Symphony Thrombectomy System
Device Facts
| Record ID | K223216 |
|---|---|
| Device Name | Symphony Thrombectomy System |
| Applicant | Truvic Medical, Inc. |
| Product Code | QEW · Cardiovascular |
| Decision Date | Feb 23, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Symphony Thrombectomy System is intended for: - The non-surgical removal of fresh, soft emboli and thrombi from blood vessels. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
Device Story
System removes thrombus/embolus from peripheral vasculature via controlled aspiration. Components include catheters (16F/24F), dilators, ProHelix assist device, generator, canister, and tubeset. Physician introduces catheter over guidewire to thrombus site under fluoroscopic guidance. ProHelix may be advanced through catheter; manual rotation of ProHelix handle facilitates thrombus removal. Generator provides vacuum source for aspiration. System used in clinical setting by physicians. Output is physical removal of thrombus; visualization provided by radiopaque markers under fluoroscopy. Benefits include non-surgical clot removal, restoring blood flow.
Clinical Evidence
Bench testing only and GLP animal study. Bench tests: visual/dimensional, kink/bend, tensile/torque, pressure/leak, lumen integrity, burst, fluoroscopy, simulated use, corrosion, coating, particulate, drop, and fatigue testing. GLP animal study: assessed acute/chronic safety, performance, and in-vivo thrombogenicity; no vascular injuries or complications observed; all vessels free from thrombus.
Technological Characteristics
System includes catheters, dilators, ProHelix, generator, canister, and tubeset. Materials: medical-grade plastics and metals. Catheters feature hydrophilic coating on distal shafts. Sensing/actuation: manual rotation of ProHelix tip; vacuum-based aspiration via generator. Connectivity: standalone system. Sterilization: Ethylene Oxide (EO).
Indications for Use
Indicated for non-surgical removal of fresh, soft emboli and thrombi from peripheral vasculature; injection, infusion, or aspiration of contrast media/fluids. Not for use in pulmonary vasculature.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Predicate Devices
- Penumbra Embolectomy Aspiration System (INDIGO® Aspiration System) (K142870)
Submission Summary (Full Text)
{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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
February 23, 2023
Truvic Medical Inc. % Semih Oktay President CardioMed Devices Consultants 1783 Forest Drive. Suite 254 Annapolis, Maryland 21401
Re: K223216
Trade/Device Name: Symphony Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: January 17, 2023 Received: January 17, 2023
Dear Semih Oktay:
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
{1}------------------------------------------------
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 (OS) 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,
Image /page/1/Picture/5 description: The image contains the name "Gregory W. O'connell -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Gregory W. O'connell -S" and "Date: 2023.02.23". The last line of text says "12:59:49 -05'00'".
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) K223216
Device Name Symphony Thrombectomy System
#### Indications for Use (Describe)
The Symphony Thrombectomy System is intended for:
- · The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
| 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary [as required by 21 CFR 807.87(h) and 21 CFR 807.92]
Image /page/3/Picture/3 description: The image shows the logo for TRUVIC. The logo consists of a stylized eagle with its wings spread, followed by the word "TRUVIC" in a bold, sans-serif font. Both the eagle and the text are in a dark blue color.
# 1359 Dell Avenue Campbell, CA 95008 USA
TRUVIC™ Symphony™ Thrombectomy System
#### 510(k) K223216
| Date Prepared: | 16 Feb 2023 |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| Applicant | TRUVIC Medical, Inc.<br>1359 Dell Avenue<br>Campbell, CA 95008, USA |
| Contact | Rey Jacinto<br>Associate Director, Regulatory Affairs<br>Tel: (714) 357-8139<br>e-mail: rjacinto@TRUVIC.com |
| Trade Name: | SymphonyTM Thrombectomy System |
| Device Classification: | Class 2 per 21 CFR §870.5150 |
| Classification Name: | Peripheral Mechanical Thrombectomy<br>With Aspiration |
| Product Code | QEW (Primary), KRA |
| Predicate Device: | Penumbra Embolectomy Aspiration<br>System (INDIGO® Aspiration System);<br>K142870 |
#### Intended Use / Indications for Use:
The TRUVIC Medical, Inc. (TRUVIC) Symphony Thrombectomy System is intended for:
- The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.
- . Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.
{4}------------------------------------------------
# Device Description:
The Symphony Thrombectomy System is comprised of several devices:
| • 24F Symphony Catheter | • 16F Symphony Catheter | • TRUVIC Generator |
|-----------------------------------------|--------------------------|--------------------|
| • 24F Symphony Dilator | • 16F Symphony Dilator | • TRUVIC Canister |
| • 24F Symphony Advance™<br>Long Dilator | • 16F Symphony ProHelix™ | • TRUVIC Tubeset |
- 24F Symphony ProHelix™
The Symphony Thrombectomy System is designed to remove thrombus/embolus (also referred to as 'thrombus' or 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the Symphony Catheter.
The Symphony Catheter has a lubricious hydrophilic coating on the distal 40 cm of the 24F catheter shaft, and distal 55 cm of the 16F catheter shaft. The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus. The Symphony Catheter is used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus.
As needed, the Symphony ProHelix may be introduced through the Symphony Catheter to assist with thrombus removal. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.
# Comparison with predicate device:
The subject device Symphony Thrombectomy System and the predicate Penumbra INDIGO System have the same intended use, operating principle, design concept, and sterilization processes. Both the subject and predicate systems utilize a catheter and wire-based device to facilitate thrombus removal, and both employ a continuous aspiration pump in this extraction function.
{5}------------------------------------------------
| | Subject Device | Predicate Device |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Device | Symphony Thrombectomy System | INDIGO Aspiration System |
| Manufacturer | TRUVIC Medical, Inc. | Penumbra, Inc. |
| 510(k) # | K223216 | K142870 |
| Indications for Use | The Symphony Thrombectomy System is intended for:<br>The non-surgical removal of fresh, soft emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature. | The Penumbra Embolectomy Aspiration System (INDIGO® Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.<br>Not for use in the coronaries or the neurovasculature. |
| Product Code | QEW (Primary)<br>KRA | QEW |
| Regulation<br>Name/Number | 21 CFR 870.5150<br>Embolectomy Catheters | 21 CFR 870.5150<br>Embolectomy Catheters |
| Prescription/ Over-<br>the-Counter Use | Prescription Only | Prescription Only |
| Single Use Only | Yes | Yes |
| Catheter Design | Single-Lumen<br>Intravascular Catheter | Single-Lumen<br>Intravascular Catheter |
| Catheter<br>Dimensions<br>(OD, Length) | 16F, 121 cm<br>24F, 85 cm | 5F, 136 cm<br>6F, 132 cm<br>8F, 85/115 cm |
| Thrombus Removal<br>Assist Device | Over-the-Wire | Wire Based |
| Packaged<br>Accessories | Dilator | RHV<br>Introducer Sheath |
| User Control | Symphony Catheter Handle<br>(On/Off and Vent) | Indigo Aspiration Tubing Switch<br>(On/Off) |
| Vacuum Source | Aspiration Pump | Aspiration Pump |
| Radiopaque<br>Markers | Yes | Yes |
| Hydrophilic coating | Yes | Yes |
| Hydrophobic<br>coating | No | No |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| System Materials | Commonly used medical grade<br>plastics and metals | Commonly used medical grade<br>plastics and metals |
| Shelf Life | Symphony Catheters and Dilators:<br>3 Months<br>ProHelix: 7 Months | 36 Months |
Table 1. Summary Comparison between the Symphony Thrombectomy System and the Indigo Aspiration System
{6}------------------------------------------------
## Non-Clinical Testing / Performance Data:
Non-clinical laboratory testing was performed on the Symphony Thrombectomy System to assure compliance with all pre-specified, clinically relevant acceptance criteria and to determine substantial equivalence as it relates to the intended use. The following testing/assessments were performed:
- Visual and Dimensional Verification ●
- Kink / Bend Verification ●
- Actuation Force Verification ●
- Tensile and Torque Strength Verification ●
- Positive Pressure / Fluid Leak Verification
- Negative Pressure / Air Leak Verification ●
- Lumen Integrity Verification
- Burst Pressure Verification
- Fluoroscopy Validation (Visibility test)
- Simulated Use Performance Validation ●
- Corrosion Resistance Testing
- Coating Integrity Testing ●
- Acute Particulate Testing
- Drop Testing Verification
- . Component Fatigue Testing Verification
The in vitro bench tests demonstrated that the Symphony Thrombectomy System met all acceptance criteria. Performance data demonstrate that the Symphony Thrombectomy System functions as intended and is substantially equivalent to the predicate device.
{7}------------------------------------------------
# Biocompatibility:
Testing was performed to assess biocompatibility of the Symphony Thrombectomy System patient-contacting components. The following tests were successfully performed:
- Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Hemocompatibility
- Direct and Indirect Hemolysis
- Sc5b-9 Complement Activation o
- In-Vivo Thrombogenicity (from GLP animal study) o
Adherence to the test methodologies and standards was maintained in all biocompatibility testing described. Each of the biocompatibility tests defined above passed. There was no evidence of toxicity, sensitization, or irritation. Testing found samples to be non-hemolytic, non-activator, and non-pyrogenic. All testing was conducted in compliance with GLP regulations, 21 CFR Part 58.
#### In-Vivo GLP Pre-Clinical Testing / Performance Data:
A GLP animal study was performed to assess the acute and chronic safety and performance of the Symphony Thrombectomy System. In-vivo thrombogenicity was also assessed.
There were no complications in Symphony Thrombectomy System device preparation or performance and no vascular injuries were observed. All treated vessels were free from thrombus formation in both acute and chronic cohorts. All acceptance criteria passed. The GLP animal study did not identify any new questions of safety or effectiveness for the TRUVIC Symphony Thrombectomy System in all measured assessments, and supports substantial equivalence to the predicate device.
## Conclusion:
The TRUVIC Symphony Thrombectomy System has the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, and operating principles as the predicate device. Performance data demonstrates that the device functions as intended. The non-clinical and in-vivo pre-clinical tests demonstrate that the Symphony Thrombectomy System is substantially equivalent to the predicate device.
