(30 days)
Not Found
No
The summary describes a standard RF generator with software for controlling device states and user interface, but there is no mention of AI, ML, or related concepts.
Yes
The "Intended Use / Indications for Use" section states that the device is "to be used ... to create an atrial septal defect," which indicates a direct medical intervention for treatment.
No
The device is an RF generator used to create an atrial septal defect, which is a therapeutic intervention, not a diagnostic one. Its purpose is to deliver power to a needle for a procedure, not to gather information about a patient's condition for diagnosis.
No
The device description clearly states it is a rechargeable battery-operated device (hardware) and includes bench testing for hardware components like the battery, charger, and footswitch, as well as electrical safety and EMC testing. While it has software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create an atrial septal defect" during cardiovascular transseptal access procedures. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is an RF generator used with RF puncture devices to deliver energy for tissue modification. This is a therapeutic/interventional device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to perform tests on samples taken from the body (in vitro), while this device is used on the body (in vivo) for a therapeutic/interventional purpose.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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. Refer to Table 4 for the Model Numbers of the Cross Vascular RF Generator and accessory devices covered by this application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial septal defect
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, 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.
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 (Weight, Operational States, Battery Discharge, Display), Cleaning Verification, Functionality (Electrical, Footswitch, Battery, Alerts), Compatibility (Footswitch, Battery, Charger), Durability.
Electrical Safety and Electromagnetic Compatibility (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, IEC 60601-1-2:2014, and IEC 60601-2-2:2017.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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.
| 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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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 Radiofrequency | ||
| Perforation Generator, Model RFP-100A | ||
| and optional footswitch (Model: RFA-FS) | Boston Scientific | |
| [formerly Baylis Medical] | K122278 |
5.1 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. Refer to Table 4 for the Model Numbers of the Cross Vascular RF Generator and accessory devices covered by this application.
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 |
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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).
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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 for | |||
| Use | 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. | The Baylis Medical Company | ||
| Radiofrequency Puncture Generator & | |||
| Footswitch (optional accessory) is to be | |||
| used with separately approved | |||
| radiofrequency devices in general | |||
| surgical procedures to cut soft tissues. | Similar. Subject and Predicate devices | ||
| are used in the identical cardiovascular | |||
| transseptal access procedures to create | |||
| an atrial septal defect. Subject device | |||
| is not intended to be used for general | |||
| surgical procedures. | |||
| Device | |||
| Components | RF Generator | RF Generator | Identical |
| Battery | N/A - device is not battery operated | Similar; minor design differences do | |
| not raise new questions of safety or | |||
| effectiveness. | |||
| The use of a battery and charger also | |||
| increases the device portability. The | |||
| device can be brought in during the | |||
| procedure and placed without the | |||
| concern of being able to reach a wall | |||
| outlet, having cords entangled or in the | |||
| Charger | way of operations. When the procedure | ||
| is completed, the device can easily be | |||
| moved and plugged into the charger as | |||
| needed. Battery-powered devices and | |||
| their associated charging are | |||
| commonly used, and charging is | |||
| standard practice across all battery- | |||
| powered devices. | |||
| Footswitch (optional) | Footswitch (optional) | Identical | |
| Energy Delivery | |||
| Type | Radiofrequency 462 kHz, Sinusoidal | Radiofrequency 468 kHz, Sinusoidal | Near identical |
Table 5: Substantial Equivalence Comparison Table
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| CrossVascular | RF Generator 510(k) Summary | ||
|---|---|---|---|
| Description | Subject Device | Predicate Device (K122278) | Conclusion |
| Similar; minor design differences do | |||
| not raise new questions of safety or | |||
| effectiveness. | |||
| Power Source | Lithium Ion Battery | AC Mains | Battery-powered devices reduce |
| patient risks associated with AC mains | |||
| connections as there is no risk of | |||
| power surges through the device, | |||
| accidental power loss via unplugging | |||
| the device, etc. | |||
| The effectiveness of the device is not | |||
| affected 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 do |
| not raise new questions of safety or | |||
| effectiveness. | |||
| The subject device has a lower | |||
| maximum output power than the | |||
| predicate, which does not add new | |||
| risks of patient or user harms which | |||
| stem from high RF power output. The | |||
| listed maximum output power for the | |||
| subject device is sufficient to | |||
| effectively execute a TSP procedure. |
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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 do |
| not raise new questions of safety or | |||
| effectiveness. | |||
| The subject device has a lower | |||
| maximum current output than the | |||
| predicate device, which does not add | |||
| any new risks of patient or user harm | |||
| from high current complications. | |||
| Output Voltage | Maximum 246 V | Maximum 565.77 V | Similar; minor design differences do |
| not raise new questions of safety or | |||
| effectiveness. | |||
| The subject device has a lower | |||
| maximum voltage output than the | |||
| predicate device, which does not add | |||
| any new risks of patient or user harm | |||
| from high voltage complications. | |||
| Measurement | |||
| Accuracy: | |||
| Power & | |||
| Impedance | Impedance Range | ||
| 200-800 ohm: | |||
| $\pm$ 10% | |||
| 800-3500 ohm: | |||
| $\pm$ 20% | Impedance Range | ||
| 100-1000 ohm: | |||
| $\pm$ 10% | |||
| 1000-3200 ohm: | |||
| $\pm$ 15% | |||
| 3200-6000 ohm: | |||
| $\pm$ 20% | Similar; minor design differences do | ||
| not raise new questions of safety or | |||
| effectiveness. | |||
| The subject device operates over a | |||
| narrower range of impedance since the | |||
| subject device is only intended for use | |||
| in TSP procedures. This narrower | |||
| impedance range does not impede the | |||
| subject device's ability to deliver the | |||
| appropriate power for TSP. | |||
| User and patient safety are not | |||
| adversely affected because the | |||
| maximum voltage output of the device | |||
| is lower than the predicate device. | |||
| Description | Subject Device | Predicate Device (K122278) | Conclusion |
| Output Modes | Single Mode, 100% Duty Cycle | Mode 10, Constant, 100% Duty Cycle | |
| Mode 10, Pulse, 30% Duty Cycle | |||
| Mode 12, Constant, 100% Duty Cycle | |||
| Mode 12, Pulse, 30 % Duty Cycle | |||
| Mode 14, STX Low, 1.5% Duty Cycle | |||
| Mode 14, STX High, 1.5% Duty Cycle | The subject device only has one mode | ||
| with 100% duty cycle as it is dedicated | |||
| to TSP procedures. The various modes | |||
| offered by the predicate allow for use | |||
| in ablation procedures. By offering | |||
| fewer modes, the subject device does | |||
| not add any new risks of patient or user | |||
| harm from incorrect setting choices. | |||
| Output Polarity | Monopolar | Monopolar | Identical |
| Neutral | |||
| Electrode Type | Conductive | Conductive | Identical |
| Dimensions | Width: 7.8 inches (19.8cm) | ||
| Length: 9.7 inches (24.6 cm) | |||
| Height (legs closed): 4.9 inches (12.4 | |||
| cm) | |||
| Height (legs extended): 6.2 inches (12.7 | |||
| cm) | Width: 11.25 inches (28.5 cm) | ||
| Length: 15.6 inches (39.6 cm) | |||
| Height: 7 inches (17.8 cm) | Similar; minor design differences do | ||
| not raise new questions of safety or | |||
| effectiveness. | |||
| The subject device is smaller 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 size | |||
| of the device. |
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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 |
|---|---|---|---|
| Storage | |||
| Environmental | |||
| Requirements | Temp: -20°C to 50°C | ||
| Humidity: 90%, non-condensing | |||
| Pressure: 500 to 1060 millibar | Temp: -20°C to 50°C | ||
| Humidity: 90%, non-condensing | |||
| Pressure: 500 to 1060 millibar | Identical | ||
| Operating | |||
| Environmental | |||
| Requirements | Temp: 15°C to 40°C | ||
| Humidity: 15% to 90%, non-condensing | |||
| Pressure: 700 to 1060 millibar | Temp: 15°C to 40°C | ||
| Humidity: 15% to 90%, non-condensing | |||
| Pressure: 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
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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).
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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).