(25 days)
No
The device description and performance studies focus on the mechanical and physical properties of the catheter system, with no mention of AI or ML capabilities.
No
The device is a microcatheter system designed to deliver diagnostic and therapeutic agents, not a therapeutic agent itself. Its function is to facilitate the delivery, rather than provide therapy directly.
No
This device is designed to deliver radiopaque media (for imaging, which is diagnostic in purpose) and therapeutic agents. While it facilitates diagnostic procedures by delivering contrast, its primary function is delivery, not image acquisition, processing, or interpretation. It is a delivery system, not a diagnostic instrument itself. The mention of attaching a pressure transducer for pressure measurement is an add-on capability, not the core function of the device itself.
No
The device description clearly outlines physical components like a microcatheter, expandable tip, PTFE inner liner, radiopaque markers, and a thumb-slide, indicating it is a hardware device.
Based on the provided information, the TriSalus Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system" during "angiographic procedures." This describes a device used within the body for direct delivery of substances, not for testing samples outside the body.
- Device Description: The description details a catheter system designed for insertion into blood vessels. This is consistent with an interventional device used in vivo, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TriSalus Infusion System's function is to deliver substances into the body, which is the opposite of how an IVD operates.
N/A
Intended Use / Indications for Use
The TriSalus Infusion System is intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
Product codes
KRA, DQO
Device Description
The TriSalus Infusion System is a 0.021" lumen coaxial microcatheter with the Expandable Tip at the distal end. The TriSalus Infusion System serves as the conduit for physician-specified agents. The device has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The Expandable Tip and distal section (100 cm) of the microcatheter are hydrophilically coated. The soft, pliable, Expandable Tip is sized for use in vessels of 2 mm to 6 mm.
There are four radiopaque markers located at the distal end of the TriSalus Infusion System to aid in positioning of Expandable Tip. The Expandable Tip can be expanded or collapsed up to 5 times for repositioning during an interventional procedure by moving the thumb-slide back and forth. When expanded, the Expandable Tip is designed to improve infusion efficiency of diagnostic and therapeutic agents.
A commercially-available pressure transducer may be attached to the sideport luer connector if pressure measurement during infusion is desired.
The system is provided sterile (EO) and for single patient use. The TriSalus Infusion System will be available in the following size:
Inner Diameter: 0.021 inch
Length: 120 cm
Tip / Vessel Size: 2.0 - 6.0 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
Not Found
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)
Biocompatibility Testing: Biocompatibility testing was conducted on the Surefire High Flow Microcatheter (K121677) and Surefire Precision Infusion System (K171355), which are constructed of identical materials to the TriSalus Infusion System. Therefore, the biocompatibility test requirements for the TriSalus Infusion System were met by leveraging previously completed biocompatibility testing.
Performance Testing: Design verification testing was performed which demonstrated that the TriSalus Infusion System meets its specified performance requirements and is equivalent to the performance of the predicate device. Design verification testing performed included:
- Visual and Dimensional Inspections
- Tensile (Pull) Strengths
- Kink Radius
- Catheter/Handle Torque Resistance
- Burst Pressure
- Coating Frictional Force
- Base Catheter Insertion/Retraction Force
- Coating Durability and Uniformity
- Particulates
- Retrograde Infusion Efficiency
Animal Testing: An animal study was performed to assess the comparative acute performance of the TriSalus Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The TriSalus Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Surefire Precision Infusion System, K171355
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food & 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.
December 3, 2019
TriSalus Life Sciences % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K193107
Trade/Device Name: TriSalus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA, DQO Dated: November 7, 2019 Received: November 8, 2019
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.
1
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 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 (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
2
Indications for Use
510(k) Number (if known)
Device Name TriSalus Infusion System
Indications for Use (Describe)
The TriSalus Infusion System is intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 FOR K193107
(DATE PREPARED: JULY 31, 2019) (DATE UPDATED: NOVEMBER 19, 2019)
Device Name
TriSalus Infusion System
Manufacturer Name and Address
TriSalus Life Sciences 6272 W. 91st Avenue Westminster, CO 80031 Owner Operator Number: 10038066
Submitter Contact Information
TriSalus Life Sciences 6272 W. 91st Avenue Westminster, CO 80031 Joanne Rupprecht. Vice President of Regulatory Affairs and Quality Assurance Contact: 720-988-3564 Phone: Fax: 303-426-1223
Common, Classification & Proprietary Names
| Common Name: | catheter, continuous flush |
|---|---|
| Classification Name: | catheter, continuous flush |
| Proprietary Name: | TriSalus Infusion System |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices/Coronary and Peripheral Interventional Device |
| Classification Regulation: | 21 CFR 870.1210 |
| Primary Product Code: | KRA |
| Secondary Product Code: | DQO |
Primary Predicate Device
- Surefire Precision Infusion System ■ (also marketed as Surefire Infusion System)
Reference Predicate Devices
Device Description
The TriSalus Infusion System is a 0.021" lumen coaxial microcatheter with the Expandable Tip at the distal end. The TriSalus Infusion System serves as the conduit for physician-specified agents. The device has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The Expandable Tip and distal section (100 cm) of the microcatheter are hydrophilically coated. The soft, pliable, Expandable Tip is sized for use in vessels of 2 mm to 6 mm.
There are four radiopaque markers located at the distal end of the TriSalus Infusion System to aid in positioning of Expandable Tip. The Expandable Tip can be expanded or collapsed up to 5 times for repositioning during an interventional procedure by moving the thumb-slide back and forth. When expanded, the Expandable Tip is designed to improve infusion efficiency of diagnostic and therapeutic agents.
4
A commercially-available pressure transducer may be attached to the sideport luer connector if pressure measurement during infusion is desired.
The system is provided sterile (EO) and for single patient use. The TriSalus Infusion System will be available in the following size:
| Inner Diameter | Length | Tip / Vessel Size |
|---|---|---|
| 0.021 inch | 120 cm | 2.0 - 6.0 mm |
Indications for Use
The TriSalus Infusion System is intended for use in angiographic procedures to deliver radiopague media and therapeutic agents to selected sites in the peripheral vascular system.
Biocompatability Testing
Biocompatibility testing was conducted on the Surefire High Flow Microcatheter (K121677) and Surefire Precision Infusion System (K171355), which are constructed of identical materials to the TriSalus Infusion System. Therefore, the biocompatibility test requirements for the TriSalus Infusion System were met by leveraging previously completed biocompatibility testing.
Performance Testing
Design verification testing was performed which demonstrated that the TriSalus Infusion System meets its specified performance requirements and is equivalent to the performance of the predicate device. Design verification testing performed included:
- . Visual and Dimensional Inspections
- . Tensile (Pull) Strengths
- 트 Kink Radius
- . Catheter/Handle Torque Resistance
- 트 Burst Pressure
- l Coating Frictional Force
- Base Catheter Insertion/Retraction Force
- l Coating Durability and Uniformity
- l Particulates
- l Retrograde Infusion Efficiency
Animal Testing
An animal study was performed to assess the comparative acute performance of the TriSalus Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The TriSalus Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.
Substantial Equivalence
The TriSalus Infusion System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate.
Comparative Summary: Design / Technological Characteristics
- The TriSalus Infusion system and predicate device are coaxial microcatheters with an Expandable ● Tip at the distal end. Both infusion systems have an outer catheter to facilitate expanding and collapsing the Expandable Tip. Though the expandable tip designs of both the new and predicate devices are designed to improve infusion efficiency of diagnostic and therapeutic agents, the predicate device has a porous tip that is optimized to prevent reflux of embolic particles while allowing forward (antegrade) flow; whereas the TriSalus Infusion System has a nonporous tip that is optimized to prevent the reflux of liquid infusates and is designed to temporarily restrict antegrade flow.
5
- The TriSalus Infusion System and the predicate device are constructed of similar materials utilizing similar construction and manufacturing processes.
- . The TriSalus Infusion System and the predicate device are available in a similar range of sizes. The predicate device is available in inner diameters 0.021" to 0.025", lengths 120 cm to 150 cm, and tip/vessel size 1.5 mm to 6 mm. The TriSalus Infusion is available in inner diameter 0.021'', length 120 cm and tip/vessel size 2 mm to 6 mm.
- . The TriSalus Infusion System and predicate device are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.
Comparative Summary: Indications for Use
- The TriSalus 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 Infusion System ● performance is comparable to the predicate device.
In summary, the TriSalus 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 that the TriSalus Infusion System performance is comparable to the predicate device.