(170 days)
EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
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
Here's an analysis of the provided text regarding the acceptance criteria and study information for the EnSite Fusion Dynamic Registration Tool.
Based on the provided 510(k) summary, there is no explicit mention of acceptance criteria or a dedicated study designed to prove the device meets specific performance criteria in the way one might expect for a new diagnostic or AI-driven device. This 510(k) is for a modification/update to an existing system, and the filing primarily focuses on demonstrating substantial equivalence to a predicate device.
Key takeaway: The submission states that "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." This implies internal testing was performed, but no details of these tests, their acceptance criteria, or their results are provided in the public summary. The conclusion explicitly 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 points to a substantial equivalence argument rather than a performance claim against predefined criteria.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The submission relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance criteria for the EnSite Fusion Dynamic Registration Tool. | Not specified in the provided document. The submission states "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." However, no specific performance metrics or results are reported publicly. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The statement "bench and user tests" suggests a mix, but no details are given. It's unclear if the "user tests" involved patient data, simulated data, or phantoms.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or described in the provided document.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study was described.
6. Standalone (Algorithm Only without Human-in-the-Loop Performance) Study
- Was a standalone study done? A standalone algorithm performance study is not explicitly mentioned or described in the provided document. The device is a "registration tool" used within a larger system, implying human interaction.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified in the provided document. Given the device's function (registering a navigation system to CT-derived anatomic models), potential ground truths could involve geometric accuracy measurements (e.g., against physical phantoms or established anatomical landmarks on imaging). However, this is speculative as the document doesn't detail it.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not specified in the provided document. It's unclear if machine learning was used in the traditional sense that requires a separate "training set" for the "EnSite Fusion Dynamic Registration Tool"; the document describes it as a "tool" for registration, which might be based on algorithmic rules rather than deep learning models.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not specified in the provided document. As mentioned above, it's unclear if an explicit "training set" with ground truth, as understood in machine learning, was used.
{0}------------------------------------------------
K071818
r 1/2
510(k) Summary for Public Disclosure
| Submitter: | St. Jude Medical1350 Energy Lane, Suite 110St. Paul, MN 55108 USAPhone: 651-523-6900Fax: 651-644-7897 | |
|---|---|---|
| Contact: | Karen J. McKelveyPrincipal Regulatory Compliance EngineerDEC 20 2007 | |
| Date Prepared: | December 19, 2007 | |
| Trade Name: | EnSite® System (Model EE3000)a) EnSite™ Array (Model EC1000)b) EnSite NavX™ Surface Electrode Kit (Model EN0010)d) EnSite Verismo™ Segmentation Tool (Model EV1000) | |
| 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: | EnSite System510(k) No. K070902 | |
| Device Description: | The EnSite System is a computerized storage and display systemfor use in electrophysiology studies of the human heart. Thesystem consists of a console workstation, patient interface unit, andan electrophysiology mapping catheter or surface electrode kit.Unlike currently available electrode recording catheters, the EnSiteArray does not require direct contact with the endocardium for thedetection of intracardiac electrograms. The EnSite System is asystem that facilitates mapping and treatment of arrhythmias.When used with the EnSite catheter, the system is useful fortreating patients with complex, non-sustained, or poorly tolerated | |
| arrhythmias that are difficult, if not impossible, to map withcurrent mapping techniques. By visualizing the global activationpattern seen on the color-coded isopotential maps in the EnSiteSystem, in conjunction with the reconstructed electrograms, theelectrophysiologist can identify the arrhythmia source and cannavigate to the defined area for therapy. When used with NavXpatches, the system is useful in treating patients with simplerarrhythmias by providing non-fluoroscopic navigation andvisualization of conventional EP catheters | K071818p 2 / 2 | |
| EnSite SystemV7.0 | ||
| Intended use: | The EnSite System is a suggested diagnostic tool in patients forwhom electrophysiology studies are indicated. | |
| • When used with the EnSite Catheter, the EnSite System isintended to be used in the right atrium of patients with complexarrhythmias that may be difficult to identify using conventionalmapping systems alone.OR• When used with the EnSite NavX Surface Electrode Kit, theEnSite System is intended to display the position ofconventional electrophysiology catheters in the heart. | ||
| EnSite FusionDynamicRegistration Tool | ||
| Intended use: | EnSite Fusion is indicated for registering the EnSite NavXnavigation system to anatomic models, derived from CT scans, ofthe four individual cardiac chambers. | |
| TechnologicalCharacteristics: | The new device has the same technological characteristics as thelegally marketed predicate device. | |
| Non-clinicalPerformance Data: | The changes made to the EnSite System underwent a battery ofbench and user tests. Device validation testing was conducted inaccordance 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. |
:
{1}------------------------------------------------
:
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines that form a profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical c/o Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer 1350 Energy Lane. Suite 110 St. Paul. MN 55108
Re: K071818
Trade/Device Name:EnSite Fusion Dynamic Registration Tool Regulation Number: 21 CFR 870,1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: October 25, 2007 Received: October 26, 2007
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
B. Bemmmer fr
Bram Ø. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
8. Indications for Use
510(k) Number (if known): K071818
Device Name: EnSite Fusion Dynamic Registration Tool
Indications for Use:
EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.
Prescription Use _ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumanna
Sian-Off of Cardiovascular Devices 510(k) Number
§ 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).