(191 days)
Not Found
No
The document describes a computerized storage and display system for electrophysiology studies, focusing on mapping and visualization techniques. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as a computerized storage and display system used for mapping and identifying arrhythmias to assist an electrophysiologist in navigating for therapy, rather than directly providing therapy itself.
Yes
The device is intended to identify arrhythmias, which is a diagnostic function. It helps the electrophysiologist "identify the arrhythmia source" and is used in electrophysiology studies to map and understand complex arrhythmias.
No
The device description explicitly states that the system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit, which are hardware components.
Based on the provided information, the EnSite System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EnSite System Function: The EnSite System is used in vivo (within the living body) to map electrical activity in the heart. It interacts directly with the patient's heart using catheters or surface electrodes.
- Intended Use: The intended use clearly describes its application in electrophysiology studies on patients to identify and treat arrhythmias.
- Device Description: The description details a system used in the human heart for mapping and treatment, not for analyzing samples outside the body.
Therefore, the EnSite System falls under the category of a medical device used for diagnosis and treatment within the patient, not an IVD device used for testing samples from the patient.
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.
Product codes
Not Found
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
Not Found
Anatomical Site
human heart, right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
EnSite System K070902
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K083328 pg 1 of 2
:
| Submitter: | St. Jude Medical
1350 Energy Lane, Suite 110
St. Paul, MN 55108
Phone: 651-523-6900
Fax: 651-523-6990 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Karen J. McKelvey
Regulatory Manager II |
| Date Prepared | May 19, 2009 |
| Trade Name: | EnSite System™ (Model EE3000)
a) EnSite Array™ (Model EC1000)
b) EnSite NavXTM Surface Electrode Kit (Model EN0010) |
| Common Name | Electrophysiology mapping system with console and
catheter |
| Classification Name: | Programmable diagnostic computer
(21 CFR 870.1425) |
| Predicate Device: | EnSite System 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 |
| 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. |
| 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 |
Page 2
1
K083328 pg. 2of2
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads, "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2009
St. Jude Medical c/o Ms. Karen J. McKelvey Regulatory Affairs Manager II 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K083328
Trade/Device Name: EnSite System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Dated: April 22, 2009 Received: April 23, 2009
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. Iisting 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 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); medical device 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
iona R. Va. Nunes
Image /page/3/Picture/6 description: The image contains a handwritten symbol that resembles a cursive letter 'w' with an additional curved line above it. The symbol is drawn in black ink on a white background. The symbol is on the left side of the image.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification: Device Modification
9. Indications for Use
Device Name: EnSite System
Indications for Use:
The EnSite System is indicated for 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.
Prescription Use _ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Suna E. V. Holmes
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko83328
St. Jude Medical
Page 9-1