(26 days)
The intended use of the CARTO mapping system is catheter-based cardiac mapping.
The CARTO mapping 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.
The CARTO 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 mapping system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.
Here's an analysis of the provided text regarding the CARTO Mapping System's acceptance criteria and studies, organized by your requested information:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary (K992968) for the CARTO Mapping System does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) nor does it provide detailed quantitative results from studies that would match such criteria directly.
Instead, the summary relies on a demonstration of substantial equivalence to a previously marketed device (CARTO mapping system, 510(k) No. K954395). The primary claim regarding performance is qualitative:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence | "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." |
| Compliance with Safety Standards | Complies with EN 60601-111990, EN 60601-1 A1/1993, EN 60601-1 A2/1995, EN 60601-2-27/1994. |
| Intended Use | Catheter-based cardiac mapping, real-time display of various cardiac maps (electrical activation, propagation, potential, chamber geometry, impedance), and display of patient signals (body surface ECG, intracardiac electrograms). |
| Radiation Exposure Reduction | "may reduce exposure to dangerous ionizing radiation." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical bench and animal testing" but does not provide details about the sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective nature). The specificity required to determine if these were "test sets" in the context of clinical performance evaluation for acceptance criteria is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for any test set. This type of detail is typically associated with clinical studies involving human subject data, which are not detailed in this 510(k) summary beyond the general statement of "non-clinical bench and animal testing."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no details are provided about expert involvement or ground truth establishment (as per point 3), there is no information available regarding any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The CARTO Mapping System is described as a cardiac mapping system utilizing magnetic location technology, and while it processes information, it predates the widespread use and regulatory discussion of "AI" in medical devices as commonly understood today.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The 510(k) summary focuses on demonstrating substantial equivalence through "non-clinical bench and animal testing" and compliance with safety standards. While the device acquires and displays data, the document does not explicitly describe a standalone algorithm-only performance study in the way one might discuss an AI algorithm's performance without human input. The system is inherently designed to assist clinicians in cardiac mapping, implying a human-in-the-loop interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the reliance on "non-clinical bench and animal testing" and the absence of detailed clinical study descriptions, the specific type of ground truth used is not specified. For animal studies, "ground truth" might refer to direct physiological measurements or post-mortem analysis. For bench testing, it would likely involve known physical parameters or simulated conditions.
8. The sample size for the training set
The document does not mention a training set or any details about machine learning model development. This 510(k) submission, dated 1999, predates the era where "training set" would be a common term in medical device submissions for AI/ML-driven devices.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), there's no information on how its ground truth might have been established.
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Kg92968
Image /page/0/Picture/2 description: The image shows the Biosense Webster logo. The logo consists of a stylized letter "B" made up of four squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is a horizontal line, and below that is the text "a Johnson & Johnson company" in a smaller, italicized font.
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bioil.jnj.il
510(k) summary for the CARTO Mapping System
| 510(k) Notification submittedby: | Biosense Webster, Inc.3333 Diamond Canyon Rd.Diamond Bar, CA 91765USAPhone: +1-800-729-9010Fax: +1-909-468-3781 |
|---|---|
| Contact person: | Sandra WilliamsonSenior Regulatory Affairs Associate |
| Proprietary device name: | CARTOTM Mapping System |
| Classification name: | Programmable diagnostic computer(per 21 CFR 870.1425) |
| Common device name: | Cardiac mapping system |
| Cleared unmodified device | CARTO mapping system510(k) No.K954395 |
The CARTO 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 mapping system the location information needed to create the cardiac maps is acquired simultaneously with the local electrogram using locatable-tip catheters equipped with a magnetic location sensor.
Currently, cardiac mapping is 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.
The CARTO mapping system complies with the following safety standards:
EN 60601-111990 EN 60601-1 A1/1993 EN 60601-1 A2/1995 EN 60601-2-27/1994
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Image /page/1/Picture/0 description: The image shows the logo for Biosense Webster, a Johnson & Johnson company. The logo consists of a stylized letter "B" made up of black squares, followed by the word "Biosense" in a bold, sans-serif font. Below the word "Biosense" is the phrase "a Johnson & Johnson company" in a smaller, serif font. A horizontal line is placed under the word "Biosense".
. .
. .
Einstein Building, Etgar St., New Industrial Zone, POB 2009, Tirat HaCarmel 39120 ISRAEL Tel: +972-4-8576057 Fax: +972-4-8571071 e-mail: sstolars@bioil.jnj.il
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.
000786
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Image /page/2/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1999
Ms. Sandra Williamson Senior Regulatory Affairs Associate Cordis Webster, Inc. 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
K992968 Re : Carto™ EP Navigation System Requlatory Class: II (two) Product Code: DQK Dated: Auqust 30, 1999 Received: September 3, 1999
Dear Ms. Williamson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sandra Williamson
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for use statement
510(k) No:
Device Name: CARTO mapping system
Indications For Use:
The intended use of the CARTO mapping system is catheter-based cardiac mapping.
The CARTO mapping 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.
Dan Va Hill
(Division Signand Neur 510k) N
Prescription Use
(Per 21 CFR 801.109)
000783
§ 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).