(28 days)
No
The description focuses on the mechanical and material properties of a microcatheter and its function in delivering agents, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section states that the device is intended to deliver "therapeutic agents." This indicates its role in treating conditions, thus qualifying it as a therapeutic device.
No
The device is an infusion system designed to deliver agents to the peripheral vascular system during angiographic procedures, not to diagnose conditions.
No
The device description clearly details a physical microcatheter with a self-expanding tip, radiopaque markers, and a PTFE inner liner. This is a hardware device, not software only.
Based on the provided information, the TriSalus TriNav® LV Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for delivering radiopaque media and therapeutic agents to selected sites in the peripheral vascular system during angiographic procedures. This is an in vivo (within the living body) application, not an in vitro (outside the living body) diagnostic test.
- Device Description: The device is a microcatheter designed for physical delivery of substances within the body. It does not perform any tests on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
Therefore, the TriSalus TriNav® LV Infusion System is a medical device used for therapeutic and imaging purposes within the body, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KRA, DQO
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.
The TriSalus® TriNav® LV Infusion System will be available in the following sizes:
Inner Diameter: 0.025 inch, Length: 120 cm, Tip / Vessel Size: 3.0 - 5.0 mm
Inner Diameter: 0.025 inch, Length: 150 cm, Tip / Vessel Size: 3.0 - 5.0 mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Bench 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.
Visual and Dimensional
Tensile (Pull) Strengths
Kink Radius
Torque Resistance
Burst Pressure
Hub Aspiration
Hub Solvent Compatibility
Coating Durability and Uniformity
EtO Residuals
Coating Frictional Force
Base Catheter Insertion/Retraction Force
Diagnostic Agent Compatibility
Embolic Agent Compatibility
Infusion Efficiency
Antegrade Flow
Particulates
Pouch Integrity
Pouch Seal Strength
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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" followed by the words "U.S. Food & Drug Administration".
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
1
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
2
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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3
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
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.
510(k) Summary Page 1 of 4
4
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.
5
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 Minimal |
| Essential Media Extract | ||
| Sensitization | ISO 10993-10 | ISO Maximization Sensitization Study - Extract - 0.9% Sodium |
| Chloride Solution Extract | ||
| ISO Maximization Sensitization Study - Extract - Sesame Oil, NF | ||
| Extract | ||
| Irritation or | ||
| Intracutaneous | ||
| Reactivity | ISO 10993-10 | ISO Intracutaneous Study - Extract - 0.9% Sodium Chloride Solution |
| Extract | ||
| ISO Intracutaneous Study - Extract - Sesame Oil, NF Extract | ||
| Systemic Toxicity | ISO 10993-11 | ISO Systemic Toxicity Study - Extract - 0.9% Sodium Chloride |
| Solution Extract | ||
| ISO Systemic Toxicity Study - Extract - Sesame Oil, NF Extract | ||
| Pyrogen - Material Mediated - 0.9% Sodium Chloride Solution | ||
| Extract | ||
| 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.
6
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.