(150 days)
Unknown
The document mentions "Conduction Pattern Recognition" and "Complex Fractionated Atrial Electrogram (CFAE) calculation" as new features, which could potentially utilize AI/ML for pattern analysis. However, the summary does not explicitly state the use of AI, ML, DNN, or provide details about training or test sets, making it impossible to confirm.
No
The device is described as a "diagnostic recording system" intended for "imaging navigation and mapping" to "identify the source(s) of the arrhythmia" rather than directly treating it.
Yes
The "Device Description" section explicitly states, "The AcQMap High Resolution Imaging and Mapping System, Model 900100 ('AcQMap System Model, 900100') is a diagnostic recording system." Additionally, its intended use involves visualizing chamber anatomy, displaying electrical impulses, and identifying the source(s) of arrhythmia, all of which are diagnostic functions.
No
The device description explicitly states that the system consists of hardware components (AcQMap Console, AcQMap Workstation, AcQMap Auxiliary Interface Box) and relies on ultrasound imaging, ECG/EGM recording, and impedance-based electrode localization, all of which involve hardware.
Based on the provided information, the AcQMap System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc., outside of the body.
- AcQMap System Function: The AcQMap System operates in vivo (within the body) using catheters inserted into the heart. It uses ultrasound and electrical signals to reconstruct the heart chamber, map electrical activity, and localize catheters. It does not analyze biological specimens in vitro.
- Intended Use: The intended use clearly describes its function within the body during electrophysiology procedures, focusing on visualizing anatomy, mapping electrical impulses, and tracking catheter location.
- Device Description: The description details a system used in the EP Lab with catheters inserted into the heart, further confirming its in vivo nature.
Therefore, the AcQMap System is a medical device used for in vivo diagnostic and procedural guidance purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, IYO, ITX
Device Description
The AcQMap High Resolution Imaging and Mapping System, Model 900100 operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The AcQMap High Resolution Imaging and Mapping System, Model 900100 ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three functional subsystems:
- . Ultrasound imaging,
- . ECG and EGM recording; and
- . Impedance based electrode Localization.
The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter 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, Model 900100 is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.
The modifications to the AcQMap System, Model 900100 includes AcQTrack™ Conduction Pattern (Conduction Pattern Recognition) feature, Composite Mapping feature and Complex Fractionated Atrial Electrogram (CFAE) calculation that adds additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac chambers, Intracardiac Structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrophysiology (EP) Lab; physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing was conducted on the modified AcQMap System. Specifically, Software Verification and Validation, Clinical Simulation (Reliability), and Map Accuracy Evaluation were repeated for the modified device. Other tests like Transportation Testing, AcQMap Verification Testing, System Accuracy Testing, Electromagnetic Compatibility and Electrical Safety Testing, AcQMap Catheter Validation Testing-Animal Study, and Accuracy Validation Testing Animal Study were incorporated by reference from the original AcQMap System 510(k). The clinical testing was completed for the original AcQMap System (K170948) through a prospective, non-randomized, open-label study involving 84 patients at eight clinical sites outside the U.S., which is incorporated by reference.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench testing (Software V/V, Clinical Simulation, Map Accuracy Evaluation, Transportation Testing, AcQMap Verification Testing, System Accuracy Testing, Electromagnetic Compatibility and Electrical Safety Testing, AcQMap Catheter Validation Testing-Animal Study, Accuracy Validation Testing Animal Study) and Clinical testing (prospective, non-randomized, open-label study for the predicate device K170948).
Sample Size: 84 patients for the clinical study of the predicate device (K170948). Bench testing sample sizes are not explicitly stated.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: The collective results of the nonclinical testing demonstrated that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications and does not raise different questions of safety or effectiveness when compared to the predicate device. The clinical study for the original AcQMap System (K170948) demonstrated substantial equivalence to its predicate device, and these results are deemed applicable to the modified device. The modifications (AcQTrack™ Conduction Pattern, Composite Mapping, and CFAE calculation) provide additional post-processing and summary data display options without changing the data gathering or display options, and they do not raise different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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August 5, 2021
Acutus Medical, Inc. Sindhu Sridhar Regulatory Affairs Manager 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K210680
Trade/Device Name: AcQMap® High Resolution Imaging and Mapping System, Model 900100 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: July 2, 2021 Received: July 6, 2021
Dear Sindhu Sridhar:
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
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Aneesh Deoras Acting 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
2
Indications for Use
510(k) Number (if known) K210680
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 charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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3
510(K) NOTIFICATION K 210680
GENERAL INFORMATION [807.92(a)(1)]
Date Prepared: 05 March 2021
| 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, 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(s): | DQK, IYO, ITX |
PREDICATE DEVICES [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQMap High Resolution | ||
| Imaging and Mapping System, | ||
| Model 900100 | Acutus Medical, Inc. | K193013 |
4
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQMap High Resolution Imaging and Mapping System, Model 900100 operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The AcQMap High Resolution Imaging and Mapping System, Model 900100 ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three functional subsystems:
- . Ultrasound imaging,
- . ECG and EGM recording; and
- . Impedance based electrode Localization.
The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter 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, Model 900100 is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.
The modifications to the AcQMap System, Model 900100 includes AcQTrack™ Conduction Pattern (Conduction Pattern Recognition) feature, Composite Mapping feature and Complex Fractionated Atrial Electrogram (CFAE) calculation that adds additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered.
5
These additional software display features have been previously documented in the literature':1-3.4.56, and/or have been validated with both simulation and clinical data. These are optional tools to provide a summarization of existing data to expedite the physician's interpretation of the data based on physicianestablished criteria.
4 C. D. Cantwell, C. H. Roney, F. S. Ng. J. H. Siggers, S. J. Sherwin, and N. S. Peters, "Techniques for automation time annotation and conduction velocity estimation in cardiac
5 P. V Bayly, B. H. KenKnight, J. M. Rogers, R. E. Hillsley, R. E. Ideker, and W. M. Smith, "Estimation of conduction velocity vector fields from epicardial mapping data,," IEEE Trans. Biomed. Eng., vol. 45, no. 5, pp. 563-71, May 1998, doi: 10.1109/10.641337
T. N. Fitzgerald, D. H. Brooks, and J. K. Triedman, "Identification of cardiac rhythm features by mathematical and your telds," (EEE Trans. Biomed. Eng., vol. 52, no. 1, pp. 19–29, 2005, doi: 10.1109/TBME.2004.839636.
2 S. Honarbakhsh et al., "Automated detection of repetitive focal activations in persistent atrial fibrillation: Validation of a novel detection algorithm and application through panoranic and sequential mapping," J. Cardiovasc. Electrophysiol., vol. 30, no. 1, pp. 58-66, 2019, doi: 10.1111/jce.13752.
3 E. G. Daoud et al., "Identification of Repetitive Activation Novel Computational Analysis of Multielectrode Recordings During Atrial Fibrillation and Flutter in Humans," JACC Clin. Electrophysiol., vol. 3, no. 3, 2016, doi: 10.1016/j.jacep.2016.08.001.
6 Nademanee, Koonlawee, et al. "Catheter ablation guided by complex fractionated atrial electrogram mapping of atrial fibrillation substrate." Journal of cardiology 55.1 (2010): 1-12.
Verma, Atul, et al. "Selective Complex Fractionated Atrial Electrograms Targeting for Atrial Fibrillation Study (SELECT AF) A Multicenter, Randomized Trial." Circulation: Arrhythmia and Electrophysiology 7.1 (2014): 55-62.
6
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 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 and indications 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 | |||
|---|---|---|---|
| Subject Device | Predicate Device | ||
| Characteristics | AcQMap® High | ||
| Resolution Imaging and | |||
| Mapping System, Model | |||
| 900100 | AcQMap® High | ||
| Resolution Imaging and | |||
| Mapping System, Model | |||
| 900100 (K193013) | Rationale for Substantial Equivalence | ||
| 510(k) Number | K210680 | K193013 | -- |
| Classification/ | |||
| Regulation | |||
| Number/ | |||
| Regulation Name/ | |||
| Product Code | Class II/ 21 CFR § | ||
| 870.1425/ Programable | |||
| diagnostic computer/ | |||
| DQK | |||
| Class II/ 21 CFR § | |||
| 892.1560/ Ultrasonic | |||
| pulsed echo imaging | |||
| system/ IYO, ITX | Class II/ 21 CFR § | ||
| 870.1425/ Programable | |||
| diagnostic computer/ | |||
| DQK | |||
| Class II/ 21 CFR § | |||
| 892.1560/ Ultrasonic | |||
| pulsed echo imaging | |||
| system/ IYO, ITX | Identical | ||
| Table 2. Comparison of Indications for Use with the Predicate Device | |||
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| 510(k) Number | K210680 | K193013 | |
| Indications for | |||
| Use | The AcQMap System is intended for use in | ||
| patients for whom electrophysiology procedures | |||
| have been prescribed. |
When used with the AcQMap Catheters, the
AcQMap System is intended to be used to
reconstruct the selected chamber from
ultrasound data for purposes of visualizing the
chamber anatomy and displaying electrical
impulses as either charge density-based or
voltage-based maps of complex arrhythmias that
may be difficult to identify using conventional
mapping systems alone.
AND
When used with the specified Patient Electrodes,
the AcQMap System is intended to display the
position of AcQMap Catheters and conventional
electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology
catheters, the AcQMap System provides
information about the electrical activity of the
heart and about catheter location during the
procedure. | The AcQMap System is intended for use in
patients for whom electrophysiology procedures
have been prescribed.
When used with the AcQMap Catheters, the
AcQMap System is intended to be used to
reconstruct the selected chamber from
ultrasound data for purposes of visualizing the
chamber anatomy and displaying electrical
impulses as either charge density-based or
voltage-based maps of complex arrhythmias that
may be difficult to identify using conventional
mapping systems alone.
AND
When used with the specified Patient Electrodes,
the AcQMap System is intended to display the
position of AcQMap Catheters and conventional
electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology
catheters, the AcQMap System provides
information about the electrical activity of the
heart and about catheter location during the
procedure. | Identical |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 (K193013) | |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical |
| Testing to Support
Substantial
Equivalence | Software V/V
•
Electromagnetic and Electrical Safety
•
Verification Testing,
•
Accuracy Testing, and
•
Animal Testing | Software V/V
•
Electromagnetic and Electrical Safety
•
Verification Testing,
•
Accuracy Testing, and
•
Animal Testing | Complete performance
testing conducted by Acutus
demonstrates that the
AcQMap System performs
as intended and that there
are no different questions of
safety or effectiveness. |
| System Safety
Standards | IEC 60601-1:2005 /A1:2012
•
IEC 60601-1-2:2014
•
IEC 60601-1-6:2010/A1:2013
•
IEC 60601-2-25:2015
•
IEC 60601-2-37:2015 | IEC 60601-1:2005 /A1:2012
•
IEC 60601-1-2:2014
•
IEC 60601-1-6:2010/A1:2013
•
IEC 60601-2-25:2015
•
IEC 60601-2-37:2015 | Identical. There are no
changes to hardware. |
| System
Components | Console
•
Workstation
•
Workstation Cable
•
Auxiliary Interface Box
•
ECG Input Cable
•
Ampere Ablation Catheter Adapter Cable
•
Ampere RF Generator Adapter Cable
•
ECG Output Cable
•
Ablation Reference Cable
•
Ablation Electrogram Cable
•
ECG w/Snaps Cable
•
ECG POST Cable
•
2mm Pin Jumper Set | 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 | Identical |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| Visual/Mapping
Characteristics | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 3-D cardiac chamber reconstructions -
Contact and non-contact (ultrasound); Three-dimensional position of the AcQMap
Catheter and conventional electrophysiology
catheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time during
the procedure; Dynamic, three-dimensional, Charge Density
maps overlaid on the cardiac chamber
reconstruction to show chamber-wide
electrical activation. | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 (K193013) 3-D cardiac chamber reconstructions - Contact
and non-contact (ultrasound); Three-dimensional position of the AcQMap
Catheter and conventional electrophysiology
catheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time during
the procedure; Dynamic, three-dimensional, Charge Density
maps overlaid on the cardiac chamber
reconstruction to show chamber-wide
electrical activation. | Identical |
| Visualization
Device/Catheter | AcQMap Catheter (electrodes & transducers)
or Conventional electrophysiology catheters | AcQMap Catheter (electrodes & transducers)
or Conventional electrophysiology catheters | |
| Physical Characteristics - Console/Amplifier Comparison | | | |
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 99 cm L x 58 cm W x 76 cm D | Identical |
| Weight Maximum | 80 kg | 80 kg | |
| Power Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | |
| Input Current | 4.6 A | 4.6 A | |
| Fuse protection | 250 V, 6.3A, two high breaking capacity fuses | 250 V, 6.3A, two high breaking capacity fuses | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| | AcQMap® High Resolution Imaging and Mapping System, Model 900100 | AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K193013) | |
| System Specifications | | | |
| Safety Information | IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide | Identical |
| Ingress Protection | The Console is rated IP20 | The Console is rated IP20 | Identical |
| Functional and Performance Characteristics | | | |
| Ultrasound Output | Frequency: 10 MHz+/-400 kHz
Maximum Voltage: 50V p-p
Maximum Power: 1 W peak | Frequency: 10 MHz+/-400 kHz
Maximum Voltage: 50V p-p
Maximum Power: 1 W peak | Identical |
| Ultrasound Performance | Single operating mode
Thermal Index less than 1.0
Mechanical Index less than 1.0 | Single operating mode
Thermal Index less than 1.0
Mechanical Index less than 1.0 | Identical |
| Localization Output | Frequency: Variable 15 kHz to 50 kHz
Maximum current: 1.2mA RMS | Frequency: Variable 30 kHz to 60 kHz
Maximum current: 2.2mA/cm2 | Identical |
| ECG & EGM Input | Bandwidth: 0.05 Hz to 500 Hz
Resolution: +/-1uV
Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.1 Hz to 500 Hz
Resolution: +/-10uV
Timing Accuracy: +/-1.6 microsecond | Identical |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| | AcQMap® High Resolution Imaging and Mapping System, Model 900100 | AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K193013) | |
| Front Panel Connections | | | |
| AcQMap Catheter | Custom, black, Defibrillator Protected Type CF | Custom, black, Defibrillator Protected Type CF | Identical |
| ECG Input | 12-pin, latching, red, Defibrillator Protected Type BF | 12-pin, latching, red, Defibrillator Protected Type BF | Identical |
| ECG Output | 14-pin, latching, blue | 14-pin, latching, blue | Identical |
| Auxiliary Interface
Box | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical |
| AcQRef Introducer
Sheath or Electrical
Reference Catheter | 1, 2mm female, yellow, Defibrillator Protected Type
CF | 1, 2mm female, yellow, Defibrillator Protected Type
CF | Identical |
| Localization
Reference
Electrodes | 6, 2-pin, square, multi-color, Defibrillator Protected
Type BF | 6, 2-pin, square, multi-color, Defibrillator Protected
Type BF | Identical |
| Patient
Reference
Electrode | 1, 2-pin, square, blue, Defibrillator Protected Type
BF | 1, 2-pin, square, blue, Defibrillator Protected Type
BF | Identical |
| Ablation Generator | 10-pin, latching, grey | 10-pin, latching, grey | Identical |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator Protected Type
CF | 10-pin, latching, grey, Defibrillator Protected Type
CF | Identical |
| Ablation Reference | 1, 2mm, female, black, Defibrillator Protected Type
BF | 1, 2mm, female, black, Defibrillator Protected Type
BF | Identical |
| Ablation
Electrogram
Interface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical |
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SUBSTANTIAL EQUIVALENCE
The AcQMap System is intended to reconstruct the physiology and display the anatomic and electrical data in the same way. These modifications are to provide additional post processing and summary data display options of the mapping data.
Specifically, the updates to the mapping software allow the user to have additional visual tools such as:
- AcQTrack Conduction Pattern (Conduction Pattern Recognition) ●
- . Composite Mapping and
- Complex Fractionated Atrial Electrogram (CFAE) ●
These features provide a summarization of existing data that can expedite the physician's interpretation of the data based on physician-established criteria. There are no changes to the current mapping data or display options. 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, Model 900100, is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the modified AcOMap 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, Model 900100 to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.
The following bench testing was repeated for the modified device:
- Software Verification and Validation
- · Clinical Simulation (Reliability)
- · Map Accuracy Evaluation
The balance of testing is incorporated by reference to the original AcQMap System 510(k), includes the following:
- Transportation Testing
- · AcQMap Verification Testing
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- · System Accuracy Testing
- · Electromagnetic Compatibility and Electrical Safety Testing
- · AcQMap Catheter Validation Testing-Animal Study
- · Accuracy Validation Testing Animal Study
The modified AcQMap High Resolution Imaging and Mapping System, Model 900100 was tested to verify that the device meets the established performance specifications. The collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use.
The collective results of the nonclinical testing, either repeated for the modified device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen, the manufacturing processes, and design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
CLINICAL TESTING SUMMARY [807.92(b)(2)]
As discussed above, no further clinical testing is required to support the modified AcQMap High Resolution Imaging and Mapping System. Model 900100. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrated that the AcQMap System is 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, Model 900100 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, Model 900100 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, Model 900100 is substantially equivalent to the predicate device.
510(K) SUMMARY