(9 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 structure. The data processed may be derived from any nuclear medicine gamma camera. JETPack 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
JETPack 2.0 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 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.
This 510(k) summary does not contain the information requested for acceptance criteria or specific study details to prove the device meets acceptance criteria.
The document is a premarket notification for a new version of a Picture Archiving and Communication System (PACS) software, JETPack 2.0. It primarily focuses on establishing substantial equivalence to a predicate device (Philips Medical Systems NM Application Suite, K080961).
Here's why the requested information is not present:
- Acceptance Criteria and Reported Device Performance: This document states that JETPack 2.0 and the predicate device "perform in a similar manner with respect to, display, review and processing applications." It concludes that JETPack 2.0 is "substantially equivalent based on similar intended use, technological comparison, and system performance." However, it does not define specific acceptance criteria (e.g., quantitative metrics, thresholds) or present a table of reported device performance against such criteria. The "system performance" is described in a general, rather than a quantifiable, manner.
- Sample Size for Test Set and Data Provenance: This information is not provided. No specific test set or clinical study data is referenced.
- Number of Experts and Qualifications: This information is not provided. There's no mention of experts establishing ground truth for a test set.
- Adjudication Method: Not applicable, as no test set requiring adjudication is mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The document relies on substantial equivalence to a previous device rather than a new comparative effectiveness study.
- Standalone Performance: While the description focuses on the software's functionality, there's no standalone performance study in the context of diagnostic accuracy or clinical impact presented here.
- Type of Ground Truth Used: Not applicable, as no specific ground truth for a performance study is described.
- Sample Size for Training Set: This information is not provided. The development process of the software, including any training data for AI/ML components (if present, which is not explicitly stated for this 2011 submission), is not detailed.
- How Ground Truth for Training Set Was Established: Not applicable, as no training set or its ground truth establishment is described.
In summary, this 510(k) filing demonstrates substantial equivalence by comparing the device's intended use and general technological characteristics to a legally marketed predicate device. It does not present detailed performance studies with specific acceptance criteria, test sets, or ground truth establishment that would be required for innovative devices making new claims or for devices undergoing more rigorous evaluation pathways.
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ADMINISTRATIVE INFORMATION
APR 2 1 2011
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.
A. Submitted By: Philips Medical Systems (Cleveland), Inc. 3860 N. First Street, San Jose California 95134
(408) 468-3042 Tel: Fax: (408) 468-3050
Contact Person:
Lori R. Peterson At address above
3/1/2011
Date Prepared:
- B. Device Trade Name: Common Name: Classification Name:
JETPack 2.0 Image Processing System Picture Archive and Communication Systems (PACS)
C. Predicate Device(s):
| Manufacturer | Product Name | 510(k)No. |
|---|---|---|
| Philips Medical Systems(Cleveland), Inc. | NM Application Suite | K080961 |
Device Description: D.
JETPack 2.0 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 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.
- E. Intended Use:
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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 structure. The data processed may be derived from any nuclear medicine gamma camera. JETPack 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
- F. Technological Comparison:
NM Application Suite (K080961) and JETPack 2.0 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 JETPack 2.0 is substantially equivalent to the NM Application Suite (K080961) a predicate device based on similar intended use, technological comparison, and system performance.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Philips Medical Systems (Cleveland), Inc. % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062
APR 2 1 201
Re: K111024
Trade/Device Name: JETPack 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 11, 2011 Received: April 12, 2011
Dear Mr. Devine:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809): medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): _ K /// D24
JETPack 2.0 Device Name:
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 structure. The data processed may be derived from any nuclear medicine gamma JETPack 2.0 should only be operated by qualified healthcare camera. professionals trained in the use of nuclear medicine equipment.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mumy Slatel
Division Sian-Of Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K111024
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§ 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).