(17 days)
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.
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.
The provided text is a 510(k) summary for the ADAC Laboratories JETStream® Workspace. It describes the device, its intended use, and states its substantial equivalence to predicate devices. However, it does not contain a detailed study report with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or details about comparative effectiveness studies (MRMC or standalone).
The document primarily focuses on establishing substantial equivalence based on:
- Similar intended use: Processing, analyzing, and displaying nuclear medicine images for diagnosis.
- Technological comparison: Similar display, review, processing applications, data storage, and system utilities to predicate devices.
- System performance: Implied to be similar to predicate devices based on the above, but no specific performance metrics or studies are reported.
Therefore, I cannot populate the requested table or provide detailed answers to most of your questions as the information is not present in the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document asserts "system performance" is similar to predicate devices but provides no specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy, processing speed, image quality benchmarks).
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. There is no mention of a specific test set or clinical study data used to demonstrate performance. The submission relies on substantial equivalence to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not available. Since no specific test set or performance study is detailed, there's no mention of experts establishing ground truth for such a study.
4. Adjudication Method for the Test Set
Not applicable/Not available. No adjudication method is described as no test set data is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, it appears no MRMC study was done or reported in this 510(k) summary. The document does not describe any studies involving human readers or comparative effectiveness of AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, it appears no standalone performance study was done or reported in this 510(k) summary. The device is described as a workstation with software applications for a nuclear physician to use as a tool, implying human-in-the-loop operation, but no specific standalone algorithm performance is detailed.
7. The Type of Ground Truth Used
Not applicable/Not available. No ground truth type (e.g., pathology, expert consensus, outcomes data) is mentioned because the document does not describe a performance study requiring ground truth.
8. The Sample Size for the Training Set
Not available in the provided text. There is no mention of a training set for any algorithmic development, as the focus is on a workstation for image display and processing, not necessarily an AI diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there's no mention of a training set, the method for establishing its ground truth is also not mentioned.
In summary, the provided 510(k) documentation focuses on the administrative and regulatory aspects of establishing substantial equivalence to existing devices, rather than presenting a detailed performance study with specific acceptance criteria and results. For a medical device like a workstation for image processing, the "performance" might refer more to its fidelity in displaying images, its processing capabilities (e.g., speed, accuracy of calculations on pixel data), and its adherence to standards, which are not explicitly quantified in this summary.
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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
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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.
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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 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.
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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
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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
§ 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).