(68 days)
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.
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.
The provided text is a 510(k) summary for the CARTO™ XP Mapping System. It briefly describes the device, its intended use, and states that non-clinical bench and animal testing demonstrate its safety and effectiveness compared to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information regarding sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the table or answer the specific questions directly from the provided text.
Based on the provided text, the following information can be extracted, though it does not fully answer the request:
Acceptance Criteria and Device Performance:
- The document states: "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." This is a general statement about meeting safety and effectiveness, but no specific performance metrics or acceptance criteria are listed.
Additional Information Not Available in the Document:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not mentioned. The device is a "mapping system" and not explicitly stated as an AI-driven diagnostic aid that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
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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 91765USAPhone: +1-800-729-9010Fax: +1-909-839-8804 |
|---|---|
| Contact person: | Amy WaltersDirector 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 system510(k) No. K000248 |
| Manufacturer: | Biosense Webster (Israel) Ltd.POB 2009Tirat HaCarmel, 39120Israel |
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.
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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
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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.
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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
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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.
§ 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).