(114 days)
No
The description focuses on traditional electromechanical mapping techniques and software improvements for efficiency, with no mention of AI or ML algorithms.
No
The device is described as a "Cardiac Navigation System" used for catheter-based cardiac mapping, which acquires, analyzes, and displays electromechanical maps of the heart. Its purpose is to aid in diagnosis and understanding of cardiac conditions, not to provide a therapy or treatment itself.
Yes
The device is described as a "computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart," and its intended use is "catheter-based cardiac mapping" which involves the display of various cardiac electrical and mechanical maps, as well as patient signals like ECG and intracardiac electrograms. This process of acquiring and analyzing data to provide detailed information about the heart's function aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "computerized electromechanical mapping system" and mentions using "commercially available Biosense Webster catheters equipped with the proprietary location sensor(s)". This indicates the system includes hardware components beyond just software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "catheter-based cardiac mapping." This involves acquiring and displaying real-time electrical and mechanical information from within the patient's body using a catheter.
- Device Description: The device is described as a "computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart." It integrates information from "intracardiac electrograms with the respective endocardial locations." This is all happening in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
The NOGA™ XP Cardiac Navigation System is clearly designed for use within the patient's body to map the heart's activity, not to test samples taken from the body.
N/A
Intended Use / Indications for Use
The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.
The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Product codes (comma separated list FDA assigned to the subject device)
74 DQK
Device Description
The NOGA™ XP Cardiac Navigation System with QwikMap™ Software is a modification of the NOGA™ Cardiac Navigation System cleared for marketing under K000332. Like the predicate device, the NOGA™ XP System is a computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart in a clear and intuitive manner. Maps are constructed by combining and integrating information from intracardiac electrograms with the respective endocardial locations. Like the CARTO™ Cardiac Navigation systems (K992968, K993729, K000248, K000190, K013083, and K020863), all commercially available Biosense Webster catheters equipped with the proprietary location sensor(s) that provide(s) real-time information on the location of the catheter can be used with the NOGA™ XP Cardiac Navigation System.
The current NOGA™ Cardiac Navigation System software was upgraded to allow for:
- . on-screen visualization of the catheter shaft.
- reduction of the steps required to create electromechanical maps .
- · NOGA™ XP software creates the equivalent of a 50-point map with only 8-10 contact points, and
- · easier mapping of transient events.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
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)
The non-clinical bench and animal testing confirms that the NOGATM XP Cardiac Navigation System with QwikMap™ Software is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness.
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.
NOGATM Cardiac Navigation System, K000332, CARTOTM XP QWIKMAPTM EP Navigation System, K020863
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.
K992968, K993729, K000248, K000190, K013083, K020863
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
§ 870.1425 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
SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
2006 MAR 9
5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765 |
|---------------------------|---------------------------------------------------------------------------------------|
| TRADE NAME: | NOGATM XP Cardiac Navigation System with QwikMapTM
Software |
| COMMON NAME: | Cardiac Mapping System |
| CLASSIFICATION
NAME: | Programmable diagnostic computer |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR §870.1425 |
| PRODUCT CODE | 74 DQK - computer, diagnostic, programmable |
| PREDICATE
DEVICE: | NOGATM Cardiac Navigation System and the CARTOTM XP
QWIKMAPTM EP Navigation System |
| MANUFACTURER | Biosense Webster (Israel) Ltd.
POB 2009
Tirat HaCarmel, 39120
Israel |
SUBSTANTIALLY EQUIVALENT TO:
The NOGA™ XP Cardiac Navigation System is substantially equivalent to the NOGA™ Cardiac Navigation System cleared for marketing under K000332 and to the CARYOTM XP QWIKMAP™ EP Navigation System cleared for marketing under K020863.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NOGA™ XP Cardiac Navigation System with QwikMap™ Software is a modification of the NOGA™ Cardiac Navigation System cleared for marketing under K000332. Like the predicate device, the NOGA™ XP System is a computerized electromechanical mapping system designed to acquire, analyze, and display electromechanical maps of the heart in a clear and intuitive manner. Maps are constructed by combining and integrating information from intracardiac electrograms with the respective endocardial locations. Like the CARTO™ Cardiac Navigation
CONFIDENTIAL
1
systems (K992968, K993729, K000248, K000190, K013083, and K020863), all commercially available Biosense Webster catheters equipped with the proprietary location sensor(s) that provide(s) real-time information on the location of the catheter can be used with the NOGA™ XP Cardiac Navigation System.
The current NOGA™ Cardiac Navigation System software was upgraded to allow for:
- . on-screen visualization of the catheter shaft.
- reduction of the steps required to create electromechanical maps .
- · NOGA™ XP software creates the equivalent of a 50-point map with only 8-10 contact points, and
- · easier mapping of transient events.
INDICATION FOR USE:
The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.
The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
PERFORMANCE DATA:
The non-clinical bench and animal testing confirms that the NOGATM XP Cardiac Navigation System with QwikMap™ Software is as safe and as effective as the previously marketed device to which it is being compared and does not raise any new questions of safety or effectiveness.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The indications for use for the NOGA™ XP Cardiac Navigation System with QwikMap™ Software are the same as the indications for use for the predicate devices. Software validation, simulated use, and testing in the porcine model demonstrate that the NOGA™ XP Cardiac Navigation System with QwikMap™ Software works in an equivalent manner to the predicates.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a symbol resembling three stylized human figures intertwined, positioned to the right. Encircling this symbol is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 9
Biosense Webster, Inc. c/o Ms. Sigi Caron MedTech Consultants, Inc 2400 Via Carrillo Palos Verdes Estates, CA 90274
Re: K053194
Trade Name: Noga™ XP Cardiac Navigation System with QwikMap™ Softwarc Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: February 16, 2006 Received: February 21, 2006
Dear Ms. Caron:
We bave 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Sigi Caron
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfummumor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K053194
Device Name: NOGA™ XP Cardiac Navigation System with QwikMap™ Software
The intended use of the NOGA™ XP Cardiac Navigation System with QwikMap™ Software is catheter-based cardiac mapping.
The NOGA™ XP Cardiac Navigation System with QwikMap™ Software allows realtime display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.Limmama
(Division Sign-Off)
Page 1 of
Division of Cardiovasc
510(k) Number K
Biosense Webster, Inc.
CONFIDENTIAL
NOGA XP Special 510(k) Page 12 of 341