(191 days)
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.
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
The provided text does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, nor does it detail a standalone or MRMC study.
Instead, the document is a 510(k) premarket notification for a modification to an existing device, the EnSite System (Model EE3000). The key statements relevant to performance are:
- "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."
- "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 indicates that the changes were validated internally against established procedures, and the conclusion is that the modified device performs comparably to the predicate device. However, no specific performance metrics, acceptance criteria, or study details (like sample size, ground truth, or expert qualifications) are provided in this document.
Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.
Here's a summary of what can be inferred or directly stated from the text, with the understanding that detailed performance criteria and study results are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The modified device is "as safe and effective as the previously marketed device" (predicate device K070902). Device validation testing was conducted per in-house procedures. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "bench and user tests," implying internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
4. Adjudication method for the test set:
- Not specified.
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:
- Not mentioned. The device is an electrophysiology mapping system, not specifically an AI-driven image analysis tool, though it is a "programmable diagnostic computer." The document only refers to "user tests" without specifying their nature or comparative effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not mentioned. The document describes a "computerized storage and display system" used in conjunction with catheters and for clinicians to identify arrhythmia sources. It does not describe a standalone algorithm performance evaluation.
7. The type of ground truth used:
- Not specified. As the device is an electrophysiology mapping system, ground truth would typically relate to accurate identification of arrhythmia sources or catheter positions, likely established by electrophysiology study results, clinical outcomes, or expert consensus during the "user tests," but this is not detailed.
8. The sample size for the training set:
- Given this is a 510(k) for a modification to an existing device, and the description does not suggest a machine learning model from scratch, there is no mention of a "training set" in the context of typical AI/ML development. The "training" would have been part of the initial development of the predicate device (K070902), if applicable.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no mention of a training set for a new algorithm in this document.
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K083328 pg 1 of 2
:
| Submitter: | St. Jude Medical1350 Energy Lane, Suite 110St. Paul, MN 55108Phone: 651-523-6900Fax: 651-523-6990 |
|---|---|
| Contact: | Karen J. McKelveyRegulatory Manager II |
| Date Prepared | May 19, 2009 |
| Trade Name: | EnSite System™ (Model EE3000)a) EnSite Array™ (Model EC1000)b) EnSite NavXTM Surface Electrode Kit (Model EN0010) |
| Common Name | Electrophysiology mapping system with console andcatheter |
| Classification Name: | Programmable diagnostic computer(21 CFR 870.1425) |
| Predicate Device: | EnSite System K070902 |
| Device Description: | The EnSite System is a computerized storage and displaysystem for use in electrophysiology studies of the humanheart. The system consists of a console workstation, patientinterface unit, and an electrophysiology mapping catheter orsurface electrode kit. |
| Unlike currently available electrode recording catheters, theEnSite Array does not require direct contact with theendocardium for the detection of intracardiac electrograms.The EnSite System is a system that facilitates mapping andtreatment of arrhythmias. When used with the EnSitecatheter, the system is useful for treating patients withcomplex, non-sustained, or poorly tolerated arrhythmias thatare difficult, if not impossible, to map with current mappingtechniques. By visualizing the global activation pattern seenon the color-coded isopotential maps in the EnSite System,in conjunction with the reconstructed electrograms, theelectrophysiologist can identify the arrhythmia source andcan navigate to the defined area for therapy. When used withNavX patches, the system is useful in treating patients withsimpler arrhythmias by providing non-fluoroscopicnavigation and visualization of conventional EP catheters | |
| Intended Use: | The EnSite System is a suggested diagnostic tool in patientsfor whom electrophysiology studies are indicated. |
| • When used with the EnSite Catheter, the EnSite Systemis intended to be used in the right atrium of patients withcomplex arrhythmias that may be difficult to identifyusing conventional mapping systems alone.OR | |
| • When used with the EnSite NavX Surface Electrode Kit,the EnSite System is intended to display the position ofconventional electrophysiology catheters in the heart. | |
| Technological Characteristics: | The new device has the same technological characteristics asthe legally marketed predicate device |
| Non-clinical Performance Data: | The changes made to the EnSite System underwent a batteryof bench and user tests. Device validation testing wasconducted in accordance with in-house procedures. |
| Conclusion: | An evaluation of the device changes indicates that thedevice is as safe and effective as the previously marketeddevice to which it is being compared and does not raise anynew issues of safety and effectiveness |
Page 2
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K083328 pg. 2of2
.
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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 and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads, "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2009
St. Jude Medical c/o Ms. Karen J. McKelvey Regulatory Affairs Manager II 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K083328
Trade/Device Name: EnSite System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Dated: April 22, 2009 Received: April 23, 2009
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. Iisting 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
iona R. Va. Nunes
Image /page/3/Picture/6 description: The image contains a handwritten symbol that resembles a cursive letter 'w' with an additional curved line above it. The symbol is drawn in black ink on a white background. The symbol is on the left side of the image.
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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510(k) Notification: Device Modification
9. Indications for Use
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 _ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suna E. V. Holmes
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko83328
St. Jude Medical
Page 9-1
§ 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).