(22 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guiding catheter, with no mention of AI or ML capabilities.
No
The device is a guiding catheter designed to provide a pathway for other therapeutic devices, not to deliver therapy itself.
No
The device is a guiding catheter designed to provide a pathway for therapeutic devices, not to diagnose a condition.
No
The device description clearly details a physical catheter with multiple layers, a Luer-Lock hub, and a radiopacifier, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TriSalus TriGuide Guiding Catheter is a device used within the body (in the peripheral vascular system) to facilitate the introduction of other therapeutic devices. It is a tool for accessing and navigating the vascular system, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for providing a pathway for therapeutic devices within the peripheral vascular system. This is an in-vivo (within the living body) application, not in-vitro (in glass/outside the body).
The description and intended use clearly indicate this is an invasive medical device used for procedural guidance, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The TriSalus TriGuide Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The TriSalus TriGuide is intended to be used in the peripheral vascular system.
Product codes
DQY
Device Description
The TriSalus TriGuideTM Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. Its principle of operation is therefore to provide a patent pathway for compatible accessories as described within its labeling.
TriSalus TriGuideTM Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The TriSalus TriGuide Catheter has a three-layer construction, consisting of a PTFE inner liner, stainless steel braid mid-layer, and an extruded Pebax polymer outer shaft jacket. The Pebax extruded polymer is filled with barium suffate (BaSO4) as a radiopacifier, to provide visibility of the TriSalus TriGuideTM Guiding Catheter under fluoroscopy.
The TriSalus TriGuideTM Guiding Catheter are 65 cm in length in three pre-shaped tip designs including Axis, Sim 1, and Cobra to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic vessel tracking.
The TriSalus TriGuideTM Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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
Bench testing and animal testing.
Simulated clinical use testing conducted in a porcine model further demonstrated that the TriSaideTM Guiding Catheter has equivalent performance to the predicate device.
The TriSalus TriGuideTM Guiding Catheter has been demonstrated to have equivalent to the predicate device with respect pull strenstance, torque resistance, burst pressure, hub aspiration, shape retention, pouch integrity, and pouch seal strength.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
December 27, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
TriSalus Life Sciences % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114
Re: K233858
Trade/Device Name: TriSalus TriGuide™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 5, 2023 Received: December 5, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Samuel G. Raben -S
for Lydia Glaw 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
2
Indications for Use
510(k) Number (if known) K233858
Device Name TriSalus TriGuide Guiding Catheter
Indications for Use (Describe)
The TriSalus TriGuide Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The TriSalus TriGuide is intended to be used 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) #: | K233858 | 510(k) Summary | Prepared on: 2023-11-22 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | TriSalus Life Sciences | |
| Applicant Address | 6272 W. 91st Ave Westminster Co 80 United States | |
| Applicant Contact Telephone | 3032434969 | |
| Applicant Contact | Mr. Michael Aymami | |
| Applicant Contact Email | michael.aymami@trisaluslifesci.com |
| Device Name | 21 CFR 807.92(a)(2) | |
|---|---|---|
| Device Trade Name | TriSalus TriGuideTM Guiding Catheter (TGC-48065-Axis TGC-48065-Sim1 TGC-48065-Cobra) | |
| Common Name | Percutaneous catheter | |
| Classification Name | Percutaneous Catheter | |
| Regulation Number | 870.1250 | |
| Product Code | DQY |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K140034 | Surefire Guiding Catheter | DQY |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
|---|---|---|
| ---------------------------- | -- | --------------------- |
The TriSalus TriGuideTM Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. Its principle of operation is therefore to provide a patent pathway for compatible accessories as described within its labeling.
TriSalus TriGuideTM Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The TriSalus TriGuide Catheter has a three-layer construction, consisting of a PTFE inner liner, stainless steel braid mid-layer, and an extruded Pebax polymer outer shaft jacket. The Pebax extruded polymer is filled with barium suffate (BaSO4) as a radiopacifier, to provide visibility of the TriSalus TriGuideTM Guiding Catheter under fluoroscopy.
The TriSalus TriGuideTM Guiding Catheter are 65 cm in length in three pre-shaped tip designs including Axis, Sim 1, and Cobra to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic vessel tracking.
| Product Code | Tip | Overall Length | Usable Length | Tip Length | ID | OD |
|---|---|---|---|---|---|---|
| TGC-48065-AXIS | Axis | 75cm | 67cm | 4cm | 0.048" | 5F |
| TGC-48065-SIM1 | Sim1 | 75cm | 67cm | 6cm | 0.048" | 5F |
| TGC-48065-COBRA | Cobra | 75cm | 67cm | 7cm | 0.048" | 5F |
The TriSalus TriGuideTM Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.
4
Device Materials (All device shape variants) Outer Jackets (Direct Contact) = Pebax 4033 SA01 MED, Pebax 6333 SA01 MED, Pebax 7233 SA01 MED Braid (Indirect Contact) = 304 Stainless Steel Braid Cover (Indirect Contact) = Polyethylene terephthalate (PET) Liner (Direct Contact) = PTFE, Bismuth Trioxide, Black 26, Titanium Dioxide,