(84 days)
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The focus is on ultrasound imaging, ECG/EGM recording, impedance-based localization, and traditional mapping techniques.
No
Explanation: The device is described as a "diagnostic recording system" intended for imaging, navigation, and mapping to help physicians identify sources of arrhythmia and electrical activity of the heart. It does not provide any therapeutic treatment itself.
Yes
The "Device Description" explicitly states, "The AcQMap High Resolution Imaging and Mapping System is a diagnostic recording system." The "Intended Use / Indications for Use" section also describes its use in visualizing chamber anatomy, displaying electrical impulses, and providing information about the heart's electrical activity, all of which are diagnostic functions.
No
The device description explicitly states that the system consists of hardware components: the AcQMap Console, the AcQMap Workstation, and the AcQMap Auxiliary Interface Box. It also mentions functional subsystems related to hardware (Ultrasound imaging, ECG and EGM recording, Impedance based electrode Localization).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The AcQMap High Resolution Imaging and Mapping System is used during an electrophysiology procedure, directly interacting with the patient's heart (intracardiac). It uses ultrasound and electrical signals to visualize and map the electrical activity of the heart chambers.
- Intended Use: The intended use clearly describes its application in patients undergoing electrophysiology procedures for imaging, navigation, and mapping of the heart's electrical activity and anatomy. This is an in vivo application.
- Device Description: The description reinforces that the system operates in the EP Lab and is used in conjunction with catheters inserted into the heart.
The device's function and intended use are focused on real-time imaging and mapping of the heart's electrical activity within the patient's body, which is characteristic of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQK, IYO, ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound data
Anatomical Site
atrial chambers of the heart, heart, Intracardiac Structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in the Electrophysiology (EP) Lab
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AcQMap High Resolution Imaging and Mapping System K220784
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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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
1
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
2
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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3
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 100 | |
| Carlsbad, CA 92008 | |
| USA | |
| Phone: 1-442-232-6080 | |
| Fax: 1-442-232-6081 | Subhadra Elango |
| Senior Specialist, Regulatory Affairs | |
| Acutus Medical, Inc. | |
| 2210 Faraday Ave., Suite 100 | |
| Carlsbad, CA 92008 | |
| USA | |
| Phone: 1-442-999-7630 | |
| Email: 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 and |
| Ultrasonic pulsed echo imaging system | |
| Classification: | Class II / 21 CFR § 870.1425 |
| Class II / 21 CFR § 892.1560 | |
| Product Code(s): | DQK, IYO, ITX |
PREDICATE DEVICE [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQMap High Resolution | ||
| Imaging 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
4
- . 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.
5
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 diagnostic | |||||
| computer | |||||
| 21 CFR § 892.1560, | |||||
| Ultrasonic pulsed echo | |||||
| imaging system | 21 CFR § 870.1425, | ||||
| Programable diagnostic | |||||
| computer | |||||
| 21 CFR § 892.1560, | |||||
| Ultrasonic pulsed echo | |||||
| imaging 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 Device | ||||
| AcQMap® High Resolution Imaging and | |||||
| Mapping System | Predicate Device | ||||
| AcQMap® High Resolution Imaging and | |||||
| Mapping System (K220784) | Rationale for Substantial | ||||
| Equivalence | |||||
| Indications for Use | 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. | 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, with the exception of | ||||
| device trade name. | |||||
| 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 | AcQMap® High Resolution Imaging and | ||||
| Mapping System (K220784) | |||||
| 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 | Identical | ||||
| System Safety | |||||
| Standards | IEC 60601-1:2005 / A1:2012 | ||||
| IEC 60601-1-2:2014 | |||||
| IEC 62366-1: 2015 | |||||
| IEC 60601-2-25:2015 | |||||
| IEC 60601-2-37:2015 | IEC 60601-1:2005 / A1:2012 | ||||
| IEC 60601-1-2:2014 | |||||
| IEC 62366-1: 2015 | |||||
| IEC 60601-2-25:2015 | |||||
| IEC 60601-2-37:2015 | Identical | ||||
| Physical Characteristics | |||||
| System | |||||
| Components & | |||||
| Accessories | 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 | |||||
| Ampere Generator Adapter | |||||
| SmartAblate Generator Adapter | |||||
| Maestro Generator Adapter | |||||
| Adapter Cable- Short - Ablation Adapter | 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 | |||||
| Ampere Generator Adapter | |||||
| SmartAblate Generator Adapter | |||||
| Maestro Generator Adapter | |||||
| Adapter Cable- Short - Ablation Adapter | All system components | ||||
| are identical, except the | |||||
| new accessories. | |||||
| Verification testing on | |||||
| the new accessories | |||||
| demonstrates that the | |||||
| AcQMap High | |||||
| Resolution Imaging and | |||||
| Mapping System and | |||||
| the new accessories | |||||
| perform as intended. | |||||
| There are no different | |||||
| questions of safety or | |||||
| effectiveness. | |||||
| 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 | AcQMap® High Resolution Imaging and | ||||
| Mapping System (K220784) | |||||
| Adapter Cable- Long - Ablation Adapter | |||||
| SmartAblate Adapter Cable - Catheter | |||||
| Maestro Adapter Cable - Catheter | |||||
| Maestro Adapter Cable – Generator | |||||
| Carto Force Adapter Cable | |||||
| DiamondTemp Generator Adapter | |||||
| DiamondTemp Adapter Cable – Generator | Adapter Cable- Long - Ablation Adapter | ||||
| SmartAblate Adapter Cable - Catheter | |||||
| Maestro Adapter Cable - Catheter | |||||
| Maestro Adapter Cable - Generator | |||||
| Carto Force Adapter Cable | |||||
| Visual/Mapping | |||||
| Characteristics | 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. | |||||
| Visualization | |||||
| Device/Catheter | |||||
| Weight | |||||
| Maximum | |||||
| 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 | |||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||||
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial | ||
| Equivalence | |||||
| Fuse protection | AcQMap® High Resolution Imaging and | ||||
| Mapping System | AcQMap® High Resolution Imaging and | ||||
| Mapping 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 | |||
| 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 | Frequency: Variable 15 kHz to 50 kHz | ||||
| Maximum current: 1.2mA | Identical | ||||
| ECG & EGM Input | Bandwidth: 0.05 Hz to 500 Hz | ||||
| Resolution: +/-1uV | |||||
| Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.05 Hz to 500 Hz | ||||
| Resolution: +/-1uV | |||||
| Timing Accuracy: +/-1.6 microsecond | Identical | ||||
| 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 | ||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | |||||
| Characteristics | Subject Device | ||||
| AcQMap® High Resolution Imaging and | |||||
| Mapping System | Predicate Device | ||||
| AcQMap® High Resolution Imaging and | |||||
| Mapping System (K220784) | Rationale for Substantial | ||||
| Equivalence | |||||
| 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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Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008
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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.