(151 days)
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.
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.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria related to AI/algorithm performance.
Instead, the document is a 510(k) summary for a medical catheter (Versus™ Catheter (VS110-8B)), comparing it to predicate devices to establish substantial equivalence.
The performance testing section (Section VII) outlines several non-clinical tests performed, including:
- Sterilization and Shelf Life: Validated per ISO 11135:2014, with a sterility assurance level of 10^-6 and a shelf life of 3 months established through accelerated aging studies.
- Biocompatibility: Evaluated against ISO 10993 and FDA Draft Guidance, including tests for acute systemic toxicity, complement activation, cytotoxicity, hemolysis, heparinized blood platelet and leukocyte count, intracutaneous irritation, material-mediated pyrogenicity, maximization sensitization, partial thromboplastin time (PTT), and particulate infrared spectroscopy.
- Human Factors Testing (Usability): Conducted per IEC 62366-1:2015 and FDA Guidance, demonstrating that intended users could perform critical tasks in a simulated environment. The results met predefined acceptance criteria, but the specific criteria and performance metrics are not detailed in this document.
- Performance Testing - Bench: Included tests for kink radius, trackability, advancement force, retraction force, infusion uniformity, pressure lumen measurement, dimensional and visual verification, luer hub compatibility, balloon inflation and integrity, corrosion resistance, and radiopacity.
- Performance Testing – Animal: A GLP porcine study comparing the Versus™ Catheter to the primary predicate device. The study met all success criteria established.
Crucially, there is no mention of:
- AI/algorithm performance: The device is a physical catheter, not an AI software.
- Test set sample size and data provenance for AI: Not applicable as it's not an AI device.
- Number of experts and their qualifications for ground truth: Not applicable for device testing of this nature.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth (e.g., expert consensus, pathology, outcomes data): Not applicable in the context of AI. The ground truth for biocompatibility and bench testing is established through standardized testing methodologies and material properties. For the animal study, the ground truth would be the physiological and pathological outcomes observed in the animals.
- Training set sample size and how ground truth was established for the training set: Not applicable as it's not an AI/machine learning device.
Therefore, I cannot populate the table or answer the questions related to AI/algorithm performance as the provided text pertains to a physical medical device (catheter) and its substantial equivalence testing, not an AI or software as a medical device.
The only "acceptance criteria" mentioned are that the human factors testing and animal study "met the predefined acceptance/success criteria," but the specific numerical or qualitative details of those criteria are not provided in this summary.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
assistance/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,
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
{3}------------------------------------------------
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)
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."
{4}------------------------------------------------
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: c.kuehn@liquetmedical.com Phone: 301-337-8159 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.
{5}------------------------------------------------
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 | the handle. | thermodilution catheter (Model | ||
| lumen and an externally located, FDA- | The catheter is advanced over a | 834F75) is equipped with a right atrium | ||
| cleared, pressure transducer. The | guidewire using standard endovascular | lumen and an additional lumen. The | ||
| device may include an additional | interventional techniques and is | catheter's right ventricular (RV) lumen | ||
| lumen that is in communication with a | compatible with standard infusion | terminates 19 cm from the catheter tip | ||
| distal flow-directed balloon. | connectors, accessories and | and the right atrial (RA) lumen | ||
| equipment. | terminates at 31 cm. The VIP lumen | |||
| allows for continuous infusion, even | ||||
| during cardiac output determinations. | ||||
| Intended Use | The Versus™ Catheter is intended for | The Bashir N-X Endovascular Catheter | Swan-Ganz thermodilution catheters | Same |
| the controlled and selective infusion of | is intended for the controlled and | are indicated for the assessment of a | The subject device | |
| physician-specified fluids, including | selective infusion of physician-specified | patient's hemodynamic condition | includes one | |
| thrombolytics, into the pulmonary | fluids into the peripheral and | through direct intracardiac and | intended use from | |
| artery vasculature in adult patients. | pulmonary artery vasculature. | pulmonary artery pressure monitoring, | the Primary | |
| The Versus™ Catheter is also intended | cardiac output determination, and for | Predicate and one | ||
| for the assessment of a patient's | infusing solutions. | intended use from | ||
| hemodynamic condition through direct | The distal (pulmonary artery) port also | the Secondary | ||
| intracardiac and pulmonary artery | allows sampling of mixed venous blood | Predicate. | ||
| pressure monitoring. | for the assessment of oxygen transport | |||
| balance and the calculation of derived | ||||
| parameters such as oxygen | ||||
| consumption, oxygen utilization | ||||
| coefficient, and intrapulmonary shunt | ||||
| fraction. | ||||
| Indications for | The Versus™ Catheter is indicated for: | The Bashir N-X Endovascular Catheter | Swan-Ganz thermodilution catheters | Similar |
| Use | is intended for the controlled and | are indicated for the assessment of a | ||
| The controlled and selectiveinfusion of physician-specified fluids, includingthrombolytics, into thepulmonary arteryvasculature in adultpatients. The assessment of apatient's hemodynamiccondition through directintracardiac and pulmonaryartery pressure monitoring. | selective infusion of physician-specified fluids into the peripheral andpulmonary artery vasculature. | patient's hemodynamic conditionthrough direct intracardiac andpulmonary artery pressure monitoring,cardiac output determination, and forinfusing solutions.The distal (pulmonary artery) port alsoallows sampling of mixed venous bloodfor the assessment of oxygen transportbalance and the calculation of derivedparameters such as oxygenconsumption, oxygen utilizationcoefficient, and intrapulmonary shuntfraction. | The indications foruse contains anindication fromeach predicatedevice. | |
| Anatomical site(s) | Insertion through venous access topulmonary arteries | Insertion through venous access topulmonary arteries or peripheralvasculature | Insertion through venous access topulmonary arteries | Same |
| Principles ofOperation | The Versus™ Catheter employs duallumens to facilitate the delivery oflocalized infusion of physician-specifiedfluids into the pulmonary arteries. Thedistal infusion segment consists of asegment with multiple infusion holes. Itis used for the delivery of thephysician-specified fluids at multiplecross-sectional points of the targetvessel location. The infusion lineconnector is located on the proximalhub.The catheter is advanced over aguidewire using standard endovascularinterventional techniques and iscompatible with standard infusionconnectors, accessories andequipment.Alternatively, the device may includean inflatable balloon at the tip, whichfacilitates its placement into thepulmonary artery through the flow ofblood.The Versus™ Catheter has a proximalluer that can be connected to astandard pressure transducer in linewith an IBP-compatible patientmonitor for direct intracardiac andpulmonary artery pressure monitoring. | Localized infusion of physician-specified fluids, into the peripheralvasculature, including the pulmonaryarteries. The distal infusion segmentconsists multiple infusion holes. It isused for the delivery of the physician-specified fluids at multiple cross-sectional points of the target vessellocation. The infusion line connector islocated on the handle.The catheter is advanced over aguidewire using standard endovascularinterventional techniques and iscompatible with standard infusionconnectors, accessories andequipment. | The Swan-Ganz catheters are wellknown pulmonary artery cathetersintended for use on critical carepatients. A Swan-Ganz Catheterincludes an inflatable balloon at the tip,which facilitates its placement into thepulmonary artery through the flow ofblood.The Swan-Ganz catheters can be usedwith compatible cardiac output patientmonitors and/or with oximetrymodules (depending on the modelnumber) to transmit signals forhemodynamic pressure monitoring,cardiac output measurements, and/oroximetry measurements. The Swan-Ganz catheters are to be used with theEdwards and/or Edwards' compatiblepatient monitors, such as the VigilanceII. | SameGuidewireplacement is thesame as PrimaryPredicate.Balloon placementand pressuremonitoring is thesame as SecondaryPredicate. |
| Pressuremeasurementlocation(s) | Image: [heart diagram with balloon]Balloon(optional)RALAPALVRVPRESSUREProximal lumen port has the capabilityfor direct blood pressure measurementat ~20cm from distal tip | Image: [heart diagram]RALAPALVRVPRESSUREDistal lumen port has the capability fordirect blood pressure measurement atthe distal tip | Image: [heart diagram]BalloonRALAPALVRVPRESSUREProximal lumen port has the capabilityfor direct blood pressure measurementat ~30cm from the catheter tip, andalso at the distal tip | Similar |
| Pressure | mmHg intracardiac or pulmonary | mmHg distal pulmonary artery | mmHg intracardiac proximal lumen | Same as Primary |
| measurement | artery pressure when connected to an | pressure when connected to an in-line | port, distal pulmonary artery pressure, | Predicate. Similar |
| outputs | in-line pressure transducer external to | pressure transducer external to the | Cardiac Output (CO), Stroke Volume | to Secondary |
| the patient | patient | (SV) | Predicate | |
| (Subject device | ||||
| does not include a | ||||
| thermistor to | ||||
| output CO, SV | ||||
| parameters) | ||||
| Energy Used | The subject device does not use or | This predicate does not use or deliver | Thermal energy emitted by the thermal | Same as Primary |
| and/or Delivered | deliver any energy. | any energy. | filament located on the catheter. | Predicate. |
| Biocompatibility | Both ISO 10993 and FDA Draft | Both ISO 10993 and FDA Draft | Not reported. | Same as Primary |
| Guidance "Use of International | Guidance "Use of International | Predicate. | ||
| Standard ISO 10993, Biological | Standard ISO 10993, Biological | |||
| Evaluation of Medical Devices Part 1: | Evaluation of Medical Devices Part 1: | |||
| Evaluation and Testing within a Risk | Evaluation and Testing within a Risk | |||
| Management Process" | Management Process" | |||
| Working Length | 100 – 107 cm | 92.50 cm | 75 – 110 cm | Similar |
| Outer Diameter | 8 French | 7 French | 7 – 7.5 French | Similar |
| Radiopaque | Radiopaque marker bands at distal and | The distal 12.50 cm (4.94 in) infusion | Not reported. | Similar |
| Marker | proximal ends of infusion segments, | segment is radiopaque and visible | ||
| and at bifurcation. | under fluoroscopy along its full length. | |||
| Guidewire | A 0.035" guidewire for placement of | A 0.035" guidewire, of the required | A 0.025" guidewire for placement | Same as Primary |
| Compatibility | the Primary Catheter. Guidewire of | length to fit the sheath. Guidewire of | Predicate | |
| 0.014" for placement of the Secondary | 0.018" for placement. | |||
| Catheter. | ||||
| Treatment | Infusion segment length of 12cm for | Infusion segment length of 12.50 cm. | Distal tip infusion, some catalog | Similar to Primary |
| zone/infusion | both Primary and Secondary | numbers include 3 or 4 infusion | Predicate. | |
| port | Catheters. | lumens. | ||
| Infusion flow rate | Set the infusion pump to the desired | Set the infusion pump to the desired | Not relevant | Same as Primary |
| infusion rate and activate per standard | infusion rate and activate per standard | Predicate. | ||
| practice. | practice. | |||
| Diameter of | 13 mm ±2 mm | Not applicable. Device does not have a | 13 mm. | Same as Secondary |
| inflated balloon | balloon. | Predicate. | ||
| Sterility | The devices are sterilized using | The devices are sterilized using | Sterile (EtO) | Same as Primary |
| standard methods and the sterilization | standard methods and the sterilization | and Secondary | ||
| cycles have been validated following | cycles have been validated following | Predicates. | ||
| international standards. The | international standards. The | |||
| sterilization validation complied with | sterilization validation complied with | |||
| ISO 11135:2014. The sterilization cycle | ISO 11135:2014. The sterilization cycle | |||
| was validated to a sterility assurance | was validated to a sterility assurance | |||
| Single Use | level of 10-6Yes | level of 10-6.Yes | Yes | Same |
| Environment foruse | Healthcare facility/hospital | Healthcare facility/hospital | Healthcare facility/hospital | Same as Primaryand Secondary |
| Predicates. | ||||
| Electrical Safety | Contains no electrical components | Contains no electrical components | Warning: Compliance to IEC 60601-1 is | Same as Primary |
| only maintained when the catheter or | Predicate. | |||
| probe (CF applied part, defibrillation | ||||
| proof) is connected to a patient | ||||
| monitor or equipment that has a Type | ||||
| CF defibrillation proof rated input | ||||
| connector. If attempting to use a third | ||||
| party monitor or equipment, check | ||||
| with the monitor or equipment | ||||
| manufacturer to ensure IEC 60601-1 | ||||
| compliance and compatibility with the | ||||
| catheter or probe. Failure to ensure | ||||
| monitor or equipment compliance to | ||||
| IEC 60601-1 and | ||||
| catheter or probe compatibility mayincrease the risk of electrical shock tothe patient/operator. |
{6}------------------------------------------------
510(k) Summary – 245181
Versus™ Catheter (VS110-8B)
{7}------------------------------------------------
510(k) Summary – 245181
Versus™ Catheter (VS110-8B)
{8}------------------------------------------------
VII. Summary of Performance Testing (Non-Clinical Testing)
This 510(k) notification provides performance data to establish the substantial equivalence of the Liquet Medical Versus™ Catheter to the Primary and Secondary Predicate devices. The following is a summary of the performance data.
Sterilization and Shelf Life: The device is sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies. The sterilization validation complied with ISO 11135:2014. The sterilization cycle was validated to a sterility assurance level of 106. The shelf life of the Versus™ Catheter was established through accelerated aging studies and support a shelf life of 3 months.
Biocompatibility: Biocompatibility evaluation has been performed to show the finished, sterilized device is biocompatible and suitable for its intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" were taken into account to evaluate the biocompatibility of the subject device. The testing included an evaluation of:
- Acute Systemic Toxicity
- Complement Activation Assay
- Cytotoxicity
- Hemolysis
- Heparinized Blood Platelet and Leukocyte Count Assay
- Intracutaneous Irritation
- Material Mediated Pyrogenicity
- . Maximization Sensitization Test
- Partial Thromboplastin Time (PTT) Assay
- Particulate Infrared Spectroscopy
Human Factors Testing: Usability testing was conducted per IEC 62366-1:2015 and FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices". The study performed, using the to-be marketed device with intended users, demonstrated that the users were able to perform novel critical tasks of the Versus™ Catheter in an anatomical model in a simulated environment. The results of this testing met the predefined acceptance criteria.
Performance Testing- Bench: Performance testing was performed to characterize the Versus™ Catheter. The testing included an evaluation of:
- . Kink radius
{9}------------------------------------------------
Versus™ Catheter (VS110-8B)
- Trackability
- Advancement force
- Retraction force
- Infusion uniformity
- Pressure lumen measurement
- Dimensional and visual verification
- Luer hub compatibility
- Balloon inflation and integrity
- Corrosion resistance
- Radiopacity
- Joint tensile strengths
The performance data demonstrate that the new devices are substantially equivalent to the Primary and Secondary Predicate devices.
Performance Testing – Animal: The Versus™ Catheter was evaluated in a GLP porcine study with comparison to the primary predicate device. All success criteria established for the study were met. Use of the catheter had no adverse effects systemically or pathologically supporting substantially equivalent safety and performance outcomes of the Versus™ Catheter when used in the target vasculature.
Determination of Substantial Equivalence to Predicate Devices VIII.
The information presented in the 510(k) Submission demonstrates that the Liquet Medical Versus™ Catheter (VS110-8B) is substantially equivalent to the Primary and Secondary Predicate devices.
§ 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).