(64 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 dipole 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.
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 Model, 900100 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 imaging,
- Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
- Cardiac electrical activity as waveform traces,
- Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcQMap System. Model 900100 is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, workstation and an auxiliary interface box. 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.
The provided text describes a 510(k) premarket notification for the AcQMap High Resolution Imaging and Mapping System, Model 900100. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (AcQMap Model 900000, K170948) rather than presenting a de novo clinical study with specific acceptance criteria and detailed performance of the new device against those criteria.
Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving the device meets them, especially in the context of typical AI/ML device performance metrics (e.g., sensitivity, specificity, AUC), is not explicitly available in the provided document. The document states that "no further clinical testing is required" for the subject device because the clinical testing conducted for the original AcQMap System (K170948) is incorporated by reference.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of quantitative acceptance criteria for the new device (Model 900100) or its specific performance against them. Instead, it relies on the predicate device's prior clearance and demonstrates the new model's substantial equivalence through:
- Identical Indications for Use: The most crucial "acceptance criterion" is that the new device performs identically to the predicate for the same intended use.
- Performance Testing: "Complete performance testing conducted by Acutus demonstrates that the AcQMap System, Model 900100 performs as intended and that there are no different questions of safety or effectiveness." This statement implies that the acceptance criterion for the new device's performance is that it is comparable to the predicate for all evaluated characteristics and that any differences do not introduce new safety or effectiveness concerns.
| Characteristic/Criterion (Inferred) | Reported Device Performance (Model 900100) |
|---|---|
| Identical Indications for Use to Predicate Device | "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 dipole 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." (Identical to Predicate) |
| Safety and Effectiveness Comparable to Predicate Device (No new questions of safety or effectiveness) | "Complete performance testing conducted by Acutus demonstrates that the AcQMap System, Model 900100 performs as intended and that there are no different questions of safety or effectiveness." Differences in physical characteristics (dimensions, weight, power, input current) and some functional characteristics (localization output frequency, ECG & EGM bandwidth/resolution, addition of Auxiliary Interface Box, Defibrillation-Proof features, new cables) are presented as not raising new safety or effectiveness questions, as demonstrated through performance testing. |
| Conformance to Design Specifications | "The collective results of the testing demonstrate that the design of the AcQMap® High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use." |
| Clinical Performance (based on predicate device study): Safe and Effective for Intended Use | "The results for 84 patients demonstrated that the AcQMap System is safe and effective for its intended use." (This refers to the DDRAMATIC-SVT study conducted for the original AcQMap System K170948, which is incorporated by reference.) No specific quantitative metrics like sensitivity/specificity for complex arrhythmia identification are provided in this summary. The device's function is to display electrical impulses and reconstruct chamber anatomy, which likely implies visual and measurement accuracy validated during the predicate's clinical study and confirmed through non-clinical testing for the new device. |
2. Sample Size for Test Set and Data Provenance:
- Test Set (for Model 900100): The primary testing for the Model 900100 involved "bench testing," "verification testing," "accuracy testing," and "animal testing." No specific "test set" in terms of patient data is mentioned for the new device, as it leverages the clinical study for the predicate.
- Clinical Study (for Predicate K170948):
- Sample Size: "84 patients"
- Data Provenance: "prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S." (The specific countries are not mentioned beyond "outside the U.S.") The study was clinical, implying prospective human data collection.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not detail how ground truth was established for the 84-patient clinical study, nor does it mention the number or qualifications of experts involved in establishing it. Given the nature of electrophysiology procedures, it is highly likely that experienced electrophysiologists served as the arbiters of truth (e.g., successful identification of arrhythmia sources, accurate anatomical reconstruction) in the context of the overall procedure outcome.
4. Adjudication Method:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document describes a clinical study for the predicate device that evaluated its safety and effectiveness. It does not explicitly mention an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size for such an improvement. The device's function is more akin to an imaging and mapping tool for electrophysiology procedures, rather than an AI diagnostic algorithm assisting human readers in interpreting images.
6. Standalone Performance (Algorithm Only):
- The document describes the performance of the "AcQMap System" itself, which is a diagnostic recording system including software and hardware. The "Algorithm" is integrated into the system for "displaying electrical impulses as either dipole density-based or voltage-based maps" and "reconstructing the selected chamber from ultrasound data." The "performance data" section focuses on the system as a whole (e.g., "System Accuracy Testing", "Software Verification and Validation"). No separate "algorithm-only" performance is detailed, as the algorithm's utility is tied to its display and mapping functions within the system.
7. Type of Ground Truth Used:
- For the predicate device's clinical study (DDRAMATIC-SVT), the ground truth would likely be established by the clinical outcomes and procedural success in "identifying the source(s) of the arrhythmia" and successful electrophysiology procedures, based on the expert assessment by the clinicians at the study sites. This would fall under the category of outcomes data and expert clinical assessment. The document states that the study "demonstrated that the AcQMap System is safe and effective for its intended use," implying clinical endpoints.
8. Sample Size for Training Set:
- Not specified. The document does not provide details on the training methodology or data used for any machine learning components within the device.
9. How Ground Truth for Training Set Was Established:
- Not specified. As no training set details are provided, the method of establishing ground truth for it is also unknown from this 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
April 2, 2019
Acutus Medical, Inc. Serena Sanginthirath Senior Regulatory Affairs Specialist 2210 Faraday Ave.. Suite 100 Carlsbad, California 92008
Re: K190131
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 23, 2019 Received: January 28, 2019
Dear Serena Sanginthirath:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mande Yellen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190131
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 chamber anatomy and displaying electrical impulses as either dipole 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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_190131
GENERAL INFORMATION [807.92(a)(1)]
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:
Serena Sanginthirath Senior Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1- 442-232-6178 FAX: 1- 442-232-6081 Email: Serena.Sanginthirath@acutus.com
Date Prepared: January 23, 2019
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
AcQMap® High Resolution Imaging and Mapping System, Model 900100
Generic/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:
DQK, IYO, ITX
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PREDICATE DEVICE [807.92(a)(3)]
AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948)
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 Model, 900100 hardware consists of three functional subsystems:
- Ultrasound imaging, ●
- ECG and EGM recording; and .
- o 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 imaging,
- Three-dimensional position of the AcQMap Catheter and conventional ● electrophysiology catheters,
- Cardiac electrical activity as waveform traces, ●
- 0 Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcOMap System. Model 900100 is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, workstation and an auxiliary interface box. 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.
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 dipole density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
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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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(A)(6)]
The indications for use for the AcQMap® High Resolution Imaging and Mapping System, Model 900100 are identical to the predicate device, AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948).
The technological characteristics of the predicate device are very similar; with only a few minor differences.
Table 1 provides a comparison of the technological characteristics for the AcQMap System, Model 900100 with the predicate device.
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| Subject Device | Predicate Device | ||
|---|---|---|---|
| Characteristics | AcQMap® High Resolution Imaging andMapping System, Model 900100 | AcQMap® High Resolution Imaging andMapping System, Model 900000(K170948) | Rationale for Substantial Equivalence |
| 510(k) Number | TBD | K170948 | N/A |
| Classification/RegulationNumber/RegulationName/Product Code | Class II/21 CFR § 870.1425/Programablediagnostic computer/DQKClass II/21 CFR § 892.1560/Ultrasonicpulsed echo imaging system/IYO, ITX | Class II/21 CFR § 870.1425/Programablediagnostic computer/DQKClass II/21 CFR § 892.1560/Ultrasonicpulsed echo imaging system/IYO, ITX | Same Classification/Regulation |
| Indications for Use | The AcQMap System is intended for use inpatients for whom electrophysiologyprocedures have been prescribed.When used with the AcQMap Catheters, theAcQMap System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizingthe chamber anatomy and displayingelectrical impulses as either dipole densityor voltage maps of complex arrhythmiasthat may be difficult to identify usingconventional 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. | The AcQMap System is intended for use inpatients for whom electrophysiologyprocedures have been prescribed.When used with the AcQMap Catheters, theAcQMap System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizingthe chamber anatomy and displayingelectrical impulses as either dipole 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. | Same Indications for Use |
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Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)
| Characteristics | Subject DeviceAcQMap® High Resolution Imaging andMapping System, Model 900100 | Predicate DeviceAcQMap® High Resolution Imaging andMapping System, Model 900000 (K170948) | Rationale for SubstantialEquivalence |
|---|---|---|---|
| Manufacturer | Acutus Medical, Inc. | Acutus Medical, Inc. | Same Manufacturer |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Same Patient Anatomy |
| 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.• Animal Testing; and• Clinical Testing | Complete performance testingconducted by Acutus demonstrates thatthe AcQMap System, Model 900100performs as intended and that there areno different questions of safety oreffectiveness. |
| System SafetyStandards | • IEC 60601-1:2005 /A1:2012• IEC 60601-1-2:2014• IEC 60601-1-6:2010/A1:2013• IEC 60601-2-25:2015• IEC 60601-2-37:2007 | • IEC 60601-1: 2005 /A1:2012• IEC 60601-2-37: 2007• IEC 60601-1-2: 2007 /AC:2010• IEC60601-1-6:2010 | Same safety standards with complianceto current revisions. Improved safetyby meeting additional relevant standard,IEC 60601-2-25:2011 |
Page 47 of 167
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| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence |
|---|---|---|---|
| AcQMap® High Resolution Imaging andMapping System, Model 900100 | AcQMap® High Resolution Imaging andMapping System, Model 900000 (K170948) | ||
| 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, Patient Electrode Kit. | Console Workstation Workstation Cable Ablation Interface Unit Ablation Interface Unit Cable Auxiliary Catheter Cable Surface ECG Input Cable Patient Interface Unit, Patient Interface Unit Cable Ablation Generator Catheter Adaptor Cables Patient Electrode Kit | The subject device no longer includesthe Patient Interface Unit and theAblation Interface Unit.Based on the performance testconducted, any differences in systemcomponents, as well as the addition ofthe Auxiliary Interface Box, does notraise different questions of safety oreffectiveness. |
| Visual/MappingCharacteristics | 3-D cardiac chamber reconstructionsimaging, Three-dimensional position of theAcQMap Catheter and conventionalelectrophysiology catheters, Cardiac electrical activity as waveformtraces, Remapping of the chamber at any timeduring the procedure; and Three-dimensional, dipole density mapsoverlaid on the cardiac chamberreconstruction to show chamber-wideelectrical activation. | 3-D cardiac chamber reconstructionsimaging, Three-dimensional position of theAcQMap Catheter and conventionalelectrophysiology catheters, Cardiac electrical activity as waveformtraces, Remapping of the chamber at any timeduring the procedure; and Three-dimensional, dipole density mapsoverlaid on the cardiac chamberreconstruction to show chamber-wideelectrical activation. | Same |
Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)
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| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
|---|---|---|---|
| AcQMap® High Resolution Imaging andMapping System, Model 900100 | AcQMap® High Resolution Imaging andMapping System, Model 900000 (K170948) | ||
| VisualizationDevice/Catheter | AcQMap Catheter (electrodes andtransducers, K170819) | AcQMap Catheter (electrodes and transducers,K170819) | Same |
| Console Physical Characteristics | |||
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 68 cm L x 48.3 cm W x 72.6 cm D | Larger dimensions due to inclusion oflocking caster base. The predicatedevice is built with non-locking casters.This slightly larger size accommodatesimprovements in clinical safety. Thedifference in dimensions does not raisesafety or effectiveness as demonstratedthrough performance testing. |
| WeightMaximum | 80 kg | 50 kg | The difference in the maximum weightdoes not raise safety or effectiveness asdemonstrated through performancetesting. |
| PowerRequirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50Hz | 110 – 240 V, 50/60 Hz | The difference in the powerrequirement does not raise safety oreffectiveness, as the power in thesubject device is lower and isdemonstrated through performancetesting. |
| Input Current | 4.6 A | 5A | The difference in the input current doesnot raise safety or effectiveness, as theinput current in the subject device islower and is demonstrated throughperformance testing. |
| Fuse protection | 250 V, 6.3A, two high breaking capacityfuses | 250 V, 6.3 A, two high breaking capacity fuses | Same |
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
Page 49 of 167
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Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
| Characteristics | Subject Device | Predicate Device | Rationale for SubstantialEquivalence |
|---|---|---|---|
| AcQMap® High Resolution Imaging andMapping System, Model 900100 | AcQMap® High Resolution Imaging andMapping System, Model 900000 (K170948) | ||
| System Specifications | |||
| SafetyInformation | IEC 60601-1, Class I, Type DefibrillatorProtected CF, continuous operation, nosterilization, equipment not suitable for usein the presence of a flammable anestheticmixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type CF, continuousoperation, no sterilization, equipment not suitablefor use in the presence of a flammable anestheticmixture with air, oxygen or nitrous oxide | The addition of Defibrillation-Proofdoes not raise safety or effectiveness asdemonstrated through performancetesting. |
| IngressProtection | The Console is rated IP20 | The Console is rated IP20 | Same |
| Functional and Performance Characteristics | |||
| UltrasoundOutput | Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-pMaximum Power: 1 W peak | Frequency: 10 MHz+/-10 kHzMaximum Voltage: 50V p-pMaximum Power: 1 W peak | |
| UltrasoundPerformance | Single operating modeThermal Index less than 1.0Mechanical Index less than 1.0 | Single operating mode AThermal Index less than 1.0Mechanical Index less than 1.0 |
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Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
| Characteristics | Subject DeviceAcQMap® High Resolution Imaging andMapping System, Model 900100 | Predicate DeviceAcQMap® High Resolution Imaging andMapping System, Model 900000 (K170948) | Rationale for SubstantialEquivalence |
|---|---|---|---|
| LocalizationOutput | Frequency: Variable 15 kHz to 50 kHzMaximum current: 1.2mA RMS | Frequency: Variable 30 kHz to 60 kHzMaximum current: 2.2mA/cm2 | The reduction in localization frequencyincreases the input impedance of thelocalization system and improveslocalization accuracy. The differencein localization output does not raisesafety or effectiveness as demonstratedthrough performance testing. |
| ECG & EGMInput | Bandwidth: 0.05 Hz to 500 HzResolution: +/-1uVTiming Accuracy: +/-1.6 microsecond | Bandwidth: 0.1 Hz to 500 HzResolution: +/-10uVTiming Accuracy: +/-1.6 microsecond | The change in bandwidth is to meetinternational standards. The change inresolution improves accuracy of dipoledensity maps. Changes does not raisesafety or effectiveness as demonstratedthrough performance testing. |
| Front Panel Connections | |||
| AcQMapCatheter | Custom, black, Defibrillator Protected TypeCF | 100-pin custom, Type CF | Defibrillation-Proof. The AcQMapCatheter connector is unchanged,system specifications have changed asdiscussed above, and does not raisedifferent questions of safety oreffectiveness as demonstrated throughperformance testing. |
| ECG Input | 12-pin, latching, red, Defibrillator ProtectedType BF | 12-pin, latching, Type BF | Defibrillation-Proof. ECG Inputconnector is unchanged, systemspecifications have changed asdiscussed above, and does not raisedifferent questions of safety oreffectiveness as demonstrated throughperformance testing. |
| ECG Output | 14-pin, latching, blue | -- | The ECG output as a front panelconnection does not raise safety oreffectiveness as demonstrated throughperformance testing. |
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Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
| Subject Device | Predicate Device | Rationale for Substantial | |
|---|---|---|---|
| Characteristics | AcQMap® High Resolution Imaging and | AcQMap® High Resolution Imaging and | Equivalence |
| Mapping System, Model 900100 | Mapping System, Model 900000 (K170948) | ||
| AuxiliaryInterface Box | Custom, green, Defibrillator Protected TypeCF | -- | Defibrillation-Proof. The AcQMapAuxiliary Interface Box providesconnection to the auxiliary catheters(optional) used during the procedure.The AcQMap Auxiliary Interface Boxalso provides amplification of signalscollected from auxiliary catheters andtransfers these signals to the AcQMapConsole for display. A universal bedrail clamp is provided for mounting.The addition of the AcQMap AuxiliaryInterface Box does not raise differentquestions of safety or effectiveness asdemonstrated through performancetesting |
| AcQRefIntroducerSheath orElectricalReferenceCatheter | 1, 2mm female, yellow, DefibrillatorProtected Type CF | 1, 2mm female, Type CF | Defibrillation-Proof. The AcQRefIntroducer Sheath connector isunchanged, system specifications havechanged as discussed above, and doesnot raise different questions of safety oreffectiveness. |
| LocalizationReferenceElectrodes | 6, 2-pin, square, multi-color, DefibrillatorProtected Type BF | 6, 2-pin, square, Type BF | Defibrillation-Proof. The LocalizationReference Electrodes connector areunchanged, system specifications havechanged as discussed above, and doesnot raise different questions of safety oreffectiveness. |
| PatientReferenceElectrode | 1, 2-pin, square, blue, Defibrillator ProtectedType BF | 1, 2-pin, square, Type BF | Defibrillation-Proof. The PatientReference Electrode connector isunchanged, system specifications havechanged as discussed above, and doesnot raise different questions of safety oreffectiveness. |
Page 52 of 167
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| Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.) | |||
|---|---|---|---|
| Characteristics | Subject DeviceAcQMap® High Resolution Imaging andMapping System, Model 900100 | Predicate DeviceAcQMap® High Resolution Imaging andMapping System (K170948) | Rationale for SubstantialEquivalence |
| AblationGenerator | 10-pin, latching, grey | 10-pin, male, Type CF | The Ablation Generator connector isunchanged, system specifications havechanged as discussed above, and doesnot raise different questions of safety oreffectiveness. |
| AblationCatheter | 10-pin, latching, grey, Defibrillator ProtectedType CF | 10-pin, female, Type CF | Defibrillation-Proof. The AblationCatheter connector is unchanged,system specifications have changed asdiscussed above, and does not raisedifferent questions of safety oreffectiveness. |
| AblationReference | 1, 2mm, female, black, DefibrillatorProtected Type BF | -- | Defibrillation-Proof. The ablationreference does not raise differentquestions of safety or effectiveness asdemonstrated through performancetesting. |
| AblationElectrogramInterface | 1, 13-pin, latching, white | -- | This new cable added to the subjectdevice does not raise differentquestions of safety or effectiveness asdemonstrated through performancetesting |
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
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SUBSTANTIAL EQUIVALENCE
The indication for use for the subject device, AcQMap® High Resolution Imaging and Mapping System. Model 900100, is substantially equivalent to the predicate. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the 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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 to support a determination of substantial equivalence to the predicate device. The necessary clinical study was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical study is required to support the subject device.
Nonclinical Testing Summary [807.92(b)(1)]
The necessary bench testing was performed on the AcQMap 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 bench testing, either repeated for the subject device or incorporated by reference to the original AcOMap System 510(k), included the following:
- Transportation Testing ●
- AcOMap Verification Testing ●
- Software Verification and Validation
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study
The 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 demonstrate that the design of the 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 proposed device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen. the manufacturing processes, and design of the AcOMap® 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 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
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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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 or incorporated by reference to the original AcQMap System 510(k), was conducted on the AcQMap System Model, 900100 to evaluate the overall performance of the device. The clinical validation of the original AcQMap System (K170948) is applicable to the subject device. The collective results demonstrate that the 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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 is as safe and effective for its intended use and 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).