(68 days)
Not Found
No
The summary describes a system for acquiring, analyzing, and displaying electroanatomical maps based on integrating electrograms with location information from magnetic sensors. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is described as a mapping system that displays cardiac maps and signals, intended for diagnostic purposes (acquiring, analyzing, and displaying electroanatomical maps), not for treating conditions.
Yes
Explanation: The device is described as a "mapping system" that allows "real-time display of cardiac maps" including "cardiac electrical activation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps." This indicates that it collects and analyzes data from the heart to identify and display abnormalities, which is characteristic of a diagnostic device. The "intended use" explicitly states "catheter-based atrial and ventricular mapping," which is a diagnostic procedure.
No
The device description explicitly states that the system uses "locatable-tip catheters equipped with a magnetic location sensor" to acquire location information, indicating the presence of hardware components beyond just software.
Based on the provided information, the CARTO XP mapping system is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "catheter-based atrial and ventricular mapping" and "real-time display of cardiac maps." This describes a system used in vivo (within the living body) to gather information about the heart's electrical activity and structure.
- Device Description: The description explicitly states the system "acquire, analyze, and display electroanatomical maps of the human heart" using "intracardiac electrograms with their respective endocardial locations." This confirms the system is interacting directly with the patient's heart.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions. The provided information does not mention the analysis of any such specimens.
The CARTO XP mapping system is clearly designed for use during a medical procedure on a living patient to assist in diagnosis and treatment planning related to cardiac electrical activity. This falls under the category of a medical device used in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the CARTO XP mapping system is catheter-based atrial and ventricular mapping.
The CARTO XP mapping system allows real-time display of cardiac maps in a number of The CARTO AT mapping system and no no roar cardiac electrical activation maps, cardiac difficient formation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface maps and cardiac impodation may also be displayed in real time on the display screen.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The CARTO™ XP mapping system is designed to acquire, analyze, and display electroanatomical 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. In the CARTO XP mapping system the location information needed to create the cardiac maps is acquired using locatable-tip catheters equipped with a magnetic location sensor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human heart, cardiac
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 I he noti-cinneal belief and allinal testing the 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.
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.
Not Found
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
K013083 p.1/2
NOV 21 2001
Image /page/0/Picture/2 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. The words "Biosense Webster" are in a bold, sans-serif font, and below that, in a smaller, italicized font, it says "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: asobel@bwiil.jnj.com
510(k) summary for the CARTO™ XP Mapping 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 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Amy Walters
Director of Regulatory and Clinical Affairs |
| Proprietary device name: | CARTOTM XP EP Navigation System |
| Classification name: | Programmable diagnostic computer
(per 21 CFR 870.1425) |
| Common device name: | Cardiac mapping system |
| Predicate device: | CARTOTM mapping system
510(k) No. K000248 |
| Manufacturer: | Biosense Webster (Israel) Ltd.
POB 2009
Tirat HaCarmel, 39120
Israel |
The CARTO™ XP mapping system is designed to acquire, analyze, and display electroanatomical 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. In the CARTO XP mapping system the location information needed to create the cardiac maps is acquired using locatable-tip catheters equipped with a magnetic location sensor.
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 mapping system enables cardiac mapping using a magnetic location technology, and may reduce exposure to dangerous ionizing radiation.
1
K013083 p.2/2
Image /page/1/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. The words "Biosense Webster" are in a bold, sans-serif font, with the tagline "a Johnson & Johnson company" in a smaller, italicized font below.
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: asobel@bwiil.jnj.com
The CARTO™ XP mapping system complies with the following safety standards:
- UL 2601-1:97/ CSA-C22.2 No. 601.1 .
- IEC 60601-2-25:93+A1(99) .
- IEC 60601-2-27:94 .
The non-clinical bench and animal testing show that the device is as safe and as effective I he noti-cinneal belief and allinal testing the which it is being compared and does not raise any new questions of safety or effectiveness.
001376
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 2001
Ms. Amy Walters Director, Regulatory and Clinical Affairs Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765
Re: K013083
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: October 19, 2001 Received: October 23, 2001
Dear Ms. Walters:
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 - Ms. Amy Walters
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 vours.
trollfo
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 2 1 2001
Indications for use statement
510(k) No: KO] 308 3
Device Name: CARTO™ XP mapping system
Indications For Use:
The intended use of the CARTO XP mapping system is catheter-based atrial and ventricular mapping.
The CARTO XP mapping system allows real-time display of cardiac maps in a number of The CARTO AT mapping system and no no roar cardiac electrical activation maps, cardiac difficient formation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface maps and cardiac impodation may also be displayed in real time on the display screen.
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K013083 |
Image /page/4/Picture/10 description: The image shows the number 001373. The numbers are in a bold, sans-serif font. The numbers are evenly spaced and aligned horizontally. The image is a close-up of the numbers, and the background is plain.