(22 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard image processing and quantification software. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as software for viewing and quantifying image data, with no indication of it actively treating or affecting a medical condition.
Yes
The device is described as software for viewing and quantifying image data from ultrasound products, and it includes plug-in applications for fetal heart and vascular plaque quantification, which are tasks typically involved in diagnosis. Additionally, the “Intended Use” section states its purpose is to "view and quantify image data acquired on Philips Healthcare ultrasound products," which is consistent with diagnostic devices that acquire and process medical images for evaluation.
Yes
The device is described as a "software application package" that can function on various computing platforms (PC, workstation, on-board ultrasound systems) and is used for viewing and quantifying image data. The description focuses solely on the software's functionality and does not mention any proprietary hardware components included with the device itself. While it processes data from ultrasound systems, the device being reviewed is the software application.
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 Healthcare ultrasound products." This describes a device that processes and analyzes medical images obtained from a patient's body, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description reinforces that it's a software application for reviewing and quantifying ultrasound studies. Ultrasound is an imaging modality used to visualize internal structures of the body.
- Input Imaging Modality: The input is explicitly stated as "Ultrasound," which is an in-vivo imaging technique.
- Anatomical Site: The anatomical sites mentioned (Fetal heart, carotid artery) are internal structures within the body.
- CFR 892.2050: This CFR section relates to "Picture archiving and communications system," which falls under the category of radiological devices, not IVDs.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. They typically involve testing samples taken from the body.
This device is clearly focused on the processing and analysis of medical images acquired directly from the patient's body using ultrasound, which is characteristic of a medical imaging device, not an IVD.
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 Healthcare ultrasound products.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The QLAB software application is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. It can be used for the on-line and off-line review and quantification of ultrasound studies. QLAB Quantification software now includes two new plug-in applications: Fetal Heart Navigator (FHN) and Vascular Plaque Quantification (VPO).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal heart, carotid artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No performance standards for PACS systems or components have been issued under the authority of Section 514. The FHN and VPQ plug-ins were tested in accordance with Philips verification and validation processes. Quality assurance measures were applied to the system design and development, including: Risk Analysis, Product Specifications, Design Reviews, Verification & Validation. The subject of this premarket submission, OLAB Quantification software with VPO and FHN did not require clinical studies to support substantial equivalence. Conclusion: Verification and validation testing concluded that the Fetal Heart Navigator and Vascular Plaque Quantification plug-ins are safe and effective and introduced no new risks.
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.
K070792, K113758, K021966, K040686
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
QLAB Quantification Software
4121223
5. 510(k) Summary
MAY 1 5 2012
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
Philips Ultrasound, Inc. 3000 Minuteman Road Andover, MA Penny Greco, Regulatory Affairs Specialist Telephone: (978) 659-4615 Facsimile: (978) 975-7324 E-mail: penny.greco@philips.com
Date prepared: April 4, 2012
- 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 Software with FHN & VPQ |
| Classification Name: | CFR 892.2050, system, image processing, radiological.
Product code LLZ, Class II |
- Substantially Equivalent Devices
Philips Ultrasound believes that the QLAB software with
- · Fetal Heart Navigator (FHN) plug-in is substantially equivalent to other commercially available products, including Philips QLAB MVQ (K070792) and GE's Voluson Expert 8 VCAD (K113758).
- · Vascular Plaque Quantification (VPO) plug-in is substantially equivalent to other commercially available products, including Philips QLAB ROI (K021966) and IMT's M'Ath® Std (K040686).
4) Device Description
The QLAB software application is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound
Philips Ultrasound
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510(k) Premarket Notification
systems. It can be used for the on-line and off-line review and quantification of ultrasound studies.
QLAB Quantification software now includes two new plug-in applications: Fetal Heart Navigator (FHN) and Vascular Plaque Quantification (VPO).
Fetal Heart Navigator
The Fetal Heart Navigator (FHN) plug-in provides a semi-automated alignment of the fetal heart from a 4D acquisition and a protocol that steps users through the standard views. The objective of the protocol is to obtain the standard set of views that best reveal the most common fetal heart anomalies. The purpose of the FHN plug-in is for visualization The Fetal Heart Navigator tools do not produce quantitative data or measurements.
Vascular Plaque Quantification
The Vascular Plaque Quantification (VPQ) plug-in provides protocol-driven tools for performing a semi-automated analysis of plaques in the carotid artery. The clinical results include the location of the maximum reduction site, the percentage of stenosis. and the plaque volume in the entire image.
5) Intended Use
QLAB Quantification software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
6) Technological comparison to predicate devices
QLAB's FHN is similar to the QLAB MVQ in that users are able to rotate an image to a desired view. While MVQ requires the user to place reference points to finish a trace, FHN finds the center of the heart and ductal arch and then displays the ductal arch view. Similar to GE's VCAD, the QLAB Fetal Heart Navigator (FHN) feature is a tool that helps guide the user through the process of obtaining standard views used for fetal heart assessment: 4-Chamber, LVOT, and RVOT. Both FHN and VCAD comply with the recommended standard screening exam of the fetal heart as outlined by AIUM, ACOG, ACR and ISOUG.
Similar to the QLAB ROI plug-in, VPQ creates ROIs and can then measure the area of arbitrarily sized/shaped ROIs. Both the QLAB VPQ plug-in and the IMT M' Ath software automate plaque visualization and characterization. Both process Ultrasound images.
7) Non-clinical performance data
No performance standards for PACS systems or components have been issued under the authority of Section 514. The FHN and VPQ plug-ins were tested in accordance with Philips verification and validation processes. Quality assurance measures were applied to the system design and development, including:
Philips Ultrasound
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2
- . Risk Analysis
- . Product Specifications
- . Design Reviews
- Verification & Validation .
Summary of Clinical Tests:
The subject of this premarket submission, OLAB Quantification software with VPO and FHN did not require clinical studies to support substantial equivalence.
Conclusion:
Verification and validation testing concluded that the Fetal Heart Navigator and Vascular Plaque Quantification plug-ins are safe and effective and introduced no new risks.
8) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the QLAB software with the Fetal Heart Navigator and Vascular Plaque Quantification plugins.
9) Conclusions
The QLAB Quantification Software with Fetal Heart Navigator and Vascular Plaque Quantification incorporate components common to all image viewing systems for the display, manipulation and quantification tasks within a clinical setting. Software development for the QLAB software follows documented processes for software design, verification and validation testing. A risk assessment was 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. Verification and validation testing of the QLAB Quantification software with Fetal Heart Navigator and Vascular Plaque Quantification indicate no new issues of safety and effectiveness.
Philips Ultrasound
ರು.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Philips Ultrasound, Inc. % Mr. Mark Job Third Party Consultant Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
MAY 1 5 2012
Re: K121223
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: May 10, 2012 Received: May 14, 2012
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name: QLAB Quantification Software
Indications for Use:
QLAB Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips Healthcare ultrasound products.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kla1223