(30 days)
No
The summary describes a system for imaging, navigation, and mapping using ultrasound, ECG, EGM, and impedance-based localization. It focuses on reconstructing cardiac chambers and displaying electrical activity. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a diagnostic recording system intended for imaging, navigation, and mapping of the heart chambers to help identify the source of arrhythmias. It does not provide any therapeutic intervention.
Yes
Explanation: The "Device Description" section explicitly states, "The AcQMap High Resolution Imaging and Mapping System, Model 900100 ('AcQMap System Model, 900100') is a diagnostic recording system." Furthermore, it describes the system's purpose as being 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" and to "identify the source(s) of the arrhythmia," all of which are diagnostic functions.
No
The device description explicitly states that the system consists of hardware components (AcQMap Console, AcQMap Workstation, AcQMap Auxiliary Interface Box) and relies on physical catheters and electrodes for data acquisition and localization.
Based on the provided information, the AcQMap System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for use in patients for electrophysiology procedures. It is used to reconstruct cardiac chambers, display electrical impulses, and show catheter positions within the heart. This is an in vivo application, meaning it is used within a living organism.
- Device Description: The description details a system that operates outside the sterile field but is used in conjunction with catheters inserted into the heart. It performs functions like ultrasound imaging, ECG/EGM recording, and impedance-based electrode localization, all of which are related to assessing the electrical and structural properties of the heart in situ.
- Lack of In Vitro Activities: There is no mention of the device being used to test samples of biological material (like blood, urine, tissue) outside of the body. IVD devices are specifically designed for such testing.
Therefore, the AcQMap System is a medical device used for in vivo diagnostic and mapping procedures within the heart, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
Product codes
DQK, IYO, ITX
Device Description
The AcQMap High Resolution Imaging and Mapping System, Model 900100 operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The AcQMap High Resolution Imaging and Mapping System, Model 900100 ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three functional subsystems:
- . Ultrasound imaging,
- . ECG and EGM recording; and
- Impedance based electrode Localization. .
The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides:
- . 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound),
- . Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
- . Cardiac electrical activity as waveform traces,
- . Contact LAT and voltage amplitude maps
- . Remapping of the chamber at any time during the procedure; and
- Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction . to show chamber-wide electrical activation.
The AcQMap System, Model 900100 is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.
The modifications to the AcQMap System, Model 900100 includes addition of new accessories (cables and adapters) to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and compatible RF Ablation Generators.
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)
The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrated that the AcQMap System is substantially equivalent to the predicate device.
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 27, 2021
Acutus Medical, Inc. Sindhu Sridhar Regulatory Affairs Manager 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K212345
Trade/Device Name: AcQMap® High Resolution Imaging and Mapping System, Model 900100 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, IYO, ITX, Dated: July 26, 2021 Received: July 28, 2021
Dear Sindhu Sridhar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director (Acting) 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) K212345
Device Name
AcQMap® High Resolution Imaging and Mapping System, Model 900100
Indications for Use (Describe)
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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3
510(K) NOTIFICATION K212345
GENERAL INFORMATION [807.92(a)(1)]
Date Prepared: 26 July 2021
| Applicant: | Contact Person: |
|---|---|
| Acutus Medical, Inc. | Sindhu Sridhar |
| 2210 Faraday Ave., Suite 100 | Regulatory Affairs Manager |
| Carlsbad, CA 92008 | Acutus Medical, Inc. |
| USA | 2210 Faraday Ave., Suite 100 |
| Phone: 1-442-232-6080 | Carlsbad, CA 92008 |
| Fax: 1-442-232-6081 | USA |
| Phone: 1-442-999-7630 | |
| Email: sindhu.sridhar@acutus.com |
DEVICE INFORMATION [807.92(a)(2)]
| Trade Name: | AcQMap® High Resolution Imaging and Mapping System, Model 900100 |
|---|---|
| Generic/Common Name: | Programable diagnostic computer and |
| Ultrasonic pulsed echo imaging system | |
| Classification: | Class II / 21 CFR § 870.1425 and |
| Class II / 21 CFR § 892.1560 | |
| Product Code(s): | DQK, IYO, ITX |
PREDICATE DEVICES [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQMap High Resolution | ||
| Imaging and Mapping System, | ||
| Model 900100 | Acutus Medical, Inc. | K201015 |
4
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQMap High Resolution Imaging and Mapping System, Model 900100 operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The AcQMap High Resolution Imaging and Mapping System, Model 900100 ("AcQMap System Model, 900100") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three functional subsystems:
- . Ultrasound imaging,
- . ECG and EGM recording; and
- Impedance based electrode Localization. .
The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides:
- . 3-D cardiac chamber reconstruction - Contact and non-contact (ultrasound),
- . Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
- . Cardiac electrical activity as waveform traces,
- . Contact LAT and voltage amplitude maps
- . Remapping of the chamber at any time during the procedure; and
- Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction . to show chamber-wide electrical activation.
The AcQMap System, Model 900100 is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.
The modifications to the AcQMap System, Model 900100 includes addition of new accessories (cables and adapters) to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and compatible RF Ablation Generators.
5
INDICATIONS FOR USE [807.92(a)(5)]
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(A)(6)[
Tables 1 and 2 provides a comparison of the modified AcQMap System classification for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.
| Table 1. Comparison of Classification with the Predicate Device | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| AcQMap® High Resolution Imaging and Mapping System, Model 900100 | AcQMap® High Resolution Imaging and Mapping System, Model 900100 (K201015) | ||
| 510(k) Number | K212345 | K201015 | -- |
| Classification/ | |||
| Regulation | |||
| Number/ | |||
| Regulation Name/ | |||
| Product Code | Class II/ 21 CFR § 870.1425/ Programmable diagnostic computer/ DQK | ||
| Class II/ 21 CFR § 892.1560/ Ultrasonic pulsed echo imaging system/ IYO, ITX | Class II/ 21 CFR § 870.1425/ Programmable diagnostic computer/ DQK | ||
| Class II/ 21 CFR § 892.1560/ Ultrasonic pulsed echo imaging system/ IYO, ITX | Identical | ||
| Table 2. Comparison of Indications for Use with the Predicate Device | |||
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| AcQMap® High Resolution Imaging and | |||
| Mapping System, Model 900100 | AcQMap® High Resolution Imaging and | ||
| Mapping System, Model 900100 (K201015) | |||
| 510(k) Number | K212345 | K201015 | Identical |
| Indications for | |||
| Use | The AcQMap System is intended for use in | ||
| patients for whom electrophysiology procedures | |||
| have been prescribed. |
When used with the AcQMap Catheters, the
AcQMap System is intended to be used to
reconstruct the selected chamber from
ultrasound data for purposes of visualizing the
chamber anatomy and displaying electrical
impulses as either charge density-based or
voltage-based maps of complex arrhythmias that
may be difficult to identify using conventional
mapping systems alone.
AND
When used with the specified Patient Electrodes,
the AcQMap System is intended to display the
position of AcQMap Catheters and conventional
electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology
catheters, the AcQMap System provides
information about the electrical activity of the
heart and about catheter location during the
procedure. | The AcQMap System is intended for use in
patients for whom electrophysiology procedures
have been prescribed.
When used with the AcQMap Catheters, the
AcQMap System is intended to be used to
reconstruct the selected chamber from
ultrasound data for purposes of visualizing the
chamber anatomy and displaying electrical
impulses as either charge density-based or
voltage-based maps of complex arrhythmias that
may be difficult to identify using conventional
mapping systems alone.
AND
When used with the specified Patient Electrodes,
the AcQMap System is intended to display the
position of AcQMap Catheters and conventional
electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology
catheters, the AcQMap System provides
information about the electrical activity of the
heart and about catheter location during the
procedure. | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial
Equivalence |
| 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 60601-1-6:2010/A1:2013 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | Different. IEC 60601-1-6:
2010/ A1: 2013 has been
withdrawn and replaced
with IEC 62366-1: 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 | 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 | All system components are
identical, except the new
accessories. Verification
testing on the new
accessories demonstrates
that the AcQMap 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, Model 900100 | AcQMap® High Resolution Imaging and Mapping System, Model 900100 (K201015) | |
| | Adapter Cable- Short - Ablation Adapter Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable - Generator | | |
6
7
8
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| 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. | 3-D cardiac chamber reconstructions - Contact and non-contact (ultrasound); Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time during the procedure; Dynamic, three-dimensional, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. | Identical |
| Visualization | |||
| Device/Catheter | AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters | AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters | Identical |
| Physical Characteristics - Console/Amplifier Comparison |
9
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 99 cm L x 58 cm W x 76 cm D | Identical |
| Weight Maximum | 80 kg | 80 kg | |
| Power Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | |
| Input Current | 4.6 A | 4.6 A | |
| Fuse protection | 250 V, 6.3A, two high breaking capacity fuses | 250 V, 6.3A, two high breaking capacity fuses |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| AcQMap® High Resolution Imaging and Mapping System, Model 900100 | AcQMap® High Resolution Imaging and Mapping System, Model 900100 (K201015) | ||
| System Specifications | |||
| Safety Information | IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide | Identical |
| Ingress Protection | The Console is rated IP20 | The Console is rated IP20 | Identical |
| Functional and Performance Characteristics | |||
| Ultrasound Output | Frequency: 10 MHz+/-400 kHz | ||
| Maximum Voltage: 50V p-p | Frequency: 10 MHz+/-400 kHz | ||
| Maximum Voltage: 50V p-p | Identical |
10
| Maximum Power: 1 W peak | Maximum Power: 1 W peak | ||
|---|---|---|---|
| Ultrasound | |||
| Performance | Single operating mode | Single operating mode | Identical |
| Thermal Index less than 1.0 | Thermal Index less than 1.0 | ||
| Mechanical Index less than 1.0 | Mechanical Index less than 1.0 | ||
| Localization | |||
| Output | Frequency: Variable 15 kHz to 50 kHz | Frequency: Variable 15 kHz to 50 kHz | Identical |
| Maximum current: 1.2mA | Maximum current: 1.2mA | ||
| ECG & EGM | |||
| Input | Bandwidth: 0.05 Hz to 500 Hz | Bandwidth: 0.05 Hz to 500 Hz | Identical |
| Resolution: +/-1uV | Resolution: +/-1uV | ||
| Timing Accuracy: +/-1.6 microsecond | Timing Accuracy: +/-1.6 microsecond | ||
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | |||
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial |
| Equivalence | |||
| AcQMap® High Resolution Imaging and Mapping | |||
| System, Model 900100 | AcQMap® High Resolution Imaging and Mapping | ||
| System, Model 900100 (K201015) | |||
| Front Panel Connections | |||
| AcQMap Catheter | Custom, black, Defibrillator Protected Type CF | Custom, black, Defibrillator Protected Type CF | Identical |
| ECG Input | 12-pin, latching, red, Defibrillator Protected Type BF | 12-pin, latching, red, Defibrillator Protected Type BF | Identical |
| ECG Output | 14-pin, latching, blue | 14-pin, latching, blue | Identical |
| Auxiliary | |||
| Interface | |||
| Box | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical |
| AcQRef Introducer | |||
| Sheath or Electrical | |||
| Reference Catheter | 1, 2mm female, yellow, Defibrillator Protected Type | ||
| CF | 1, 2mm female, yellow, Defibrillator Protected Type | ||
| CF | Identical | ||
| Localization | |||
| Reference | |||
| Electrodes | 6, 2-pin, square, multi-color, Defibrillator Protected | ||
| Type BF | 6, 2-pin, square, multi-color, Defibrillator Protected | ||
| Type BF | Identical | ||
| Patient | |||
| Reference | |||
| Electrode | 1, 2-pin, square, blue, Defibrillator Protected Type | ||
| BF | 1, 2-pin, square, blue, Defibrillator Protected Type | ||
| BF | Identical | ||
| Ablation Generator | 10-pin, latching, grey | 10-pin, latching, grey | Identical |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator Protected Type | ||
| CF | 10-pin, latching, grey, Defibrillator Protected Type | ||
| CF | Identical | ||
| Ablation Reference | 1, 2mm, female, black, Defibrillator Protected Type | ||
| BF | 1, 2mm, female, black, Defibrillator Protected Type | ||
| BF | Identical | ||
| Ablation | |||
| Electrogram | |||
| Interface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical |
11
12
SUBSTANTIAL EQUIVALENCE
The AcQMap System is intended to reconstruct the physiology and display the anatomic and electrical data in the same way. These modifications are to include the below new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and some commercially available compatible RF Ablation Generators.
- Generator adapters and ●
- Adapter cables
The changes submitted in this 510(k) do not impact the hardware and software of the original AcQMap System, Model 900100. The indications for use of the subject device are identical to those of the predicate device. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the modified AcQMap High Resolution Imaging and Mapping System, Model 900100, is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the modified AcQMap System to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical testing is required to support the subject device.
NONCLINICAL TESTING SUMMARY [807.92(b)(1)]
The necessary bench testing was performed on the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.
The following bench testing was repeated for the modified device:
- . Third party system Compatibility with AcQMap 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 ●
- In-vitro Localization Accuracy Study ●
The balance of testing is incorporated by reference to the original AcQMap System 510(k), includes the following:
- Transportation Testing
- AcQMap Verification Testing ●
- . System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study ●
13
- Accuracy Validation Testing Animal Study ●
- . Software Verification and Validation
- Clinical Simulation (Reliability) ●
- Map Accuracy Evaluation ●
The modified AcQMap High Resolution Imaging and Mapping System, Model 900100 was tested to verify that the device meets the established performance specifications. The collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use.
The collective results of the nonclinical testing, either repeated for the modified device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen, the manufacturing processes, and design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
CLINICAL TESTING SUMMARY [807.92(b)(2)]
As discussed above, no further clinical testing is required to support the modified AcQMap High Resolution Imaging and Mapping System, Model 900100. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrated that the AcQMap System is substantially equivalent to the predicate device.
CONCLUSIONS [807.92(b)(3)]
Extensive nonclinical performance testing, either repeated for the modified device or incorporated by reference to the original AcQMap System 510(k), was conducted on the AcQMap High Resolution Imaging and Mapping System, Model 900100 to evaluate the overall performance of the clinical validation of the original AcQMap System (K170948) is applicable to the modified device. The collective results demonstrate that the modified AcQMap System, Model 900100 is substantially equivalent to the predicate device.
SUMMARY
Based on the performance testing and the technological characteristics, it can be concluded that the modified AcQMap® High Resolution Imaging and Mapping System, Model 900100 is substantially equivalent to the predicate device.