(98 days)
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.
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
The provided text is a 510(k) Summary for the EnSite 3000® System. It describes the device, its intended use, and a general statement about non-clinical performance data. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative results that would allow for a comprehensive analysis of the device's performance against defined criteria.
Therefore, I cannot fully complete the requested table and answer all questions. Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states that "Device validation testing was conducted in accordance with in-house procedures," but does not detail the specific criteria for success. | "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. Sample size used for the test set and the data provenance
The document mentions "a battery of bench and user tests" for non-clinical performance data. However, no specific sample size for a test set (e.g., number of patients or cases) is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). The tests appear to be internal validation steps rather than a formal clinical study with a specified test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the document. There is no mention of experts establishing ground truth for any test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present in the document. No adjudication method is mentioned, as there's no described test set with ground truth established by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present in the document. The EnSite 3000® System is described as a "computerized storage and display system" that aids electrophysiologists. It facilitates mapping and visualization but isn't explicitly described as an AI system that improves human reader performance in the context of an MRMC study. No MRMC study or effect size data is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as assisting human operators ("electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy"). There is no mention of a standalone algorithm-only performance study. The system is intended to be used with human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not present in the document. There is no detailed description of ground truth establishment for any performance evaluation.
8. The sample size for the training set
The document describes "bench and user tests" for non-clinical performance data but does not mention a training set or its sample size. This suggests that if machine learning was involved (which isn't explicitly stated but could be inferred from "computerized system"), the details of its development and validation are not included in this summary.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not present in the document.
Summary of what the document does state regarding performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Endocardial Solutions EnSite 3000® System, K012926). The non-clinical performance data mentioned refers to "a battery of bench and user tests" conducted internally ("in-house procedures"). The conclusion states that the device is "as safe and effective as the previously marketed device" and "does not raise any new issues of safety and effectiveness." This indicates that the performance evaluation was likely focused on verifying that the changes made did not negatively impact the established performance of the predicate device, rather than establishing new, quantitative performance metrics against specific acceptance criteria.
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APR 2 2 2003
长030129
510(k) Summary
:
| Submitter: | Endocardial Solutions, Inc.1350 Energy Lane, Suite 110St. Paul, MN 55108 USAPhone: 651-523-6900Fax: 651-523-6990 |
|---|---|
| Contact: | Karen J. McKelveyRegulatory Compliance Engineer |
| Date Prepared: | February 28, 2003 |
| Trade Name: | EnSite 3000® System |
| a) Model EC 1000 EnSite® Multi-electrode Diagnostic Catheterb) EnSite 3000® Electrophysiology Workstationc) 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® System510(k) No. K012926 |
| Device Description: | The EnSite 3000® System is a computerized storage and displaysystem for use in electrophysiology studies of the human heart.The system consists of a console workstation, patient interfaceunit, and an electrophysiology mapping catheter or surfaceelectrode kit.Unlike currently available electrode recording catheters, the EnSiteCatheter does not require direct contact with the endocardium forthe detection of intracardiac electrograms. The EnSite 3000®System is a system that facilitates mapping and treatment ofarrhythmias. When used with the EnSite catheter, the system isuseful for treating patients with complex, non-sustained, or poorlytolerated arrhythmias that are difficult, if not impossible, to mapwith current mapping techniques. By visualizing the globalactivation pattern seen on the color-coded isopotential maps in theEnSite 3000® System, in conjunction with the reconstructed |
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030129 92/2
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.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three intertwined lines that form a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration i 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2003
Endocardial Solutions, Inc. c/o Ms. Karen J. McKelvey Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, Minnesota 55108-5254
Re: K030129
Trade Name: EnSite 3000® System with NavX Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II (two) Product Code: DQK Dated: March 31, 2003 Received: April 1, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
Warning: The use of this device in conjunction with radiofrequency ablation as a part of the diagnosis and treatment of cardiac arrhythmias may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.
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Page 2 - Ms. Karen J. McKelvey
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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.
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 (OS) 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 information about the application of other labeling requirements to your device (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" (21 CFR 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,
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K030129
Device Name: EnSite 3000® System with NavX
FDA's Statement of the Indications For Use for device:
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.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030129
§ 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).