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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the TRUSELECT™ Microcatheter in the form of thresholds or target values. Instead, it details a comprehensive list of non-clinical (bench) tests and biocompatibility tests that were performed to demonstrate conformance to requirements for its intended use and substantial equivalence to the predicate device (Direxion™ Microcatheter, K163701).

The "reported device performance" is summarized by the statement: "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." This implies that the device met the internal design and performance specifications that correspond to each test.

Here's a table based on the tests conducted:

Test Category	Specific Test Name	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO 10993-5)	No significant cytotoxic effects beyond acceptable limits	Met acceptable limits
	Sensitization (ISO 10993-10)	No significant sensitization potential	Met acceptable limits
	Irritation (ISO 10993-10)	No significant irritation	Met acceptable limits
	Material Mediated Pyrogenicity (ISO 10993-11)	No significant pyrogenicity	Met acceptable limits
	Acute Systemic Toxicity (ISO 10993-11)	No significant acute systemic toxicity	Met acceptable limits
	Hemocompatibility (ISO 10993-4)	Acceptable blood compatibility (e.g., no excessive hemolysis)	Met acceptable limits
	Genotoxicity (ISO 10993-3)	No significant genotoxic effects	Met acceptable limits
In-Vitro Performance	Manifold Connection	Secure connection, no leaks	Conformed to requirements
	Guidewire Compatibility	Compatible with specified guidewire sizes	Achieved compatibility
	Guide Catheter Compatibility	Compatible with specified guide catheter sizes	Achieved compatibility
	Proximal OD/Outside Diameter	Met specified dimensions	Conformed to requirements
	Catheter ID	Met specified dimensions	Conformed to requirements
	Microcatheter Coating Lubricity & Durability	Maintained lubricity and durability for intended use	Conformed to requirements
	Microcatheter Coating Length	Met specified length	Conformed to requirements
	Distal End Flexibility (Distal 5cm)	Met specified flexibility requirements	Conformed to requirements
	Proximal End Stiffness	Met specified stiffness requirements	Conformed to requirements
	Proximal Shaft Kink	Resisted kinking under defined conditions	Conformed to requirements
	Distal Shaft Kink	Resisted kinking under defined conditions	Conformed to requirements
	Effective Length	Met specified effective length	Conformed to requirements
	Tip OD	Met specified dimensions	Conformed to requirements
	Steam Shaping Mandrel Compatibility	Compatible with steam shaping mandrels	Achieved compatibility
	Shapability	Maintained desired shape after manipulation	Conformed to requirements
	Infusion Stability	Maintained stable infusion characteristics	Conformed to requirements
	Marker Band Location/Tip Length	Met specified location and length	Conformed to requirements
	Microcatheter to Microspheres Compatibility	Compatible with microspheres up to 700 microns	Achieved compatibility
	Microcatheter to PVA particle Compatibility	Compatible with PVA particles	Achieved compatibility
	Microcatheter to Gelfoam Compatibility	Compatible with Gelfoam	Achieved compatibility
	Microcatheter to 0.018 Embolic Coil Compatibility	Compatible with 0.018" embolic coils	Achieved compatibility
	Dead Space Volume	Met specified volume	Conformed to requirements
	Max Infusion Pressure (Dynamic Burst)	Withstood specified dynamic burst pressure	Conformed to requirements
	Static Burst	Withstood specified static burst pressure	Conformed to requirements
	Chemical Compatibility	Compatible with specified diagnostic/embolic/therapeutic agents	Achieved compatibility
	Flow Rate	Met specified flow rate performance	Conformed to requirements
	Marker Band Tensile	Maintained integrity under specified tensile forces	Conformed to requirements
	Full Catheter Tensile	Maintained integrity under specified tensile forces	Conformed to requirements
	Tip Tensile	Maintained integrity under specified tensile forces	Conformed to requirements
	Tip Shape	Met specified tip shapes (straight or bern)	Conformed to requirements
	Particulate Matter	Met acceptable particle limits	Met acceptable limits
	Corrosion Resistance	Exhibited resistance to corrosion in simulated physiological environment	Conformed to requirements

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for each individual test. It mentions "bench testing and biocompatibility testing were performed," implying that appropriate sample sizes were used for each test according to relevant standards (e.g., ISO, ASTM, or internal test protocols).
Data Provenance: This was a non-clinical study (bench and biocompatibility testing). Therefore, there is no "country of origin of the data" in the sense of patient data. The tests were conducted in a lab setting, presumably by Boston Scientific or a contracted lab. The data is prospective in the sense that the tests were specifically conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

N/A. This was a non-clinical (bench) study, not a clinical study involving experts establishing ground truth from patient data. The "ground truth" for these tests would be the established scientific and engineering principles, material specifications, and regulatory standards (e.g., ISO 10993 series) against which the device's performance was measured.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers or observers. This document describes non-clinical testing where objective measurements and observations are made against predetermined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This document focuses solely on non-clinical (bench) testing and biocompatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a physical medical device (microcatheter), not a software algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For the biocompatibility tests, the ground truth is based on the requirements and methodologies outlined in the ISO 10993 series of standards. For the in-vitro performance tests, the ground truth would be the engineering specifications, design requirements, and relevant industry standards for microcatheters, ensuring the device performs as intended for its specified uses. It's essentially "conformance to specifications."

8. The Sample Size for the Training Set

N/A. This is not a study involving machine learning or AI where a "training set" would be used. The document describes a physical medical device submission based on non-clinical testing.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no training set for an AI/ML algorithm involved, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 ( Select one or both, as applicable )
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X Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Sub

|_ | 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: 011-353-21-4531341/011-353-86-1009795 Fax: 011-353-21-4343354 e-mail: Aoife.Tobin@bsci.com

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 orUsual Name	ClassificationNumber	ClassificationName	ProductCode	ProductCode Name	RegulatoryClass
Microcatheter	21 CFR Part870.1210	ContinuousFlushCatheter	KRA	ContinuousFlushCatheter	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

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 / MaterialChanges	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.

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).