K112007 · Biosense Webster, Inc. · DQK · Oct 5, 2011 · Cardiovascular
Device Facts
Record ID
K112007
Device Name
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
Applicant
Biosense Webster, Inc.
Product Code
DQK · Cardiovascular
Decision Date
Oct 5, 2011
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.1425
Device Class
Class 2
Indications for Use
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, nonnavigational, electrophysiology catheters without magnetic location sensors.
Device Story
System acquires/analyzes intracardiac electrograms and body surface ECG signals; utilizes magnetic sensor technology and Advanced Catheter Location (ACL) technology for real-time 3D anatomical/electroanatomical mapping. Used in clinical EP labs by physicians; provides visualization of cardiac activation, propagation, potential, impedance, and geometry. Integrates CT/MRI structural images (CARTOMERGE® Plus), intracardiac echo (CARTOSOUND®), and enables rapid volume creation (Fast Anatomical Mapping). Supports high-metallic environments and magnetic fields up to 0.1 T; provides data link to Stereotaxis Niobe® system. Output displayed on screen to guide catheter navigation and clinical decision-making during cardiac procedures; benefits patient through enhanced visualization and procedural guidance.
Clinical Evidence
Bench and animal pre-clinical testing performed to verify new features and ensure no negative impact on existing functionality. No clinical data provided.
Technological Characteristics
Cardiac mapping system using magnetic sensor and Advanced Catheter Location (ACL) technology. Hardware includes ECG board and extension cables. Supports specialized magnetic navigation catheters and conventional non-navigational catheters. Integrates with external imaging (CT/MRI/ICE). Operates in magnetic fields up to 0.1 T.
Indications for Use
Indicated for catheter-based atrial and ventricular mapping in patients undergoing electrophysiology procedures. Supports use of specialized magnetic navigation catheters and conventional non-navigational catheters.
Regulatory Classification
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.
{0}------------------------------------------------
#### 16 510(k) SUMMARY
16.1
General Information
Image /page/0/Picture/2 description: The image shows the text 'K112007' in a handwritten style. The characters are connected, giving it a cursive appearance. The text is written in black ink on a white background, and the numbers are slightly smaller than the letters.
# Applicant: Biosense Webster, Inc. 3333 Diamond Canyon Road Diamond Bar, CA 91765 USA Phone: 909-839-8597 Fax: 909-839-8804 July 8, 2011 Date: Wayne R. Hohman Contact Person: Project Manager Regulatory Affairs Trade/Proprietary Device CARTO® 3 V2.2 EP Navigation System and Accessories Name: Manufacturing Part FG-5400-00 (with standard location pad) Numbers: FG-5600-00 (with RMT location pad) Common Device Name: Cardiac mapping system Programmable diagnostic computer Classification Name: Device Classification: Class II, 21 CFR 870.1425 Product Code DQK CARTO® 3 V2.0 EP Navigation System and Accessories Predicate Device: 510(k) K103746, January 21, 2011 Manufacturing Facility: Biosense Webster (Israel) Ltd. 4 Hatnufa Street, POB 275 Yokneam 20692 Israel
Page 1 of 3
CONFIDENTIAL
{1}------------------------------------------------
# Description of Device 16.2
The CARTO® 3 V2.2 EP Navigation System is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps of the human heart in real-time. The location information needed to create the cardiac maps and the local electrograms are acquired using a specialized mapping catheters and reference devices. The system allows real-time display of electrograms and cardiac maps based on the received intra cardiac signals in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the display screen. The CARTO® 3 V2.2 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
### 16.3 New Features
The new features in this Special 510(k) Notification were software additions of Fluoro Effect Reduction (FER), support of Biosense Webster PENTARAY® Catheter, and support of SOUNDSTAR® eco Catheters with Split Handle, and hardware modification of an ECG board and addition of an Extension Cable. In addition, all modifications cleared via documentation since the prior predicate version were described.
#### 16.4 Indications for Use
The Indications for Use for the modified device are identical to the predicate device:
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® Plus functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of
Page 2 of 3
Biosense Webster, Inc. CARTO® 3 x 7 2 Snecial 510/k) CONFIDENTIAL
Page 80 of 631
{2}------------------------------------------------
K112007
intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, nonnavigational, electrophysiology catheters without magnetic location sensors.
# Summary of Non-Clinical Performance Testing 16.5
The CARTO® 3 V2.2 EP Navigation System underwent extensive bench and animal testing to verify the new and enhanced features and to demonstrate with regression testing that the new features did not negatively affect existing features. The CARTO® 3 V2.2 EP Navigation System passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness.
# Substantial Equivalence 16.6
The Carto® 3 EP Navigation System, Version 2.2, is substantially equivalent to the legally marketed Carto® 3 EP Navigation System, Version 2.0, 510(k) K103746, cleared on January 21, 2011.
#### 16.7 Conclusions
The bench and animal pre-clinical testing demonstrated that the CARTO® 3 V2.2 EP Navigation System is safe, effective, and performs as well as or better than the predicate device. This testing program supports the determination of substantial equivalence to the predicate device.
Page 3 of 3
Biosense Webster, Inc. CARTO® 3 v 7 7 Snerial SIN/k) CONFIDENTIAL
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The text is small and difficult to read, but it appears to be part of an organization's name. The graphic consists of three curved lines that resemble a stylized human figure or a flowing design, with wavy lines at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20903-0002
Biosense Webster, Inc. c/o Mr. Wayne R. Hohmann Project Manager Regulatory Affairs 3333 Diamond Canyon Road. Diamond Bar, CA 91765
2.11
Re: [510(k)] K112007 [210(W)] Trade/Device Name: CARTO 3 V2.2 EP Navigation System (Version 2.2) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 9, 2011
Dear Mr. Hohmann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
{4}------------------------------------------------
Page 2 - Mr. Wayne R. Hohmann
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.
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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/About/DA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
## · INDICATIONS FOR USE
510(k) No (if known): K112007
Device Name: CARTO® 3 V2.2 EP Navigation System
# Indications for Use:
The CARTO® 3 V2.2 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 V2.2 System is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V2.2 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.
Prescription Use V (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 IF NEEDED)
Concurrence of (Division Sign-Off) Device Evaluation (ODE)
Division of Cardiovascular Devices
| 510(k) Number | 1/1/2007 |
|---------------|----------|
|---------------|----------|
Page 1 of 1Biosense Webster, Inc. CARTOR 3 x 7 7 Snecial 510/k) CONFIDENTIAL
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
