(27 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 describes a 510(k) summary for the EnSite 3000® System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics. Therefore, many of the requested sections about acceptance criteria, study sizes, and ground truth establishment cannot be fully populated from the given information.
However, based on the non-clinical performance data section, some inferences and summaries can be made regarding testing.
Here's an attempt to populate the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states, "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." It does not explicitly define specific numerical acceptance criteria or detail the quantitative performance of the device against such criteria. The conclusion simply states, "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." This implies that the device met internal performance benchmarks consistent with the predicate device, but these are not specified.
| Aspect of Performance | Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (Summary from text) |
|---|---|---|
| Safety & Effectiveness | Consistent with legally marketed predicate device (K030129) and not raising new safety/effectiveness issues. | "As safe and effective as the previously marketed device... and does not raise any new issues of safety and effectiveness." |
| Functionality | (Implied) Successful operation in bench and user tests for described functions of the EnSite 3000® System components (console, patient interface unit, mapping catheter/surface electrode kit). | "Underwent a battery of bench and user tests." |
| Technological Characteristics | Identical to the legally marketed predicate device. | "The new device has the same technological characteristics as the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance
The document refers to "bench and user tests" but does not specify the sample size (e.g., number of cases, number of subjects, or number of test scenarios) for these tests.
The data provenance is not specified (e.g., retrospective or prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for a test set. The evaluation seems to be focused on comparing the new device against the predicate and against internal validation procedures.
4. Adjudication method for the test set
Not applicable, as no external expert adjudication for a test set is described.
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
No such MRMC study is mentioned. The device described is an electrophysiology mapping system, not an AI-assisted diagnostic tool that would typically involve human "readers" in the context of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe a "standalone" algorithmic performance study in the context of AI. The testing described involves "bench and user tests" for a medical device system, which inherently includes the device's integrated functionalities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the context of evaluating a diagnostic/mapping system's accuracy (e.g., against true anatomical locations or arrhythmia sources) is not explicitly detailed in the provided summary. The evaluation focuses on the safety and effectiveness relative to a predicate device and adherence to internal validation procedures.
8. The sample size for the training set
Not applicable. The document does not describe an AI/machine learning model that would require a "training set." The device is a "computerized storage and display system" and mapping system, not a learning algorithm that is "trained."
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI/machine learning model.
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OCT 3 0 2003
K033211 11/2
510(k) Summary for Public Disclosure
| Submitter: | Endocardial Solutions1350 Energy Lane, Suite 110St. Paul, MN 55108 USAPhone: 651-523-6900Fax: 651-644-7897 |
|---|---|
| Contact: | Karen J. McKelveyRegulatory Compliance Engineer |
| Date Prepared: | October 1, 2003 |
| Trade Name: | EnSite 3000® Systema) 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. 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 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 reconstructedelectrograms, the electrophysiologist can identify the arrhythmiasource and can navigate to the defined area for therapy. When usedwith NavX patches, the system is useful in treating patients withsimpler arrhythmias by providing non-fluoroscopic navigation andvisualization of conventional EP catheters | |
| Intended use: | The EnSite 3000® System is indicated for patients for whomelectrophysiology studies are indicated. |
| When used with the EnSite® Catheter, the EnSite 3000®System is intended to be used in the right atrium of patientswith complex arrhythmias that may be difficult to identifyusing conventional mapping systems alone. OR When used with the EnSite NavX™ Surface Electrode Kit, theEnSite 3000® System is intended to display the position of | |
| conventional electrophysiology catheters in the heart. | |
| TechnologicalCharacteristics: | The new device has the same technological characteristics as thelegally marketed predicate device. |
| Non-clinicalPerformance Data: | The changes made to the EnSite 3000® System underwent a batteryof bench and user tests. Device validation testing was conductedin accordance with in-house procedures. |
| Conclusion: | An evaluation of the device changes indicates that the device is assafe and effective as the previously marketed device to which it isbeing compared and does not raise any new issues of safety andeffectiveness. |
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.
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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 (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
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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
§ 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).