K070240 · Biosense Webster, Inc. · DQK · May 4, 2007 · Cardiovascular
Device Facts
Record ID
K070240
Device Name
CARTO XP EP NAVIGATION SYSTEM, VERSION 9
Applicant
Biosense Webster, Inc.
Product Code
DQK · Cardiovascular
Decision Date
May 4, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1425
Device Class
Class 2
Indications for Use
The intended use of the CARTO® XP EP Navigation System, Version 9 is catheter-based atrial and ventricular mapping. The CARTO® XP EP Navigation System, Version 9 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, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen. CARTO® XP EP Navigation System, Version 9 includes the CARTOMERGE capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiac echo (ICE) visualization to provide 3D combined maps.
Device Story
System acquires, analyzes, and displays electro-anatomical maps of human heart; inputs include intracardiac electrograms, body surface ECG, and location data from catheters. Integrates pre-acquired CT/MRI structural images via CARTOMERGE module; incorporates real-time intracardiac echo (ICE) via SOUNDSTAR 3D Ultrasound Catheter. System transforms inputs into 3D cardiac maps (electrical activation, propagation, potential, impedance, and chamber geometry). Used in clinical settings by physicians; provides real-time visualization of catheter position relative to cardiac anatomy. Output assists clinicians in navigating catheters and identifying cardiac electrical activity; facilitates diagnosis and treatment of arrhythmias.
Clinical Evidence
Bench and electrical testing performed; simulated use conditions in animals conducted. System met all intended criteria; no new safety or effectiveness questions raised. No human clinical trial data provided.
Technological Characteristics
Electro-anatomical mapping system; integrates intracardiac electrograms, body surface ECG, CT/MRI images, and ultrasound data. Includes SOUNDSTAR 3D Ultrasound Catheter (10F, 90cm) with embedded acoustic array and location sensor. Connectivity includes integration with external imaging modalities. Software-based processing for 3D reconstruction and real-time display.
Indications for Use
Indicated for catheter-based atrial and ventricular mapping in patients requiring cardiac electrophysiological evaluation.
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.
Predicate Devices
CARTO® XP EP Navigation System, Version 8 (K042999)
Submission Summary (Full Text)
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K070240
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## 5 510(K) SUMMARY
Applicant:
Date:
Contact Person:
Biosense Webster, Inc. 3333 Diamond Canyon Rd, Diamond Bar, CA 91765 USA Phone: +1-800-729-9010 Fax: +1-909-839-8804
January 24, 2007
Neelu Medhekar Manager, Regulatory Affairs
Proprictary Device Name:
Common Device Name: Classitication Name:
Predicate Devices:
Manufacturer:
CARTO" XP EP Navigation System, Version 9
Cardiac mapping system Programmable diagnostic computer (per 21 CFR 870.1425, Product Code DQK) Class II Device
CARTO® XP EP Navigation System, Version 8 510(k) K042999
:
.
Biosense Webster (Israel) Ltd. POB 2009 Tiral HaCarmel 39120 Isracl
MAY - 4 2007
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K070240
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### ર્સ I SUBSTANTIALLY EQUIVALENT TO
The Biosense Webster, Inc., CARTO® XP EP Navigation System, Version 9, is substantially cquivalent to the CARTO® XP EP Navigation System. Version 8, cleared under 510(k) K042999 on March 21, 2005.
#### 5.2 INTENDED USE
The intended use of the CARTO® XP EP Navigation System, Version 9, is catherer-based atrial and ventricular mapping,
The CARTO® XP EP Navigation System, Version 9, allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac clectrical activation maps, cardiae clectrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac clectrograms may also be displayed in real-time on the display screen.
Carto" XP EP Navigation System, Version 9, includes the CARTO CAR Capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and realtime catheter navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiac ccho (ICE) visualization to provide 3D combined maps.
#### 5.3 GENERAL DEVICE DESCRIPTION
The CARTO® XP EP Navigation System, Version 9, is designed to acquire, analyze, and display clectro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac clectrograms with their respective cndocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry 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® XP EP Navigation System, Version 9, includes the following capabilities:
- The CARTOMERGE Module, released with the CARTO® XP EP . Navigation System, Version 8 under 510(k) K042999. This module enables the integration of pre-acquired Computed Tomography (CT) and Magnetic Resonance (MR) images.
- The now CARTOSOUND" Image Integration Module. This module, when used on the CARTO® XP EP Navigation System, Version 9, with a SOUNDSTAR 3D Ultrasound Catheter (510(k) bundled with the
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CARTO XP Version 9 FP Navigation System Traditional 510(k)
CARTO" XP EP Navigation System Version 9 System submission) enables interfacing with intracardiac ultrasound devices, providing for real-time integration of ultrasound (U/S) images with CARTO clectromagnetic acquired maps.
The Biosense Webster SOUNDSTAR 3DTM Ultrasound Catherer is a 90 cm 10F IntraCardiac Echo (ICE) catheter with an acoustic array cmbedded in the catherer tip that allows the acquisition of real time ultrasound images. The catherer also contains a location sensor that enables the accurate location of the U/S-observed intrucardiac analomics in the CARTO® XP EP Navigation System Version 9 spatial coordinates.
#### ર્ડ.4 PERFORMANCE DATA AND CONCLUSION
The CARTO XP EP Navigation System, Version 9, underwent bench and clectrical testing and was also tested under simulated use conditions in animals. The System passed all intended criteria in accordance with appropriate test criteria and standards and did not raise any new questions of safety or effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2007
Biosense Webster c/o Neelu Medhekar Manager, Regulatory Affairs 3333 Diamond Canyon Rd. Diamond Bar, CA 91765
Re: K070240
Trade/Device Name: Carto XP EP Navigation System, Version 9 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: April 6, 2007 Received: April 9, 2007
Dear Mr. Medhekar:
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 - Mr. Medhekar
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Donna R. Lo Lane
Sram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CARTO XP Version 9 EP Navigation System Traditional 510(k)
# INDICATIONS FOR USE STATEMENT
510(k) No (if known): KO 70240
Device Name: Carrow XP EP Navigation System, Version 9
Indications for Use:
4
The intended use of the CARTO" XP EP Navigation System, Version 9 is catheter-based atrial and ventricular mapping.
The CARTO® XP EP Navigation System, Version 9 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, impedance maps, and cardiac chamber geomery maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in realtime on the display screen.
CARTO® XP EP Navigation System, Version 9 includes the CARTOMERGE capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real-time cather navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiae ccho (ICE) visualization to provide 3D combined maps.
Over-The-Counter Use Prescription Use X - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW TIHS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_ of _ 1_
Duma R. Vachner
(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices
510(k) Number_Ko70240
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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.
