(219 days)
Not Found
No
The summary describes a real-time 3D mapping system using localization technology and electrograms, but there is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The RHYTHMIA HDx™ Mapping System is indicated for catheter-based atrial and ventricular mapping, allowing real-time visualization and display of cardiac maps and signals. It is a diagnostic and mapping system, not designed to provide therapeutic treatment.
Yes
The 'Intended Use / Indications for Use' states that the system is indicated for "catheter-based atrial and ventricular mapping" and allows "real-time visualization of intracardiac catheters as well as display of cardiac maps." This process of mapping and displaying cardiac information to understand the state of the heart is a diagnostic function. The 'Device Description' further clarifies its purpose: "designed to display 3D anatomical and electroanatomical maps of the human heart in real-time" and "intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data." All these activities are aimed at understanding and identifying conditions within the heart, which is inherently diagnostic.
No
The device description explicitly mentions hardware components like the "Signal Station and related accessories" and the "system Workstation computer," which are integral to the system's function and data processing. It is described as "reusable capital equipment."
Based on the provided information, the RHYTHMIA HDx™ Mapping System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "catheter-based atrial and ventricular mapping" and "real-time visualization of intracardiac catheters as well as display of cardiac maps." This involves directly interacting with the patient's body (intracardiac) and displaying physiological signals and anatomical information.
- Device Description: The description reinforces its use during "electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data." It uses "catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms." These are all in-vivo measurements and procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
The RHYTHMIA HDx™ Mapping System is used in vivo (within the living body) to map the electrical activity and anatomy of the heart, not to analyze specimens in vitro.
N/A
Intended Use / Indications for Use
The RHYTHMIA HDx™ Mapping System (with software Version 2.0) and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
Product codes
DQK
Device Description
The RHYTHMIA HDx™ Mapping System is a catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time. The mapping system is intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data. In addition, based on user-defined criteria, the system is able to acquire data over multiple cardiac beats. It is capable of real-time display through construction of maps using catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms.
The Signal Station and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system Workstation computer and software.
The subject device is reusable capital equipment that is intended to be used in an electrophysiology laboratory by physicians fully trained in cardiac electrophysiology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians fully trained in cardiac electrophysiology / electrophysiology laboratory
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
Software Verification and Validation: Software verification and validation testing was conducted based on 'major' level of concern in accordance with FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.
Bench Performance Testing:
- Mapping and Visualization - Confirmed that incorporation of the new software features does not negatively impact the ability to use the subject mapping system to: (1) accurately create 3D maps of the cardiac chambers of the heart; and (2) support visualization of magnetic and impedance tracked catheters.
- Software Performance - Confirmed that the new software features meet the functional requirements.
- System Level Performance - Confirmed system level functionality under expected and worst case use conditions.
Animal Study: A pre-clinical animal study conducted with 21 CFR § 58 GLP regulations was performed and demonstrated that the subject device software does not present new questions of safety associated with its use.
Key results: The RHYTHMIA HDx Mapping System software Version 2.0 passed all tests in accordance with appropriate test acceptance criteria and standards. No new questions of safety and effectiveness were raised. The software verification and validation, bench performance testing and animal study demonstrated that the RHYTHMIA HDx™ Mapping System software Version 2.0 performs as intended. This data supports that the subject device is substantially equivalent to identified predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 25, 2018
Boston Scientific Corporation Gregory Neal Senior Regulatory Affairs Specialist 125 Cambridgepark Drive Cambridge, Massachusetts 02140
Re: K173837
Trade/Device Name: RHYTHMIA HDx™ Mapping System (with software Version 2.0) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: June 21, 2018 Received: June 25, 2018
Dear Gregory Neal:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
(1-800-638-2041 or 301-796-7100).
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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
Sincerely,
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173837
Device Name
RHYTHMIA HDx™ Mapping System (with software Version 2.0)
Indications for Use (Describe)
The RHYTHMIA HDx™ Mapping System (with software Version 2.0) and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
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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510(K) SUMMARY 510(K) SUMMARY COMPLYING WITH 21 CFR 807.92
I. SUBMITTER
Boston Scientific Corporation 125 Cambridgepark Drive, Suite 600 Cambridge, MA 02140
Phone: 617-218-3813 Fax: 617-218-3850
Contact Person: Gregory Neal Date Prepared: December 18, 2017
II. DEVICE
Name of Device: RHYTHMIA HDx™ Mapping System (with software Version 2.0) Common or Usual Name: Cardiac Mapping System Classification Name: Programmable diagnostic computer (21 CFR 870.1425) Regulatory Class: Class II Product Code: DQK
III. PREDICATE DEVICES
Predicate: RHYTHMIA HDx™ Mapping System Boston Scientific Corporation (K162793, S.E. 03/10/2017) Predicate: CARTO® 3 EP Navigation System version 4.2, Biosense Webster, Inc. (K133916, S.E. 07/01/2014)
IV. DEVICE DESCRIPTION
The RHYTHMIA HDx™ Mapping System is a catheter-based atrial and ventricular mapping system designed to display 3D anatomical and electroanatomical maps of the human heart in real-time. The mapping system is intended to be used during electrophysiology procedures for cardiac mapping and storage of cardiac electrophysiological data. In addition, based on user-defined criteria, the system is able to acquire data over multiple cardiac beats. It is capable of real-time display through construction of maps using catheter magnetic and impedance localization technology and data from intracardiac and surface electrograms.
The Signal Station and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system Workstation computer and software.
The subject device is reusable capital equipment that is intended to be used in an electrophysiology laboratory by physicians fully trained in cardiac electrophysiology.
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V. INDICATIONS FOR USE
The RHYTHMIA HDxTM Mapping System (with software Version 2.0) and accessories are indicated for catheter-based atrial and ventricular mapping system allows realtime visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Substantial equivalence of the RHYTHMIA HDx™ Mapping System with software Version 2.0 was established in terms of design features, performance testing, and indications for use as compared to the predicates RHYTHMIA HDx™ Mapping System and CARTO® 3 EP Navigation System. The subject device system has a similar design to the primary predicate device to include the same primary system components, operating principle, catheter tracking methods, and same intended use while incorporating the same feature functionality as the secondary predicate feature.
The technological differences between the subject device and the predicate RHYTHMIA HDx™ Mapping System include the following software enhancements:
- DirectSense™ feature provides real-time display of local impedance which . complements other diagnostic measures for the purpose of determining catheter location within the heart chamber.
- Enhanced CT and MRI capabilities, which allow import of pre-segmented file types. ●
- Improved initial map setup through enhanced mapping workflow. ●
- Support for multiple monitor displays. ●
- . Minor bug fixes.
VII. PERFORMANCE DATA
Testing was performed to verify functional performance, safety, and to support substantial equivalence determination. The subject RHYTHMIA HDx Mapping System software Version 2.0 passed all tests in accordance with appropriate test acceptance criteria and standards. No new questions of safety and effectiveness were raised.
Software Verification and Validation
Software verification and validation testing was conducted based on 'major' level of concern in accordance with FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005.
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Bench Performance Testing
- Mapping and Visualization - Confirmed that incorporation of the new software features does not negatively impact the ability to use the subject mapping system to: (1) accurately create 3D maps of the cardiac chambers of the heart; and (2) support visualization of magnetic and impedance tracked catheters.
- Software Performance Confirmed that the new software features meet the functional ● requirements.
- System Level Performance - Confirmed system level functionality under expected and worst case use conditions.
Animal Study
A pre-clinical animal study conducted with 21 CFR § 58 GLP regulations was performed and demonstrated that the subject device software does not present new questions of safety associated with its use.
VIII. CONCLUSIONS
The software verification and validation, bench performance testing and animal study demonstrated that the RHYTHMIA HDx™ Mapping System software Version 2.0 performs as intended. This data supports that the subject device is substantially equivalent to identified predicate devices.