The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Device Description

The TriSalus® TriNav® LV Infusion System is a 0.025" lumen microcatheter, a self-expanding tip at the distal end. The TriNav® LV serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires with outer diameter up to 0.018" (0.46 mm), guiding catheters with inner diameter at least 0.048" (1.22 mm), embolic hydrogel particles 500 um or less in size and glass microspheres 110 um or less in size. The TriNav® LV has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels 3.0 mm to 5.0 mm in diameter. An optional, commercially available hemostasis valve (HV) is included. There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

AI/ML Overview

The TriSalus® TriNav® LV Infusion System is explicitly stated as not having undergone clinical testing to demonstrate substantial equivalence. Instead, the submission relies on animal and bench performance test data. Therefore, the request for details on acceptance criteria and study proving the device meets them in the context of human clinical performance cannot be fully answered from the provided text.

However, based on the provided text, we can describe the performance testing conducted and the general acceptance criteria used:

The document states that the TriSalus® TriNav® LV Infusion System meets the same performance specifications and acceptance criteria as the predicate device. This implies that the acceptance criteria are tied to demonstrating equivalence or non-inferiority to the predicate device across various performance aspects.

Here's an attempt to extract relevant information based on the provided text, focusing on the type of studies conducted and what constitutes "performance" in this context for the device's clearance:

Device Performance Study (Bench and Animal Testing for Substantial Equivalence)

The performance of the TriSalus® TriNav® LV Infusion System was demonstrated through a series of bench testing and an animal study to show substantial equivalence to a predicate device (Surefire Spark Infusion System (rebranded as TriNav) K180677).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "meets the same performance specifications" and "acceptable/comparable" to the predicate device.
Since this document is a 510(k) summary, specific numerical acceptance thresholds and detailed performance results are not typically disclosed. However, the categories of performance evaluated are provided.

Acceptance Criteria (Inferred)	Reported Device Performance (Summary from Text)
Visual and Dimensional	Meets specifications; comparable to predicate.
Tensile (Pull) Strengths	Meets specifications; comparable to predicate.
Kink Radius	Meets specifications; comparable to predicate.
Torque Resistance	Meets specifications; comparable to predicate.
Burst Pressure	Meets specifications; comparable to predicate.
Hub Aspiration	Meets specifications; comparable to predicate.
Hub Solvent Compatibility	Meets specifications; comparable to predicate.
Coating Durability and Uniformity	Meets specifications; comparable to predicate.
EtO Residuals	Meets specifications; comparable to predicate.
Coating Frictional Force	Meets specifications; comparable to predicate.
Base Catheter Insertion/Retraction Force	Meets specifications; comparable to predicate.
Diagnostic Agent Compatibility	Meets specifications; comparable to predicate.
Embolic Agent Compatibility	Meets specifications; comparable to predicate.
Infusion Efficiency	Meets specifications; comparable to predicate.
Antegrade Flow	Meets specifications; comparable to predicate.
Particulates	Meets specifications; comparable to predicate.
Pouch Integrity	Meets specifications; comparable to predicate.
Pouch Seal Strength	Meets specifications; comparable to predicate.
Biocompatibility (various tests per ISO 10993)	No significant biological reaction; acceptable through GLP testing.
Acute performance in simulated clinical environment (Animal Study)	Acceptable in all evaluated categories, met defined user needs, performed comparably to predicate.

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

Test Set (Bench Testing): Not specified.
Test Set (Animal Study): Not specified. The text only states "An animal study was performed."
Data Provenance: Not specified, but generally, bench testing would be conducted in a lab and animal studies in a vivarium. The studies are prospective in nature for device validation.

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

Bench Testing: Not applicable in the context of human expert ground truth.
Animal Study: The study assessed performance "as defined by physicians in a simulated clinical environment." The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

Not specified. This is less relevant for bench and animal studies compared to human reader studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was NOT done. The document explicitly states: "No clinical testing was required to demonstrate the substantial equivalence of the subject device to its predicates. Therefore, no pre-market clinical testing was performed nor is any included within this 510(k) submission."

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

Not applicable as this is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

Bench Testing: Engineering specifications, material standards, and comparisons against predicate device performance data (presumably internal data or published specifications for the predicate).
Animal Study: Direct observation by "physicians" in a "simulated clinical environment" and relevant biological/physiological measurements. The "ground truth" for success was defined by "defined user needs" and "comparability to the predicate device."

8. The Sample Size for the Training Set

Not applicable as this is a physical medical device, not a machine learning model.

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

Not applicable.

Summary

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May 2, 2023

TriSalus Life Sciences % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K230957

Trade/Device Name: TriSalus TriNav® LV Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA. DOO Dated: April 4, 2023 Received: April 4, 2023

Dear Prithul Bom:

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

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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 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 W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.05.02
13:52:07 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230957

Device Name TriSalus TriNav® LV Infusion System

Indications for Use (Describe)

The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures.

It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

(DATE PREPARED: 01 FEBRUARY 2023

Device Name

TriSalus TriNav® LV Infusion System

Manufacturer Name and Address

TriSalus Life Sciences, Inc. 6272 W. 918t Avenue Westminster, CO 80031 Owner Operator Number: 10038066

Submitter Contact Information

TriSalus Life Sciences, Inc. 6272 W. 91st Avenue Westminster, CO 80031 Michael Aymami, Sr. Director of Regulatory Affairs Contact: 303-243-4969 Fax: 303-426-1223 Phone:

Common, Classification & Proprietary Names

Common Name:	Catheter, Continuous Flush
Classification Name:	Catheter, Continuous Flush
Proprietary Name:	TriSalus® TriNav® LV Infusion System
Classification:	Class II
Classification Panel:	Cardiovascular Devices/Coronary and Peripheral Interventional Devices
Classification Regulation:	21 CFR 870.1210
Primary Product Code:	KRA (Primary)
Secondary Product Code:	DQO (Secondary)

Predicate Device

Surefire Spark Infusion System (rebranded as TriNav)	K180677
Reference Device
Surefire Infusion System	K160662

Device Description

There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels.

510(k) Summary Page 1 of 4

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The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

The TriSalus® TriNav® LV Infusion System will be available in the following sizes:

Inner Diameter	Length	Tip / Vessel Size
0.025 inch	120 cm	3.0 - 5.0 mm
0.025 inch	150 cm	3.0 - 5.0 mm

Indications for Use

The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Substantial Equivalence

The TriSalus® TriNav® LV Infusion System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate device. Where the proposed device has been scaled to accommodate the larger vessel sizes for which it is recommended the proposed device sizing is equivalent to the reference device.

Comparative Summary: Design / Technological Characteristics

The TriSalus® TriNav® LV Infusion System is similar in design to the predicate device. Both devices are microcatheters with an expandable tip on the distal end. Both the proposed TriSalus® TriNav® LV Infusion System and the predicate Surefire Spark Infusion system (rebranded as TriNav) leverage a single-lumen microcatheter design. Both devices employ a self-expanding tip. Both the proposed and predicate devices use an introducer to collapse the tip so that it can be introduced into the guide catheter.

The TriSalus® TriNav® LV Infusion System and the predicate device are constructed of similar materials utilizing similar construction and manufacturing processes.

The TriSalus® TriNav® LV Infusion System and the predicate device have equivalent lengths while the proposed device has a larger diameter to accommodate selective therapy delivery to larger vessel sizes.

The TriSalus® TriNav® LV Infusion System and the predicate device are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.

Comparative Summary: Indications for Use

The TriSalus® TriNav® LV Infusion System has the same indications for use as the predicate device. Both devices are intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Comparative Summary: Performance

Animal and bench performance test data demonstrate that The TriSalus® TriNav® LV Infusion System performance is comparable to the predicate device.

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Biocompatibility Testing

Biocompatibility testing of the patient-contact materials used in the construction of the catheter was performed in accordance with ISO 10993-1 for an external communicating device in contact with circulating blood with a limited duration of less than 24 hours. The following testing was conducted in accordance with GLP by NAMSA (Northwood, OH).

Category	Standard	Test Method
Cytotoxicity	ISO 10993-5	Cytotoxicity Study Using the ISO Elution Method - 1x MinimalEssential Media Extract
Sensitization	ISO 10993-10	ISO Maximization Sensitization Study - Extract - 0.9% SodiumChloride Solution Extract
		ISO Maximization Sensitization Study - Extract - Sesame Oil, NFExtract
Irritation orIntracutaneousReactivity	ISO 10993-10	ISO Intracutaneous Study - Extract - 0.9% Sodium Chloride SolutionExtract
		ISO Intracutaneous Study - Extract - Sesame Oil, NF Extract
Systemic Toxicity	ISO 10993-11	ISO Systemic Toxicity Study - Extract - 0.9% Sodium ChlorideSolution Extract
		ISO Systemic Toxicity Study - Extract - Sesame Oil, NF Extract
		Pyrogen - Material Mediated - 0.9% Sodium Chloride SolutionExtract
Hemocompatibility	ISO 10993-4	ASTM Hemolysis - CMF-PBS Extract
		C3a Complement Assay - Normal Human Serum Extract
		SC5b-9 Complement Assay - Normal Human Serum Extract
		Coagulation - ASTM Partial Thromboplastin Time

Additionally, testing for thrombogenicity was performed on the TriSalus® TriNav® LV Infusion System as a part of an Animal Study.

The results of the biocompatibility testing did not indicate any significant biological reaction that would affect the patient due to contact with the materials used in the device construction.

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Performance Testing

The following design verification / validation tests were performed. The test results demonstrate that the TriSalus® TriNav® LV Infusion System meets the same performance specifications and acceptance criteria as the predicate device.

I Visual and Dimensional
I Tensile (Pull) Strengths
. Kink Radius
l Torque Resistance
l Burst Pressure
트 Hub Aspiration
l Hub Solvent Compatibility
I Coating Durability and Uniformity
I EtO Residuals
I Coating Frictional Force
I Base Catheter Insertion/Retraction Force
l Diagnostic Agent Compatibility
Embolic Agent Compatibility
I Infusion Efficiency
I Antegrade Flow
l Particulates
Pouch Integrity
Pouch Seal Strength

Animal Testing

An animal study was performed to assess the comparative acute performance of the TriSalus® TriNav® LV Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The TriSalus® TriNav® LV Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.

Clinical Testing

No clinical testing was required to demonstrate the substantial equivalence of the subject device to its predicates. Therefore, no pre-market clinical testing was performed nor is any included within this 510(k) submission.

Conclusion

In summary, The TriSalus® TriNav® LV Infusion System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate device. Animal and bench performance test data demonstrate The TriNav® LV Infusion System has substantially equivalent safety, effectiveness, and performance outcomes as the predicate device. Differences between the devices do not raise different 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).