(170 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on traditional electrophysiology mapping techniques.
No.
The primary purpose of the EnSite Fusion and EnSite System, as described, is for mapping and navigation to identify arrhythmia sources, not for directly delivering therapy. While it facilitates treatment, it is not depicted as the therapeutic device itself.
Yes
The device assists electrophysiologists in identifying the arrhythmia source, which is a diagnostic purpose.
No
The device description explicitly states the system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit, indicating hardware components are included.
Based on the provided information, the EnSite Fusion device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for registering a navigation system to anatomical models derived from CT scans of the heart chambers. This is a process performed in vivo (within the living body) to guide medical procedures, not a test performed in vitro (outside the living body) on biological samples to diagnose a condition.
- Device Description: The description details a computerized system used in electrophysiology studies of the human heart, facilitating mapping and treatment of arrhythmias. This is a therapeutic and procedural guidance system, not a diagnostic test kit or instrument for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.), diagnostic testing, or the generation of diagnostic results based on such analysis.
Therefore, the EnSite Fusion device falls under the category of a medical device used for procedural guidance and visualization during electrophysiology studies, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EnSite System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
• When used with the EnSite Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
• When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.
EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The EnSite System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit.
Unlike currently available electrode recording catheters, the EnSite Array does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
heart, cardiac chambers, right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
electrophysiologist
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 changes made to the EnSite System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510, 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
K071818
r 1/2
510(k) Summary for Public Disclosure
| Submitter: | St. Jude Medical
1350 Energy Lane, Suite 110
St. Paul, MN 55108 USA
Phone: 651-523-6900
Fax: 651-644-7897 | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Contact: | Karen J. McKelvey
Principal Regulatory Compliance Engineer
DEC 20 2007 | |
| Date Prepared: | December 19, 2007 | |
| Trade Name: | EnSite® System (Model EE3000)
a) EnSite™ Array (Model EC1000)
b) EnSite NavX™ Surface Electrode Kit (Model EN0010)
d) EnSite Verismo™ Segmentation Tool (Model EV1000) | |
| Common name: | Electrophysiology cardiac mapping system | |
| Classification Name: | a) Electrode recording catheter or electrode recording probe (21CFR 870.1220)
b) Programmable diagnostic computer (21 CFR 870.1425) | |
| Predicate Device: | EnSite System
510(k) No. K070902 | |
| Device Description: | The EnSite System is a computerized storage and display system
for use in electrophysiology studies of the human heart. The
system consists of a console workstation, patient interface unit, and
an electrophysiology mapping catheter or surface electrode kit.
Unlike currently available electrode recording catheters, the EnSite
Array does not require direct contact with the endocardium for the
detection of intracardiac electrograms. The EnSite System is a
system that facilitates mapping and treatment of arrhythmias.
When used with the EnSite catheter, the system is useful for
treating patients with complex, non-sustained, or poorly tolerated | |
| | arrhythmias that are difficult, if not impossible, to map with
current mapping techniques. By visualizing the global activation
pattern seen on the color-coded isopotential maps in the EnSite
System, in conjunction with the reconstructed electrograms, the
electrophysiologist can identify the arrhythmia source and can
navigate to the defined area for therapy. When used with NavX
patches, the system is useful in treating patients with simpler
arrhythmias by providing non-fluoroscopic navigation and
visualization of conventional EP catheters | K071818
p 2 / 2 |
| EnSite System
V7.0 | | |
| Intended use: | The EnSite System is a suggested diagnostic tool in patients for
whom electrophysiology studies are indicated. | |
| | • When used with the EnSite Catheter, the EnSite System is
intended to be used in the right atrium of patients with complex
arrhythmias that may be difficult to identify using conventional
mapping systems alone.
OR
• When used with the EnSite NavX Surface Electrode Kit, the
EnSite System is intended to display the position of
conventional electrophysiology catheters in the heart. | |
| | | |
| EnSite Fusion
Dynamic
Registration Tool | | |
| Intended use: | EnSite Fusion is indicated for registering the EnSite NavX
navigation system to anatomic models, derived from CT scans, of
the four individual cardiac chambers. | |
| Technological
Characteristics: | The new device has the same technological characteristics as the
legally marketed predicate device. | |
| Non-clinical
Performance Data: | The changes made to the EnSite System underwent a battery of
bench and user tests. Device validation testing was conducted in
accordance with in-house procedures. | |
| Conclusion: | An evaluation of the device changes indicates that the device is as
safe and effective as the previously marketed device to which it is
being compared and does not raise any new issues of safety and
effectiveness. | |
:
1
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines that form a profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical c/o Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer 1350 Energy Lane. Suite 110 St. Paul. MN 55108
Re: K071818
Trade/Device Name:EnSite Fusion Dynamic Registration Tool Regulation Number: 21 CFR 870,1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 25, 2007 Received: October 26, 2007
Dear Ms. McKelvey:
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. Karen J. McKelvey
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
B. Bemmmer fr
Bram Ø. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
8. Indications for Use
510(k) Number (if known): K071818
Device Name: EnSite Fusion Dynamic Registration Tool
Indications for Use:
EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
Prescription Use _ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumanna
Sian-Off of Cardiovascular Devices 510(k) Number