(105 days)
No
The summary describes a system for imaging, navigation, and mapping using ultrasound, ECG, EGM, and impedance-based localization. It focuses on reconstructing cardiac chambers and displaying electrical activity. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "SuperMap" feature is described as a method for time-aligning data from multiple positions, not an AI/ML algorithm.
No.
The device is described as a "diagnostic recording system" and its intended use is for imaging, navigation, and mapping to help physicians identify sources of arrhythmia, rather than directly treating a disease or condition.
Yes
The "Device Description" section explicitly states, "The AcQMap High Resolution Imaging and Mapping System, Model 900100 ('AcQMap System Model, 900100') is a diagnostic recording system." Additionally, it describes its function in "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," which serves to aid in diagnosing the source(s) of arrhythmia.
No
The device description explicitly states that the system consists of hardware components (AcQMap Console, AcQMap Workstation, AcQMap Auxiliary Interface Box) and is used in conjunction with a catheter. It also mentions hardware subsystems (Ultrasound imaging, ECG and EGM recording, Impedance based electrode Localization).
Based on the provided text, the AcQMap System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring or compatibility purposes.
- AcQMap System Function: The AcQMap System operates in vivo (within the living body) by using ultrasound and electrical signals to reconstruct and map the electrical activity of the heart's atrial chambers. It directly interacts with the patient's internal anatomy and electrical system.
- Intended Use: The intended use clearly states it's for use in patients for electrophysiology procedures, visualizing chamber anatomy, and displaying electrical impulses within the heart.
- Device Description: The description confirms it's a "diagnostic recording system" used in the Electrophysiology (EP) Lab, capable of imaging, navigation, and mapping of the atrial chambers of the heart. It uses ultrasound imaging, ECG and EGM recording, and impedance-based electrode localization, all of which are in vivo techniques.
Therefore, the AcQMap System is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DQK, IYO, ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac chamber/Intracardiac Structures (atrial chambers of the heart)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians/Electrophysiology (EP) Lab
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)
Nonclinical Testing Summary:
- Software Verification and Validation
- SuperMap Mapping Validation Testing Animal Study
- Clinical Simulation (Reliability)
- Map Accuracy Testing
- Transportation Testing
- AcQMap Verification Testing
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study
- Accuracy Validation Testing Animal Study
The collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use. The collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
Clinical Testing Summary:
Study Type: Prospective, non-randomized, open-label study
Study Name: "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)"
Sample Size: 84 patients
Data Source: Eight clinical sites outside the U.S.
Key Results: The study demonstrated that the AcQMap System is safe and effective for its intended use. This clinical data from the original AcQMap System (K170948) is incorporated by reference and applies to the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AcQMap High Resolution Imaging and Mapping System, Model 900100 (K191392)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: 1-442-232-6080 Fax: 1-442-232-6081
Contact Person:
Karla Schaffner Principal Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6161 FAX: 1-442-232-6081 Email: karla.schaffner@acutus.com
Device Information [807.92(a)(2)]
| Trade Name: | AcQMap® High Resolution Imaging and Mapping System, Model 900100 |
|---|---|
| Common Name: | Programable diagnostic computer and |
| Ultrasonic pulsed echo imaging system | |
| Classification: | Class II / 21 CFR § 870.1425 and |
| 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)
4
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.
5
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 | |||
| Resolution Imaging and | |||
| Mapping System, Model | |||
| 900100 | AcQMap® High | ||
| Resolution Imaging and | |||
| Mapping System, Model | |||
| 900100 (K191392) | |||
| 510(k) Number | TBD | K191392 | -- |
| Classification/ | |||
| Regulation | |||
| Number/ | |||
| Regulation Name/ | |||
| Product Code | Class II/ 21 CFR § | ||
| 870.1425/ Programmable | |||
| diagnostic computer/ | |||
| DQK | |||
| Class II/ 21 CFR § | |||
| 892.1560/ Ultrasonic | |||
| pulsed echo imaging | |||
| system/ IYO, ITX | Class II/ 21 CFR § | ||
| 870.1425/ Programmable | |||
| diagnostic computer/ | |||
| DQK | |||
| Class II/ 21 CFR § | |||
| 892.1560/ Ultrasonic | |||
| pulsed echo imaging | |||
| system/ IYO, ITX | Identical | ||
| Table 2. Comparison of Indications for Use with the Predicate Device | |||
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| AcQMap® High Resolution Imaging and Mapping | |||
| System, Model 900100 | AcQMap® High Resolution Imaging and Mapping | ||
| System, Model 900100 (K191392) | |||
| 510(k) Number | TBD | K191392 | |
| Indications for | |||
| 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
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. | 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. | Identical |
6
7
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical |
| Testing to Support | |||
| Substantial | |||
| 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 |
| testing conducted by | |||
| Acutus demonstrates that | |||
| the AcQMap System | |||
| performs as intended and | |||
| that there are no different | |||
| questions of safety or | |||
| effectiveness. | |||
| System Safety | |||
| 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 |
| changes to hardware. | |||
| Physical Characteristics | |||
| System | |||
| 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 |
| Equivalence | |||
| Visual/Mapping | |||
| Characteristics | AcQMap® High Resolution Imaging and Mapping | ||
| System, Model 900100 3-D cardiac chamber reconstructions - | |||
| 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; Dynamic, three-dimensional, Charge Density | |||
| maps overlaid on the cardiac chamber | |||
| reconstruction to show chamber-wide | |||
| electrical activation. | AcQMap® High Resolution Imaging and Mapping | ||
| System, Model 900100 (K191392) 3-D cardiac chamber reconstructions - | |||
| 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; Dynamic, three-dimensional, Charge Density | |||
| maps overlaid on the cardiac chamber | |||
| reconstruction to show chamber-wide | |||
| electrical activation. | Identical | ||
| Visualization | |||
| Device/Catheter | AcQMap Catheter (electrodes & transducers) | ||
| or Conventional electrophysiology catheters | AcQMap Catheter (electrodes & transducers) | ||
| 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 | |||
| 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 |
| Equivalence | |||
| AcQMap® High Resolution Imaging and Mapping | |||
| System, Model 900100 | AcQMap® High Resolution Imaging and Mapping | ||
| System, Model 900000 (K191392) | |||
| System Specifications | |||
| Safety | |||
| Information | IEC 60601-1, Class I, Type Defibrillator Protected CF, | ||
| continuous operation, no sterilization, equipment not | |||
| suitable for use in the presence of a flammable | |||
| anesthetic mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type Defibrillator Protected | ||
| CF, continuous operation, no sterilization, equipment | |||
| not suitable for use in the presence of a flammable | |||
| anesthetic mixture with air, oxygen or nitrous oxide | Identical | ||
| Ingress | |||
| Protection | The Console is rated IP20 | The Console is rated IP20 | Identical |
| Functional and Performance Characteristics | |||
| Ultrasound | |||
| Output | Frequency: 10 MHz+/-400 kHz | ||
| Maximum Voltage: 50V p-p | |||
| Maximum Power: I W peak | Frequency: 10 MHz+/-400 kHz | ||
| Maximum Voltage: 50V p-p | |||
| Maximum Power: I W peak | Identical | ||
| Ultrasound | |||
| Performance | Single operating mode | ||
| Thermal Index less than 1.0 | |||
| Mechanical Index less than 1.0 | Single operating mode | ||
| Thermal Index less than 1.0 | |||
| Mechanical Index less than 1.0 | Identical | ||
| Localization | |||
| Output | Frequency: Variable 15 kHz to 50 kHz | ||
| Maximum current: 1.2mA RMS | Frequency: Variable 30 kHz to 60 kHz | ||
| Maximum current: 2.2mA/cm2 | Identical | ||
| ECG & EGM | |||
| Input | Bandwidth: 0.05 Hz to 500 Hz | ||
| Resolution: +/-1uV | |||
| Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.1 Hz to 500 Hz | ||
| Resolution: +/-10uV | |||
| Timing Accuracy: +/-1.6 microsecond | Identical |
8
9
10
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial
Equivalence | | |
|-----------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------|--|--|
| | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 | AcQMap® High Resolution Imaging and Mapping
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
Interface
Box | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical | | |
| AcQRef Introducer
Sheath or Electrical
Reference Catheter | 1, 2mm female, yellow, Defibrillator Protected Type
CF | 1, 2mm female, yellow, Defibrillator Protected Type
CF | Identical | | |
| Localization
Reference
Electrodes | 6, 2-pin, square, multi-color, Defibrillator Protected
Type BF | 6, 2-pin, square, multi-color, Defibrillator Protected
Type BF | Identical | | |
| Patient
Reference
Electrode | 1, 2-pin, square, blue, Defibrillator Protected Type
BF | 1, 2-pin, square, blue, Defibrillator Protected Type
BF | Identical | | |
| Ablation Generator | 10-pin, latching, grey | 10-pin, latching, grey | Identical | | |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator Protected Type
CF | 10-pin, latching, grey, Defibrillator Protected Type
CF | Identical | | |
| Ablation Reference | 1, 2mm, female, black, Defibrillator Protected Type
BF | 1, 2mm, female, black, Defibrillator Protected Type
BF | Identical | | |
| Ablation
Electrogram
Interface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical | | |
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SUBSTANTIAL EQUIVALENCE
The indications for use of the subject device are identical to those of the predicate device. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. The AcQMap System is intended to reconstruct the physiology and display the anatomic and electrical data in the same way. SuperMap slightly modifies the current workflow for regular rhythms by allowing the user to efficiently collect significantly more electrical data by roving the device throughout the chamber and aligning the electrical data from multiple positions to a timing reference.
Specifically, the updates to the mapping software allow the user to gather more data with regular rhythms. Since the catheter is already roved during the gathering of the anatomy data, clinical data and performance evaluation data for the original device is sufficient to demonstrate safety and efficacy of the modified workflow with the required characteristics and performance. Thus, the modified AcQMap High Resolution Imaging and Mapping System, Model 900100, is substantially equivalent to the predicate device.
Performance Data [807.92(b)]
All necessary bench testing was conducted on the modified AcQMap System to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap System (KI70948) and is incorporated by reference. No further clinical testing is required to support the subject device.
Nonclinical Testing Summary [807.92(b)(1)]
The necessary bench testing was performed on the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.
The following bench testing was repeated for the modified device:
- . Software Verification and Validation
- . SuperMap Mapping Validation Testing Animal Study
- Clinical Simulation (Reliability) .
- Map Accuracy Testing .
The balance of testing is incorporated by reference to the original AcQMap System 510(k), includes the following:
- . Transportation Testing
- . AcQMap Verification Testing
- . System Accuracy Testing
- . Electromagnetic Compatibility and Electrical Safety Testing
- . AcQMap Catheter Validation Testing-Animal Study
- . Accuracy Validation Testing Animal Study
The modified AcQMap High Resolution Imaging and Mapping System, Model 900100 was tested to verify that the device meets the established performance specifications. The collective results of the testing
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demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use.
The collective results of the nonclinical testing, either repeated for the modified device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen, the manufacturing processes, and design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
Clinical Testing Summary [807.92(b)(2)]
As discussed above, no further clinical testing is required to support the modified AcQMap High Resolution Imaging and Mapping System, Model 900100. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrated that the AcQMap System is safe and effective for its intended use.
Conclusions [807.92(b)(3)]
Extensive nonclinical performance testing, either repeated for the modified device or incorporated by reference to the original AcQMap System 510(k), was conducted on the AcQMap High Resolution Imaging and Mapping System, Model 900100 to evaluate the overall performance of the device. The clinical validation of the original AcQMap System (K170948) is applicable to the modified device. The collective results demonstrate that the modified AcQMap System, Model 900100 is safe and effective for its intended use.
SUMMARY
Based on the performance testing and the technological characteristics, it can be concluded that the modified AcQMap® High Resolution Imaging and Mapping System, Model 900100 is safe and effective for its intended use and is substantially equivalent to the predicate device.