(98 days)
Not Found
No
The summary describes image processing for noise reduction but does not mention AI, ML, or any related terms like deep learning or neural networks. The performance studies focus on phantom and image quality comparisons, not on the performance metrics typically associated with AI/ML diagnostic aids (like sensitivity, specificity, AUC).
No
The device is intended for image processing and enhancement of CT images to assist radiologists in diagnosis, not for direct therapeutic intervention.
No
The device is described as an image enhancement and processing tool for CT images, intended to assist professionals in reaching their own diagnosis, but not to make the diagnosis itself. Its purpose is to reduce noise and enhance image quality, which supports diagnostic interpretation but is not a diagnostic function in itself.
Yes
The device description explicitly states "PixelShine is a medical imaging application" and describes its function as receiving, transferring, and processing images. The performance studies focus on software testing (Unit Integration, System-Level, Verification, Validation) and image quality assessment using phantoms and collected data, without mentioning any associated hardware components being part of the device itself.
Based on the provided information, the AlgoMedica PixelShine System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the PixelShine System processes and enhances CT images (medical images of the body), not biological samples like blood, urine, or tissue.
- The device's function is image processing and enhancement. Its purpose is to improve the quality of existing medical images for interpretation by a professional, not to analyze biological markers or substances within a specimen.
The device falls under the category of medical imaging software or a picture archiving and communication system (PACS) component with image processing capabilities, which are distinct from IVDs.
N/A
Intended Use / Indications for Use
The AlgoMedica PixelShine System is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3.0 mm The AlgoMedica PixelShine is not intended for use with or for diagnostic interpretation of mammography images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
PixelShine is a medical imaging application that can receive, transfer and perform noise reduction of CT DICOM images over a user network. Received images are processed by the PixelShine to reduce noise, thereby enhancing image quality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images in DICOM format.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional radiologists and specialists
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)
The following non-clinical performance testing was performed with satisfactory results. All of the testing was performed with the use of an approved testing protocol.
- Unit Integration Testing Pass; .
- PixelShine System-Level-Testing Pass; .
- PixelShine Verification Testing Pass; and .
- PixelShine Validation Testing Pass. .
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.
Medic Vision Brain Technologies, LTD – SafeCT (K100372)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September, 19, 2016
AlgoMedica % Christopher J. Devine, Ph.D. President Devine Guidance International, Inc. 4730 South Fort Apache Road, Suite 300 LAS VEGAS NV 89147
Re: K161625 Trade/Device Name: PixelShine Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 19, 2016 Received: August 24, 2016
Dear Dr. Devine:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
к161625
Device Name PixelShine
Indications for Use (Describe)
The AlgoMedica PixelShine System is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3.0 mm The AlgoMedica PixelShine is not intended for use with or for diagnostic interpretation of mammography images.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Section Five (5) - 510(k) Summary
510(k) SUMMARY
[As Required by 21 CFR 807.92(c)]
| Submitter's Name & Address: | AlgoMedica
2600 El Camino Real
Suite 100
Palo Alto, CA 94306 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher J. Devine, Ph.D.
Telephone (702) 939-5507
Mobile (702) 917-0585
chris.devine@devineguidanceinternational.com |
| Date Summary Prepared: | June 06, 2016 |
| Device Name: | Trade/Proprietary Name – PixelShine |
| | Common/Usual Name - System, Image Processing,
Radiological |
| | Classification Name – 892.2050 - Picture archiving and
communications system |
| Classification: | Class II |
| Product Code: | LLZ |
| Regulation Number: | 892.2050 |
| Predicate Device: | Medic Vision Brain Technologies, LTD – SafeCT
(K100372) |
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Previous FDA Submissions & Clearances
AlgoMedica has no previous regulatory submissions with the FDA.
Device Description
PixelShine is a medical imaging application that can receive, transfer and perform noise reduction of CT DICOM images over a user network. Received images are processed by the PixelShine to reduce noise, thereby enhancing image quality.
Intended Use
The AlgoMedica PixelShine is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm The AlgoMedica PixelShine is not intended for use with or for diagnostic interpretation of Mammography images.
Prescriptive Statement
Caution: Federal law restricts this device to sale by or on the order of a physician.
Safety & Effectiveness
The PixelShine has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2012 (risk management). The PixelShine performance has been validated through the use of phantoms and the comparison of collected image data to ascertain image quality. The results of the performance testing demonstrate the safety and effectiveness of the PixelShine.
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Technological Characteristics/Principles of Operation
PixelShine is a medical imaging application that runs on an AlgoMedica-specified, customer's Off-the-Shelf Personal Computer (PC) and performs noise reduction processing and transfer of CT DICOM images over a user network. Once installed by AlgoMedica trained personnel, PixelShine operates independently, without the need for I/O devices such as mouse and keyboard. It is indicated for assisting radiologists and other medical specialists in arriving at their own diagnosis. The technology for noise reduction is based on a non-linear filter, which reduces noise in the original image. Figure 5.1 depicts a typical deployment of the PixelShine at a customer site.
PixelShine Components and Hardware Requirements
The following components and hardware requirements are an integral part of the PixelShine:
- PixelShine Version 1 Software Package; .
- . Linux Operating System;
- DICOM Server software installed on PixelShine provides all DICOM communications: . and
- . AlgoMedica specified off-the-shelf PC Hardware (minimum Requirements) containing:
- -Intel CPU with 4 cores;
- -16GB RAM;
- -500GB hard drive; and
- Two 1 Gigabit Ethernet ports -
PixelShine Functional Capabilities
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The following functions are associated with performance of the PixelShine (reference
Figure 5.1):
- Operates in a network server mode environment; .
- Functions as a DICOM device on the user network; .
- Capable of receiving CT images from different DICOM devices over the ● network:
- Capable of receiving images from multiple DICOM devices; ●
- Processes the CT images upon receiving them from a DICOM device; and ●
- . Sends the processed CT image to one or more destination DICOM devices.
Figure 5.1 – Pixel Shine Functional Block Diagram (deployment scenario)
Image /page/6/Figure/9 description: The image shows a diagram of a CT scanning process. The CT scanner sends original CT images to PACS and technologists' workstations. The original CT images are also sent to the AlgoMedica PixelShine Server, which enhances the quality of the images. The enhanced quality images are then sent to PACS and diagnostic workstations.
Note: PixeShine receives original CT images, processes them and routes the enhanced quality images to a PACS system. As in current practice, the technologist is able to view both the processed images on his workstation and take appropriate action as necessary. Both the original and processed images can be stored on the PACS server.
Summary of Non-Clinical Performance and Safety Testing
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The following non-clinical performance testing was performed with satisfactory results. All of the testing was performed with the use of an approved testing protocol. Details of each test, including protocols and reports are located in Appendix E of this 510(k).
- Unit Integration Testing Pass; .
- PixelShine System-Level-Testing Pass; .
- PixelShine Verification Testing Pass; and .
- PixelShine Validation Testing Pass. .
Substantial Equivalence Discussion
Medic Vision Brain Technologies Ltd. – SafeCT (K100372)
The PixelShine is substantially equivalent to the devices previously cleared by FDA (reference 510(k) – K100372). AlgoMedica claims this equivalence because the proposed device has an equivalent intended use, theory of operation, operating principals, and operational specifications as compared to the predicate device. The similarities and differences between the proposed and predicate device have been delineated within a comparison chart which has been included in Section 12 of this 510(k) submission.
Conclusion Statement
The AlgoMedica PixelShine has the same intended use as the predicate device. Any technological changes to the device do not raise new questions of safety or effectiveness. Performance testing, along with verification and validation activities demonstrate that the AlgoMedica PixelShine is as safe and effective, and performs as well as the predicate device. Therefore, the AlgoMedica PixelShine can be considered substantially equivalent to the predicate device.