· 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 Description

The Symphony Thrombectomy System is comprised of several devices:
• 24F Symphony Catheter
• 24F Symphony Dilator
• 24F Symphony Advance™ Long Dilator
• 24F Symphony ProHelix™
• 16F Symphony Catheter
• 16F Symphony Dilator
• 16F Symphony ProHelix™
• TRUVIC Generator
• TRUVIC Canister
• TRUVIC Tubeset

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Truvic Medical Inc. Symphony Thrombectomy System. It outlines the device's intended use and compares it to a predicate device, the Penumbra INDIGO Aspiration System. The document also details the non-clinical and in-vivo testing performed to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:

Table of Acceptance Criteria and Reported Device Performance

The document generally states that "Non-clinical laboratory testing was performed on the Symphony Thrombectomy System to assure compliance with all pre-specified, clinically relevant acceptance criteria" and that "The in vitro bench tests demonstrated that the Symphony Thrombectomy System met all acceptance criteria." It also mentions for the in-vivo study that "All acceptance criteria passed." However, the specific, quantitative acceptance criteria themselves are not explicitly listed in the provided text. The document lists the types of tests performed, but not the pass/fail thresholds or the numerical results achieved by the device against those thresholds.

Test Type	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (General Statement in document)
Visual and Dimensional Verification	(e.g., within specified tolerances)	Met all acceptance criteria.
Kink / Bend Verification	(e.g., maintained lumen patency)	Met all acceptance criteria.
Actuation Force Verification	(e.g., within specified range)	Met all acceptance criteria.
Tensile and Torque Strength Verification	(e.g., no breakage, within strength limits)	Met all acceptance criteria.
Positive Pressure / Fluid Leak Verification	(e.g., no leaks at specified pressure)	Met all acceptance criteria.
Negative Pressure / Air Leak Verification	(e.g., no leaks at specified vacuum)	Met all acceptance criteria.
Lumen Integrity Verification	(e.g., no obstructions or damage)	Met all acceptance criteria.
Burst Pressure Verification	(e.g., withstands specified pressure)	Met all acceptance criteria.
Fluoroscopy Validation (Visibility test)	(e.g., clearly visible under fluoroscopy)	Met all acceptance criteria.
Simulated Use Performance Validation	(e.g., effectively removes thrombus in simulator)	Met all acceptance criteria.
Corrosion Resistance Testing	(e.g., no evidence of corrosion)	Met all acceptance criteria.
Coating Integrity Testing	(e.g., maintained integrity after use)	Met all acceptance criteria.
Acute Particulate Testing	(e.g., below specified particulate limits)	Met all acceptance criteria.
Drop Testing Verification	(e.g., maintains functionality after drops)	Met all acceptance criteria.
Component Fatigue Testing Verification	(e.g., withstood specified cycles without failure)	Met all acceptance criteria.
Biocompatibility (Cytotoxicity etc.)	(e.g., non-toxic, non-sensitizing, non-irritant)	Passed, no evidence of toxicity, sensitization, or irritation.
In-Vivo GLP Pre-Clinical Testing	(e.g., no complications, no vascular injuries, no thrombus formation)	All acceptance criteria passed. No new questions of safety or effectiveness. Treated vessels free from thrombus formation.

Sample sizes used for the test set and the data provenance
- The document does not specify the exact sample sizes (number of devices or tests) for each non-clinical in vitro test. It generally refers to "non-clinical laboratory testing."
- For the in-vivo GLP animal study, the sample size is also not explicitly stated in terms of the number of animals used.
- Data Provenance: The in vitro testing is described as "non-clinical laboratory testing." The in-vivo study is a "GLP animal study." The location or country of origin for these studies is not specified, but they are subject to GLP regulations (21 CFR Part 58), indicating a regulated environment. These are prospective studies designed to evaluate the new device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The testing described (bench tests, animal study) does not involve human expert interpretation in the way that, for example, an AI imaging device would requiring ground truth from radiologists. The "ground truth" for these engineering and biologic tests would be objective measurements and observations (e.g., lumen patency, force measurements, histological analysis in the animal study).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the described tests are objective laboratory and animal studies, not subjective assessments requiring human adjudication of findings.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. The Symphony Thrombectomy System is a medical device for thrombus removal, not an AI imaging or diagnostic algorithm that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. This is a physical medical device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical in vitro tests, the ground truth is established by objective engineering measurements and functional assessments against pre-defined specifications (e.g., force values, dimensions, leak rates, visual integrity).
- For the in-vivo GLP animal study, the ground truth includes direct observation of vascular injuries, thrombus formation, and other biological responses. This would likely involve macroscopic and potentially histopathological evaluations. The document explicitly states "no vascular injuries were observed" and "All treated vessels were free from thrombus formation."
The sample size for the training set
- This is not applicable. The Symphony Thrombectomy System is a physical medical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established
- This is not applicable as there is no training set for a physical medical device.

Summary

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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

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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

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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)

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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.1359 Dell AvenueCampbell, CA 95008, USA
Contact	Rey JacintoAssociate Director, Regulatory AffairsTel: (714) 357-8139e-mail: rjacinto@TRUVIC.com
Trade Name:	SymphonyTM Thrombectomy System
Device Classification:	Class 2 per 21 CFR §870.5150
Classification Name:	Peripheral Mechanical ThrombectomyWith Aspiration
Product Code	QEW (Primary), KRA
Predicate Device:	Penumbra Embolectomy AspirationSystem (INDIGO® Aspiration System);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.

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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™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.

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.

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	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: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.Not for use in the coronaries or the neurovasculature.
Product Code	QEW (Primary)KRA	QEW
RegulationName/Number	21 CFR 870.5150Embolectomy Catheters	21 CFR 870.5150Embolectomy Catheters
Prescription/ Over-the-Counter Use	Prescription Only	Prescription Only
Single Use Only	Yes	Yes
Catheter Design	Single-LumenIntravascular Catheter	Single-LumenIntravascular Catheter
CatheterDimensions(OD, Length)	16F, 121 cm24F, 85 cm	5F, 136 cm6F, 132 cm8F, 85/115 cm
Thrombus RemovalAssist Device	Over-the-Wire	Wire Based
PackagedAccessories	Dilator	RHVIntroducer Sheath
User Control	Symphony Catheter Handle(On/Off and Vent)	Indigo Aspiration Tubing Switch(On/Off)
Vacuum Source	Aspiration Pump	Aspiration Pump
RadiopaqueMarkers	Yes	Yes
Hydrophilic coating	Yes	Yes
Hydrophobiccoating	No	No
Sterilization Method	Ethylene Oxide (EO)	Ethylene Oxide (EO)
System Materials	Commonly used medical gradeplastics and metals	Commonly used medical gradeplastics and metals
Shelf Life	Symphony Catheters and Dilators:3 MonthsProHelix: 7 Months	36 Months

Table 1. Summary Comparison between the Symphony Thrombectomy System and the Indigo Aspiration System

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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.

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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.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).