(27 days)
Not Found
No
The summary describes a computerized storage and display system for electrophysiology studies, focusing on visualizing global activation patterns and providing non-fluoroscopic navigation. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The changes described are related to system components and visualization capabilities, not algorithmic learning or adaptation.
No
The device is described as a computerized storage and display system used for mapping and identifying the source of arrhythmias, which aids in treatment but does not directly perform a therapeutic action itself.
Yes
The EnSite 3000 System is used for electrophysiology studies to identify and map arrhythmias in the heart, providing information to help identify the arrhythmia source, which aligns with the definition of a diagnostic device.
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 beyond just software.
Based on the provided information, the EnSite 3000® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- EnSite 3000® System Function: The description clearly states that the EnSite 3000® System is a computerized storage and display system used in electrophysiology studies of the human heart. It works with catheters or surface electrodes placed in or on the patient's body to map electrical activity.
- No Specimen Examination: The system does not examine specimens (like blood, tissue, or urine) in vitro (outside the body). It directly interacts with the patient's electrical signals in vivo (within the body).
Therefore, the EnSite 3000® System falls under the category of an in vivo diagnostic or therapeutic device, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
DOK
Device Description
The EnSite 3000® 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 Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® 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 3000® 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
right atrium, heart
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 3000® 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
OCT 3 0 2003
K033211 11/2
510(k) Summary for Public Disclosure
| Submitter: | Endocardial Solutions
1350 Energy Lane, Suite 110
St. Paul, MN 55108 USA
Phone: 651-523-6900
Fax: 651-644-7897 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Karen J. McKelvey
Regulatory Compliance Engineer |
| Date Prepared: | October 1, 2003 |
| Trade Name: | EnSite 3000® System
a) Model EC 1000 EnSite Multi-electrode Diagnostic Catheter
b) EnSite 3000® Electrophysiology Workstation
c) Model EN 0010 EnSite™ NavX Surface Electrode |
| 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: | Endocardial Solutions EnSite 3000® System
510(k) No. K030129 |
| Device Description: | The EnSite 3000® 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 Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® |
| | 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 3000® 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 3000® System is indicated for patients for whom
electrophysiology studies are indicated. |
| | When used with the EnSite® Catheter, the EnSite 3000®
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 3000® 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 3000® 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. |
Endocardial Solutions, Inc. EnSite® System
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
OCT 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endocardial Solutions, Inc. c/o Ms. Karen J. McKelvey Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K033211 Trade Name: EnSite System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DOK Dated: October 3, 2003 Received: October 3, 2003
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 Office of Compliance at (301) 594-4646. 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/cdrh/dsma/dsmamain.html
Sincerely yours.
Ana Heschke
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
13. 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.
Note: There is no change to the Indications for Use.
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sion of Cardiovasc
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Dma Xeumler
510(k) Number K033211