(14 days)
Not Found
No
The summary describes standard image processing and display software for nuclear medicine, with no mention of AI, ML, or related concepts.
Yes
The device is a therapeutic device because its output, which can be used by a nuclear physician as a tool for determining the diagnosis of patient disease conditions, directly contributes to patient care by informing therapeutic decisions.
Yes
The "Intended Use / Indications for Use" section states that "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." This directly indicates its use in aiding diagnosis.
Yes
The device description explicitly states it is a "software package" deployable on hardware platforms, and the intended use describes it as an "application suite." There is no mention of proprietary hardware being included or required beyond a standard computer platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this device is a "nuclear medicine image display and processing application suite." It processes and displays medical images/data derived from a "nuclear medicine gamma camera." This involves analyzing images generated from radioactive tracers administered to the patient within their body, not analyzing samples taken from the body.
- Intended Use: The intended use is to provide a tool for a nuclear physician to determine the diagnosis of patient disease conditions based on the processed images. This is a diagnostic tool, but it operates on imaging data, not in vitro samples.
Therefore, while it is a diagnostic tool used in healthcare, its function and the type of data it processes fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
nuclear medicine gamma camera
Anatomical Site
various organs, tissues, and other anatomical structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nuclear physician, qualified healthcare professionals trained in the use of nuclear medicine equipment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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.
2
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.
3
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
4
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