PROWLER SELECT PLUS; PROWLER EX

K210838 · Medos International SARL · KRA · Aug 25, 2021 · Cardiovascular

Device Facts

• Record ID: K210838
• Device Name: PROWLER SELECT PLUS; PROWLER EX
• Applicant: Medos International SARL
• Product Code: KRA · Cardiovascular
• Decision Date: Aug 25, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

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 Story

Variable stiffness, single-lumen microcatheters designed for accessing small, tortuous peripheral and neuro vasculature. Devices feature hydrophilic coating for lubricity and PTFE inner lining to facilitate movement of guidewires and interventional devices. Distal sections and tips are radiopaque for fluoroscopic visualization. Operated by physicians in clinical settings; used to navigate vasculature to deliver therapeutic devices (e.g., stents, coils) or diagnostic agents. Output is the successful placement of interventional tools or infusion of agents at target sites. Benefits include improved access to complex anatomy and reliable delivery of therapeutic interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only, including simulated use in tortuous anatomical models, particulate generation testing, and static burst pressure testing.

Technological Characteristics

Variable stiffness, single-lumen catheter. Materials: Girlamid hub, Nylon/Pellethane shaft, PTFE inner lining, stainless-steel shaft braid, Pt-W distal tip coils. Hydrophilic coating on distal 30 cm. Lengths: 110-170 cm. Sterilization: Ethylene Oxide. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring introduction of interventional devices, delivery of therapeutic 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

• YOGA Microcatheter (K162563)
• CERENOVUS Large Bore Catheter (K191237)
• MODIFIED CONCENTRIC MICROCATHETER (K131437)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> X Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# K210838: 510(K) SUMMARY

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

Tel: [phone]

Contact Person: Samuel Shimp Email of Contact Person: [e-mail] Date Prepared: 23 Aug 2021

#### II. Device

| Table 1. Device | |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | PROWLER SELECT PLUS Microcatheter;<br>PROWLER EX Microcatheter |
| Common or Usual Name | Catheter, Percutaneous |
| Classification Name | Class II - 21 CFR 870.1210 – Continuous flush catheter<br>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<br>Predicate | K021591 | 22 May 2002 | PROWLER SELECT (10, 14,<br>AND PLUS) INFUSION<br>CATHETERS WITH AND<br>WITHOUT PRE-SHAPED TIPS | Medos<br>International<br>SÀRL |
| Reference | K162563 | 5 Jan 2017 | YOGA Microcatheter | |
| | K191237 | 8 Nov 2019 | CERENOVUS Large Bore<br>Catheter | |
| | K131437 | 11 Oct 2013 | MODIFIED CONCENTRIC<br>MICROCATHETER | Concentric<br>Medical, Inc. |

### IV. 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.

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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 PROWLER<br>SELECT PLUS<br>Microcatheter is<br>intended for the<br>introduction of<br>interventional devices,<br>delivery of therapeutic<br>devices, and infusion of<br>diagnostic agents into<br>the peripheral and<br>neuro vasculature. | The PROWLER EX<br>Microcatheter is<br>intended for the<br>introduction of<br>interventional devices,<br>delivery of therapeutic<br>devices, and infusion of<br>diagnostic agents into<br>the peripheral and<br>neuro vasculature. | The PROWLER<br>SELECT (10, 14, and<br>PLUS) Infusion<br>Catheters with and<br>without pre-shaped tips<br>are intended to be used<br>as a mechanism for the<br>infusion of various<br>diagnostic, embolic,<br>and therapeutic agents<br>into the vascular<br>systems (Neuro,<br>Peripheral, Coronary),<br>for Guidewire<br>Exchange/Support, and<br>for superselective<br>angiography of the<br>peripheral and<br>coronary 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 | PROWLER<br>SELECT®PLUS | PROWLER®EX | PROWLER<br>SELECT® (K021591) |
| Useable Length<br>(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<br>shaft. | | |
| Shaft Braid | Stainless-steel | | |
| Distal Tip<br>Radiopaque<br>Marker | 1 or 2 Pt-W coils | | |
| Accessories | Shaping mandrel | | |
| Packaging | HDPE Hoop or PETG Tray, Tyvek pouch sealed to PET/PE film, SBS<br>paperboard carton | | |
| Sterilization<br>Method | 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 Use<br>Testing in a<br>tortuous<br>anatomical<br>model | To provide evidence that the subject<br>devices can safely and effectively<br>deliver interventional devices to the<br>peripheral and neurovasculature.<br>The test method and anatomical<br>model were the same established for<br>reference devices K162563 and<br>K191237. | Test<br>sample microcatheters<br>successfully delivered interventional<br>devices, including vascular stents,<br>stent retrievers, and aneurysm coils.<br>Results demonstrated substantial<br>equivalence for delivery<br>of<br>interventional devices. |
| Particulate<br>Testing | To evaluate and compare the<br>quantity of particles generated by the<br>subject device during simulated<br>device delivery in a tortuous<br>anatomical model versus particles<br>generated by an applicable reference<br>device (K131437). The test method<br>and anatomical model were the same<br>established for reference devices<br>K162563 and K191237. | Particle generation from baseline and<br>aged subject devices were<br>comparable with the reference device<br>(K131437). |
| Static<br>Burst<br>Pressure<br>Testing | This test verified that the subject<br>devices meet the established static<br>burst pressure specification, after<br>simulating the delivery of an<br>interventional device. Static burst<br>pressure specifications were the<br>same as those established<br>for<br>predicate K021591. The test method<br>was the same established for<br>reference devices K162563 and<br>K191237. | All tested baseline and aged samples<br>met the minimum static burst<br>pressure acceptance criteria with a<br>demonstrated 95% confidence and<br>99% reliability and substantial<br>equivalence for delivery<br>of<br>interventional devices. |

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# K210838: 510(k) Summary, continued

| VII. Non-Clinical<br>Performance<br>Testing, continued | Shelf-Life |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Comparison testing of baseline and real-time aged samples supports a product shelf-life of<br>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<br>Performance Data | No clinical studies were required as appropriate verification and validation of the catheter<br>modifications were achieved based on the similarities of the proposed device to the primary<br>predicate device, and from results of bench testing. |
| IX. Conclusion | The selective non-clinical tests performed support the substantial equivalence of the subject<br>devices for the proposed indications for use, with a shelf-life of 27 months. Comparison of the<br>technological characteristics and the intended use of the subject device and the predicate does not<br>raise new questions of safety and effectiveness. |

End of 510(k) Summary