(60 days)
No
The summary does not mention AI, ML, or related terms, and the description of the technology focuses on traditional signal processing and imaging techniques.
No
The device is described as a "diagnostic recording system" intended for "imaging, navigation, and mapping" to help identify the source of arrhythmias, not to treat them.
Yes
The Device Description explicitly states: "The AcQMap High Resolution Imaging and Mapping System is a diagnostic recording system." Additionally, its intended use and capabilities, such as visualizing chamber anatomy, displaying electrical impulses, and identifying sources of arrhythmia through electrical mapping, are diagnostic in nature.
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 and impedance-based electrode localization, which are hardware-dependent functions.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The AcQMap High Resolution Imaging and Mapping System operates in vivo (within the body) by using ultrasound and electrical signals to image, navigate, and map the heart's chambers and electrical activity. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes its application during electrophysiology procedures performed directly on patients.
Therefore, the device falls under the category of an in vivo diagnostic or therapeutic device, not an IVD.
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 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 maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure.
Product codes
DOK, 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 and 900009 (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 arrythmia. 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 AcOMap 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 and Mapping System include software modification and the addition of new accessories to support compatibility with the AcQBlate Force Sensing Ablation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
atrial chambers of the heart, Intracardiac Structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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.
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 and Mapping 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 and Mapping 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.
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, open-label 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 2, 2023
Acutus Medical, Inc. Subhadra Elango Senior Specialist. Regulatory Affairs 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K230606
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: DOK, IYO, ITX Dated: March 3, 2023 Received: March 3, 2023
Dear Subhadra Elango:
We have reviewed vour 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 S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230606
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 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 maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping 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
Image /page/3/Picture/1 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in black, sans-serif font, with a small orange circle above the left side of the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, orange, sans-serif font. A circled R symbol is located to the right of the letter "S" in "ACUTUS".
510(k) Summary
General Information [807.92(a)(1)]
Date Prepared: March 3, 2023
| 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. | K222209 |
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 and 900009 (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,
4
Image /page/4/Picture/1 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in bold, black letters, with a small orange dot above the left side of the "A". Below the word "ACUTUS" is the word "MEDICAL" in smaller, orange letters. The logo is simple and modern, and the use of black and orange gives it a professional look.
- 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 arthythmia.
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 AcOMap 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 and Mapping System include software modification and the addition of new accessories to support compatibility with the AcQBlate Force Sensing Ablation System.
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.
| Table 1: Device Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Characteristics | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| (K222209) | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| Classification | Class II | Same as K222209. |
| Table 1: Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| Regulation | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| (K222209) | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| Regulation | 21 CFR § 870.1425, Programable | |
| diagnostic computer | Same as K222209. | |
| 21 CFR § 892.1560, Ultrasonic pulsed | ||
| echo imaging system | ||
| Product Code | DQK, IYO, and ITX | Same as K222209. |
| 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. | Same as K222209. | |
| Patient Anatomy | Intracardiac Structures | Same as K222209. |
| Testing to Support | ||
| Substantial | ||
| Equivalence | Software V/V | |
| Electromagnetic and Electrical Safety | ||
| Verification Testing, | ||
| Accuracy Testing, and | ||
| Animal Testing | Same as K222209. | |
| System Safety | ||
| Standards | IEC 60601-1:2005 /A1:2012 | |
| IEC 60601-1-2:2014 | ||
| IEC 62366-1: 2015 | Same as K222209. | |
| Table 1: Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| AcQMap® High Resolution Imaging and | ||
| Mapping System | ||
| (K222209) | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| IEC 60601-2-25:2015 | ||
| IEC 60601-2-37:2015 | ||
| 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 | ||
| 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 | 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 | ||
| 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 | ||
| Qubic RF Generator Adapter | ||
| Qubic RF Generator Adapter Cable | ||
| RS-232 Spy Cable | ||
| Ethernet Isolator | ||
| 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 mans overlaid on the cardiac | Same as K222209. | |
| Table 1: Device Comparison | ||
| Predicate Device | Subject Device | |
| Characteristics | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| (K222209) | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| chamber reconstruction to show chamber- | ||
| wide electrical activation. | ||
| Visualization | ||
| Device/Catheter | AcQMap Catheter (electrodes & | |
| transducers) or | ||
| Conventional electrophysiology catheters | Same as K222209. | |
| Physical Characteristics – Console/Amplifier Comparison | ||
| Dimensions | 99 cm L x 58 cm W x 76 cm D | Same as K222209. |
| Weight Maximum | 80 kg | Same as K222209. |
| Power | ||
| Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, | |
| 50 Hz | Same as K222209. | |
| Input Current | 4.6 A | Same as K222209. |
| Fuse protection | 250 V, 6.3A, two high breaking capacity | |
| fuses | Same as K222209. | |
| 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 | Same as K222209. | |
| Ingress Protection | The Console is rated IP20 | Same as K222209. |
| 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 | Same as K222209. | |
| Ingress Protection | The Console is rated IP20 | Same as K222209. |
| Functional and Performance Characteristics | ||
| Ultrasound Output | Frequency: 10 MHz+/-400 kHz | |
| Maximum Voltage: 50V p-p | ||
| Maximum Power: 1 W peak | Same as K222209. | |
| Ultrasound | ||
| Performance | Single operating mode | |
| Thermal Index less than 1.0 | ||
| Mechanical Index less than 1.0 | Same as K222209. | |
| Localization | ||
| Output | Frequency: Variable 15 kHz to 50 kHz | |
| Maximum current: 1.2mA | Same as K222209. | |
| ECG & EGM | ||
| Input | Bandwidth: 0.05 Hz to 500 Hz | |
| Resolution: +/-1uV | ||
| Timing Accuracy: +/-1.6 microsecond | Same as K222209. | |
| Table 1: Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| AcQMap® High Resolution Imaging and | ||
| Mapping System | ||
| (K222209) | AcQMap® High Resolution Imaging and | |
| Mapping System | ||
| AcQMap Catheter | Custom, black, Defibrillator Protected | |
| Type CF | Same as K222209. | |
| ECG Input | 12-pin, latching, red, Defibrillator | |
| Protected Type BF | Same as K222209. | |
| ECG Output | 14-pin, latching, blue | Same as K222209. |
| Auxiliary | ||
| Interface Box | Custom, green, Defibrillator Protected | |
| Type CF | Same as K222209. | |
| AcQRef | ||
| Introducer Sheath | ||
| or Electrical | ||
| Reference | ||
| Catheter | 1, 2mm female, yellow, Defibrillator | |
| Protected Type CF | Same as K222209. | |
| Localization | ||
| Reference | ||
| Electrodes | 6, 2-pin, square, multi-color, Defibrillator | |
| Protected Type BF | Same as K222209. | |
| Patient Reference | ||
| Electrode | 1, 2-pin, square, blue, Defibrillator | |
| Protected Type BF | Same as K222209. | |
| Ablation | ||
| Generator | 10-pin, latching, grey | Same as K222209. |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator | |
| Protected Type CF | Same as K222209. | |
| Ablation | ||
| Reference | 1, 2mm, female, black, Defibrillator | |
| Protected Type BF | Same as K222209. | |
| Ablation | ||
| Electrogram | ||
| Interface | 1, 13-pin, latching, white | Same as K222209. |
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Image /page/5/Picture/1 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in black, sans-serif font, with a small orange circle above the left side of the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, orange, sans-serif font. The logo is simple and modern, and the use of orange and black gives it a professional look.
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Image /page/6/Picture/1 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is in large, bold, black letters, with a small orange dot above the left side of the "A". Below the word "ACUTUS" is the word "MEDICAL" in smaller, orange letters. A registered trademark symbol is located to the right of the "S" in "ACUTUS".
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Image /page/7/Picture/1 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in black, with a small orange circle above the left side of the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in orange. There is a registered trademark symbol to the right of the letter "S" in "ACUTUS".
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Image /page/8/Picture/1 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in bold, sans-serif font, with a small orange dot above the left side of the "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font. The letters in "MEDICAL" are orange.
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. 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.
Non-clinical 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.
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Image /page/9/Picture/1 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in bold, sans-serif font, with a small orange dot above the left side of the "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font. The letters in "MEDICAL" are spaced out more than the letters in "ACUTUS", and the color of the letters in "MEDICAL" is orange.
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 and Mapping 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 and Mapping 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, open-label 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
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Image /page/10/Picture/1 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in black, sans-serif font, with a small orange circle inside the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in orange, sans-serif font. The logo is simple and modern, and the use of orange and black gives it a professional look.
the device. The clinical validation of the original AcQMap High Resolution Imaging and Mapping 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.