The Cross Vascular RF Generator and Footswitch (optional accessory) are to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.

Device Description

The Cross Vascular RF Generator (Figure 1) is a rechargeable battery-operated device used with compatible, separately cleared RF Transseptal Needles (i.e., Cross Vascular Models RFN-XX-CX) which are connected to the RF Generator through a Cross Vascular Connection Cable. The RF Generator delivers power in a monopolar mode between the distal tip electrode and a commercially available patient return electrode such as the Valleylabs Patient Return Electrode Model #E7507. An optional Cross Vascular Footswitch may be used with the RF Generator.

AI/ML Overview

This document is a 510(k) summary for the Cross Vascular RF Generator and Footswitch, detailing its substantial equivalence to a predicate device. It primarily focuses on the device's technical specifications, non-clinical performance data, and regulatory compliance.

However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria related to a clinical performance study with a test set, expert involvement, or comparative effectiveness with AI. The document explicitly states "Nonclinical Performance Data" and details software validation, bench testing, electrical safety, and electromagnetic compatibility. It concludes that the device performs as intended and presents no unacceptable risks based on these non-clinical tests.

Therefore, it is not possible to fill in the requested table and answer the study-specific questions based on the provided document. The device in question is a radiofrequency generator, which, in this context, is likely evaluated based on its power output, safety features, and mechanical/electrical performance, rather than on diagnostic accuracy or clinical outcomes that would typically involve a multi-reader multi-case (MRMC) study or ground truth established by experts.

Summary of what can be extracted from the document regarding acceptance criteria and performance (non-clinical):

The document details performance information in the "Nonclinical Performance Data" section (Section 5.5). The acceptance criteria are implicit in the conformance to standards and the successful completion of various bench tests.

Acceptance Criteria (Implicit from testing conducted):

Software Validation: The custom software for controlling the user interface and device settings/outputs must be validated, and risks appropriately assessed and mitigated. (Major Level of Concer SW, no cybersecurity concerns as it's not Wi-Fi enabled).
Transit Testing: The device and accessories must withstand simulated transit conditions.
Labeling Verification: Labels must be accurate and compliant.
Visual Inspection: Device passes visual inspection.
Unit Verification:
- Weight: Meets specified weight.
- Operational States: All 5 defined operational states (Standby, Ready, RF On, Alert, Error) function correctly.
- Battery Discharge: Battery discharges as expected.
- Display: Display functions correctly.
Cleaning Verification: Device can be effectively cleaned.
Functionality:
- Electrical: Electrical functions perform as intended.
- Footswitch: Footswitch functions correctly.
- Battery: Battery functions correctly.
- Alerts: Alerts function correctly.
Compatibility:
- Footswitch: Compatible with the RF Generator.
- Battery: Compatible with the RF Generator.
- Charger: Compatible with the RF Generator.
Durability: Device demonstrates durability.
Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
Power Output: The device successfully delivers RF power, with a maximum output of 25 Watts. (Implicit acceptance that this power is sufficient for the intended use of TSP procedures, highlighted in the comparison table).
Impedance Range: Operates effectively over a specified impedance range (200-800 ohm: ±10%; 800-3500 ohm: ±20%).

Reported Device Performance (Implicit success in meeting the above criteria):

The document states, "The Cross Vascular RF Generator performs as intended and presents no unacceptable risks to the intended patient population or end user. The software validation, electrical compatibility and safety testing, and non-clinical bench data support the safety of the device and demonstrate that the Cross Vascular RF Generator performs as intended in the specified use conditions." This implies that all the above-mentioned tests were passed successfully, meeting their implicit performance criteria.

Unable to Answer/Not Applicable based on the provided document:

A table of acceptance criteria and the reported device performance (for clinical or AI studies): As explained, the document focuses on non-clinical engineering and safety performance. A specific table with quantitative clinical performance metrics (e.g., sensitivity, specificity, AUC) and their acceptance thresholds is not present because this is not a diagnostic AI device requiring such evaluation.
Sample sized used for the test set and the data provenance: Not applicable, as no clinical test set data is described. The "test set" discussed is for engineering bench testing (e.g., a sample of devices tested for durability).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no clinical "ground truth" or expert review process described for this type of device (RF Generator).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is an RF energy delivery device, not a diagnostic imaging AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. While software validation was done, it's for controlling the device, not for a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the physical and electrical phenomena being measured (e.g., power output accuracy, impedance).
The sample size for the training set: Not applicable. This device is not an AI/ML system that undergoes "training."
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document focuses on the engineering, electrical, and safety performance of an RF generator, demonstrating its substantial equivalence through non-clinical testing. It does not contain information related to the clinical performance studies, AI integration, or expert ground truth establishment typically associated with diagnostic AI devices.

Summary

{0}------------------------------------------------

October 12, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cross Vascular Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K232809

Trade/Device Name: Cross Vascular RF Generator and Footswitch (optional accessory) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2023 Received: September 12, 2023

Dear Prithul Bom:

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 (the 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.

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"

{1}------------------------------------------------

(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 (QS) 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 OS 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.

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 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.

Colin K. Chen -S

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

{2}------------------------------------------------

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K232809

Device Name

Cross Vascular RF Generator and Footswitch (optional accessory)

Indications for Use (Describe)

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."

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows the logo for CrossVascular. The logo consists of a circular design with three blue lines forming a V shape inside the circle. To the right of the circular design, the text "CrossVascular" is written in gray.

1.0 510(K) SUMMARY

510(k) Number: K232809

Date Prepared: September 12, 2023

Table 1: Submitter Information

Manufacturer:	Manufacturer's Contact Person:
Cross Vascular Inc.	Jennifer Willner, President
535 Stevens Ave West	JW Regulatory Consulting LLC
Solana Beach, CA 92705	Phone: (612) 240 - 8904
US FDA ERN: Pending	Email: Jennifer@JWRegulatoryConsulting.com

Table 2: Device Information

Table 2. Device Information
Trade Name	Cross Vascular RF Generator and Footswitch (optional accessory)
Common Name	Radiofrequency Generator
Classification Name	Electrosurgical, Cutting & Coagulating & Accessories
Regulation	21CFR 878.4400
Product Code	GEI
Regulatory Classification:	Class II
Device Panel:	General & Plastic Surgery

The Cross Vascular RF Generator device is substantially equivalent to the previously cleared predicate RF Puncture Generator (Table 3). Neither of these devices have been subject to a design-related recall.

Table 3: Predicate Device

Predicate Device	Manufacturer	FDA 510(k)
Baylis Medical Company RadiofrequencyPerforation Generator, Model RFP-100Aand optional footswitch (Model: RFA-FS)	Boston Scientific[formerly Baylis Medical]	K122278

5.1 Device Description

Table 4: Model Numbers for Subject Device and Accessories

Device Name/Description	Model Number
Cross Vascular RF Generator	RFG-01-00
Cross Vascular RF Generator Battery	RFG-01-BT
Cross Vascular RF Generator Replacement Charger	RFG-01-CG

{5}------------------------------------------------

Image /page/5/Picture/3 description: The image shows the logo for CrossVascular. The logo consists of a circular design on the left and the text "CrossVascular" on the right. The circular design is made up of several concentric circles and a "V" shape in the center. The text "CrossVascular" is in a sans-serif font and is gray in color.

Device Name/Description	Model Number
Cross Vascular RF Generator Footswitch	RFG-01-FS

The Cross Vascular RF Generator is used with Cross Vascular RF Transseptal Needles in transseptal surgical procedures to puncture the fossa ovalis and gain access from the right side of the heart to the left atrium. The RF Generator is used to provide RF energy through the Connection Cable and into the RF Transseptal Needle to facilitate the septal puncture.

Image /page/5/Picture/7 description: The image shows a medical device with a gray metal casing and blue trim. The front panel features a screen, a power button, a red button, and other controls. The device is labeled "CrossVascular" in white lettering. The device appears to be a portable unit designed for medical procedures.

Figure 1: Cross Vascular RF Generator

5.2 Indications for Use

The Cross Vascular RF Generator and Footswitch (optional accessory) are to be used with a separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.

5.3 Comparison of Technological Characteristics with the Predicate Device

The Subject and Predicate Devices are based on the same technological elements of generating, controlling and delivering RF power in a monopolar mode between the distal tip electrode of an RF device and commercially available Patient Return Electrode. The Subject and Predicate Devices both connect to RF devices through a connection cable, are electrically powered and have an optional, separately provided footswitch.

The following technological differences exist between the Subject and Predicate Device:

The Subject Device is battery-powered while the Predicate Device requires plug into a ● properly grounded AC mains.
The Subject Device has a lower maximum power output (25 Watts) than the Predicate ● Device maximum power output (50 Watts).

{6}------------------------------------------------

Image /page/6/Picture/2 description: The image contains the logo for CrossVascular. The logo consists of a circular design on the left and the word "CrossVascular" on the right. The circular design features a stylized "V" shape formed by three parallel lines, enclosed within three concentric circles. The word "CrossVascular" is written in a simple, sans-serif font, with the first word in a darker shade of gray than the second.

The Subject Device only outputs power in a continuous monopolar mode while the ● Predicate Device allows for power output in a continuous monopolar mode and a pulse mode.
These differences provide convenience and efficiency over the Predicate Device and do not impact the intended use. No new questions regarding safety or effectiveness arise from this difference.

Description	Subject Device	Predicate Device (K122278)	Conclusion
Product Name	Cross Vascular RF Generator	Radiofrequency Puncture Generator
Manufacturer	Cross Vascular, Inc.	Boston Scientific[formerly Baylis Medical]
Product Code /Regulation	GEI / 21CFR 878.4400	GEI / 21CFR 878.4400	Identical
Indications forUse	The Cross Vascular RF Generator andFootswitch (optional accessory) are tobe used with separately cleared RFpuncture devices in cardiovasculartransseptal access procedures to createan atrial septal defect.	The Baylis Medical CompanyRadiofrequency Puncture Generator &Footswitch (optional accessory) is to beused with separately approvedradiofrequency devices in generalsurgical procedures to cut soft tissues.	Similar. Subject and Predicate devicesare used in the identical cardiovasculartransseptal access procedures to createan atrial septal defect. Subject deviceis not intended to be used for generalsurgical procedures.
DeviceComponents	RF Generator	RF Generator	Identical
	Battery	N/A - device is not battery operated	Similar; minor design differences donot raise new questions of safety oreffectiveness.The use of a battery and charger alsoincreases the device portability. Thedevice can be brought in during theprocedure and placed without theconcern of being able to reach a walloutlet, having cords entangled or in the
	Charger		way of operations. When the procedureis completed, the device can easily bemoved and plugged into the charger asneeded. Battery-powered devices andtheir associated charging arecommonly used, and charging isstandard practice across all battery-powered devices.
	Footswitch (optional)	Footswitch (optional)	Identical
Energy DeliveryType	Radiofrequency 462 kHz, Sinusoidal	Radiofrequency 468 kHz, Sinusoidal	Near identical

Table 5: Substantial Equivalence Comparison Table

{7}------------------------------------------------

CrossVascular		RF Generator 510(k) Summary
Description	Subject Device	Predicate Device (K122278)	Conclusion
			Similar; minor design differences donot raise new questions of safety oreffectiveness.
Power Source	Lithium Ion Battery	AC Mains	Battery-powered devices reducepatient risks associated with AC mainsconnections as there is no risk ofpower surges through the device,accidental power loss via unpluggingthe device, etc.
			The effectiveness of the device is notaffected by the use of a battery as thebattery is capable of delivering the required power to complete the transseptal puncture (TSP) procedure.Further it is shown to be capable of maintaining RF power output within the specified accuracy range.
Output Power	Maximum 25 Watts	Maximum 50 Watts	Similar; minor design differences donot raise new questions of safety oreffectiveness.The subject device has a lowermaximum output power than thepredicate, which does not add newrisks of patient or user harms whichstem from high RF power output. Thelisted maximum output power for thesubject device is sufficient toeffectively execute a TSP procedure.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for CrossVascular. The logo consists of a stylized "V" shape formed by three concentric circles, with three lines extending from the top of the "V". The text "CrossVascular" is written to the right of the symbol, with "Cross" in a darker gray and "Vascular" in a lighter gray.

Description	Subject Device	Predicate Device (K122278)	Conclusion
Output Current	Maximum 0.5 A	Maximum 1.27 A	Similar; minor design differences donot raise new questions of safety oreffectiveness.The subject device has a lowermaximum current output than thepredicate device, which does not addany new risks of patient or user harmfrom high current complications.
Output Voltage	Maximum 246 V	Maximum 565.77 V	Similar; minor design differences donot raise new questions of safety oreffectiveness.The subject device has a lowermaximum voltage output than thepredicate device, which does not addany new risks of patient or user harmfrom high voltage complications.
MeasurementAccuracy:Power &Impedance	Impedance Range200-800 ohm:$\pm$ 10%800-3500 ohm:$\pm$ 20%	Impedance Range100-1000 ohm:$\pm$ 10%1000-3200 ohm:$\pm$ 15%3200-6000 ohm:$\pm$ 20%	Similar; minor design differences donot raise new questions of safety oreffectiveness.The subject device operates over anarrower range of impedance since thesubject device is only intended for usein TSP procedures. This narrowerimpedance range does not impede thesubject device's ability to deliver theappropriate power for TSP.User and patient safety are notadversely affected because themaximum voltage output of the deviceis lower than the predicate device.
Description	Subject Device	Predicate Device (K122278)	Conclusion
Output Modes	Single Mode, 100% Duty Cycle	Mode 10, Constant, 100% Duty CycleMode 10, Pulse, 30% Duty CycleMode 12, Constant, 100% Duty CycleMode 12, Pulse, 30 % Duty CycleMode 14, STX Low, 1.5% Duty CycleMode 14, STX High, 1.5% Duty Cycle	The subject device only has one modewith 100% duty cycle as it is dedicatedto TSP procedures. The various modesoffered by the predicate allow for usein ablation procedures. By offeringfewer modes, the subject device doesnot add any new risks of patient or userharm from incorrect setting choices.
Output Polarity	Monopolar	Monopolar	Identical
NeutralElectrode Type	Conductive	Conductive	Identical
Dimensions	Width: 7.8 inches (19.8cm)Length: 9.7 inches (24.6 cm)Height (legs closed): 4.9 inches (12.4cm)Height (legs extended): 6.2 inches (12.7cm)	Width: 11.25 inches (28.5 cm)Length: 15.6 inches (39.6 cm)Height: 7 inches (17.8 cm)	Similar; minor design differences donot raise new questions of safety oreffectiveness.The subject device is smaller than thepredicate device, making the subjectdevice more conducive for use in acrowded operating room.There are no new risks to the user orpatient introduced by the reduced sizeof the device.

{9}------------------------------------------------

Image /page/9/Picture/2 description: The image shows the logo for CrossVascular. The logo consists of a blue circular design with three lines forming a V shape inside the circle. To the right of the circular design, the text "CrossVascular" is written in gray. The word "Cross" is slightly larger and bolder than the word "Vascular".

Weight	5.5lb. (2.5 kg)	20 lb. (9.1 kg)	Similar, minor design differences do not raise new questions of safety or effectiveness.The subject device is lighter than the predicate device, making the subject device more conducive for use in a crowded operating room.There are no new risks to the user or patient introduced by the reduced weight of the device.
--------	-----------------	-----------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Description	Subject Device	Predicate Device (K122278)	Conclusion
StorageEnvironmentalRequirements	Temp: -20°C to 50°CHumidity: 90%, non-condensingPressure: 500 to 1060 millibar	Temp: -20°C to 50°CHumidity: 90%, non-condensingPressure: 500 to 1060 millibar	Identical
OperatingEnvironmentalRequirements	Temp: 15°C to 40°CHumidity: 15% to 90%, non-condensingPressure: 700 to 1060 millibar	Temp: 15°C to 40°CHumidity: 15% to 90%, non-condensingPressure: 700 to 1060 millibar	Identical

5.4 Performance Standards

The Cross Vascular RF Generator has been developed in conformance with the following standards and FDA guidance, as applicable:

IEC 60601-1:2005+A1:2012, Medical Electrical Equipment Part 1: General ● Requirements For Basic Safety And Essential Performance
IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements ● For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-2-2:2017, Medical Electrical Equipment Part 2-2: Particular Requirements ● For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
IEC 62133-2:2017, Safety requirements for portable sealed secondary cells ●
ISO 15223-1:2021, Medical devices Symbols to be used with medical device labels, ● labeling and information to be supplied
ISO 20417:2021, Medical devices Information to be supplied by the manufacturer ●
ISO 60417:2002, Graphical symbols for use on equipment ●

5.5 Nonclinical Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Software and Bench Testing

The Cross Vascular RF Generator software (SW) is custom software responsible for controlling the user interface and all device settings and outputs. The Cross Vascular SW integrates user input to control the following 5 device states:

Standby State ●
Ready State

{10}------------------------------------------------

Image /page/10/Picture/2 description: The image shows the logo for CrossVascular. The logo consists of a circular design with a V shape in the center, and the text "CrossVascular" to the right of the design. The circular design is made up of three concentric circles, with the innermost circle being the darkest shade of blue and the outermost circle being the lightest shade of blue. The text "CrossVascular" is in a sans-serif font, with the "Cross" part of the name being in a darker shade of gray than the "Vascular" part of the name.

RF On State ●
. Alert State
Error State ●

The Cross Vascular SW is considered a Major Level of Concern whose risk has been appropriately assessed and mitigated and has undergone software validation testing. As the RF Generator is not Wi-Fi enabled or connected to hospital systems or programs, there is no cybersecurity concern.

Bench Testing

Design verification testing was conducted on the Cross Vascular RF Generator and accessories (Battery, Charger & Footswitch) after being subjected to simulated transit conditions. The following types of testing were conducted:

Transit Testing
Labeling Verification
Visual Inspection ●
Unit Verification ●
- o Weight
- Operational States O
- Battery Discharge O
- o Display
0 Cleaning Verification
Functionality ●
- o Electrical
- Footswitch O
- Battery O
- Alerts O
Compatibility ●
- Footswitch O
- Battery O
- Charger O
Durability ●

Electrical Safety and Electromagnetic Comnatibility (EMC)

Electrical safety and EMC testing were conducted on the Cross Vascular RF Generator. The testing complies with the applicable sections of IEC 60601-1:2005+A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for the basic safety and essential performance - Collateral standard: Electromagnetic compatibility – Requirements and tests, and IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This testing is consistent with that conducted by the Predicate Device Baylis Medical Company Radiofrequency Perforation Generator, Model RFP-100A and optional footswitch (Model: RFA-FS) (K122278).

{11}------------------------------------------------

Image /page/11/Picture/2 description: The image shows the logo for CrossVascular, which includes a stylized blue "V" shape made of three lines, along with the company name in gray. Below the logo, the text "5.6 Conclusions" is written in a bold, black font. The text appears to be a section heading or title within a larger document.

The Cross Vascular RF Generator is of similar design to the Predicate Device and has similar technical requirements. The RF Generator performs as intended and presents no unacceptable risks to the intended patient population or end user. The software validation, electrical compatibility and safety testing, and non-clinical bench data support the safety of the device and demonstrate that the Cross Vascular RF Generator performs as intended in the specified use conditions.

The Cross Vascular RF Generator is substantially equivalent to the Predicate Device, Baylis Medical Company Radiofrequency Perforation Generator, Model RFP-100A and optional footswitch (Model: RFA-FS) (K122278).

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.