(118 days)
No
The summary describes a device for collecting ultrasound and electrical data for mapping the heart, but there is no mention of AI or ML being used for data processing, analysis, or interpretation.
No
The device is described as an "Imaging and Mapping Catheter" intended for visualizing the selected chamber and recording electrical impulses for identifying complex arrhythmias, which are diagnostic functions, not therapeutic ones.
Yes
The device collects ultrasound data for visualizing the selected chamber and recording electrical impulses, which are used to identify complex arrhythmias. This process of collecting data to identify a medical condition is diagnostic.
No
The device description clearly details a physical catheter with electrodes and ultrasound transducers, which is an invasive hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AcQMap 3D Imaging and Mapping Catheter is an invasive device that is inserted directly into the heart chambers to collect ultrasound data and electrical impulses in vivo (within the living body).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with the internal environment of the heart.
Therefore, the function and application of this device fall outside the scope of in vitro diagnostics. It is a medical device used for imaging and mapping within the body.
N/A
Intended Use / Indications for Use
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Product codes (comma separated list FDA assigned to the subject device)
MTD, ITX
Device Description
The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.
The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector, as shown in Figure II.I. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations and directions of interest within the heart. Refer to Figure 10.1 for images of the device.
The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
right and left atrial chambers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Extensive nonclinical performance testing, either repeated for the modified device or incorporated by reference to the original AcQMap 3D Imaging and Mapping Catheter 510(k), was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to evaluate the overall performance of the device. The clinical validation of the original AcQMap 3D Imaging Catheter (K170819) is applicable to the modified device. The collective results demonstrate that the modified AcQMap 3D Imaging and Mapping Catheter is safe and effective for its intended use, and further, is substantially equivalent to the predicate device.
The necessary clinical testing for the original AcQMap Catheter (K170819) 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 3D Imaging and Mapping Catheter is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
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September 15, 2020
Acutus Medical, Inc. Karla Schaffner Principal Regulatory Affairs Specialist 2210 Faraday Ave., Suite 100 Carlsbad, California 92008
Re: K201341
Trade/Device Name: AcOMap 3D Imaging and Mapping Catheter, Model 900009 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD, ITX Dated: August 5, 2020 Received: August 6, 2020
Dear Karla Schaffner:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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,
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201341
Device Name
AcQMap 3D Imaging and Mapping Catheter, Model 900009
Indications for Use (Describe)
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
| 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
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5 | 0(K) Notification K20 | 34 I
General Information [807.92(a)(l)]
Date Prepared: 15 September 2020
Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6080 Fax: 1-442-232-6081
Contact Person:
Applicant:
Karla Schaffner Principal Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6161 FAX: 1-442-232-6081 Email: karla.schaffner@acutus.com
Device Information [807.92(a)(2)]
Trade Name:
AcQMap® 3D Imaging and Mapping Catheter, Model 900009
Generic/Common Name:
Electrode Recording Catheter or Electrode Recording Probe/ Transducer Ultrasonic
Classification:
Class II / 21 CFR § 870.1220 and Class II / 21 CFR § 892.1570
Product Code(s): MTD/ITX
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PREDICATE DEVICE [807.92(a)(3)]
AcQMap 3D Imaging and Mapping Catheter (K170819)
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.
The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector, as shown in Figure II.I. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations and directions of interest within the heart. Refer to Figure 10.1 for images of the device.
The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability.
INDICATIONS FOR USE [807.92(a)(5)]
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
DEVICE MODIFICATIONS
The following changes were introduced for the AcQMap Catheter Model 900009:
- . Changed the distal basket material from nitinol to a molded plastic
- Updated the handle design from a rotating knob deployment to a sliding knob deployment
- Changed the distal tip design to a PEEK distal core and stainless steel distal ring .
- . Modified distal seal design
- · Introduced a re-usable cable to reduce hospital waste
- · Updated the design to accommodate a more common 0.035" guidewire
- · Changed the sterilization method from e-beam radiation to EO
- Replaced coaxial wires with long flex circuits .
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Image /page/5/Picture/0 description: The image shows the logo for Acutus Medical. The logo consists of the word "ACUTUS" in gray block letters, with a small orange circle in the lower left corner of the "A". Below the word "ACUTUS" is the word "MEDICAL" in smaller, orange letters. The "®" symbol is located in the upper right corner of the "S".
ACQMAP® 3D IMAGING AND MAPPING CATHETER
Comparison of Technological Characteristics with the Predicate Device [807.92(A)(6)]
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(A)(6)] | |||
|---|---|---|---|
| Characteristics | SUBJECT | ||
| Modified AcQMap 3D Imaging & | |||
| Mapping Catheter, Model 900009 | PREDICATE | ||
| AcQMap 3D Imaging & Mapping | |||
| Catheter, Model 900003 | Rationale for | ||
| Substantial | |||
| Equivalence | |||
| Regulatory | |||
| 510(k) Number | K201341 | K170819 | -- |
| Classification/ | |||
| Regulation Number/ | |||
| Regulation Name/ | |||
| Product Code | Class II / 21 CFR §870.1220 / | ||
| Electrode recording catheter or | |||
| electrode recording probe / MTD | |||
| Class II / 21 CFR §892.1570 / | |||
| Transducer Ultrasonic/ ITX | Class II / 21 CFR §870.1220 / | ||
| Electrode recording catheter or | |||
| electrode recording probe / MTD | |||
| Class II / 21 CFR §892.1570 / | |||
| Transducer Ultrasonic/ ITX | Identical | ||
| Indications for Use | The AcQMap 3D Imaging and | ||
| Mapping Catheter is intended to be | |||
| used in the right and left atrial | |||
| chambers to collect ultrasound data | |||
| for visualizing the selected chamber | |||
| and recording electrical impulses in | |||
| patients with complex arrhythmias | |||
| that may be difficult to identify using | |||
| conventional mapping systems alone. | The AcQMap 3D Imaging and | ||
| Mapping Catheter is intended to be | |||
| used in the right and left atrial | |||
| chambers to collect ultrasound data | |||
| for visualizing the selected chamber | |||
| and recording electrical impulses in | |||
| patients with complex arrhythmias | |||
| that may be difficult to identify | |||
| using conventional mapping systems | |||
| alone. | Identical | ||
| Physical Characteristics | |||
| Configuration | Electrode/Transducer mounted on | ||
| splines | Electrode/Transducer mounted on | ||
| splines | Identical | ||
| Deployed Diameter | 25mm | 25mm | Identical |
| Working Length | 100 cm | 100 cm | Identical |
| Number of Spines | 6 | 6 | Identical |
| Heart Wall Contacting | No | No | Identical |
| Deflection Y/N | No | No | Identical |
| Flush Port | Yes | Yes | Identical |
| Technical Specifications - Electrical | |||
| Voltage | Yes | Yes | Identical |
| Charge Density | Yes | Yes | Identical |
| Number of Electrodes | 48 | 48 | Identical |
| Data Points/heartbeat | 2500 | 2500 | Identical |
| Power source | Electrical source from AcQMap | ||
| System | Electrical source from AcQMap | ||
| System | Identical | ||
| Technical Specifications – Ultrasound | |||
| Mode | M-mode | M-mode | Identical |
| Number of | |||
| transducers | 48 | 48 | Identical |
| Phased Array Y/N | N | N | Identical |
| Center Frequency | 10 MHz | 10 MHz | Identical |
| Characteristics | SUBJECT | ||
| Modified AcQMap 3D Imaging | |||
| and Mapping Catheter, Model | |||
| 900009 | PREDICATE | ||
| AcQMap 3D Imaging and | |||
| Mapping Catheter, Model | |||
| 900003 | Rationale for | ||
| Substantial | |||
| Equivalence | |||
| Acoustic Output | |||
| MI (Mechanical Index) | 0.06 | 0.06 | Identical |
| ISTPA.3 (Derated | |||
| Spatial-Peak | |||
| Temporal-Average | |||
| Intensity (milliwatts | |||
| per square | |||
| centimeter)) | 0.08 (mW/cm2) | 0.08 (mW/cm2) | |
| ISPPA.3 (Derated | |||
| Spatial-Peak Pulse | |||
| Average Intensity | |||
| (watts per square | |||
| centimeter)) | 1.03 | 1.03 | |
| Accessories | |||
| Compatible Sheath | For Use with Acutus Medical | ||
| AcQGuide 12 F Steerable Sheath | |||
| (K162925) | For Use with Acutus Medical | ||
| AcQGuide 12 F Steerable Sheath | |||
| (K162925) | Identical | ||
| Compatible Guidewire | 0.035" (0.89 mm) diameter J-tip | ||
| guidewire | 0.032" (0.81 mm) diameter J-tip | ||
| guidewire | The difference in | ||
| accessory size | |||
| compatibility does | |||
| not raise different | |||
| questions of safety | |||
| or effectiveness |
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Image /page/6/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, with a small orange dot above the left side of the "A". Below the word "ACUTUS" is the word "MEDICAL" in orange, with each letter spaced out. The logo is simple and modern, and the colors are muted and professional.
SUBSTANTIAL EQUIVALENCE
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 3D Imaging and Mapping Catheter, is substantially equivalent to the predicate AcQMap 3D Imaging and Mapping Catheter device.
Performance Data [807.92(b)]
All necessary bench testing was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap Catheter (K170819) and is incorporated by reference. No further clinical testing is required to support the subject device.
Nonclinical Testing Summary [807.92(b)(1)]
The nonclinical, bench testing is repeated or included in this submission by reference. A full list of the non-clinical testing is provided below:
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- Design Verification .
- Dimensional Inspection o
- Visual Inspection 0
- Functional (electrical) and Compatibility Testing 0
- Mechanical Testing (tensile testing) O
- Corrosion Testing O
- Electrode Coating Particulate Testing O
- Acoustic Output Testing O
- Accuracy Testing o
- Design Validation ●
- Usability Testing 0
- 0 Animal Testing
- Biocompatibility Testing including NAVI testing ●
In addition, Acutus performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap 3D Imaging and Mapping Catheter meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQMap 3D Imaging and Mapping Catheter does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps that display chamber-wide electrical activation 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 3D Imaging and Mapping Catheter. The necessary clinical testing was completed for the original AcQMap 3D Imaging and Mapping Catheter (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 3D Imaging and Mapping Catheter is safe and effective for its intended use.
Conclusions [807.92(b)(3)]
Extensive nonclinical performance testing, either repeated for the modified device or incorporated by reference to the original AcQMap 3D Imaging and Mapping Catheter 510(k), was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to evaluate the overall performance of the device. The clinical validation of the original AcQMap 3D Imaging Catheter (K170819) is applicable to the modified device. The collective results demonstrate that the modified AcQMap 3D Imaging and Mapping Catheter is safe and effective for its intended use, and further, is substantially equivalent to the predicate device