(106 days)
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 High Resolution Imaging and Mapping System 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 ("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 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). 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 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. There are no changes to the current mapping data. The modifications to the AcQMap System includes: The addition of a corresponding mV scale in the color bar of charge density amplitude maps; This is an optional tool to provide the physician with a familiar quantitative metric for signal amplitude that may be used to aid the physician's interpretation of the data. User-initiated system checks for common connection errors such as cable disconnections and patch placement locations; This is an optional tool to provide an on-demand assessment of systemmeasured data that may aid the user in troubleshooting of common connection errors. An improvement to the generation of the anatomic surface from ultrasound points; This improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user. This improvement also has the potential to preserve anatomic detail in the resulting shell with the reduction of the geometric artifacts. There are no changes to the current method of ultrasound data gathering or the type of data gathered.
The provided document describes the AcQMap® High Resolution Imaging and Mapping System (K220784) and its substantial equivalence to a predicate device (K212345).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
Important Note: This submission is for a modification to an already cleared device, asserting substantial equivalence to the previously cleared version. Therefore, much of the performance and clinical data is incorporated by reference from the original clearance (K170948). The current submission focuses on verifying that the modifications do not introduce new safety or effectiveness concerns.
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a table of specific acceptance criteria (e.g., specific accuracy thresholds for cardiac chamber reconstruction or electrical mapping). Instead, it relies on demonstrating that the modified device conforms to design specifications and does not raise different questions of safety or effectiveness compared to the predicate device.
The document implicitly uses the performance of the predicate device (K212345, which itself relied on K170948) as the baseline for "acceptance." The modifications are described as improvements for "ease-of-use" and to reduce artifacts, without changing the underlying mapping data.
The relevant "performance" reported for the modified device is its conformance to established specifications through verification and validation testing, as detailed in the nonclinical summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to design specifications. | Verified through Software V/V, Electromagnetic and Electrical Safety Verification, Accuracy Testing (repeated for modified device) |
| Performance of anatomical surface generation from ultrasound points. | "This improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user." |
| No new safety or effectiveness questions raised by modifications. | Demonstrated by nonclinical testing and comparison to predicate device. |
| Clinical performance for indications for use (incorporated by reference). | Results from DDRAMATIC-SVT study (K170948) demonstrated substantial equivalence. |
2. Sample size used for the test set and the data provenance
For the modifications in this specific K220784 submission:
- Sample Size: Not applicable in the traditional sense for a clinical test set, as the focus was on nonclinical verification of the modifications.
- Data Provenance: The document does not specify a separate "test set" for the modifications in terms of patient data. The nonclinical bench testing would use various test data as part of software verification/validation and system accuracy testing.
For the original AcQMap System (K170948), which established the clinical effectiveness and is incorporated by reference:
- Sample Size: 84 patients
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated for the nonclinical testing of the modifications. For the clinical study (DDRAMATIC-SVT), the "ground truth" would be established by the clinicians (e.g., electrophysiologists) performing and interpreting the procedures, but specific expert count or qualifications aren't provided in this summary.
4. Adjudication method for the test set
Not explicitly stated. Given that the modified device's clinical performance is based on an incorporated-by-reference study (DDRAMATIC-SVT) which demonstrated substantial equivalence, specific adjudication methods for a novel clinical test set of the modified device are not detailed as no new clinical study was required for this particular submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not explicitly mentioned or described. The AcQMap System is a diagnostic and mapping system, not specifically an AI-driven interpretation tool in the context of "human readers improving with AI assistance." Its primary function is to visualize chamber anatomy and electrical impulses, guiding physician decisions.
- Effect Size: Not applicable in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The AcQMap System is described as a "diagnostic recording system" that aids physicians by providing "information about the electrical activity of the heart and about catheter location during the procedure." While it performs automated tasks like 3D reconstruction and mapping, it is presented as a tool for physician use, not a standalone diagnostic AI. Therefore, a standalone algorithm-only performance study in the absence of human interpretation isn't directly relevant to its intended use as described. The system generates data and visualizations that physicians interpret.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study (DDRAMATIC-SVT) incorporated by reference, the "ground truth" for evaluating the system's ability to identify complex arrhythmias and guide procedures would likely be clinical outcomes and expert interpretation of the electrical maps and other diagnostic information generated by the system during electrophysiology procedures. The document states the study "demonstrated that the AcQMap System is substantially equivalent to the predicate device," implying its ability to accurately guide diagnosis and therapy, which would be based on clinical judgment and observed therapeutic success.
For the nonclinical testing for the modifications, ground truth would be established by design specifications and known physical/electrical properties for accuracy validation.
8. The sample size for the training set
The document does not mention a "training set" in the context of machine learning. The AcQMap system is a diagnostic imaging and mapping system, not described as being based on machine learning from a training dataset in the same way an AI diagnostic algorithm might be. The "improvements to the generation of the anatomic surface from ultrasound points" are described as an algorithm refinement, but no training set details are provided.
9. How the ground truth for the training set was established
Not applicable as no "training set" is described for this device in the context of machine learning.
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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 1, 2022
Acutus Medical, Inc. Karla Schaffner Regulatory Affairs Manager 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K220784
Trade/Device Name: AcQMap® High Resolution Imaging and Mapping System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: May 20, 2022 Received: May 23, 2022
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
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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 and Part 809 ); medical device reporting (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 medical devices and radiation-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,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K220784
Device Name
AcQMap® High Resolution Imaging and Mapping System
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 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.
| 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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510(K) NOTIFICATION K
GENERAL INFORMATION [807.92(a)(1)]
Date Prepared: 30 June 2022
| Applicant: | Contact Person: |
|---|---|
| Acutus Medical, Inc. | Sindhu Sridhar |
| 2210 Faraday Ave., Suite 100 | Regulatory Affairs Manager |
| Carlsbad, CA 92008 | Acutus Medical, Inc. |
| USA | 2210 Faraday Ave., Suite 100 |
| Phone: 1-442-232-6080 | Carlsbad, CA 92008 |
| Fax: 1-442-232-6081 | USA |
| Phone: 1-442-999-7630 | |
| Email: sindhu.sridhar@acutus.com |
DEVICE INFORMATION [807.92(a)(2)]
| Trade Name: | AcQMap® High Resolution Imaging and Mapping System |
|---|---|
| Generic/Common Name: | Programable diagnostic computer andUltrasonic pulsed echo imaging system |
| Classification: | Class II / 21 CFR § 870.1425 andClass II / 21 CFR § 892.1560 |
| Product Code(s): | DQK, IYO, ITX |
PREDICATE DEVICE [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQMap High Resolution Imaging andMapping System | Acutus Medical, Inc. | K212345 |
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQMap High Resolution Imaging and Mapping System 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 ("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.
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The AcOMap System hardware consists of three functional subsystems:
- . Ultrasound imaging,
- . ECG and EGM recording; and
- . Impedance based electrode Localization.
The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). 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 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.
There are no changes to the current mapping data. The modifications to the AcQMap System includes:
- . The addition of a corresponding mV scale in the color bar of charge density amplitude maps; This is an optional tool to provide the physician with a familiar quantitative metric for signal amplitude that may be used to aid the physician's interpretation of the data.
- User-initiated system checks for common connection errors such as cable disconnections and patch . placement locations; This is an optional tool to provide an on-demand assessment of systemmeasured data that may aid the user in troubleshooting of common connection errors.
- An improvement to the generation of the anatomic surface from ultrasound points; This . improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user. This improvement also has the potential to preserve anatomic detail in the resulting shell with the reduction of the geometric artifacts. There are no changes to the current method of ultrasound data gathering or the type of data gathered.
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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 1 and 2 provides a comparison of the modified AcQMap System classification for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.
| Table 1. Comparison of Classification with the Predicate Device | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| AcQMap® HighResolution Imaging andMapping System | AcQMap® HighResolution Imaging andMapping System | ||
| 510(k) Number | K220784 | K212345 | -- |
| Classification/RegulationNumber/Regulation Name/Product Code | Class II/ 21 CFR §870.1425/ Programablediagnostic computer/DQKClass II/ 21 CFR §892.1560/ Ultrasonicpulsed echo imagingsystem/ IYO, ITX | Class II/ 21 CFR §870.1425/ Programablediagnostic computer/DQKClass II/ 21 CFR §892.1560/ Ultrasonicpulsed echo imagingsystem/ IYO, ITX | Identical |
| Table 2. Comparison of Indications for Use with the Predicate Device | |||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence |
| AcQMap® High Resolution Imaging andMapping System | AcQMap® High Resolution Imaging andMapping System | ||
| 510(k) Number | K220784 | K212345 | |
| Indications forUse | The AcQMap System is intended for use inpatients for whom electrophysiology procedureshave been prescribed. | The AcQMap System is intended for use inpatients for whom electrophysiology procedureshave been prescribed. | Identical |
| When used with the AcQMap Catheters, theAcQMap System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizing thechamber anatomy and displaying electricalimpulses as either charge density-based orvoltage-based maps of complex arrhythmias thatmay be difficult to identify using conventionalmapping systems alone.AND | When used with the AcQMap Catheters, theAcQMap System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizing thechamber anatomy and displaying electricalimpulses as either charge density-based orvoltage-based maps of complex arrhythmias thatmay be difficult to identify using conventionalmapping systems alone.AND | ||
| When used with the specified Patient Electrodes,the AcQMap System is intended to display theposition of AcQMap Catheters and conventionalelectrophysiology (EP) catheters in the heart.OR | When used with the specified Patient Electrodes,the AcQMap System is intended to display theposition of AcQMap Catheters and conventionalelectrophysiology (EP) catheters in the heart.OR | ||
| When used with conventional electrophysiologycatheters, the AcQMap System providesinformation about the electrical activity of theheart and about catheter location during theprocedure. | When used with conventional electrophysiologycatheters, the AcQMap System providesinformation about the electrical activity of theheart and about catheter location during theprocedure. | ||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||
| Subject Device | Predicate Device | ||
| Characteristics | AcQMap® High Resolution Imaging and MappingSystem | AcQMap® High Resolution Imaging and MappingSystem (K212345) | Rationale for SubstantialEquivalence |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical |
| Testing to SupportSubstantialEquivalence | 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 | Identical |
| System SafetyStandards | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | Identical. |
| Physical Characteristics | |||
| SystemComponents | 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 | 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 | The subject device includesadditional Carto ForceAdapter cable. The CartoForce Adapter Cable is usedin conjunction with theSmartAblate Generator tosupport SmartTouchnavigation to the AcQMapSystem. The SmartAblateGenerator was cleared touse with AcQMap system in |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence |
| AcQMap® High Resolution Imaging and MappingSystem | AcQMap® High Resolution Imaging and MappingSystem (K212345) | ||
| Patient Electrode Kit Ampere generator adapter SmartAblate generator adapter Maestro generator adapter Adapter Cable- Short - Ablation Adapter Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable – Generator Carto Force Adapter Cable | Ampere generator adapter SmartAblate generator adapter Maestro generator adapter Adapter Cable- Short - Ablation Adapter Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable - Generator | the predicate 510kK212345. | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | |||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence |
| Visual/MappingCharacteristics | 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. | 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 |
| VisualizationDevice/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 SubstantialEquivalence |
| AcQMap® High Resolution Imaging and MappingSystem | AcQMap® High Resolution Imaging and MappingSystem, Model 900000 (K212345) | ||
| System Specifications | |||
| SafetyInformation | IEC 60601-1, Class I, Type Defibrillator Protected CF,continuous operation, no sterilization, equipment notsuitable for use in the presence of a flammableanesthetic mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type Defibrillator ProtectedCF, continuous operation, no sterilization, equipmentnot suitable for use in the presence of a flammableanesthetic mixture with air, oxygen or nitrous oxide | Identical |
| IngressProtection | The Console is rated IP20 | The Console is rated IP20 | Identical |
| Functional and Performance Characteristics | |||
| UltrasoundOutput | Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-pMaximum Power: 1 W peak | Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-pMaximum Power: 1 W peak | Identical |
| UltrasoundPerformance | Single operating modeThermal Index less than 1.0Mechanical Index less than 1.0 | Single operating modeThermal Index less than 1.0Mechanical Index less than 1.0 | Identical |
| LocalizationOutput | Frequency: Variable 15 kHz to 50 kHzMaximum current: 1.2mA | Frequency: Variable 15 kHz to 50 kHzMaximum current: 1.2mA | Identical |
| ECG & EGMInput | Bandwidth: 0.05 Hz to 500 HzResolution: +/-1uVTiming Accuracy: +/-1.6 microsecond | Bandwidth: 0.05 Hz to 500 HzResolution: +/-1uVTiming Accuracy: +/-1.6 microsecond | Identical |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | |||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence |
| AcQMap® High Resolution Imaging and MappingSystem | AcQMap® High Resolution Imaging and MappingSystem, Model 900000 (K212345) | ||
| 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 InterfaceBox | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical |
| AcQRef IntroducerSheath or ElectricalReference Catheter | 1, 2mm female, yellow, Defibrillator Protected TypeCF | 1, 2mm female, yellow, Defibrillator Protected TypeCF | Identical |
| LocalizationReferenceElectrodes | 6, 2-pin, square, multi-color, Defibrillator ProtectedType BF | 6, 2-pin, square, multi-color, Defibrillator ProtectedType BF | Identical |
| PatientReferenceElectrode | 1, 2-pin, square, blue, Defibrillator Protected TypeBF | 1, 2-pin, square, blue, Defibrillator Protected TypeBF | Identical |
| Ablation Generator | 10-pin, latching, grey | 10-pin, latching, grey | Identical |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator Protected TypeCF | 10-pin, latching, grey, Defibrillator Protected TypeCF | Identical |
| Ablation Reference | 1, 2mm, female, black, Defibrillator Protected TypeBF | 1, 2mm, female, black, Defibrillator Protected TypeBF | Identical |
| AblationElectrogramInterface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical |
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ACQMAP® HIGH RESOLUTION IMAGING AND MAPPING SYSTEM
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ACQMAP® HIGH RESOLUTION IMAGING AND MAPPING SYSTEM
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ACQMAP® HIGH RESOLUTION IMAGING AND MAPPING SYSTEM
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SUBSTANTIAL EQUIVALENCE
The AcQMap System is intended to reconstruct the physiology the anatomic and electrical data in the same way. These modifications are to improve the ease-of-use of some system capabilities. The updates to the mapping software includes:
- . The addition of a corresponding mV scale in the color bar of charge density amplitude maps;
- . User-initiated system checks for common connection errors such as cable disconnections and patch placement locations:
- An improvement to the generation of the anatomic surface from ultrasound points; .
These modifications are to improve the ease-of-use of some system capabilities. There are no changes to the current mapping data. 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. Thus, the modified AcQMap High Resolution Imaging and Mapping System, 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 (K170948) 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 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
The balance of testing is incorporated by reference to the original AcQMap System 510(k), includes the following: -
· Transportation Testing
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· AcQMap Verification Testing
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System Accuracy Testing
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· Electromagnetic Compatibility and Electrical Safety Testing
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AcQMap Catheter Validation Testing-Animal Study
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· Accuracy Validation Testing Animal Study
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The modified AcQMap High Resolution Imaging and Mapping System was tested to verify that the device meets the established performance specifications. The collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging System 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 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. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Divole 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 substantially equivalent to the predicate device.
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 to evaluate the overall performance of the clinical validation of the original AcQMap System (K170948) is applicable to the modified device. The collective results demonstrate that the modified AcQMap System is substantially equivalent to the predicate device.
SUMMARY
Based on the performance testing and the technological characteristics, it can be concluded that the modified AcQMap® High Resolution Imaging and Mapping System is substantially equivalent to the predicate device.
§ 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).