(29 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on conventional electrophysiology mapping technology.
No
The device facilitates mapping and diagnosis (displaying catheter position, identifying arrhythmias), but it does not directly treat or provide therapy to the patient. Its primary function is diagnostic and guidance-oriented for the electrophysiologist.
Yes
The EnSite System is described as being used in electrophysiology studies to identify and map complex arrhythmias, which is a diagnostic function. It helps display the position of catheters and detect intracardiac electrograms to characterize the nature and location of arrhythmias.
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 it includes hardware components.
Based on the provided information, the EnSite System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- EnSite System's Function: The EnSite System is described as a computerized storage and display system used in electrophysiology studies of the human heart. It works with catheters or surface electrodes to map electrical activity within the heart.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The system directly interacts with the patient's heart to record electrical signals.
Therefore, the EnSite System falls under the category of a medical device used for diagnostic and potentially therapeutic guidance (facilitating mapping and treatment of arrhythmias), but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DRF
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
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(k) pathway, 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
K070902 11/2 510(k) Summary for Public Disclosure Submitter: St. Jude Medical 1350 Energy Lane, Suite 110 St. Paul, MN 55108 USA MAY - 1 2007 Phone: 651-523-6900 651-644-7897 Fax: Contact: Karen J. McKelvey Principal Regulatory Compliance Engineer March 21, 2007 Date Prepared: EnSite® System (Model EE3000) Trade Name: a) EnSite™ Array (Model EC1000) b) EnSite NavXTM 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. K060954 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
St. Jude Medical, Inc. - Endocardial Solutions
1
02
| | 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 (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. |
. I
i
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features the department's name encircling a stylized eagle. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The seal is simple and conveys the department's role in health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
11 2007 MAY
St. Jude Medical Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K070902
Trade Name: EnSite™ System v7.0
Regulation Number: 21 CFR 870.1425 and 870.1220
Regulation Name: Programmable Diagnostic Computer And Electrode Recording Catheter Or Electrode Recording Probe
Regulatory Class: Class II Product Code: DQK and DRF Dated: March 30, 2007 Received: April 2, 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. McKelvev
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,
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): _ _ K070902
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 × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular Devices |
|---|
| ------------------------------------ |
| 510(k) Number | R67092 |
|---|---|
| --------------- | -------- |
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