(29 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.
The provided text appears to be a 510(k) summary for the St. Jude Medical EnSite System (Model EE3000), along with its associated components. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria based on detailed performance studies with clinical endpoints.
Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The 510(k) process relies on demonstrating that the new device has "the same technological characteristics" and is "as safe and effective as the previously marketed device" based on a comparison to a predicate device.
Here's what can be extracted based on the provided text, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
The document 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." and "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 document does not provide a table of
specific, quantifiable acceptance criteria or reported device performance metrics against such criteria. The focus is on demonstrating equivalence to a predicate device.
| Acceptance Criteria (Not explicitly stated, inferred to be similar to predicate) | Reported Device Performance (Not explicitly stated, inferred to be equivalent to predicate) |
|---|---|
| Safe and Effective as predicate device | "as safe and effective as the previously marketed device" |
| No new issues of safety and effectiveness | "does not raise any new issues of safety and effectiveness" |
| Technological characteristics same as predicate | "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 mentions "a battery of bench and user tests" and "device validation testing," but does not specify the sample size, data provenance (country of origin), or whether the data was retrospective or prospective.
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 ground truth or their qualifications. Testing appears to be primarily bench and user-based as part of internal validation.
4. Adjudication method for the test set
The document does not mention any adjudication method for the test set.
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
The document does not mention a multi-reader multi-case (MRMC) study or any comparison related to human readers improving with or without AI assistance. The EnSite system described is an electrophysiology cardiac mapping system, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study for assessing reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not provide details on standalone algorithmic performance. The system is described as a "computerized storage and display system for use in electrophysiology studies" which implies human interaction.
7. The type of ground truth used
The document does not specify the type of ground truth used. Given the context of comparing to a predicate device and internal validation, the "ground truth" would likely be based on established engineering and clinical standards for electrophysiology systems or direct comparison to the predicate device's output.
8. The sample size for the training set
The document does not mention a training set sample size. This type of 510(k) submission generally does not involve machine learning "training sets" in the way that AI/ML devices do.
9. How the ground truth for the training set was established
As no training set is mentioned, there is no information on how its ground truth was established.
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K070902 11/2 510(k) Summary for Public Disclosure Submitter: St. Jude Medical 1350 Energy Lane, Suite 110 St. Paul, MN 55108 USA MAY - 1 2007 Phone: 651-523-6900 651-644-7897 Fax: Contact: Karen J. McKelvey Principal Regulatory Compliance Engineer March 21, 2007 Date Prepared: EnSite® System (Model EE3000) Trade Name: a) EnSite™ Array (Model EC1000) b) EnSite NavXTM 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 System 510(k) No. K060954 Device Description: 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
St. Jude Medical, Inc. - Endocardial Solutions
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| 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 | |
|---|---|
| Intended use: | The 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. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features the department's name encircling a stylized eagle. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The seal is simple and conveys the department's role in health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
11 2007 MAY
St. Jude Medical Ms. Karen J. McKelvey Principal Regulatory Compliance Engineer 1350 Energy Lane, Suite 110 St. Paul, MN 55108
Re: K070902
Trade Name: EnSite™ System v7.0
Regulation Number: 21 CFR 870.1425 and 870.1220
Regulation Name: Programmable Diagnostic Computer And Electrode Recording Catheter Or Electrode Recording Probe
Regulatory Class: Class II Product Code: DQK and DRF Dated: March 30, 2007 Received: April 2, 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.
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Page 2 - Ms. Karen J. McKelvev
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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): _ _ K070902
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 × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular Devices |
|---|
| ------------------------------------ |
| 510(k) Number | R67092 |
|---|---|
| --------------- | -------- |
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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).