(11 days)
eNTEGRA PE is designed to display, process, archive, and communicate data required and stored by Emission Tomography cameras and Nuclear Medicine/PET workstations. It is intended that use of the device be limited to review of studies, tagging images for detailed reading, determining whether the correct images were captured, and similar uses. The limited image size availble on eNTEGRA PE has not been fully demonstrated to be suitable for diagnostic use, and it is not intended to be used for direct diagnosis.
The eNTEGRA PE Diagnostic Imaging Personal Digital Assistant is a device intended to provide the same functionality as the eNTEGRA Workstation (cleared in 510(k) number K000395 as the "Einstein Processing And Review Workstation"). The eNTEGRA PE is different in that this functionality is implemented on a handheld personal computer or personal digital assistant (PDA). The eNTEGRA PE will extend the eNTEGRA P&R services to be utilized by the clinician while away from her office/desk.
This 510(k) submission describes the eNTEGRA PE, a personal digital assistant (PDA) intended to provide similar functionality to the existing eNTEGRA Workstation (K000395) for displaying, processing, archiving, and communicating data from Emission Tomography cameras and Nuclear Medicine/PET workstations.
The submission does not contain specific acceptance criteria with quantifiable metrics, nor does it present a detailed study with performance outcomes against such criteria for the eNTEGRA PE beyond a general statement. The submission is focused on demonstrating substantial equivalence to a predicate device.
Here's the information extracted and organized based on your request, with explicit notes about what is not present in the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Criteria for Substantial Equivalence to Predicate Device (K000395): | |
| Functionality (display, process, archive, communicate data for Emission Tomography cameras and Nuclear Medicine/PET workstations) | "Bench testing with representative sample images has concluded that the eNTEGRA PE system is fully functional and is operating as designed." |
| Safety and Effectiveness | "In the opinion of GE Medical Systems, the eNTEGRA PE system is substantially equivalent in terms of safety and effectiveness to the above mentioned legally marketed predicate device." |
| No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed) are provided in this document. | No specific quantitative performance metrics are provided in this document. |
2. Sample Size and Data Provenance for Test Set
- Sample Size (Test Set): "representative sample images" are mentioned for bench testing, but the specific number or characteristics of these images are not provided.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Not applicable. The document describes bench testing for functionality rather than a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for Test Set
- Not applicable. The document does not describe a process involving adjudication of results from a test set by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. A MRMC comparative effectiveness study was not performed as described in this document. The submission focuses on functional equivalence through bench testing.
6. Standalone (Algorithm Only) Performance Study
- Yes, implicitly. The "Bench testing with representative sample images" constitutes a standalone evaluation of the device's functionality. However, it's not a performance study in the sense of a diagnostic accuracy trial.
7. Type of Ground Truth Used (Test Set)
- The "ground truth" for the bench testing appears to be the expected/designed functionality of the eNTEGRA PE system. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on patient diagnoses) for the test set.
8. Sample Size for Training Set
- Not applicable/not specified. This document describes a new device built upon existing technology and demonstrated through bench testing for functional equivalence. It does not mention machine learning or AI models requiring a training set in the contemporary sense.
9. How Ground Truth for Training Set Was Established
- Not applicable. As above, no training set for a machine learning model is mentioned.
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014058
DEC 2 1 2001
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
DEC 2 1 2001
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 10. 807.87(h))
Date:
November 16, 2001
Device Name eNTEGRA PE Proprietary Device Name:
Establishment Name and Registration Number of Submitter
Name: GE Medical Systems 3000 N. Grandview Blvd. Waukesha, WI 53118 2122726 Registration Number: Corresponding Official: D. Duersteler Safety and Regulatory Project Engineer GE Medical Systems EX-493 P.O. Box 414 Milwaukee. WI 53201 FAX 262-317-9190, Phone 262-317-9463 Device Classification
| Classification Code: | 90 LLZ |
|---|---|
| Panel Identification: | Radiology |
| Classification Name: | Picture Archiving and Communication System (per 21CFR 892.2050) |
| Common Name: | Nuclear Medicine Imaging Workstation |
| Classification Class: | Class II Product |
Reason for 510(k) Submission Modification of legally marketed device.
Identification of Legally Marketed Equivalent Devices eNTEGRA Processing and Review Workstation (K000395)
Device Description and Intended Use of Device
The eNTEGRA PE Diagnostic Imaging Personal Digital Assistant is a device intended to provide the same functionality as the eNTEGRA Workstation (cleared in 510(k) number K000395 as the "Einstein Processing And Review Workstation"). The eNTEGRA PE is different in that this functionality is implemented on a handheld personal computer or personal digital assistant (PDA). The eNTEGRA PE will extend the
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General Electric Company P O. Box 414, Milwaukee, WI 53201
eNTEGRA P&R services to be utilized by the clinician while away from her office/desk.
The intended use of the device is to display, process, archive, and communicate data required and stored by Emission Tomography cameras and Nuclear Medicine/PET workstations.
Summary of Studies
Bench testing with representative sample images has concluded that the eNTEGRA PE system is fully functional and is operating as designed.
Conclusion
In the opinion of GE Medical Systems, the eNTEGRA PE system is substantially equivalent in terms of safety and effectiveness to the above mentioned legally marketed predicate device.
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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 is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol resembles a stylized eagle or bird in flight, depicted in black. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2001
General Electric Medical Systems % Mr. Reiner Krumme Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K014058
Trade/Device Name: eNTEGRA PE Personal Digital Assistant Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 5, 2001 Received: December 10, 2001
Dear Mr. Krumme:
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 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 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
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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Seneral Siectic Company 20. Box 114. Milwaukse. WI 53201
Statement Of Intended Use ல்
Intended Use
eNTEGRA PE is designed to display, process, archive, and communicate data required and stored by Emission Tomography cameras and Nuclear Medicine/PET workstations.
It is intended that use of the device be limited to review of studies, tagging images for detailed reading, determining whether the correct images were captured, and similar uses.
The limited image size availble on eNTEGRA PE has not been fully demonstrated to be suitable for diagnostic use, and it is not intended to be used for direct diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR Over-The-Counter Use
David A. Siegman
(Division Sian-Off Division of Reproduc and Radiological De 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).