Prodigy Thrombectomy System

K214114 · Truvic Medical, Inc. · QEW · Apr 6, 2022 · Cardiovascular

Device Facts

• Record ID: K214114
• Device Name: Prodigy Thrombectomy System
• Applicant: Truvic Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Apr 6, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prodigy™ Thrombectomy System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries, pulmonary vasculature, or the neurovasculature.

Device Story

System removes thrombus from peripheral vasculature via aspiration. Components include Prodigy™ Catheter, Prodigy™ Twist (wire-based device with soft polymeric tip), Prodigy™ Hotshot™ Controller, TRUVIC Generator, TRUVIC Canister, and TRUVIC Tubeset. Catheter targets aspiration from generator to thrombus; Twist facilitates removal. System used in clinical settings by physicians; radiopaque marker bands allow visualization under fluoroscopy. Hotshot™ Controller enables user to control aspiration flow and visualize extracted thrombus. Aspiration pump provides continuous suction. Device benefits patients by enabling mechanical removal of emboli/thrombi, restoring blood flow.

Clinical Evidence

No human clinical data. Evidence based on extensive non-clinical bench testing (visual/dimensional, mechanical integrity, simulated use, coating/particulate, fatigue) and a GLP-compliant animal study. Animal study assessed acute/chronic safety, performance, and in-vivo thrombogenicity; results showed no vascular injuries, no complications, and no thrombus formation in treated vessels, demonstrating equivalence to the predicate.

Technological Characteristics

Catheter system composed of medical-grade plastics and metals. Features include hydrophilic coating, radiopaque marker bands (90% Platinum, 10% Iridium), and multiple diameters (5F, 6F, 8F). Energy source: aspiration pump (TRUVIC Generator). Sterilization: Ethylene Oxide (EO). Connectivity: physical tubing/controller interface. No software algorithm described.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous systems. Contraindicated for use in coronary, pulmonary, or neurovasculature.

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)

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April 6, 2022

Truvic Medical Inc. % Semih Oktay President CardioMed Device Consultants, LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K214114

Trade/Device Name: Prodigy™ Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW Dated: March 7, 2022 Received: March 9, 2022

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

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

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# Indications for Use

510(k) Number (if known) K214114

Device Name Prodigy™ Thrombectomy System

Indications for Use (Describe)

The Prodigy™ Thrombectomy System is intended for the removal and thrombi and thrombi from vessels of the peripheral arterial and venous systems.

Not for use in the coronaries, pulmonary vasculature, or the neurovasculature

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

| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

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510(k) Summary [as required by 21 CFR 807.92(c)]

Image /page/3/Picture/2 description: The image shows the logo for TRUVIC, which includes a stylized image of an eagle in dark blue on the left. To the right of the eagle is the company name, TRUVIC, also in dark blue. Below the logo is the address "1359 Dell Avenue Campbell, CA 95008 USA".

# TRUVIC Prodigy™ Thrombectomy System

# 510(k) K214114

| DATE PREPARED: | 30 March 2022 |
|------------------------|--------------------------------------------------------------------------------------------|
| APPLICANT | Truvic Medical, Inc.<br>1359 Dell Avenue<br>Campbell, CA 95008 USA |
| CONTACT | Michael Buck<br>Chief Executive Officer<br>Tel: [phone]<br>e-mail: [e-mail] |
| TRADE NAME: | Prodigy™ Thrombectomy System |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.5150 |
| CLASSIFICATION NAME: | Catheter, Embolectomy |
| PRODUCT CODE | QEW |
| PREDICATE DEVICES: | Penumbra Embolectomy Aspiration System<br>(INDIGO™ Aspiration System)<br>K142870 |

## Intended Use / Indications for Use

The Prodigy™ Thrombectomy System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

Not for use in the coronaries, pulmonary vasculature, or the neurovasculature.

#### Device Description:

The Prodigy™ Thrombectomy System is designed to remove thrombus from the vasculature using aspiration. The Prodigy™ Thrombectomy System is comprised of several components including:

- . Prodigy™ Catheter
- . Prodigy™ Twist
- . Prodigy™ Hotshot™ Controller
- TRUVIC Generator
- TRUVIC Canister
- . TRUVIC Tubeset

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The single-lumen Prodigy™ Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The wire-based Prodigy™ Twist utilizes a soft, flexible polymeric tip to facilitate thrombus removal through the Prodigy™ Catheter as needed. The Prodigy™ Catheter is available in multiple diameters and both the Prodigy™ Catheter and Prodigy™ Twists are available in multiple effective lengths and are visible under fluoroscopy via radiopaque marker bands.

The Prodigy™ Hotshot™ Controller connects the Prodigy™ Catheter to the TRUVIC Generator and provides the user with the ability to control aspiration flow and visualize the extracted thrombus.

# Comparison with predicate device:

The subject device Prodigy™ Thrombectomy System and the predicate Penumbra INDIGO System have the same intended use, operating principle, design concept, materilization 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.

| | | Subject | Predicate |
|-----------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Name of Device | Prodigy™ Thrombectomy System | INDIGO Aspiration System |
| | Manufacturer | Truvic Medical, Inc. | Penumbra, Inc. |
| | 510(k) # | K214114 | K142870 |
| Indications for Use | | The Prodigy™ Thrombectomy System<br>is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. | 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. |
| | | Not for use in the coronaries, pulmonary vasculature, or the neurovasculature. | Not for use in the coronaries or the neurovasculature. |
| Catheter Shaft<br>Characteristics | Device Design | Intravascular catheter | Intravascular Embolectomy catheter |
| | Catheter Size(s) | 5F, 6F, 8F | 3F, 5F, 6F, 8F |
| | Useable Length(s) | 50cm, 90cm, 137cm, 160cm | 85cm, 115cm, 132cm, 135cm, 150cm |
| | Radiopaque Markers | 90%, Platinum, 10% Iridium | 90%, Platinum, 10% Iridium |
| | Hydrophilic coating | Yes | Yes |
| Hydrophobic coating | | No | No |
| Sterilization Method | | Ethylene Oxide (EO) | Ethylene Oxide (EO) |

Table 1. Summary of Comparison Between Subject and Predicate Device

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| | Subject | Predicate |
|------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| Thrombus Removal<br>Assist Device | Twist | Separator |
| Size / Length | 5F, 177cm<br>6F, 154cm<br>8F, 67cm<br>8F, 107cm | 3F, 190cm<br>5F, 175cm<br>6F, 175cm<br>8F, 150cm |
| User Control | Prodigy™ Hotshot™ Controller<br>On/Off and Vent | INDIGO Aspiration Tubing Valve<br>On/Off |
| User Control Patient<br>Contacting? | No | No |
| Material Comparison | | |
| Materials for<br>Catheter, Twist and<br>User Control | Commonly used medical grade<br>plastics and metals | Commonly used medical grade<br>plastics and metals |

## Non-Clinical testing / Performance Data:

Non-clinical laboratory testing was performed on the Prodigy™ 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 successfully performed:

- Visual and Dimensional Verification ●
- Twist Distal Tip Stiffness Verification
- Kink / Bend / Flex Verification
- Tensile / Bond Strength Verification ●
- Positive Pressure / Liquid Leak Verification
- Vacuum / Air Leak Verification
- Lumen Integrity Verification
- Torque Strength Verification
- Burst Pressure Verification
- Fluoroscopy Validation (Visibility test)
- Simulated Use Performance Validation
- Corrosion Resistance Testing
- . Coating Integrity Testing
- Acute Particulate Testing
- Drop Testing Verification
- Fatigue Testing Verification
- Component Actuation Force Testing Verification

The in vitro bench tests demonstrated that the Prodigy™ Thrombectomy System met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the Prodigy™ Thrombectomy System devices function as intended and has a safety and effectiveness profile that is similar to the predicate devices.

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### BIOCOMPATIBILITY:

Testing was performed to assess biocompatibility of the Prodigy™ Thrombectomy System patientcontacting components. The following tests were successfully performed:

- Cytotoxicity
- Sensitization
- . Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity ●
- Hemocompatibility
- Complement Activation
- In-Vivo Thrombogenicity (from GLP animal study)

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 Part58.

# 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 Prodigy™ Thrombectomy System as compared to the predicate. In-vivo thrombogenicity was also assessed.

There were no complications in Prodigy™ Thrombectomy System device preparation or performance and no vascular injuries were observed. All treated vere free from thrombus formation in both acute and chronic cohorts. All acceptance criteria passed. The Truvic Prodigy™ Thrombectomy System was deemed equivalently safe as compared to the predicate in all measured assessments.

## Conclusion:

The Truvic Prodigy™ Thrombectomy System has the 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 nonclinical and in-vivo pre-clinical tests demonstrate that the Prodigy™ Thrombectomy System is equivalently safe and effective in achieving its intended use as the predicate.

Therefore, the Truvic Prodigy™ Thrombectomy System is substantially equivalent to the predicate device.