafts reinforced with Platinum/Tungsten coil for flexibility. Distal 30 cm features hydrophilic coating for lubricity. Used by physicians in clinical settings to navigate vasculature for delivery of embolic devices or diagnostic agents. Device supports guidewires up to 0.014 in. diameter. Output is the successful placement of embolic devices or infusion of agents, facilitating minimally invasive neuro/peripheral interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by referenced non-clinical performance testing and design verification/validation.

Technological Characteristics

Variable stiffness, single-lumen microcatheter. Materials: Stainless-steel braid (proximal), Platinum/Tungsten coil (distal), Grilamid hub, hydrophilic coating (distal 30 cm). Max guidewire diameter 0.014 in. Sterilization: Ethylene Oxide. Shelf life: 27 months.

Indications for Use

Indicated for patients requiring introduction of embolic devices or infusion of diagnostic agents into peripheral and neuro vasculature.

Regulatory Classification

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.

Predicate Devices

• PROWLER SELECT (10, 14, and PLUS) Infusion Catheters with and without pre-shaped tips (K021591)

Reference Devices

• PROWLER SELECT PLUS Microcatheter (K210838)
• PROWLER EX Microcatheter (K210838)
• CES Infusion Catheters (K965181)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|------------------------------------------------------------------------------------|
| <span style="font-size:100%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:100%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| I. Submitter | Medos International SÀRL<br>Chemin-Blanc 38<br>2400 Le Locle, Switzerland |
|--------------|---------------------------------------------------------------------------|
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Contact Person: Ivenette Guzman Email of Contact Person: [e-mail] Telephone of Contact Person: [phone]

Date Prepared: 07 April 2022

#### II. Device

III. Predicate

and Reference Devices

| Table 1. Device | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Device Proprietary<br>Name | PROWLER SELECT LP ES Microcatheter;<br>PROWLER XS Microcatheter |
| Common or Usual<br>Name | Catheter, Percutaneous |
| Classification Name | Class II - 21 CFR 870.1210 – Continuous flush<br>catheter<br>Class II - 21 CFR 870.1250 - Catheter,<br>Percutaneous |
| Regulatory<br>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<br>Cleared | Name | Manufacturer |
| Primary<br>Predicate | K021591 | 22 May<br>2002 | PROWLER SELECT (10,<br>14, and PLUS) Infusion<br>Catheters with and<br>without pre-shaped tips | |
| Reference | K210838 | 25 Aug<br>2021 | PROWLER SELECT<br>PLUS Microcatheter;<br>PROWLER EX<br>Microcatheter | Medos<br>International<br>SÀRL |
| | K965181 | 21 Mar<br>1997 | CES Infusion<br>Catheters | |

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| IV. Device<br>Description | The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-<br>zone construction that enables smoother transitions to enhance the stability of the<br>microcatheter. The microcatheters are variable stiffness, single lumen catheters<br>designed to access small, tortuous vasculature. The maximum outer diameter of a<br>guidewire that is allowed inside the subject microcatheter is 0.014 in.<br><br>The proximal shaft is reinforced with a stainless-steel braid to aid in pushability. The<br>distal shafts are reinforced with a Platinum/Tungsten coil to provide flexibility. To<br>provide lubricity, the distal 30 cm of the catheter is coated with a hydrophilic<br>coating. |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| V. Indications for<br>Use | The PROWLER SELECT LP ES Microcatheter is intended for the introduction of<br>embolic devices and infusion of diagnostic agents into the peripheral and neuro<br>vasculature.<br><br>The PROWLER XS Microcatheter is intended for the introduction of embolic<br>devices and infusion of diagnostic agents into the peripheral and neuro vasculature. |
| VI. Comparison<br>of Technological<br>Characteristics<br>with Predicate<br>Device | Table 3 provides comparison of technological characteristics with the predicate<br>device. Based on design verification and validation testing, the minor differences in<br>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<br>Microcatheter; PROWLER XS<br>Microcatheter (K214025) | PROWLER SELECT (10, 14, and PLUS)<br>Infusion Catheters with and without pre-shaped tips (K021591) |
| Indications for Use | The PROWLER SELECT LP ES<br>Microcatheter is intended for the<br>introduction of embolic devices and<br>infusion of diagnostic agents into the<br>peripheral and neuro vasculature.<br><br>The PROWLER XS Microcatheter is<br>intended for the introduction of embolic<br>devices and infusion of diagnostic<br>agents into the peripheral and neuro<br>vasculature. | The PROWLER SELECT (10, 14, and PLUS)<br>Infusion Catheters with and without pre-shaped tips are intended to be used as a<br>mechanism for the infusion of various<br>diagnostic, embolic, and therapeutic agents<br>into the vascular systems (Neuro, Peripheral,<br>Coronary), for Guidewire Exchange/Support,<br>and for superselective angiography of the<br>peripheral and coronary vasculatures. |
| Useable Length (cm) | 150 | 150 |
| Tip Shapes | | Straight, J, 45-, and 90-degree |
| Inner Diameter | 0.0165" | 0.021" (PLUS)<br>0.0165" (14)<br>0.015" (10) |
| Outer<br>Diameter | 2.3F /1.9F | 2.8F / 2.3F (PLUS)<br>2.3F / 1.9 F (14)<br>2.3F / 1.7F (10) |
| Hub Material | Grilamid | Grilamid |
| Shaft Material | | Nylon and Pellethane |
| Inner Lining | | PTFE |
| Outer<br>Coating | | Hydrophilic coating on distal-most 30 cm of the outside surface<br>of the shaft |
| Shaft Braid | | Stainless-steel |
| Distal Tip<br>Radiopaque Marker | | 1 or 2 Pt-W coils |
| Accessories | | Shaping mandrel |
| Packaging | | HDPE Hoop or PETG Tray, Tyvek pouch sealed to PET/PE<br>film, SBS paperboard carton |
| Sterilization<br>Method | | 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