(14 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.
This 510(k) summary does not contain the level of detail necessary to answer all the questions about acceptance criteria and the study proving the device meets them as typically presented for AI/ML-based medical devices. This document predates the widespread use of sophisticated AI/ML in medical devices and therefore focuses on traditional medical device validation.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format requested for an AI/ML device. Instead, it relies on a qualitative assessment of "safety and effectiveness" compared to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "as safe as the previously marketed device" |
| Effectiveness | "as effective as the previously marketed device" |
| No new safety/effectiveness issues | "does not raise any new issues of safety and effectiveness" |
| Bench and User Tests | "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." (Specific results not provided) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The abstract mentions "bench and user tests," but details on sample size, data type, or provenance are omitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Given the nature of the device (an electrophysiology cardiac mapping system and its components), ground truth would likely be established through physician observation during electrophysiology studies, but the specifics are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study as typically understood for AI/ML evaluation was not performed or reported. The document describes a traditional medical device submission based on substantial equivalence to a predicate device, not an AI efficacy study. The concept of "human readers improve with AI vs without AI assistance" is not applicable here as it is not an AI/ML device in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The EnSite System is a computerized storage and display system that supports electrophysiology studies, not a standalone AI algorithm producing diagnoses or interpretations without human involvement. Its "performance" is inherently linked to its use by an electrophysiologist in conjunction with catheters or surface electrodes.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth. For an electrophysiology mapping system, "ground truth" would likely relate to accurate identification and visualization of cardiac activation patterns and catheter positions, validated through clinical observation and established electrophysiological principles, rather than pathology or outcomes data in the traditional sense of a diagnostic AI device.
8. The sample size for the training set
This information is not provided and is not applicable in the context of this traditional medical device submission. The device is not an AI/ML system that undergoes "training" in the computational sense.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
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510(k) Summary for Public Disclosure
| Submitter: | St. Jude Medical, Inc.Endocardial Solutions1350 Energy Lane, Suite 110St. Paul, MN 55108 USAPhone: 651-523-6900Fax: 651-644-7897 | APR 21 2006 |
|---|---|---|
| Contact: | Karen J. McKelveyPrincipal Regulatory Compliance Engineer | |
| Date Prepared: | March 23, 2006 | |
| 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. K042493 | |
| 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, and | |
| Intended use: | When used with the EnSite catheter, the system is useful fortreating patients with complex, non-sustained, or poorly toleratedarrhythmias 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 cathetersThe EnSite System (EE3000) is indicated for patients for whomelectrophysiology studies are indicated.When used with the EnSite Array, 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. | |
| 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. |
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.
an electrophysiology mapping catheter or surface electrode kit.
St. Jude Medical, Inc. - Endocardial Solutions
Appendix-O page 2
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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text appears to be part of the official seal of the U.S. Department of Health and Human Services. The central symbol consists of three curved lines that resemble a stylized human figure or a bird in flight. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
St. Jude Medical, Inc. c/o Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer Endocardial Solutions 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K060954
Trade Name: Ensite" System (Model EE3000) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: April 05, 2006 Received: March 07, 2006
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 (240) 276-0120. 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/cdrl/industry/support/index.html.
Sincerely yours,
Blummenau for
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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Indications for Use
510(k) Number (if known): K060954
Device Name:
Indications For Use:
Indications for Use
The EnSite System is indicated for patients for whom electrophysiology studies are
indicated. 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.
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)
Blemmel
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§ 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).