(60 days)
The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap 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.
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 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 arrhythmia 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.
The provided text includes general information about the device's classification, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, reported device performance data, or detailed information about the study design elements you requested for a comparative effectiveness study or standalone performance evaluation.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in a table format. It states that "The modified AcQMap High Resolution Imaging and Mapping System was tested to verify that the device meets the established performance specifications" and "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." However, it does not detail what these specific performance specifications or criteria are, nor does it present the results against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: For the original AcQMap High Resolution Imaging and Mapping System (K170948), the clinical study included 84 patients. This study's results are incorporated by reference for the modified device.
- Data provenance: The clinical study (DDRAMATIC-SVT) was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
- Country of origin: Outside the U.S.
- Retrospective or prospective: Prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document mentions "physicians" using the system to identify arrhythmia sources but does not detail the number or qualifications of experts for establishing ground truth in the clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC comparative effectiveness study: The document describes a clinical study "DDRAMATIC-SVT", which demonstrated the substantial equivalence of the original AcQMap system. However, this study did not evaluate human readers with AI assistance versus without AI assistance. The AcQMap system itself (which includes imaging and mapping capabilities) is the device being assessed, not an AI assisting human readers with interpreting external data.
- Effect size: Therefore, no information on the effect size of human reader improvement with AI assistance is provided, as this type of study was not conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the AcQMap High Resolution Imaging and Mapping System as a diagnostic recording system intended for use in an Electrophysiology (EP) Lab, used by physicians. It generates 3-D reconstructions, electrical maps, and displays electrical impulses. The description strongly implies it's a tool for physicians, not a standalone AI algorithm producing diagnoses without human interpretation. Therefore, a standalone (algorithm-only) performance study as you describe would likely not be directly applicable, and no such study is reported in the provided text. The performance assessed is of the system as a whole, which operates in the context of clinical procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated. The system is intended to help physicians "identify the source(s) of the arrhythmia" and provides "information about the electrical activity of the heart." While this implies clinical assessment by physicians based on the system's output and potentially other diagnostic tools, the specific method for establishing the definitive "ground truth" for arrhythmias in the study (e.g., confirmed by a separate gold standard, follow-up outcomes, expert consensus) is not detailed.
8. The sample size for the training set
The document describes a modified device being compared to a predicate device (K222209). The necessary clinical testing for the original AcQMap High Resolution Imaging and Mapping System (K170948) is incorporated by reference. There is no mention of a "training set" in the context of AI/machine learning in this document, as the device is not presented as an AI-driven diagnostic algorithm that requires a separate training set. It's a system for imaging and mapping.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI algorithm in this context, this information is not applicable/not provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo 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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh 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
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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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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 100Carlsbad, CA 92008USAPhone: 1-442-232-6080Fax: 1-442-232-6081 | Subhadra ElangoSenior Specialist, Regulatory AffairsAcutus Medical, Inc.2210 Faraday Ave., Suite 100Carlsbad, CA 92008USAPhone: 1-442-999-7630Email: Subhadra.elango@acutus.com |
Device Information [807.92(a)(2)]
| Trade Name: | AcQMap High Resolution Imaging and Mapping System |
|---|---|
| Generic/Common Name: | Programable diagnostic computer andUltrasonic pulsed echo imaging system |
| Classification: | Class II / 21 CFR § 870.1425Class II / 21 CFR § 892.1560 |
| Product Code(s): | DQK, IYO, ITX |
Predicate Device [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQMap High ResolutionImaging and Mapping System | Acutus Medical, Inc. | 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,
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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 andMapping System(K222209) | AcQMap® High Resolution Imaging andMapping System |
| Classification | Class II | Same as K222209. |
| Table 1: Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| Regulation | AcQMap® High Resolution Imaging andMapping System(K222209) | AcQMap® High Resolution Imaging andMapping System |
| Regulation | 21 CFR § 870.1425, Programablediagnostic computer | Same as K222209. |
| 21 CFR § 892.1560, Ultrasonic pulsedecho imaging system | ||
| Product Code | DQK, IYO, and ITX | Same as K222209. |
| Indications forUse | The AcQMap High Resolution Imagingand Mapping System is intended for use inpatients for whom electrophysiologyprocedures have been prescribed.When used with the AcQMap Catheters,the AcQMap High Resolution Imagingand Mapping System is intended to beused to reconstruct the selected chamberfrom ultrasound data for purposes ofvisualizing the chamber anatomy anddisplaying electrical impulses as eithercharge density-based or voltage-basedmaps of complex arrhythmias that may bedifficult to identify using conventionalmapping systems alone.ANDWhen used with the specified PatientElectrodes, the AcQMap High ResolutionImaging and Mapping System is intendedto display the position of AcQMapCatheters and conventionalelectrophysiology (EP) catheters in theheart.ORWhen used with conventionalelectrophysiology catheters, the AcQMapHigh Resolution Imaging and MappingSystem provides information about theelectrical activity of the heart and aboutcatheter location during the procedure. | Same as K222209. |
| Patient Anatomy | Intracardiac Structures | Same as K222209. |
| Testing to SupportSubstantialEquivalence | Software V/VElectromagnetic and Electrical SafetyVerification Testing,Accuracy Testing, andAnimal Testing | Same as K222209. |
| System SafetyStandards | IEC 60601-1:2005 /A1:2012IEC 60601-1-2:2014IEC 62366-1: 2015 | Same as K222209. |
| Table 1: Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| AcQMap® High Resolution Imaging andMapping System(K222209) | AcQMap® High Resolution Imaging andMapping System | |
| IEC 60601-2-25:2015IEC 60601-2-37:2015 | ||
| Physical Characteristics | ||
| SystemComponents &Accessories | ConsoleWorkstationWorkstation CableAuxiliary Interface BoxECG Input CableAmpere Ablation Catheter Adapter CableAmpere RF Generator Adapter CableECG Output CableAblation Reference CableAblation Electrogram CableECG w/Snaps CableECG POST Cable2mm Pin Jumper SetPatient Electrode KitAmpere Generator AdapterSmartAblate Generator AdapterMaestro Generator AdapterAdapter Cable- Short - Ablation AdapterAdapter Cable- Long - Ablation AdapterSmartAblate Adapter Cable - CatheterMaestro Adapter Cable - CatheterMaestro Adapter Cable – GeneratorCarto Force Adapter CableDiamondTemp Generator AdapterDiamondTemp Adapter Cable – Generator | ConsoleWorkstationWorkstation CableAuxiliary Interface BoxECG Input CableAmpere Ablation Catheter Adapter CableAmpere RF Generator Adapter CableECG Output CableAblation Reference CableAblation Electrogram CableECG w/Snaps CableECG POST Cable2mm Pin Jumper SetPatient Electrode KitAmpere Generator AdapterSmartAblate Generator AdapterMaestro Generator AdapterAdapter Cable- Short - Ablation AdapterAdapter Cable- Long - Ablation AdapterSmartAblate Adapter Cable - CatheterMaestro Adapter Cable - CatheterMaestro Adapter Cable – GeneratorCarto Force Adapter CableDiamondTemp Generator AdapterDiamondTemp Adapter Cable – GeneratorQubic RF Generator AdapterQubic RF Generator Adapter CableRS-232 Spy CableEthernet Isolator |
| Visual/MappingCharacteristics | 3-D cardiac chamber reconstructions –Contact and non-contact (ultrasound);Three-dimensional position of theAcQMap Catheter and conventionalelectrophysiology catheters;Cardiac electrical activity as waveformtraces;Contact LAT and voltage amplitude maps;Remapping of the chamber at any timeduring the procedure;Dynamic, three-dimensional, ChargeDensity mans overlaid on the cardiac | Same as K222209. |
| Table 1: Device Comparison | ||
| Predicate Device | Subject Device | |
| Characteristics | AcQMap® High Resolution Imaging andMapping System(K222209) | AcQMap® High Resolution Imaging andMapping System |
| chamber reconstruction to show chamber-wide electrical activation. | ||
| VisualizationDevice/Catheter | AcQMap Catheter (electrodes &transducers) orConventional 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. |
| PowerRequirement | 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 capacityfuses | Same as K222209. |
| System Specifications | ||
| SafetyInformation | IEC 60601-1, Class I, Type DefibrillatorProtected CF, continuous operation, nosterilization, equipment not suitable foruse in the presence of a flammableanesthetic mixture with air, oxygen ornitrous oxide | Same as K222209. |
| Ingress Protection | The Console is rated IP20 | Same as K222209. |
| System Specifications | ||
| SafetyInformation | IEC 60601-1, Class I, Type DefibrillatorProtected CF, continuous operation, nosterilization, equipment not suitable foruse in the presence of a flammableanesthetic mixture with air, oxygen ornitrous oxide | Same as K222209. |
| Ingress Protection | The Console is rated IP20 | Same as K222209. |
| Functional and Performance Characteristics | ||
| Ultrasound Output | Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-pMaximum Power: 1 W peak | Same as K222209. |
| UltrasoundPerformance | Single operating modeThermal Index less than 1.0Mechanical Index less than 1.0 | Same as K222209. |
| LocalizationOutput | Frequency: Variable 15 kHz to 50 kHzMaximum current: 1.2mA | Same as K222209. |
| ECG & EGMInput | Bandwidth: 0.05 Hz to 500 HzResolution: +/-1uVTiming Accuracy: +/-1.6 microsecond | Same as K222209. |
| Table 1: Device Comparison | ||
| Characteristics | Predicate Device | Subject Device |
| AcQMap® High Resolution Imaging andMapping System(K222209) | AcQMap® High Resolution Imaging andMapping System | |
| AcQMap Catheter | Custom, black, Defibrillator ProtectedType CF | Same as K222209. |
| ECG Input | 12-pin, latching, red, DefibrillatorProtected Type BF | Same as K222209. |
| ECG Output | 14-pin, latching, blue | Same as K222209. |
| AuxiliaryInterface Box | Custom, green, Defibrillator ProtectedType CF | Same as K222209. |
| AcQRefIntroducer Sheathor ElectricalReferenceCatheter | 1, 2mm female, yellow, DefibrillatorProtected Type CF | Same as K222209. |
| LocalizationReferenceElectrodes | 6, 2-pin, square, multi-color, DefibrillatorProtected Type BF | Same as K222209. |
| Patient ReferenceElectrode | 1, 2-pin, square, blue, DefibrillatorProtected Type BF | Same as K222209. |
| AblationGenerator | 10-pin, latching, grey | Same as K222209. |
| Ablation Catheter | 10-pin, latching, grey, DefibrillatorProtected Type CF | Same as K222209. |
| AblationReference | 1, 2mm, female, black, DefibrillatorProtected Type BF | Same as K222209. |
| AblationElectrogramInterface | 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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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.
§ 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).