(15 days)
The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
The O LAB software provides a means of opening and displaying image files. The O LAB software provides a means of creating AVI and BMP files from the image data displayed by the software. The Q LAB software provides a means of quantifying the image data using a plugin module designed to operate with the core engine of the software. The O LAB software provides a means for performing an automatic distance measurement of the intima media thickness of an artery represented in the image file data. The Q LAB software provides a means of creating region of interest figures overlaid on the image data displayed by the software. The Q LAB software provides a means of analyzing the content of the image data contained within the ROI figure. The Q LAB software provides a means of presenting the ROI data in an XY graphic format. The O LAB software provides a means to perform a curve fit operation on a data set generated by the ROI analysis software. The O LAB software provides a means of exporting the data generated by the plugin modules in a form accessible to the end user.
The provided K021966 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study data. This submission is for Q LAB Quantification Software, which is described as a Picture Archiving and Communications Systems (PACS) Workstation with quantification capabilities.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics for the Q LAB Quantification Software, beyond general statements about safety and effectiveness. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to software development processes.
2. Sample Size Used for the Test Set and Data Provenance:
The 510(k) summary does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document describes software verification and validation but doesn't provide details on the data used for these activities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The 510(k) summary does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set.
4. Adjudication Method for the Test Set:
Given the absence of information on a test set and ground truth establishment, the 510(k) summary does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The 510(k) summary does not mention any MRMC comparative effectiveness study. The focus is on the software's functionality and its substantial equivalence to predicate devices for image viewing and quantification. There is no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
While the device is a software application and performs quantification, the 510(k) summary does not present a formal standalone performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for its algorithms. It describes the software's capabilities (e.g., automatic distance measurement of intima media thickness, ROI analysis) but without quantified performance data.
7. Type of Ground Truth Used:
The 510(k) summary does not specify the type of ground truth used for any evaluations, as detailed performance studies are not described.
8. Sample Size for the Training Set:
The 510(k) summary does not provide any information regarding the sample size used for a training set. This filing appears to be for a software product that, while performing "quantification," is primarily described in terms of its ability to display, analyze, and export data, rather than a novel AI/ML algorithm requiring extensive training data.
9. How Ground Truth for the Training Set Was Established:
Given the absence of information on a training set, the 510(k) summary does not describe how ground truth for a training set was established.
Summary of Available Information:
The K021966 510(k) summary describes a software device (Q LAB Quantification Software) that provides image viewing, creation of AVI/BMP files, quantification using plug-in modules, automatic intima media thickness measurement, region of interest (ROI) creation and analysis, graphic presentation of ROI data, curve fitting, and data export.
The submission focuses heavily on:
- Substantial Equivalence: Comparing the Q LAB software's image viewing capabilities to the MedLink Workstation and its ROI quantification capabilities to the Hewlett Packard Acoustic Densitometry Option.
- Software Design Controls: Stating that software development follows documented processes for design, verification, and validation testing, and that a risk assessment was completed.
- Compliance with Standards: Mentioning compliance with Microsoft Developer's Network (MSDN) and ISO Joint Photographic Experts Group (JPEG) standards.
In conclusion, this 510(k) filing provides a high-level overview of the software's functionalities and its adherence to regulatory processes, but it does not contain the specific, quantitative performance data or detailed study descriptions that your request specifies for demonstrating acceptance criteria. This level of detail is often not included in the public 510(k) summaries for devices cleared under substantial equivalence, especially for software applications of this nature from this era. Device performance data, if collected, would typically be part of the full 510(k) submission reviewed by the FDA but often not made public in the summary.
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510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92
1) Submitter's name, address, telephone number, contact person
Lynn Harmer, Manager, Regulatory Submissions ATL Ultrasound (d/b/a Philips Ultrasound) a Philips Medical System Company 22100 Bothell Everett Highway Bothell. WA 98021-8431 Telephone: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.Harmer(a)Philips.com
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: Picture Archiving and Communications Systems Workstation Proprietary Name: Q LAB software Picture Archiving and Communications System, Class II Classification Name:
3) Device Description
The O LAB software provides a means of opening and displaying image files. The O LAB software provides a means of creating AVI and BMP files from the image data displayed by the software. The Q LAB software provides a means of quantifying the image data using a plugin module designed to operate with the core engine of the software. The O LAB software provides a means for performing an automatic distance measurement of the intima media thickness of an artery represented in the image file data. The Q LAB software provides a means for creating region of interest figures overlaid on the image data displayed by the software. The Q LAB software provides a means of analyzing the content of the image data contained within the ROI figure. The Q LAB software provides a means of presenting the ROI data in an XY graphic format. The O LAB software provides a means to perform a curve fit operation on a data set generated by the ROI analysis software. The O LAB software provides a means of exporting the data generated by the plugin modules in a form accessible to the end user.
4) Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514. The O LAB software has been designed to comply with the following voluntary standards:
MSDN - Microsoft Developer's Network October 2001 ISO Joint Photographic Experts Group (JPEG) Image Compression Standard
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5) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the O LAB software.
6) Substantially Equivalent Devices
ATL believes that the image viewing capabilities of the Q LAB software makes it substantially equivalent to other image display products commercially available, specifically the MedLink Workstation.
ATL believes that the Region of Interest quantification capabilities of the Q LAB software makes it substantially equivalent to other commercially available products, specifically the Hewlett Packard Acoustic Densitometry Option.
7) Software
Software development for the Q LAB software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image display and quantification product.
8) Conclusions
The O LAB software is designed and manufactured to meet United States and international standards for the display and quantification of images acquired on Phillips Ultrasound devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. The Q LAB software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Advanced Technology Laboratories, Inc. % Mr. Mark Job Responsible Third Party Official TÜV Product Services 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K021966
Trade/Device Name: Q LAB Quantification Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: June 14, 2001 Received: June 17, 2002
Dear Mr. Job:
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 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.
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.
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This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancv 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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Appendix E
510K Number (if known)
Device Name: Q LAB Quantification Software
Indications for Use:
The Q LAB Quantification software is a Windows 2000/Windows XP software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Prescription Use
Vance Hodgson
(Division Sign-Off)/ Division of Reproductive, Ab 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).