(17 days)
Not Found
No
The document describes a standard nuclear medicine image processing workstation with no mention of AI or ML capabilities.
No
The device is described as an image display and processing workstation used by physicians to help diagnose patient disease conditions. It does not directly treat or alleviate symptoms, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states that the results obtained from the device "may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions." This directly indicates its role as a diagnostic aid.
No
The device description explicitly states that the system will consist of specific hardware components (Hewlett Packard XW4300 workstation or HP Compaq nc6230 Notebook or their equivalents), indicating it is not solely software.
Based on the provided information, the JETStream® Workspace is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The JETStream® Workspace processes and displays images derived from a nuclear medicine gamma camera, which is an in vivo imaging modality (imaging the body directly).
- The intended use is for processing, analyzing, and displaying medical images/data. This is characteristic of medical imaging software, not IVD devices.
- The input is from a nuclear medicine gamma camera. This confirms it's an imaging device, not a device that analyzes biological samples.
Therefore, the JETStream® Workspace falls under the category of medical imaging software or a picture archiving and communication system (PACS) workstation with processing capabilities, not an IVD.
N/A
Intended Use / Indications for Use
JETStream® Workspace is a nuclear medicine image display and processing workstation 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 JETStream® Workspace system 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
JETStream® Workspace is a Windows®-based Nuclear Medicine workstation for the Nuclear Medicine market segment. The computer system will consist of a Hewlett Packard XW4300 workstation or HP Compaq nc6230 Notebook or their equivalents. 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
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
K 06/02
ADAC Laboratories JETStream® Workspace CONFIDENTIAL
510(k) Premarket Notification Section B. Administrative Information
ADMINISTRATIVE INFORMATION
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- A. Submitted By: ADAC Laboratories A Philips Medical Systems Company 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: JETStream® Workspace Workstation Common Name: Image Processing System Classification Name: Picture Archive and Communication Systems (PACS)
். Predicate Device(s):
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| ADAC Laboratories | Pegasys Ultra™ | K993946 |
| ADAC Laboratories | Predicate JETStream® Workspace | K042880 |
D. Device Description:
JETStream® Workspace is a Windows®-based Nuclear Medicine workstation for the Nuclear Medicine market segment. The computer system will consist of a Hewlett Packard XW4300 workstation or HP Compaq nc6230 Notebook or their equivalents. 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.
E. Intended Use:
JETStream® Workspace is a nuclear medicine image display and processing workstation that provides software applications used to
1
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 JETStream® Workspace system 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 (Predicate - K042880) and the JETStream® Workspace (modified) have similar indications for use and overall function and perform in a similar manner with respect to, display, review and processing applications, data storage, and system utilities.
II. CONCLUSION
JETStream® Workspace is substantially equivalent to the following predicate devices, Pegasys Ultra™ (K993946) and JETStream® Workspace (Predicate - K042880) 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 department's name around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 1 2006
2006
ADAC Laboratories % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131
Re: K061029
Trade/Device Name: JETStream® Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 13, 2006 Received: April 14, 2006
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 (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.
Image /page/2/Picture/11 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular with the words "FDA Centennial" in the center. The words "Protecting and Promoting Public Health" are written in a fancy font below the logo. The logo is black and white.
3
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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
Indications for Use
510(k) Number (if known):
Device Name:
JETStream® Workspace
Indications For Use:
JETStream® Workspace is a nuclear medicine image display and processing workstation 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 JETStream® Workspace system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.
Prescription Use (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.)
Page 1 of
David A. Swanson
(Division Sian-Off Division of Reproductive, and Radiological Device 510(k) Number