(84 days)
The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap High Resolution Imaging and Mapping 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 High Resolution Imaging 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 High Resolution Imaging 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 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 High Resolution Imaging and Mapping System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording; and Impedance based electrode Localization. The AcQMap High Resolution Imaging and Mapping System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 (cleared under K201341). The AcQMap High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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. The modifications to the AcQMap High Resolution Imaging System include the addition of new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and DiamondTemp™ Ablation Generator.
Below is an analysis of the provided text regarding the AcmMap High Resolution Imaging and Mapping System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) submission does not specify numerical acceptance criteria for the device's performance regarding imaging, mapping accuracy, or specific clinical outcomes. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (AcQMap High Resolution Imaging and Mapping System, K220784) and the original version of the system (K170948).
Therefore, the "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly to the predicate/original device and meets established non-clinical performance specifications.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Non-clinical Performance: Meets design specifications, including: | The modified device met all established performance specifications. The collective results of nonclinical testing demonstrate that the materials, manufacturing processes, and design meet established specifications for consistent performance. |
| - Third party system Compatibility | Successfully demonstrated. |
| - System RF Attenuation characterization | Successfully demonstrated. |
| - Therapeutic Waveform Fidelity Assessment | Successfully demonstrated. |
| - Safety Testing | Successfully demonstrated. |
| - Packaging Testing | Successfully demonstrated. |
| - Inspection and Labeling Review | Successfully demonstrated. |
| - Common Mode Choke (CMC) performance verification Testing | Successfully demonstrated. |
| - Transportation Testing (incorporated by reference) | Successfully demonstrated. |
| - AcQMap High Resolution Imaging and Mapping Verification Testing (incorporated by reference) | Successfully demonstrated. |
| - System Accuracy Testing (incorporated by reference) | Successfully demonstrated. |
| - Electromagnetic Compatibility and Electrical Safety Testing (incorporated by reference) | Successfully demonstrated. |
| - Map Accuracy Evaluation (incorporated by reference) | Successfully demonstrated. |
| - In-vitro Localization Accuracy Study (incorporated by reference) | Successfully demonstrated. |
| Clinical Performance: Substantially equivalent to predicate device (K170948) regarding intended use and clinical outcomes for complex arrhythmias. | The original AcQMap High Resolution Imaging and Mapping System (K170948) demonstrated substantial equivalence in a clinical study with 84 patients, which is incorporated by reference. The modified device's indications for use are identical, and modifications do not raise new safety or effectiveness concerns. |
Note: The document explicitly states "The collective results of the nonclinical testing... demonstrate that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device." This implies the performance is at least equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Nonclinical Testing Test Set (Modified Device): Not explicitly stated as a number of devices. The description implies testing was conducted on "the modified AcQMap High Resolution Imaging and Mapping System" to verify specifications. It's likely one or a few units were tested for each specific bench test (e.g., RF attenuation, waveform fidelity).
- Clinical Testing Test Set (Original Device, K170948, incorporated by reference): "84 patients".
- Data Provenance (Clinical Study): "prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S." This indicates the data is prospective and from international sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided document does not specify the number or qualifications of experts for establishing ground truth.
- For the nonclinical bench testing, "ground truth" would be engineering specifications and measurements.
- For the clinical study (DDRAMATIC-SVT), it's a study on "Assesment of Therapy In Complex Supraventricular Tachycardia," suggesting clinical outcomes and electrophysiological assessments would be the standard. The direct role of external experts in establishing "ground truth" as a separate process from the study conduct itself is not detailed. Standard clinical trials rely on physician diagnoses and assessments, but the specific process for ground truth establishment by an independent panel is not mentioned.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set, either for nonclinical testing or for the clinical study incorporated by reference. Clinical trials usually involve endpoint adjudication, but the details are not included here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned. The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study designed to assess the performance of the original AcQMap System (K170948) and demonstrate its substantial equivalence. It does not appear to be a study comparing human readers with and without AI assistance to measure an effect size.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The document primarily focuses on the system as a diagnostic recording system, capable of imaging, navigation, and mapping for use by physicians to identify sources of arrhythmia. The outputs (3-D reconstructions, electrical maps, catheter positions, waveforms) are intended to assist physicians.
While there are "System Accuracy Testing" and "Map Accuracy Evaluation" as part of the non-clinical testing, these likely assess the technical accuracy of the algorithms in generating mapping data against defined inputs, rather than an "algorithm only" clinical performance study in the sense of making diagnostic decisions without human interpretation. The system is designed to provide information to the clinician, not to make a standalone diagnosis.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Nonclinical Testing: Engineering specifications, physical measurements, and established safety standards (
IEC 60601-1,IEC 60601-1-2,IEC 62366-1, etc.) would serve as ground truth for these tests. - Clinical Study (DDRAMATIC-SVT): The study title "Assessment of Therapy In Complex Supraventricular Tachycardia" suggests the ground truth would involve clinical outcomes related to the diagnosis and treatment of arrhythmias, likely including electrophysiological assessments and patient responses to therapy. The specifics of how "ground truth" was established (e.g., confirmed arrhythmia diagnosis by an independent panel, successful ablation outcomes) are not detailed in this excerpt.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. The device is described as "Programable diagnostic computer and Ultrasonic pulsed echo imaging system," but the application is for a modification to an existing system (adding connectivity accessories). The previous versions of the system (K220784 predicate and K170948 original) would have undergone validation, but whether a machine learning model with a distinct "training set" was used for the core mapping functionalities is not specified in this document. Given the nature of previous predicate devices for mapping systems, it's less likely to be a deep learning model requiring a large training set in the modern AI sense, and more likely based on signal processing and physics-based reconstruction algorithms.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned for an AI/ML component, the method for establishing its ground truth is not described. For traditional signal processing and reconstruction algorithms, "ground truth" during development often comes from simulated data, phantom studies, and expert-validated real-world data used for algorithm design and initial tuning. These details are not in the provided document.
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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 is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 17, 2022
Acutus Medical, Inc. Subhadra Elango Senior Specialist, Regulatory Affairs 2210 Faraday Ave., Suite 100 Carlsbad, California 92008
Re: K222209
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: July 22, 2022 Received: July 25, 2022
Dear Subhadra Elango:
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); 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 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) K22209
Device Name
AcQMap High Resolution Imaging and Mapping System
Indications for Use (Describe)
The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcOMap High Resolution Imaging and Mapping 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 AcOMap High Resolution Imaging 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 AcOMap High Resolution Imaging 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 K222209
GENERAL INFORMATION [807.92(a)(1)]
Date Prepared: 17 October 2022
| Applicant: | Contact Person: |
|---|---|
| Acutus Medical, Inc.2210 Faraday Ave., Suite 100Carlsbad, CA 92008USAPhone: 1-442-232-6080Fax: 1-442-232-6081 | Subhadra ElangoSenior Specialist, Regulatory AffairsAcutus Medical, Inc.2210 Faraday Ave., Suite 100Carlsbad, CA 92008USAPhone: 1-442-999-7630Email: Subhadra.elango@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 § 870.1425Class 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 ResolutionImaging and Mapping System | Acutus Medical, Inc. | K220784 |
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 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 High Resolution Imaging and Mapping System hardware consists of three functional subsystems:
- Ultrasound imaging, .
- ECG and EGM recording; and
- . Impedance based electrode Localization.
The AcQMap High Resolution Imaging and Mapping System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 (cleared under K201341). The AcQMap High Resolution Imaging and Mapping System provides:
- 3-D cardiac chamber reconstruction Contact and non-contact (ultrasound), ●
K222209
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- . 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 High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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.
The modifications to the AcQMap High Resolution Imaging System include the addition of new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and DiamondTemp™ Ablation Generator.
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INDICATIONS FOR USE [807.92(A)(5)]
The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping System classification and indications for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap High Resolution Imaging and Mapping System against the predicate device.
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence | ||
|---|---|---|---|---|---|
| AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System(K220784) | Rationale for Substantial Equivalence | ||
| 510(k) Number | K222209 | K220784 | -- | ||
| Classification/ | Class II | Class II | Identical | ||
| Regulation | 21 CFR § 870.1425,Programable diagnosticcomputer21 CFR § 892.1560,Ultrasonic pulsed echoimaging system | 21 CFR § 870.1425,Programable diagnosticcomputer21 CFR § 892.1560,Ultrasonic pulsed echoimaging system | Identical | ||
| Product Code | DQK, IYO, and ITX | DQK, IYO, and ITX | Identical | ||
| Table 2: Comparison of Indications for Use with the Predicate Device | |||||
| Characteristics | Subject DeviceAcQMap® High Resolution Imaging andMapping System | Predicate DeviceAcQMap® High Resolution Imaging andMapping System (K220784) | Rationale for SubstantialEquivalence | ||
| Indications for Use | The AcQMap High Resolution Imaging andMapping System is intended for use inpatients for whom electrophysiologyprocedures have been prescribed.When used with the AcQMap Catheters,the AcQMap High Resolution Imaging andMapping System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizingthe chamber anatomy and displayingelectrical impulses as either charge density-based or voltage-based maps of complexarrhythmias that may be difficult to identifyusing conventional mapping systems alone.ANDWhen used with the specified PatientElectrodes, the AcQMap High ResolutionImaging and Mapping System is intended todisplay the position of AcQMap Cathetersand conventional electrophysiology (EP)catheters in the heart.ORWhen used with conventionalelectrophysiology catheters, the AcQMapHigh Resolution Imaging and MappingSystem provides information about theelectrical activity of the heart and aboutcatheter location during the procedure. | The AcQMap System is intended for use inpatients for whom electrophysiologyprocedures have been prescribed.When used with the AcQMap Catheters,the AcQMap System is intended to be usedto reconstruct the selected chamber fromultrasound data for purposes of visualizingthe chamber anatomy and displayingelectrical impulses as either charge density-based or voltage-based maps of complexarrhythmias that may be difficult to identifyusing conventional mapping systems alone.ANDWhen used with the specified PatientElectrodes, the AcQMap System is intendedto display the position of AcQMapCatheters and conventionalelectrophysiology (EP) catheters in theheart.ORWhen used with conventionalelectrophysiology catheters, the AcQMapSystem provides information about theelectrical activity of the heart and aboutcatheter location during the procedure. | Identical, with the exception ofdevice trade name. | ||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence | ||
| AcQMap® High Resolution Imaging andMapping System | AcQMap® High Resolution Imaging andMapping System (K220784) | ||||
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical | ||
| Testing toSupportSubstantialEquivalence | Software V/VElectromagnetic and Electrical SafetyVerification Testing,Accuracy Testing, andAnimal Testing | Software V/VElectromagnetic and Electrical SafetyVerification Testing,Accuracy Testing, andAnimal Testing | Identical | ||
| System SafetyStandards | IEC 60601-1:2005 / A1:2012IEC 60601-1-2:2014IEC 62366-1: 2015IEC 60601-2-25:2015IEC 60601-2-37:2015 | IEC 60601-1:2005 / A1:2012IEC 60601-1-2:2014IEC 62366-1: 2015IEC 60601-2-25:2015IEC 60601-2-37:2015 | Identical | ||
| Physical Characteristics | |||||
| SystemComponents &Accessories | ConsoleWorkstationWorkstation CableAuxiliary Interface BoxECG Input CableAmpere Ablation Catheter Adapter CableAmpere RF Generator Adapter CableECG Output CableAblation Reference CableAblation Electrogram CableECG w/Snaps CableECG POST Cable2mm Pin Jumper SetPatient Electrode KitAmpere Generator AdapterSmartAblate Generator AdapterMaestro Generator AdapterAdapter Cable- Short - Ablation Adapter | ConsoleWorkstationWorkstation CableAuxiliary Interface BoxECG Input CableAmpere Ablation Catheter Adapter CableAmpere RF Generator Adapter CableECG Output CableAblation Reference CableAblation Electrogram CableECG w/Snaps CableECG POST Cable2mm Pin Jumper SetPatient Electrode KitAmpere Generator AdapterSmartAblate Generator AdapterMaestro Generator AdapterAdapter Cable- Short - Ablation Adapter | All system componentsare identical, except thenew accessories.Verification testing onthe new accessoriesdemonstrates that theAcQMap HighResolution Imaging andMapping System andthe new accessoriesperform as intended.There are no differentquestions of safety oreffectiveness. | ||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence | ||
| AcQMap® High Resolution Imaging andMapping System | AcQMap® High Resolution Imaging andMapping System (K220784) | ||||
| Adapter Cable- Long - Ablation AdapterSmartAblate Adapter Cable - CatheterMaestro Adapter Cable - CatheterMaestro Adapter Cable – GeneratorCarto Force Adapter CableDiamondTemp Generator AdapterDiamondTemp Adapter Cable – Generator | Adapter Cable- Long - Ablation AdapterSmartAblate Adapter Cable - CatheterMaestro Adapter Cable - CatheterMaestro Adapter Cable - GeneratorCarto Force Adapter Cable | ||||
| Visual/MappingCharacteristics | 3-D cardiac chamber reconstructions –Contact and non-contact (ultrasound);Three-dimensional position of the AcQMapCatheter and conventional electrophysiologycatheters;Cardiac electrical activity as waveform traces;Contact LAT and voltage amplitude maps;Remapping of the chamber at any time duringthe procedure;Dynamic, three-dimensional, Charge Densitymaps overlaid on the cardiac chamberreconstruction to show chamber-wideelectrical activation. | ||||
| VisualizationDevice/Catheter | |||||
| Weight | |||||
| Maximum | |||||
| PowerRequirement | 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 | |||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||||
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence | ||
| Fuse protection | AcQMap® High Resolution Imaging andMapping System | AcQMap® High Resolution Imaging andMapping System (K220784) | 250 V, 6.3A, two high breaking capacity fuses | ||
| System Specifications | 250 V, 6.3A, two high breaking capacity fuses | 250 V, 6.3A, two high breaking capacity fuses | |||
| SafetyInformation | IEC 60601-1, Class I, Type DefibrillatorProtected CF, continuous operation, nosterilization, equipment not suitable for use inthe presence of a flammable anestheticmixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type DefibrillatorProtected CF, continuous operation, nosterilization, equipment not suitable for use inthe presence of a flammable anestheticmixture 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 & EGM Input | 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 | ||
| Front Panel Connections | |||||
| AcQMapCatheter | Custom, black, Defibrillator Protected Type CF | Custom, black, Defibrillator Protected Type CF | Identical | ||
| ECG Input | 12-pin, latching, red, Defibrillator ProtectedType BF | 12-pin, latching, red, Defibrillator ProtectedType BF | Identical | ||
| ECG Output | 14-pin, latching, blue | 14-pin, latching, blue | Identical | ||
| AuxiliaryInterface Box | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical | ||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||||
| Characteristics | Subject DeviceAcQMap® High Resolution Imaging andMapping System | Predicate DeviceAcQMap® High Resolution Imaging andMapping System (K220784) | Rationale for SubstantialEquivalence | ||
| AcQRefIntroducerSheath orElectricalReferenceCatheter | 1, 2mm female, yellow, Defibrillator ProtectedType CF | 1, 2mm female, yellow, Defibrillator ProtectedType CF | Identical | ||
| LocalizationReferenceElectrodes | 6, 2-pin, square, multi-color, DefibrillatorProtected Type BF | 6, 2-pin, square, multi-color, DefibrillatorProtected Type BF | Identical | ||
| PatientReferenceElectrode | 1, 2-pin, square, blue, Defibrillator ProtectedType BF | 1, 2-pin, square, blue, Defibrillator ProtectedType BF | Identical | ||
| AblationGenerator | 10-pin, latching, grey | 10-pin, latching, grey | Identical | ||
| AblationCatheter | 10-pin, latching, grey, Defibrillator ProtectedType CF | 10-pin, latching, grey, Defibrillator ProtectedType CF | Identical | ||
| AblationReference | 1, 2mm, female, black, Defibrillator ProtectedType BF | 1, 2mm, female, black, Defibrillator ProtectedType BF | Identical | ||
| AblationElectrogramInterface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical |
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Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008
Page 4 of 10
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SUBSTANTIAL EQUIVALENCE
The AcQMap High Resolution Imaging and Mapping System is intended to reconstruct the physiology and display the anatomic and electrical data in the same way. These modifications are to include new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and the DiamondTemp Ablation Generator. 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 High Resolution Imaging and Mapping System to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap High Resolution Imaging and Mapping 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:
- . Third party system Compatibility with AcQMap High Resolution Imaging and Mapping System, Model 900100 Testing
- . System RF Attenuation characterization
- Therapeutic Waveform Fidelity Assessment
- Safety Testing
- Packaging Testing
- Inspection and Labeling Review
- Common Mode Choke (CMC) performance verification Testing
The balance of testing is incorporated by reference to the original AcQMap High Resolution Imaging and Mapping System 510(k), includes the following:
- Transportation Testing
- AcQMap High Resolution Imaging and Mapping Verification Testing
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study
- . Accuracy Validation Testing Animal Study
- Software Verification and Validation
- Clinical Simulation (Reliability)
- Map Accuracy Evaluation
- In-vitro Localization Accuracy Study
Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008
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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 High Resolution Imaging 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 High Resolution Imaging and Mapping 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, openlabel study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrated that the AcQMap High Resolution Imaging and Mapping 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 High Resolution Imaging System 510(k), was conducted on the AcQMap High Resolution Imaging and Mapping System to evaluate the overall performance of the device. The clinical validation of the original AcQMap High Resolution Imaging System (K170948) is applicable to the modified device. 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).