(14 days)
A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The NM Application Suite should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
The NM Application Suite is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The NM Application Suite includes both review and processing functionality and can be segmented into separate review and analysis configurations, such as a Planar and SPECT. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.
This document is a 510(k) premarket notification for the "NM Application Suite" from Philips Medical Systems. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
Explanation: This document does not specify quantitative acceptance criteria or report device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The 510(k) process for this type of device (image processing system) primarily focuses on demonstrating substantial equivalence to existing legally marketed devices based on similar intended use, technological characteristics, and system performance. Performance is implicitly assessed through comparison to predicate devices, not through a formal study with defined acceptance criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document does not describe a specific clinical test set used for performance evaluation that would necessitate detailing data provenance. The assessment is based on a functional and technical comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study Done? No. This document describes an image processing application suite, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to assess reader improvement. The focus is on the software's functionality and its equivalence to other PACS/image processing systems.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study Done? No, not in the sense of a clinical performance study with metrics like sensitivity/specificity. The document explains the device as a "suite of image display and processing applications," implying it's a tool for human professionals, not a fully autonomous diagnostic algorithm. Its "performance" is assessed through its functional equivalence (display, review, processing) to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. No specific ground truth establishment is described, as the evaluation is not based on a clinical performance study against a definitive diagnosis.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The document describes an application suite for image display and processing, not a machine learning model that would typically have a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
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APR 1 8 2008
| PMS (Cleveland), Inc. | |
|---|---|
| NM Application Suite |
CONFIDENTIAL
510(k) Premarket Notification Section B. Administrative Information
ADMINISTRATIVE INFORMATION
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.
A. Submitted By:
Philips Medical Systems (Cleveland). Inc. 540 Alder Drive Milpitas, California 95035
Tel: (408) 468-3042 Fax: (408) 468-3050
Contact Person:
Lori R. Peterson At address above
B. Device Trade Name: Common Name: Classification Name: NM Application Suite Image Processing System Picture Archive and Communication Systems (PACS)
C. Predicate Device(s):
Manufacturer 510(k) No. Product Name Pegasys Ultra™M K993946 ADAC Laboratories ADAC Laboratories JETStream® Workspace K061029
D. Device Description:
The NM Application Suite is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The NM Application Suite includes both review and processing functionality and can be segmented into separate review and analysis configurations, such as a Planar and SPECT. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.
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E. Intended Use:
A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The NM Application Suite should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
F. Technological Comparison:
The Pegasys Ultra™ (K993946), JETStream® Workspace (K061029) and the NM Application Suite have similar indications for use and overall function and perform in a similar manner with respect to, display, review and processing applications.
II. CONCLUSION
The NM Application Suite is substantially equivalent to the following predicate devices, Pegasys Ultra™ (K993946) and JETStream® Workspace (K061029) based on similar intended use, technological comparison, and system performance.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2008
Philips Medical Systems (Cleveland), Inc. % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
Re: K080961
Trade/Device Name: NM Application Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 2, 2008 Received: April 4, 2008
Dear Mr. Christensen:
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
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 one of the following numbers, 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 |
| Other | 240-276-0100 |
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/cdrb/industry/support/index.html.
Sincerely vours.
Nancy Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Eyaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name:
NM Application Suite
Indications For Use:
A nuclear medicine image display and processing application suite that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The NM Application Suite should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Aroni Dothan
Page 1 of
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080961
§ 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).