(14 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on conventional computerized storage and display.
No
The document states that the EnSite System is a "computerized storage and display system" used for electrophysiology studies, which suggests a diagnostic rather than therapeutic purpose. Its function is to identify and display information related to heart arrhythmias, not to treat them.
Yes
The device is used for electrophysiology studies to identify complex arrhythmias and display the position of catheters, which are diagnostic purposes for heart conditions.
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, indicating the presence of hardware components.
Based on the provided information, the EnSite System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The EnSite System is used in vivo (within the living body) to map electrical activity in the heart.
- The intended use describes a system for electrophysiology studies and displaying catheter positions within the heart. This is a diagnostic procedure performed directly on the patient, not on a sample taken from the patient.
- The device description details a system with a console, patient interface unit, and catheters/electrodes. These components are consistent with an in vivo medical device used for mapping and navigation within the body.
Therefore, the EnSite System falls under the category of an in vivo diagnostic or therapeutic device, not an IVD.
N/A
Intended Use / 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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium, heart
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
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
Not Found
Predicate Device(s)
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
510(k) Summary for Public Disclosure
| Submitter: | St. Jude Medical, Inc.
Endocardial Solutions
1350 Energy Lane, Suite 110
St. Paul, MN 55108 USA
Phone: 651-523-6900
Fax: 651-644-7897 | APR 21 2006 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Karen J. McKelvey
Principal Regulatory Compliance Engineer | |
| Date Prepared: | March 23, 2006 | |
| 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. K042493 | |
| 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 | |
| Intended use: | 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
The EnSite System (EE3000) is indicated for patients for whom
electrophysiology studies are indicated.
When used with the EnSite Array, 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. | |
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.
an electrophysiology mapping catheter or surface electrode kit.
St. Jude Medical, Inc. - Endocardial Solutions
Appendix-O page 2
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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text appears to be part of the official seal of the U.S. Department of Health and Human Services. The central symbol consists of three curved lines that resemble a stylized human figure or a bird in flight. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
St. Jude Medical, Inc. c/o Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer Endocardial Solutions 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K060954
Trade Name: Ensite" System (Model EE3000) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: April 05, 2006 Received: March 07, 2006
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.
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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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Blummenau for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060954
Device Name:
Indications For Use:
Indications for Use
The EnSite System is indicated for patients for whom electrophysiology studies are
indicated. 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.
Note: There is no change to the Indications for Use.
Prescription Use (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 CDRH. Office of Device Evaluation (ODE)
Blemmel
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