(297 days)
Not Found
No
The summary describes a system for acquiring, analyzing, and displaying electro-anatomical maps using magnetic location technology and electrograms. There is no mention of AI or ML algorithms being used for analysis, interpretation, or any other function. The analysis is described as "reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations."
No.
The device is described as a "Navigation System" intended to "acquire real time catheter based cardiac electrophysioligcal maps" and "acquire, analyze, and display electro-anatomical maps" of the heart. It is a diagnostic and mapping tool, not one that delivers therapy.
Yes
Explanation: The device is intended to acquire real-time catheter-based cardiac electrophysiological maps and allows real-time display of cardiac maps in various formats (activation, propagation, potential, geometry, impedance maps) along with acquired patient signals (ECG, electrograms). This gathering and display of information related to physiological states for analysis indicates a diagnostic purpose.
No
The device description explicitly states that the system uses catheters equipped with magnetic proximal and distal location sensors to acquire location information, indicating the presence of hardware components beyond just software.
Based on the provided text, the CARTO XP EP Navigation System with QWIKMAP software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The CARTO XP system is described as a catheter-based cardiac electrophysiological navigation and mapping system. It acquires real-time data directly from within the patient's heart using catheters.
- The system's purpose is to acquire and display electro-anatomical maps of the human heart and display patient signals like ECG and intracardiac electrograms. This is an in-vivo procedure, not an in-vitro examination of specimens.
Therefore, the CARTO XP EP Navigation System is a medical device used for in-vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The CARTO XP EP Navigation System with QWIKMAP software is intended to acquire real time catheter based cardiac electrophysiogical maps in patients who are eligible for a conventional electrophysiological study. There are no special contraindications when using the CARTO XP with OWIKMAP software.
The intended use of the CARTO XP EP Navigation System is catheter-based atrial and ventricular mapping.
The CARTO XP EP Navigation System allows real-time 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 and cardiac impedance 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
DQK
Device Description
The CARTO XP EP Navigation system with QWIKMAP software is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, chamber geometry maps, and impedance maps. In the CARTO XP with OWKMAP mapping system the location information needed to create the cardiac maps is acquired using catheters equipped with magnetic proximal and distal location sensors. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
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
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 show that the device 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)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized graphic to the left of the company name, "Biosense Webster," written in a serif font. Below the company name, in a smaller, italicized font, is the text "a Johnson & Johnson company."
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: icitron@bwiil.jnj.com
510(k) summary for the CARTO™ XP EP Navigation System
| 510(k) Notification submitted by: | Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar, CA 91765
USA
Phone: +1-800-729-9010
Fax: +1-909-839-8804 | JAN 09 2003 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact person: | Marcia Yaross
Vice President, Regulatory and Clinical Affairs | |
| Proprietary device name: | CARTO™ XP EP Navigation System with
QWIKMAP™ software | |
| Classification name: | Programmable diagnostic computer
(per 21 CFR 870.1425) | |
| Common device name: | Cardiac Mapping System | |
| Predicate device: | CARTO™ XP mapping system
510(k) No. K013083 | |
| Manufacturer: | Biosense Webster (Israel) Ltd.
POB 2009
Tirat HaCarmel, 39120
Israel | |
Indications For Use
The CARTO XP EP Navigation System with QWIKMAP software is intended to acquire real time catheter based cardiac electrophysiogical maps in patients who are eligible for a conventional electrophysiological study. There are no special contraindications when using the CARTO XP with OWIKMAP software.
General Device Description
The CARTO XP EP Navigation system with QWIKMAP software is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, chamber geometry maps, and impedance maps. In the CARTO XP with OWKMAP mapping system the location information needed to create the cardiac maps is acquired using catheters equipped with magnetic proximal and distal location sensors. The
1
Image /page/1/Picture/0 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized graphic to the left of the company name, "Biosense Webster," which is written in a serif font. Below the company name, in a smaller, cursive font, is the phrase "a Johnson & Johnson company."
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: icitron@bwiil.jnj.com
acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Cardiac EP mapping procedures are generally performed using a roving mapping catheter, a computerized mapping system, and fluoroscopy to determine the location of the tip of the mapping catheter. In the conventional procedure both the patient and the physician are exposed to harmful ionizing radiation during the course of the lengthy procedure. The CARTO XP with QWIKMAP mapping system enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.
Safety and Effectiveness
The CARTO™ XP EP Navigation System with QWIKMAP™ software complies with the following safety standards:
- UL 2601-1: 97/CSA C22.2 No. 601.1 ●
- IEC 60601-2-25: 93 and A1(99) .
- IEC 60601-2-27: 94 ●
The non-clinical bench and animal testing show that the device 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or birds in flight, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
Biosense Webster, Inc. c/o Mr. William Welch, RAC Regulatory Affairs Project Manager 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K020863
Trade Name: Carto™ XP EP Navigation System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: August 9, 2002 Received: August 12, 2002
Dear Mr. Welch:
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.
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 - Mr. William Welch
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
R.Z. MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for use statement
510(k) No: K020863
Device Name: CARTO XP EP Navigation System
Indications For Use:
The intended use of the CARTO XP EP Navigation System is catheter-based atrial and ventricular mapping.
The CARTO XP EP Navigation System allows real-time 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 and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
Della Teth
Prescription Use $\checkmark$