(15 days)
TomTec 4D MV -Assessment software., GE Healthcare AFI software.
No
The description focuses on image processing techniques like pattern-matching and quantification of anatomical structures, without mentioning AI or ML algorithms.
No.
The device is a software application package designed to view and quantify image data, providing tools for assessing structures like the mitral valve and myocardial wall. It aids in diagnosis and assessment by providing quantitative measurements from ultrasound images, but it does not directly perform therapy.
Yes
The software quantifies ultrasound image data to assess anatomical structures (mitral valve, myocardial walls), providing measurements and calculations (lengths, distances, areas, volumes, angles, strains, rotation, speed) that are used for the assessment of global function, indicating its role in diagnosis.
Yes
The device is described as a "software application package" and its function is to "view and quantify image data acquired on Philips Medical Systems ultrasound products." It processes existing image data and does not include any hardware components or control any hardware directly.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "view and quantify image data acquired on Philips Medical Systems ultrasound products." This is focused on processing and analyzing medical images obtained from a living patient, not on testing samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description details software tools for analyzing ultrasound images of anatomical structures (mitral valve, myocardial wall, cardiac annular). This is consistent with medical image analysis, not in vitro testing.
- Input Imaging Modality: The input is Ultrasound, which is an in vivo imaging technique.
- Anatomical Site: The anatomical sites mentioned are within the human body.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This software operates on images of the body itself, not on samples taken from the body.
N/A
Intended Use / Indications for Use
QLAB Quantification software is a 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)
LLZ
Device Description
QLAB version 6.0 adds the OLAB MVO Plug-in and OLAB TMO/TMOA Plug-ins to the cleared QLAB software.
QLAB MVQ Plug-in (MVQ stands for Mitral Valve Quantification) Tool to assess lengths, distances, areas, volumes and angles of mitral valve structures from a Philips Ultrasound system 3D dataset.
QLAB TMQ/TMQA Plug-ins (TMQ and TMQA stands respectively for Tissue Motion Quantification and Tissue Motion Quantification Advanced) TMQ and TMQA plug-ins are an addition to the existing 2DQ plug-in already
described on the iE33 510(k) submission K042540. The QLAB TMQ/TMQA plugins provide ultrasound tracking algorithm using pattern-matching method of wall lengthening, shortening and displacement in a set of 2D image. Radial, longitudinal, circumferential, lengths and strains are computed as well as rotation and rotation gradient and absolute speed. TMQ provides only one myocardial layer and 17 segmentation model only; TMQA will provide Multi Myocardial Layers and a choice of Segmentation on and off. CAK (Cardiac Annular Kinesis) feature is an addition to the existing 2DQ plug-in already described on the iE33 510(k) submission K042540. CAK will be a feature of existing 2DQ plug-in as well as TMQ and TMQA plug-ins. CAK is Quick survey tool of global function assessment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Mitral valve structures, myocardial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical setting
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.
TomTec 4D MV -Assessment software., GE Healthcare AFI software.
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.
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).
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Image /page/0/Picture/0 description: The image shows the text 'K070792' in a bold, handwritten style. The text is underlined with a thin, dark line. The characters are distinct and easily readable against the plain background.
510(k) Premarket Notification
QLAB Quantification Software
B - Administrative Information
APR - 6 2007
510(k) Summary of Safety and Effectiveness 1
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
- Submitter's name, address, telephone number, contact person
Lynn Harmer, Regulatory Submissions Manager Philips Ultrasound, Inc. P.O. Box 3003 Bothell, WA 98041-3003 Telephone: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.Harmer@philips.com
Date prepared: March 16, 2007
- 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: | QLAB Quantification |
| | Classification Name: | Picture Archiving and Communications System, Class I |
3) Device Description
OLAB version 6.0 adds the OLAB MVO Plug-in and OLAB TMO/TMOA Plug-ins to the cleared QLAB software.
QLAB MVQ Plug-in (MVQ stands for Mitral Valve Quantification) Tool to assess lengths, distances, areas, volumes and angles of mitral valve structures from a Philips Ultrasound system 3D dataset.
QLAB TMQ/TMQA Plug-ins (TMQ and TMQA stands respectively for Tissue Motion Quantification and Tissue Motion Quantification Advanced) TMQ and TMQA plug-ins are an addition to the existing 2DQ plug-in already
described on the iE33 510(k) submission K042540. The QLAB TMQ/TMQA plugins provide ultrasound tracking algorithm using pattern-matching method of wall
1
lengthening, shortening and displacement in a set of 2D image. Radial, longitudinal, circumferential, lengths and strains are computed as well as rotation and rotation gradient and absolute speed. TMQ provides only one myocardial layer and 17 segmentation model only; TMQA will provide Multi Myocardial Layers and a choice of Segmentation on and off. CAK (Cardiac Annular Kinesis) feature is an addition to the existing 2DQ plug-in already described on the iE33 510(k) submission K042540. CAK will be a feature of existing 2DQ plug-in as well as TMQ and TMQA plug-ins. CAK is Quick survey tool of global function assessment.
4) Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514. The QLAB software has been designed to comply with the following voluntary standards:
- JPEG (lossy and lossless): ITU-T T.81, ISO/IEC IS 10918-1 .
5) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the QLAB software.
6) Substantially Equivalent Devices
Philips Ultrasound believes that the QLAB 6.0 software with - MVQ plug-in is substantially equivalent to other commercially available products, specifically TomTec 4D MV -Assessment software.
- TMQ/TMQA plug-in is substantially equivalent to other commercially available products, specifically GE Healthcare AFI software.
7) Software
Software development for the QLAB 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.
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:
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8) Conclusions
The OLAB 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 QLAB software incorporates features of the legally marketed devices cleared through premarket notification and no new issues of safety or effectiveness are raised.
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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, wavy lines that are stacked vertically. The lines appear to be connected or overlapping, creating a sense of unity or flow.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Philips Medical Systems c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
APR - 6 2007
K070792 Re:
Trade/Device Name: QLAB Quantification Software Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 21, 2007 Received: March 22, 2007
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 (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/3/Picture/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, there is some text that is difficult to read, but it appears to start with "ISO". Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a circular border with some text that is difficult to read.
Protecting and Promoting Public Health
4
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 (OS) 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) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
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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QLAB Quantification Software
2 FDA Indication for Use Form
510(k) Number:
Device Name: QLAB 6.0 Quantification Software with additional MVQ plug-in, and TMQ/TMQA plug-ins.
Indications for Use: QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Prescription Use: _ X OR Over-The-Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number