(31 days)
Not Found
No
The description focuses on a computerized storage and display system for electrophysiology studies, utilizing a mapping catheter or surface electrodes to visualize electrical activity. There is no mention of AI, ML, or related concepts like deep learning, image processing (in the context of AI analysis), or training/test sets for algorithmic development. The system's functionality appears to be based on signal processing and visualization of electrical data, not AI/ML-driven analysis or interpretation.
No
The device is used for mapping and identifying the source of arrhythmias, not for providing direct therapy or treatment. Its function is diagnostic and assistive to the clinician in guiding treatment.
Yes
Explanation: The device is described as facilitating mapping and identifying arrhythmia sources, which are diagnostic purposes for medical conditions.
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, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- The EnSite 3000® System is used within the human body (intracardiac) to map electrical activity and guide procedures. It interacts directly with the patient's heart.
The description clearly states the system is used in electrophysiology studies of the human heart, utilizing catheters and surface electrodes to visualize and map electrical activity in vivo. This is a diagnostic and therapeutic tool used directly on the patient, not a device that analyzes samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
DQK
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)
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
OCT 15 2004
K0462493
page 1 of 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: | September 10, 2004 |
| 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® |
.
Endocardial Solutions, Inc. EnSite® System
1
K040493
page 2 of 2
| 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. |
.
:
:
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
Endocardial Solutions, Inc. c/o Ms. Karen J. McKelvey Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul MN 55108
Re: K042493
Trade Name: EnSite System: EnSite 3000 Electrophysiology Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 30, 2004 Received: October 4, 2004
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 Erth 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. product from to begin marketing your device as described in your Section 510(k) rremarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicated 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 may be obtained from the O wision 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,
Bhiminor 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):
Device Name:
Indications For Use:
The EnSite System is indicated for patients for whom electrophysiology studies are indicated in the
-
Site System is indicated for patients r, the EnSite System is intended to be used in the . When used with the EnDito' Catheter, 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 . Which used with the Diffice National electrophysiology catheters in the heart.
) 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)
Bhummer
28
310(k) Number
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