(15 days)
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No
The description focuses on standard image processing and quantification techniques, with no mention of AI or ML terms or concepts.
No
The device is a software for viewing and quantifying image data, not for treating or providing therapy.
Yes
The software quantifies image data from medical devices (ultrasound), analyzes content, and performs measurements (intima media thickness), which are typical functions of diagnostic devices used to assess medical conditions.
Yes
The device is described as a "software application package" designed to view and quantify image data. The description focuses solely on the software's functionalities for image processing, analysis, and data export, without mentioning any associated hardware components that are part of the device itself. While it processes data from ultrasound products, the device itself is presented as a software package.
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.
- Device Function: The Q LAB software processes and quantifies image data acquired from an ultrasound machine. It analyzes the physical characteristics of the artery (intima media thickness) directly from the image.
- No Sample Analysis: The software does not analyze any biological samples taken from the patient.
Therefore, while it is a medical device used in a clinical setting for diagnosis, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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).
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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