HOTWIRE™ System RF Generator and Footswitch (optional accessory)

K252083 · Atraverse Medical, Inc. · GEI · Aug 12, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K252083
• Device Name: HOTWIRE™ System RF Generator and Footswitch (optional accessory)
• Applicant: Atraverse Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 12, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

The HOTWIRE™ System RF Generator is an AC-powered electrosurgical unit used in cardiovascular transseptal access procedures. It delivers monopolar radiofrequency (RF) energy (470 kHz, sinusoidal) to a compatible, separately cleared RF guidewire (e.g., HOTWIRE™ RF Guidewire) to puncture the fossa ovalis and create an atrial septal defect. The system includes an optional footswitch for activation. The device is operated by clinicians in a clinical setting. The generator monitors impedance and power, delivering energy between the distal tip electrode of the guidewire and a standard patient return electrode. The output is controlled via a user interface that manages device states (Self-Test, Standby, Ready, RF On, Setting, Error). By facilitating precise septal puncture, the device assists in gaining access from the right heart to the left atrium, enabling subsequent cardiac interventions.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing, including transit testing, labeling verification, visual inspection, unit verification, weight, operational states, display, functionality, electrical safety, footswitch durability, and compatibility testing. In-vivo animal study data was also conducted to demonstrate safety and effectiveness.

Technological Characteristics

AC mains-powered RF generator; 470 kHz sinusoidal output; max 50W power; monopolar mode; conductive neutral electrode. Dimensions: 11.4 x 25.7 x 11.7 cm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 15223-1, ISO 20417. Software lifecycle per IEC 62304. Cybersecurity per FDA guidance. Materials: Plastic housing (UL 94 flammability rated).

Indications for Use

Indicated for use with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect in patients requiring such access.

Regulatory Classification

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.

Predicate Devices

• Cross Vascular RF Generator and Footswitch (optional accessory) (K232809)

Reference Devices

• Baylis Medical Company Radiofrequency Perforation Generator, Model RFP-100A and optional footswitch (Model: RFA-FS) (K122278)
• HOTWIRE™ RF Guidewire (K240900)
• Valleylabs Patient Return Electrode Model #E7507 (K822572)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 12, 2025

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

Re: K252083
Trade/Device Name: HOTWIRE™ System 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: July 24, 2025
Received: August 1, 2025

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (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 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 (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

JAMES H. JANG-S
Digitally signed by
JAMES H. JANG-S
Date: 2025.08.12
17:51:01 -04'00'

James Jang, Ph.D.
Acting Assistant Director

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DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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HOTWIRE System RF Generator
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252083 | ? |
| Please provide the device trade name(s). | | ? |
| HOTWIRE System RF Generator and Footswitch (optional accessory) | | |
| Please provide your Indications for Use below. | | ? |
| The HOTWIRE System RF Generator and Footswitch (optional accessory) is to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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# 510(K) SUMMARY

This 510(k) summary for HOTWIRE™ System RF Generator and Footswitch (optional accessory) is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.

# SUBMITTER [807.92(a)(1)]

Atraverse Medical, Inc.

2611 S Coast Hwy 101 #204

Cardiff By The Sea, CA 92007

Contact Person: Charles Yang, SVP QA/RA

Telephone: [phone]

Email: [e-mail]

Date prepared: July 24, 2025

# DEVICE [807.92(a)(2)]

Table 1: Device Information

| Trade Name | HOTWIRE™ System RF Generator and Footswitch (optional accessory) |
| --- | --- |
| Common Name | Radiofrequency Generator |
| Classification Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Classification | Class II |
| Device Panel: | General & Plastic Surgery |

# PREDICATE DEVICE [807.92(a)(3)]

Cross Vascular RF Generator and Footswitch (optional accessory) (K232809)

# REFERENCE DEVICE

Baylis Medical Company Radiofrequency Perforation Generator, Model RFP-100A and optional footswitch (Model: RFA-FS) (K122278)

# DEVICE DESCRIPTION [807.92(a)(4)]

The HOTWIRE™ System RF Generator (Figure 1) is a AC mains power-operated device used with compatible, separately cleared RF device (i.e., HOTWIRE™ RF guidewire - K240900) which

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are connected to the RF Generator through a HOTWIRE™ System Handpiece. 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 (K822572). An optional HOTWIRE™ System Footswitch may be used with the RF Generator. Refer to Table 2 for the Model Numbers of the HOTWIRE™ System RF Generator and accessory devices covered by this application.

Table 2: Model Numbers for Subject Device and Accessories

| Device Name/Description | Model Number |
| --- | --- |
| HOTWIRE™ System RF Generator | HB1 |
| HOTWIRE™ System Footswitch | FS1 |

The HOTWIRE™ System RF Generator is used with HOTWIRE™ RF Guidewire 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 HOTWIRE™ System Handpiece and into the RF Guidewire to facilitate the septal puncture.

Figure 1: HOTWIRE™ System RF Generator

## INDICATIONS FOR USE [807.92(a)(5)]

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

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

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.

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The minor differences do not impact the intended use and do not raise new questions regarding safety or effectiveness.

Table 3: Substantial Equivalence Comparison Table

| Description | Subject Device | Predicate Device (K232809) | Reference Device (K122278) | Conclusion |
| --- | --- | --- | --- | --- |
| Product Name | HOTWIRE™ System RF Generator | Cross Vascular RF Generator | Baylis Medical Company Radiofrequency Perforation Generator | |
| Manufacturer | Atraverse Medical, Inc. | Cross Vascular, Inc. | Baylis Medical Company Inc. | |
| Product Code / Regulation | GEI / 21 CFR 878.4400 | GEI / 21 CFR 878.4400 | GEI / 21 CFR 878.4400 | Identical |
| Indications for Use | The HOTWIRE™ System RF Generator and Footswitch (optional accessory) is to be used with separately cleared RF puncture device (i.e., HOTWIRE™ RF Guidewire - K240900) in cardiovascular transseptal access procedures to create an atrial septal defect. | 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 BMC Radiofrequency Perforation Generator is indicated for use in general surgical procedures to cut and coagulate soft tissue | Similar. The difference in compatible RF device does not raise new questions of safety or effectiveness. The Subject device shall be specifically used with the HOTWIRE™ RF Guidewire (K240900). |
| Device Components | RF Generator | RF Generator | RF Generator | Identical |
| | N/A – device is not battery operated | Battery | N/A – device is not battery operated | Similar, minor design differences do not raise new questions of safety or effectiveness. |
| | | Charger | | Identical to Reference Device |
| | Footswitch (Optional) | Footswitch (Optional) | Footswitch (Optional) | Identical |
| Energy Delivery Type | Radiofrequency 470 kHz, Sinusoidal | Radiofrequency 462 kHz, Sinusoidal | Radiofrequency 468 kHz, Sinusoidal | Similar. Minor design differences do not raise new questions of safety or effectiveness. |
| Power Source | AC Mains | Lithium Ion Battery | AC Mains | Similar. Minor design differences do not raise new questions of safety or effectiveness. Identical to Reference Device |
| Output Power | Maximum 50 Watts | Maximum 25 Watts | Maximum 50 Watts | Identical to Reference Device |
| Output Current | Maximum 0.6 A | Maximum 0.5 A | Maximum 1.27 A | Similar, minor design differences do not raise new questions of safety or effectiveness. |
| Output Voltage | Maximum 494.98 V | Maximum 246 V | Maximum 565.77 V | Similar, minor design differences do not raise new questions of safety or effectiveness. |
| Measuring Accuracy: Power & Impedance | Impedance Range Accuracy ± 10% ± 20%
800-3500 ohm: | Impedance Range Accuracy ± 10% ± 20%
800-3500 ohm: | Impedance Range Accuracy ± 10% ± 20%
100-1000 ohm: ± 10%
1000-3200 ohm: ± 15%
3200 – 6000 ohm: ± 20% | Identical to Predicate Device |
| Output Modes | Single Mode 100% Duty Cycle | Single Mode 100% Duty Cycle | 100% Duty Cycle (“Constant”) Mode Or 30% Duty Cycle (“Pulse”) Mode | Identical to Predicate |
| Output Polarity | Monopolar | Monopolar | Monopolar | Identical |
| Neutral Electrode (NE) Type | Conductive | Conductive | Conductive | Identical |
| Dimensions | Width: 4.5 inches (11.4 cm)
Length: 10.1 inches (25.7 cm)
Height 4.6 inches (11.7 cm)
Power Cord: 10 ft | Width: 7.8 inches (19.8 cm)
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)
Power Cord: 10 ft | Similar, minor design differences do not raise new questions of safety or effectiveness. |

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| Description | Subject Device | Predicate Device (K232809) | Reference Device (K122278) | Conclusion |
| --- | --- | --- | --- | --- |
| Weight | 4.90 lb (2.2 kg) | 5.5 lb. (2.5 kg) | 20lb. (9.1 kg) | Similar, minor design differences do not raise new questions of safety or effectiveness. |
| 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 | 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 | Temp: 15°C to 40°C
Humidity: 15% to 90% non-condensing
Pressure: 700 to 1060 millibar | Identical |

# PERFORMANCE STANDARDS

The HOTWIRE™ System RF Generator has been developed in conformance with the following standards and FDA guidance, as applicable:

- IEC 60601-1:2005 + AMD1:2012 + AMD2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- IEC 60601-2-2:2017 + AMD1:2023, 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
- IPC-A-600, Acceptability of Printed Boards Endorsement Program
- IPC-A-610, Acceptability of Electronic Assemblies
- ISTA Procedure 2A, [Shipping of] Packaged-Products weighing 150 lb (68 kg) or Less
- ROHS 2015/863/EU, Restriction of Hazardous Substances (RoHS)
- UL Standard 94, Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances (Ed. 6)
- IEC 62304:2015, Medical device software — Software life cycle processes
- FDA-2021-D-1158, Guidance on Cybersecurity in medical devices, September 2023
- FDA-2021-D-0775, FDA Guidance on Content of Premarket Submissions for Device Software Functions (June 14, 2023)
- 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
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff - September 27, 2023
- AAMI TIR57:2016 Principles for medical device security—Risk management
- Postmarket Management of Cybersecurity in Medical Devices – December 28, 2016
- Cybersecurity for Networked Medical Devices Containing Off- The-Shelf (OTS) Software - January 14, 2005
- Off-The-Shelf (OTS) Software Use in Medical Devices – September 27, 2019

NONCLINICAL PERFORMANCE DATA [807.92(b)(1)]

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

## Software Testing (including Cybersecurity)

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

- SELF-TEST State
- Standby States
- Ready State
- RF On State
- Setting State
- Error State

The HOTWIRE™ System RF Generator SW is considered a Major Level of Concern whose risk has been appropriately assessed and mitigated and has undergone software validation and cybersecurity testing.

## In-Vivo Evaluation

Non-clinical in vivo performance and useability testing was completed to demonstrate safety and effectiveness of the subject device. All test requirements were met as specified by applicable standards and test protocols.

## Bench Testing

Design Verification testing was conducted on the HOTWIRE™ System RF Generator and accessories (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
- Display
- Functionality
- Electrical

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- Footswitch
- Alerts
- Compatibility
- Footswitch
- Neutral Electrode
- Durability

# Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the HOTWIRE™ System RF Generator. The testing complies with the applicable sections of IEC 60601-1:2005 + AMD1:2012 + AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2020, 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 + AMD1:2023, 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 Cross Vascular RF Generator, Model RFG-01-00 and optional footswitch (Model: RFG-01-FS) (K232809).

# CONCLUSIONS [807.92(b)(3)]

The HOTWIRE™ System 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, non-clinical bench, and animal study data support the safety of the device and demonstrate that the HOTWIRE™ System RF Generator performs as intended in the specified use conditions.

The HOTWIRE™ System RF Generator is substantially equivalent to the Predicate Device, Cross Vascular RF Generator, Model RFG-01-00, and optional footswitch (Model: RFG-01-FS) (K232809).

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