Versus™ Catheter (VS110-8B)

K241851 · Liquet Medical, Inc. · QEY · Nov 25, 2024 · Cardiovascular

Device Facts

• Record ID: K241851
• Device Name: Versus™ Catheter (VS110-8B)
• Applicant: Liquet Medical, Inc.
• Product Code: QEY · Cardiovascular
• Decision Date: Nov 25, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Versus™ Catheter is indicated for: The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients. The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

Device Story

Versus™ Catheter is a dual-tip infusion catheter for pulmonary artery access. Device features two lumens for delivering physician-specified fluids (e.g., thrombolytics) to each lung via a single access site; secondary tip telescopes for contralateral lung infusion. Optional distal flow-directed balloon facilitates placement. Pressure monitoring is achieved by connecting a proximal luer to an external, FDA-cleared pressure transducer and IBP-compatible monitor. Used in hospital/healthcare facilities by clinicians; advanced over a guidewire using standard endovascular techniques. Output provides localized fluid delivery and real-time hemodynamic pressure data to assist clinical decision-making in pulmonary artery management.

Clinical Evidence

No human clinical trials. Evidence includes bench testing (kink radius, trackability, infusion uniformity, pressure measurement, balloon integrity, tensile strength), biocompatibility testing (ISO 10993), human factors usability testing (IEC 62366-1), and a GLP porcine animal study comparing the device to the primary predicate, which met all success criteria.

Technological Characteristics

Dual-tip infusion catheter, 8 French outer diameter, 100-107 cm working length. Materials evaluated per ISO 10993. Sensing principle: fluid-filled lumen interface to external pressure transducer. No internal energy source. Radiopaque marker bands at distal/proximal ends and bifurcation. Sterilization: EtO (ISO 11135:2014). Single-use.

Indications for Use

Indicated for adult patients requiring controlled, selective infusion of physician-specified fluids (including thrombolytics) into the pulmonary artery vasculature and hemodynamic assessment via direct intracardiac and pulmonary artery pressure monitoring.

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

• Bashir N-X Endovascular Catheter (K183290)
• Swan Ganz Catheters (K160084)

Submission Summary (Full Text)

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November 25, 2024

Liquet Medical Inc. Carrie Kuehn Regulatory Affairs Consultant Evergreen Strategic Consulting 108 N Rolling RD Catonsville, Maryland 21228

Re: K241851

Trade/Device Name: Versus™ Catheter (VS110-8B) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEY, KRA, DOO, DYG Dated: June 20, 2024 Received: June 27, 2024

Dear Carrie Kuehn:

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 (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.

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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).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

Ariel G. Ash- Digitally signed by
shakoor -S Ariel G. Ash-shakoor -S
Date: 2024.11.25
09:26:01 -05'00'

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) K241851

Device Name Versus™ Catheter (VS110-8B)

Indications for Use (Describe) The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

| 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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## 510(K) SUMMARY - K241581

## VERSUS™ CATHETER (VS110-8B)

#### l. SUBMITTER'S NAME

Liquet Medical Inc. 5619 Country Hills Ln Glen Allen VA 23059, United States

Contact Name: Carrie M. Kuehn, Head of Regulatory Email: [e-mail] Phone: [phone] Date prepared: November 21, 2024

#### II. Device Information

Proprietary Name: Versus™ Catheter (VS110-8B) Common Name: Embolectomy Catheter Classification Name: Mechanical Thrombolysis Catheter Regulation Number: 870.5150 Classification Codes: QEY Associated Product Codes: KRA, DQO, DYG

#### III. Predicate Devices

Primary Predicate Device: Bashir N-X Endovascular Catheter (K183290) Secondary Predicate Device: Swan Ganz Catheters (K160084)

#### IV. Device Description

The Versus™ Pulmonary Artery Catheter is a dual-tip infusion catheter. Two lumens access and deliver physician-specified fluids, including thrombolytics, into the pulmonary arteries of each lung via a single access site. The Secondary Catheter tip telescopes independently to facilitate infusion into the contralateral lung. The device may allow for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Pressure is measured through an interface between the catheter's fluid lumen and an externally located, FDA-cleared, pressure transducer. The device may include an additional lumen that is in communication with a distal flow-directed balloon.

#### V. Indications for Use

The Versus™ Catheter is indicated for:

The controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients.

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The assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring.

### VI. Comparison of Technological Characteristics with the Predicate Devices

| Table 1. Comparison of Subject Device to Predicate Devices | | | |
|------------------------------------------------------------|--|--|--|
|------------------------------------------------------------|--|--|--|

| Category | Subject Device – | Predicate Device – | Predicate Device – | Comparison |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Versus™ Catheter (VS110-8B) | Bashir Endovascular Catheter Model | Swan-Ganz Catheters | |
| | K241851 | 7201, Bashir N-X Endovascular | K160084 | |
| | | Catheter, Mode 7200 | | |
| | | K183290 | | |
| Class | II | II | II | Same |
| Product Code | QEY - Mechanical Thrombolysis | QEY - Mechanical Thrombolysis | DYG - Catheter, Flow Directed | Similar |
| | Catheter | Catheter | DQE - Catheter, Oximeter, Fiberoptic | A combination of |
| | KRA - Catheter, Continuous Flush | KRA - Catheter, Continuous Flush | DQO - Catheter, Intravascular, | the predicates' |
| | DQO - Catheter, Intravascular | | Diagnostic | product codes |
| | Diagnostic | | KRA - Catheter, Continuous Flush | |
| | DYG - Catheter, Flow Directed | | | |
| Device | The Versus™ Pulmonary Artery | The Bashir N-X Endovascular Catheter | The Swan-Ganz thermodilution | Similar |
| Description | Catheter is a dual-tip infusion catheter | (Ref. No. 7200) is a device intended for | catheters provide diagnostic | |
| | Two lumens access and deliver | the localized infusion of physician- | information to rapidly determine | |
| | physician-specified fluids, including | specified fluids, into the peripheral | hemodynamic pressures and cardiac | |
| | thrombolytics, into the pulmonary | vasculature, including the pulmonary | output when used with a compatible | |
| | arteries of each lung via a single access | arteries. The distal infusion segment of | cardiac output computer. | |
| | site. The Secondary Catheter tip | the device is 12.50 cm (4.94 in) long | In addition to the standard distal | |
| | telescopes independently to facilitate | and consists of a segment with mini- | (pulmonary artery) and injectate | |
| | infusion into the contralateral lung. | infusion catheters, each with multiple | lumens, the Swan-Ganz VIP | |
| | The device may allow for assessment | infusion holes. It is used for the | thermodilution catheter (Models | |
| | of a patient's hemodynamic condition | delivery of the physician-specified | 831F75, 831F75P and 831VF75P) has | |
| | through direct intracardiac and | fluids at multiple cross-sectional points | an additional lumen that provides | |
| | pulmonary artery pressure monitoring. | of the target vessel location. The | direct access to the right atrium. The | |
| | Pressure is measured through an | infusion line connector is located on | Swan-Ganz VIP+ tri-lumen infusion | |
| | interface between the catheter's fluid…