(39 days)
The EnSite Verismo™ Segmentation Tool (EV 1000) is indicated for use in generating 3D models from slice-based DICOM3 image data. Generated models are intended to be displayed on the EnSite® System.
The EnSite Verismo™ Segmentation Tool is designed to function on the EnSite System's display workstation. This software tool allows importation of DICOM slice data from a variety of CT and MRI manufacturers. Once imported into the EnSite System, this slice data can be segmented into a 3D surface model. This model can be displayed during EP studies conducted on the EnSite System.
The provided document is a 510(k) summary for the EnSite Verismo™ Segmentation Tool (EV1000). It focuses on establishing substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria or a comprehensive study demonstrating performance against specific metrics. It primarily addresses the device's intended use, technological characteristics, and non-clinical performance data in a general sense.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study parameters, and quantitative performance metrics is not available in the provided text.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Non-clinical Performance Data: The EnSite Verismo Software underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures. |
| Conclusion: 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. | Conclusion: An evaluation of new software EnSite Verismo 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. |
| Technological Characteristics: The new device has the same technological characteristics as the legally marketed predicate device. | Technological Characteristics: The new device has the same technological characteristics as the legally marketed predicate device. |
Missing Information: The document does not specify quantitative acceptance criteria (e.g., specific accuracy, precision, sensitivity, or specificity thresholds) that the device needed to meet. The "reported device performance" is a high-level statement about the tests performed and the conclusion of substantial equivalence rather than granular performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document states that "device validation testing was conducted," but it does not provide any details about the sample size of the test set, the provenance of the data (e.g., country of origin), or whether the study was retrospective or prospective.
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)
Missing Information: This information is not provided. The document mentions "user tests" but does not detail the number or qualifications of experts involved in establishing ground truth or evaluating the device's performance in these tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: The document does not describe any adjudication method used for a 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
Missing Information: There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed, nor any data on how human readers might improve with or without AI assistance. The device is a "Segmentation Tool" to generate 3D models from DICOM data, which implies it's a tool for image processing and visualization rather than a diagnostic AI that would typically be evaluated in an MRMC study for reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Provided Information: The document states, "The EnSite Verismo Software underwent a battery of bench and user tests." This implies that both standalone (bench tests) and human-in-the-loop (user tests) evaluations were conducted. However, no specific details or results for either are provided.
Missing Information: The results and specific methodology of the "standalone" bench tests are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: The document does not specify the type of ground truth used for any validation or testing.
8. The sample size for the training set
Missing Information: The document mentions "device validation testing" but does not refer to a "training set" or its size. This is common for a 510(k) submission where the focus is often on verifying the device's functionality and safety rather than a detailed AI model development and training process. The device's function as a "Segmentation Tool" suggests it might be based on deterministic algorithms or established image processing techniques rather than a machine learning model requiring a large training set in the modern sense.
9. How the ground truth for the training set was established
Missing Information: Since there is no mention of a training set, the method for establishing its ground truth is also not provided.
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AUG 1 5 2005
510(k) Summary for Public Disclosure
St. Jude Medical, Inc Submitter: Endocardial Solutions 1350 Energy Lane, Suite 110 St. Paul. MN 55108 USA Phone: 651-523-6900 651-644-7897 Fax:
Karen J. McKelvey Contact: Regulatory Compliance Engineer
May 23, 2005 Date Prepared:
EnSite Verismo Trade Name:
Electrophysiology cardiac mapping system Common name:
(21 CFR Processing, Radiological lmage Classification Name: System, 892.2050)
Predicate Device: Vital Images, Inc - Vitrea®2
- Device Description: The EnSite Verismo™ Segmentation Tool is designed to function on the EnSite System's display workstation. This software tool allows importation of DICOM slice data from a variety of CT and MRI manufacturers. Once imported into the EnSite System, this slice data can be segmented into a 3D surface model. This model can be displayed during EP studies conducted on the EnSite System.
- The EnSite Verismo™ Segmentation Tool (EV 1000) is Intended use: indicated for use in generating 3D models from slice-bases
St. Jude Medical, Inc. Endocardial Solutions EnSite Verismo
Appendix 11, page 2
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| DICOM3 image data. Generated models are intended to bedisplayed on the EnSite® System. | |
|---|---|
| TechnologicalCharacteristics: | The new device has the same technological characteristics as thelegally marketed predicate device. |
| Non-clinicalPerformance Data: | The EnSite Verismo Software underwent a battery of bench anduser tests. Device validation testing was conducted in accordancewith in-house procedures. |
| Conclusion: | An evaluation of new software EnSite Verismo indicates that thedevice is as safe and effective as the previously marketed device towhich it is being compared and does not raise any new issues ofsafety and effectiveness. |
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
St. Jude Medical, Inc. Endocardial Solutions % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K051840
AUG 1 5 2005
Trade/Device Name: EnSite Verismo™ Segmentation Tool (EV1000) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: LLZ Dated: August 2, 2005 Received: August 3, 2005
Dear Mr. Job:
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 (Premarket Approval), 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.
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.
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This letter will allow you to begin marketing your device as described in your decise (10(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The I DA miding or bassification 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 If you desire specific advice for your deriver mumbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| 240-276-0100 | ||
| Other |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entition, "Allsonation on your responsibilities under the Act from the 807.97). You may obtain other general mismation on John of Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Kos 8 4 O
لقت تبت ترت ترتف
Device Name: EnSite Verismo™ Segmentation Tool (EV1000)
Indications For Use:
The EnSite Verismo™ Segmentation Tool (EV 1000) is indicated for use in generating 3D models from slice-based DICOM3 image data. Generated models are intended to be displayed on the EnSite® System.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ryerson
(Division Sign-Off)
Page 1 of 1
Division of Reproductive, Abdom and Radiological Devices 510(k) Number _
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).