TRUSELECT Microcatheter

K201792 · Boston Scientific Corporation · KRA · Jul 28, 2020 · Cardiovascular

Device Facts

• Record ID: K201792
• Device Name: TRUSELECT Microcatheter
• Applicant: Boston Scientific Corporation
• Product Code: KRA · Cardiovascular
• Decision Date: Jul 28, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRUSELECTM Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

Device Story

TRUSELECT™ Microcatheter is a 2.0F low-profile device for peripheral vascular access; used by physicians to navigate distal, tortuous vessels coaxially over a steerable guidewire. Once positioned, it enables controlled, selective infusion of diagnostic agents, embolic materials (PVA flakes, microspheres, coils), or therapeutic agents (chemotherapy). Device features HydroPass hydrophilic coating to reduce friction. Available in lengths 105-175cm with straight or bern tip configurations. Provided sterile via ethylene oxide; single-use only. Benefits include improved access to distal vasculature and compatibility with various embolic/therapeutic agents.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility testing (ISO 10993-3, 4, 5, 10, 11). In-vitro performance testing confirmed device integrity, compatibility with guidewires/guide catheters/embolic agents, and mechanical properties (tensile strength, burst pressure, kink resistance, flow rate).

Technological Characteristics

2.0F OD microcatheter; 0.021" ID. Materials include catheter shaft and HydroPass hydrophilic coating. Compatible with 0.040" ID guide catheters and 0.014"/0.016" guidewires. Sterilized via 100% ethylene oxide. Mechanical design features include variable lengths (105-175cm) and tip shapes (straight/bern).

Indications for Use

Indicated for patients requiring selective infusion of diagnostic, embolic, or therapeutic materials into the peripheral 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

• Direxion™ Microcatheter (K163701)

Submission Summary (Full Text)

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July 28, 2020

Boston Scientific Corporation Ms. Aoife Tobin Senior Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311

Re: K201792

Trade/Device Name: TRUSELECT™ Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: June 29, 2020 Received: June 30, 2020

Dear Ms. Tobin:

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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K201792

Device Name TRUSELECT™ Microcatheter

Indications for Use (Describe)

The TRUSELECTM Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Sub </span> </div> |

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

510(k) Summary Complying with 21 CFR 807.92

#### l. SUBMITTER INFORMATION

Submitter name: Boston Scientific Corporation

Submitter address: Three Scimed Place Maple Grove, MN 55311-1566 USA

Telephone: [phone] Fax: [phone] e-mail: [e-mail]

Contact person name: Aoife Tobin Date Prepared: July 27, 2020

#### II. DEVICE INFORMATION

Trade Name: TRUSELECT™ Microcatheter

Table 1 and 2 as follows summarizes the relevant device information for the subject devices.

| Table 1. TRUSELECT™ Microcatheter Name of Devices |
|---------------------------------------------------|
| |

| UPN | GTIN | Product Description |
|---------------|----------------|-------------------------------|
| M001394101050 | 08714729976608 | TRUSELECT™ 105cm Straight Tip |
| M001394101300 | 08714729976615 | TRUSELECT™ 130cm Straight Tip |
| M001394101550 | 08714729976622 | TRUSELECT™ 155cm Straight Tip |
| M001394101750 | 08714729976639 | TRUSELECT™ 175cm Straight Tip |
| M001394111050 | 08714729976646 | TRUSELECT™ 105cm Bern Tip |
| M001394111300 | 08714729976653 | TRUSELECT™ 130cm Bern Tip |
| M001394111550 | 08714729976660 | TRUSELECT™ 155cm Bern Tip |
| M001394111750 | 08714729976677 | TRUSELECT™ 175cm Bern Tip |

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| Common or<br>Usual Name | Classification<br>Number | Classification<br>Name | Product<br>Code | Product<br>Code Name | Regulatory<br>Class |
|-------------------------|--------------------------|---------------------------------|-----------------|---------------------------------|---------------------|
| Microcatheter | 21 CFR Part<br>870.1210 | Continuous<br>Flush<br>Catheter | KRA | Continuous<br>Flush<br>Catheter | II |

## Table 2 Additional Device Information

#### lll. PREDICATE DEVICE IDENTIFICATION

## Name of Predicate Device

Direxion™ Microcatheter, K163701

Predicate devices referenced above have not been subject to a design-related recall.

#### IV. DEVICE DESCRIPTION

The TRUSELECT™ Microcatheter is a low profile 2.0F microcatheter intended for use in the peripheral vasculature. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.

Diagnostic, therapeutic and embolic agents such as heparinized saline, contrast media, chemotherapy agents such as doxorubicin and irinotecan, polyvinyl alcohol (PVA) flakes and polymer and hydrogel spherical embolics (microspheres) can be delivered to targeted vessels. The microcatheter maintains chemotherapy chemical compatibility.

It has a straight internal diameter design (021" ID, (0.53 mm)) with a 2.0F OD tapered tip. The microcatheter includes eight UPNs, covering a range of lengths (105, 130, 155 and 175cm) and tip shapes (straight or bern), and is compatible with 0.040" ID guide catheters and 0.014" & 0.016" quidewires. It is compatible with embolic particles of up to 700 microns and 0.018" (0.46 mm) embolic coils.

The TRUSELECT™ Microcatheters are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize HydroPass Hydrophillic Coating for the reduction of surface friction during placement.

#### V. INDICATIONS FOR USE

The TRUSELECT™ Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel

Predicate and subject device Intended use and Indications for Use are the same.

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#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

There are differences in the technological characteristics between the predicate and subject devices. However, the differences in materials, dimensions and packaging, as documented in the following table, do not raise new questions of safety and effectiveness in comparison to the predicate device (K163701).

| Materials | Catheter shaft materials and coating differ from the predicate. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | The catheter is available in an additional length, 175cm, compared to the predicate. The outer diameter of the subject device distal tip is 2.0 Fr compared to the predicate outer tip diameter of 2.4 Fr. |
| Packaging | The predicate device also uses a mounting card in addition to the carrier tube assembly to contain the microcatheter in the pouch. |

The purpose of this 510(k) submission is to receive clearance for the different technological differences between the subject and predicate devices.

#### SUMMARY OF NON-CLINICAL PERFORMANCE TESTING VII.

Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.

The following biocompatibility tests were completed on the TRUSELECT™ Microcatheter:

| Cytotoxicity ISO 10993-5 |
|---------------------------------------------|
| Sensitization ISO 10993-10 |
| Irritation ISO 10993-10 |
| Material Mediated Pyrogenicity ISO 10993-11 |
| Acute Systemic Toxicity ISO 10993-11 |
| Hemocompatibility ISO 10993-4 |
| Genotoxicity ISO 10993-3 |

The following in-vitro performance tests were completed for the TRUSELECT™ Microcatheter:

| Catheter Design / Material<br>Changes | Manifold Connection |
|---------------------------------------|----------------------------------------------|
| | Guidewire Compatibility |
| | Guide Catheter Compatibility |
| | Proximal OD/ Outside Diameter |
| | Catheter ID |
| | Microcatheter Coating Lubricity & Durability |
| | Microcatheter Coating Length |
| | Distal End Flexibility (Distal 5cm) |
| | Proximal End Stiffness |
| | Proximal Shaft Kink |

TRUSELECT™ Microcatheters Premarket Notification - Special 510(k) Page 3 of 4

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| Distal Shaft Kink |
|---------------------------------------------------|
| Effective Length |
| Tip OD |
| Steam Shaping Mandrel Compatibility |
| Shapability |
| Infusion Stability |
| Marker Band Location/Tip Length |
| Microcatheter to Microspheres Compatibility |
| Microcatheter to PVA particle Compatibility |
| Microcatheter to Gelfoam Compatibility |
| Microcatheter to 0.018 Embolic Coil Compatibility |
| Dead Space Volume |
| Max Infusion Pressure (Dynamic Burst) |
| Static Burst |
| Chemical Compatibility |
| Flow Rate |
| Marker Band Tensile |
| Full Catheter Tensile |
| Tip Tensile |
| Tip Shape |
| Particulate Matter |
| Corrosion Resistance |

#### CONCLUSION VIII.

Based on the intended use, technological characteristics, and non-clinical performance data provided, the TRUSELECT™ Microcatheter is substantially equivalent to the predicate device K163701. The design and material changes for the subject device do not raise new questions of safety or effectiveness.