AcQMap High Resolution Imaging and Mapping System

K193013 · Acutus Medical, Inc. · DQK · Feb 11, 2020 · Cardiovascular

Device Facts

• Record ID: K193013
• Device Name: AcQMap High Resolution Imaging and Mapping System
• Applicant: Acutus Medical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chanber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

Device Story

AcQMap High Resolution Imaging and Mapping System (Model 900100) is a computer-based diagnostic recording system for use in Electrophysiology (EP) labs by physicians. It integrates ultrasound imaging, ECG/EGM recording, and impedance-based electrode localization. The system reconstructs 3D cardiac chamber anatomy and displays electrical activity as waveform traces or dynamic charge density/voltage maps to identify arrhythmia sources. It supports both contact and non-contact mapping. The 'SuperMap' mode allows for efficient data collection during regular rhythms by roving the AcQMap catheter throughout the chamber and time-aligning measurements to a stable timing reference (e.g., CS catheter). Physicians use the visual output to guide clinical decision-making and potential treatment of arrhythmias. The system operates outside the sterile field.

Clinical Evidence

No new clinical testing was performed. Clinical evidence is incorporated by reference from the original AcQMap System (K170948) study, 'DDRAMATIC-SVT'. This was a prospective, non-randomized, open-label study of 84 patients conducted at eight clinical sites outside the U.S., demonstrating safety and effectiveness for the intended use.

Technological Characteristics

System consists of a console, workstation, and auxiliary interface box. Sensing/actuation: 10 MHz ultrasound for imaging, impedance-based localization (15-50 kHz), and ECG/EGM recording (0.05-500 Hz). Connectivity: Wired connections for catheters and electrodes. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-25, IEC 60601-2-37. Power: 100-127/220-230 VAC. Dimensions: 99cm x 58cm x 76cm. Weight: 80 kg. Software: Computer-based diagnostic recording system.

Indications for Use

Indicated for patients undergoing electrophysiology procedures. Used for 3D cardiac chamber reconstruction, visualization of anatomy, and mapping of electrical impulses (charge density or voltage-based) for complex arrhythmias. Also used for catheter localization and display of cardiac electrical activity.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• AcQMap High Resolution Imaging and Mapping System, Model 900100 (K191392)

Reference Devices

• AcQMap System (K170948)

Submission Summary (Full Text)

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February 11, 2020

Acutus Medical, Inc. Karla Schaffner Principal Regulatory Affairs Specialist 2210 Faraday Ave., Suite 100 Carlsbad, California 92008

Re: K193013

Trade/Device Name: AcQMap High Resolution Imaging and Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: January 6, 2020 Received: January 8, 2020

Dear Karla Schaffner:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K193013

#### Device Name

AcQMap® High Resolution Imaging and Mapping System, Model 900100

#### Indications for Use (Describe)

The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.

When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chanber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

#### AND

When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

#### OR

When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 5 I 0(K) Notification K I 930 I 3

## General Information [807.92(a)(1)]

#### Date Prepared: 30 December 2019

#### Applicant:

Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: [phone] Fax: [phone]

### Contact Person:

Karla Schaffner Principal Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: [phone] FAX: [phone] Email: [e-mail]

## Device Information [807.92(a)(2)]

| Trade Name: | AcQMap® High Resolution Imaging and Mapping System, Model 900100 |
|------------------|------------------------------------------------------------------------------|
| Common Name: | Programable diagnostic computer and<br>Ultrasonic pulsed echo imaging system |
| Classification: | Class II / 21 CFR § 870.1425 and<br>Class II / 21 CFR § 892.1560 |
| Product Code(s): | DQK, IYO, ITX |

PREDICATE DEVICE: AcQMap High Resolution Imaging and Mapping System, Model 900100 (K 191392)

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## Device Description [807.92(a)(4)]

The AcQMap High Resolution Imaging and Mapping System, Model 900100 operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.

The AcQMap High Resolution Imaging and Mapping System, Model 900100 ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart.

The AcQMap System hardware consists of three functional subsystems:

- . Ultrasound imaging,
- . ECG and EGM recording; and
- . Impedance based electrode Localization.

The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter (cleared under K170819). The AcQMap System provides:

- . 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound),
- . Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
- . Cardiac electrical activity as waveform traces,
- . Contact LAT and voltage amplitude maps
- Remapping of the chamber at any time during the procedure; and
- . Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.

The AcQMap System, Model 900100 is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.

Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.

SuperMap is an adjunct mapping mode to the standard, single position non-contact mapping that makes use of a timing reference (i.e. regular, stable signals from a CS catheter) to time-align measurements from multiple positions throughout the chamber (similar to the manner in which signals are time-aligned when contact mapping).

SuperMap slightly modifies the current workflow for regular rhythms by allowing the user to efficiently collect significantly more electrical data by roving (AKA "hovering") the AcQMap Catheter throughout the chamber and aligning the electrical data from multiple positions to a timing reference.

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

The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.

When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

### AND

When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

### OR

When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

## Comparison of Technological Characteristics with the Predicate Devices [807.92(A)(6)]

Tables I provides a comparison of the modified AcQMap System classifications for use against the predicate device. Table 2 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.

| Table I. Comparison of Classification with the Predicate Device | | | |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| | AcQMap® High<br>Resolution Imaging and<br>Mapping System, Model<br>900100 | AcQMap® High<br>Resolution Imaging and<br>Mapping System, Model<br>900100 (K191392) | |
| 510(k) Number | TBD | K191392 | -- |
| Classification/<br>Regulation<br>Number/<br>Regulation Name/<br>Product Code | Class II/ 21 CFR §<br>870.1425/ Programmable<br>diagnostic computer/<br>DQK<br>Class II/ 21 CFR §<br>892.1560/ Ultrasonic<br>pulsed echo imaging<br>system/ IYO, ITX | Class II/ 21 CFR §<br>870.1425/ Programmable<br>diagnostic computer/<br>DQK<br>Class II/ 21 CFR §<br>892.1560/ Ultrasonic<br>pulsed echo imaging<br>system/ IYO, ITX | Identical |
| Table 2. Comparison of Indications for Use with the Predicate Device | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900100 | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900100 (K191392) | |
| 510(k) Number | TBD | K191392 | |
| Indications for<br>Use | The AcQMap System is intended for use in<br>patients for whom electrophysiology<br>procedures have been prescribed.<br><br>When used with the AcQMap Catheters, the<br>AcQMap System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing the<br>chamber anatomy and displaying electrical<br>impulses as either charge density-based or<br>voltage-based maps of complex arrhythmias that<br>may be difficult to identify using conventional<br>mapping systems alone.<br>AND<br><br>When used with the specified Patient<br>Electrodes, the AcQMap System is intended to<br>display the position of AcQMap Catheters and<br>conventional electrophysiology (EP) catheters in<br>the heart.<br>OR<br><br>When used with conventional electrophysiology<br>catheters, the AcQMap System provides<br>information about the electrical activity of the<br>heart and about catheter location during the<br>procedure. | The AcQMap System is intended for use in<br>patients for whom electrophysiology<br>procedures have been prescribed.<br><br>When used with the AcQMap Catheters, the<br>AcQMap System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing the<br>chamber anatomy and displaying electrical<br>impulses as either charge density-based or<br>voltage-based maps of complex arrhythmias that<br>may be difficult to identify using conventional<br>mapping systems alone.<br>AND<br><br>When used with the specified Patient<br>Electrodes, the AcQMap System is intended to<br>display the position of AcQMap Catheters and<br>conventional electrophysiology (EP) catheters in<br>the heart.<br>OR<br><br>When used with conventional electrophysiology<br>catheters, the AcQMap System provides<br>information about the electrical activity of the<br>heart and about catheter location during the<br>procedure. | Identical |

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| Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical |
| Testing to Support<br>Substantial<br>Equivalence | Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, and Animal Testing | Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, and Animal Testing | Complete performance<br>testing conducted by<br>Acutus demonstrates that<br>the AcQMap System<br>performs as intended and<br>that there are no different<br>questions of safety or<br>effectiveness. |
| System Safety<br>Standards | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 60601-1-6:2010/A1:2013 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 60601-1-6:2010/A1:2013 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | Identical. There are no<br>changes to hardware. |
| Physical Characteristics | | | |
| System<br>Components | Console Workstation Workstation Cable Auxiliary Interface Box ECG Input Cable Ampere Ablation Catheter Adapter Cable Ampere RF Generator Adapter Cable ECG Output Cable Ablation Reference Cable Ablation Electrogram Cable ECG w/Snaps Cable ECG POST Cable 2mm Pin Jumper Set Patient Electrode Kit | Console Workstation Workstation Cable Auxiliary Interface Box ECG Input Cable Ampere Ablation Catheter Adapter Cable Ampere RF Generator Adapter Cable ECG Output Cable Ablation Reference Cable Ablation Electrogram Cable ECG w/Snaps Cable ECG POST Cable 2mm Pin Jumper Set Patient Electrode Kit | Identical |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| Visual/Mapping<br>Characteristics | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900100 3-D cardiac chamber reconstructions -<br>Contact and non-contact (ultrasound); Three-dimensional position of the AcQMap<br>Catheter and conventional electrophysiology<br>catheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time during<br>the procedure; Dynamic, three-dimensional, Charge Density<br>maps overlaid on the cardiac chamber<br>reconstruction to show chamber-wide<br>electrical activation. | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900100 (K191392) 3-D cardiac chamber reconstructions -<br>Contact and non-contact (ultrasound); Three-dimensional position of the AcQMap<br>Catheter and conventional electrophysiology<br>catheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time during<br>the procedure; Dynamic, three-dimensional, Charge Density<br>maps overlaid on the cardiac chamber<br>reconstruction to show chamber-wide<br>electrical activation. | Identical |
| Visualization<br>Device/Catheter | AcQMap Catheter (electrodes & transducers)<br>or Conventional electrophysiology catheters | AcQMap Catheter (electrodes & transducers)<br>or Conventional electrophysiology catheters | |
| Physical Characteristics - Console/Amplifier Comparison | | | |
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 99 cm L x 58 cm W x 76 cm D | Identical |
| Weight Maximum | 80 kg | 80 kg | |
| Power<br>Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | |
| Input Current | 4.6 A | 4.6 A | |
| Fuse protection | 250 V, 6.3A, two high breaking capacity fuses | 250 V, 6.3A, two high breaking capacity fuses | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900100 | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900000 (K191392) | |
| System Specifications | | | |
| Safety<br>Information | IEC 60601-1, Class I, Type Defibrillator Protected CF,<br>continuous operation, no sterilization, equipment not<br>suitable for use in the presence of a flammable<br>anesthetic mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type Defibrillator Protected<br>CF, continuous operation, no sterilization, equipment<br>not suitable for use in the presence of a flammable<br>anesthetic mixture with air, oxygen or nitrous oxide | Identical |
| Ingress<br>Protection | The Console is rated IP20 | The Console is rated IP20 | Identical |
| Functional and Performance Characteristics | | | |
| Ultrasound<br>Output | Frequency: 10 MHz+/-400 kHz<br>Maximum Voltage: 50V p-p<br>Maximum Power: I W peak | Frequency: 10 MHz+/-400 kHz<br>Maximum Voltage: 50V p-p<br>Maximum Power: I W peak | Identical |
| Ultrasound<br>Performance | Single operating mode<br>Thermal Index less than 1.0<br>Mechanical Index less than 1.0 | Single operating mode<br>Thermal Index less than 1.0<br>Mechanical Index less than 1.0 | Identical |
| Localization<br>Output | Frequency: Variable 15 kHz to 50 kHz<br>Maximum current: 1.2mA RMS | Frequency: Variable 30 kHz to 60 kHz<br>Maximum current: 2.2mA/cm2 | Identical |
| ECG & EGM<br>Input | Bandwidth: 0.05 Hz to 500 Hz<br>Resolution: +/-1uV<br>Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.1 Hz to 500 Hz<br>Resolution: +/-10uV<br>Timing Accuracy: +/-1.6 microsecond | Identical |

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| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence | | |
|-----------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------|--|--|
| | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900100 | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900000 (K191392) | | | |
| Front Panel Connections | | | | | |
| AcQMap Catheter | Custom, black, Defibrillator Protected Type CF | Custom, black, Defibrillator Protected Type CF | Identical | | |
| ECG Input | 12-pin, latching, red, Defibrillator Protected Type BF | 12-pin, latching, red, Defibrillator Protected Type BF | Identical | | |
| ECG Output | 14-pin, latching, blue | 14-pin, latching, blue | Identical | | |
| Auxiliary<br>Interface<br>Box | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical | | |
| AcQRef Introducer<br>Sheath or Electrical<br>Reference Catheter | 1, 2mm female, yellow, Defibrillator Protected Type<br>CF | 1, 2mm female, yellow, Defibrillator Protected Type<br>CF | Identical | | |
| Localization<br>Reference<br>Electrodes | 6, 2-pin, square, multi-color, Defibrillator Protected<br>Type BF | 6, 2-pin, square, multi-color, Defibrillator Protected<br>Type BF | Identical | | |
| Patient<br>Reference<br>Electrode | 1, 2-pin, square, blue, Defibrillator Protected Type<br>BF | 1, 2-pin, square, blue, Defibrillator Protected Type<br>BF | Identical | | |
| Ablation Generator | 10-pin, latching, grey | 10-pin, latching, grey | Identical | | |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator Protected Type<br>CF | 10-pin, latching, grey, Defibrillator Protected Type<br>CF | Identical | | |
| Ablation Reference | 1, 2mm, female, black, Defibrillator Protected Type<br>BF | 1, 2mm, female, black, Defibrillator Protected Type<br>BF | Identical | | |
| Ablation<br>Electrogram<br>Interface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical…