(89 days)
PICTools Medical Compression Toolkit is intended to be used by software developers in the development of applications for the compression of the data in digital medical images.
PICTools Medical is a software development kit written in 'C' for software developers to write applications interfaces to integrate particular image data compression algorithms into their medical imaging applications. It provides an array of high performance image compression libraries intended for use by developers of medical devices in the fields of radiology, cardiology, digital dentistry, ultrasound, and telepathology.
This is a 510(k) summary for a software development kit (SDK) rather than a medical device that directly interacts with patients or provides diagnostic information. Therefore, the typical acceptance criteria and study design for medical imaging AI/ML devices, which focus on diagnostic accuracy metrics, are not applicable here.
The document describes PICTools Medical Compression Toolkit, a software development kit designed for developers to integrate image compression algorithms (Wavelet and JPEG) into medical imaging applications. The submission is focused on demonstrating substantial equivalence to predicate devices for its functionality as a compression toolkit, not its diagnostic efficacy.
Here's an analysis of the provided information in the context of a software toolkit:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a software toolkit for image compression, the "acceptance criteria" are not related to diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, they are about the existence and functionality of the compression algorithms compared to predicate devices.
| Acceptance Criteria (Implied for a Compression Toolkit) | Reported Device Performance |
|---|---|
| Presence of Wavelet Image Compression | Device includes Wavelet image compression. |
| Presence of JPEG Image Compression | Device includes JPEG image compression. |
| Substantial Equivalence in Clinical Functionality to Predicates | Demonstrated by comparing features with Access Radiology (Wavelet) and WinRad Teleradiology System (JPEG). |
Note: The document explicitly states "The clinical functionalities of the three devices are compared below" and then provides a table simply indicating which devices have which compression methods. This implies the "performance" for equivalence is the presence of these functionalities. There are no quantitative performance metrics (e.g., compression ratios, image quality impact) discussed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a software toolkit for compression algorithms. The submission does not describe a clinical "test set" of images for evaluating diagnostic performance or image quality impacts. The evaluation is at the functional level of providing compression algorithms.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As there's no clinical test set for diagnostic evaluation or image quality assessment by experts, no ground truth experts were used for this type of submission.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This software toolkit does not directly involve human readers in making diagnostic interpretations, nor does it aim to improve their performance in a diagnostic context in the way AI/ML diagnostic tools do. Therefore, an MRMC study is not relevant to this submission.
6. Standalone Performance Study
Not applicable in the typical sense of a diagnostic AI algorithm. The "standalone" performance here refers to the SDK providing compression algorithms, which is its intended function. There's no separate "standalone" performance study for diagnostic accuracy outlined. The study outlined is a comparison of functionality to predicate devices.
7. Type of Ground Truth Used
Not applicable. As this device provides compression algorithms and is not for diagnostic interpretation, there is no "ground truth" in the clinical sense (e.g., pathology, outcomes data). The "ground truth" for the submission is the reported functionality of the predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that learns from a training set of data. It's a set of pre-defined compression algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
Summary of the Study for Substantial Equivalence:
The "study" presented is a comparison of functional equivalence between the PICTools Medical Compression Toolkit and two predicate devices:
- Access Radiology (Framewave) K972925 for Wavelet image compression.
- WinRad Teleradiology System (K936179) for JPEG image compression.
The evidence for this substantial equivalence is primarily a direct comparison of the documented "clinical functionalities" (i.e., the presence of specific compression algorithms) as shown in the table provided in the 510(k) summary. The submission asserts that because the PICTools Medical Compression Toolkit offers both Wavelet and JPEG compression, it is functionally equivalent to or encompasses the compression capabilities of the two predicate devices.
This type of submission relies on demonstrating that the device performs the same intended use as legally marketed predicate devices and does not raise new questions of safety or effectiveness. The core of the "proof" is the declaration of included compression types matching those of already cleared devices. No clinical trials, performance studies on image quality, or diagnostic accuracy evaluations are mentioned or required for this specific type of software toolkit.
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SEP 1 4 1998
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510 (k) Summary as required by 807.92 9 (c) for PICTools Medical Compression Toolkit Prepared June 8, 1998
| Submitted by: | Pegasus Imaging Corporation4010 Boy Scout BoulevardSuite 400Tampa, Florida 33607-5799telephone: 813-875-7575 |
|---|---|
| Contact: | Andrew HudsonDirector of Business Development |
| Device Trade Name: | PICTools Medical Compression Toolkit |
| Common Name: | Medical Image Compression Software Toolkit |
| Classification: | Picture Archiving and Communications Systems were reviewed bythe Radiology Panel and are classified in Class II per 21 CFR892.2050. Image compression devices that label all lossilycompressed images as such are being considered by the agency forexemption from premarket notification requirements [510(k)]. |
| Predicate Devices: | Access Radiology (Framewave) K972925 and WinRadTeleradiology System (K936179). |
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Description of Devices:
PICTools Medical is a software development kit written in 'C' for software developers to write applications interfaces to integrate particular image data compression algorithms into their medical imaging applications. It provides an array of high performance image compression libraries intended for use by developers of medical devices in the fields of radiology, cardiology, digital dentistry, ultrasound, and telepathology.
Intended Use of Device:
PICTools Medical Compression Toolkit is intended to be used by software developers in the development of applications for the compression of the data in digital medical images.
Substantial Equivalence to Predicate Device:
The wavelet compression algorithm in PICTools Medical Compression Toolkit is substantially equivalent to that in Access Radiology (Framewave) (K972925). The JPEG compression algorithms in PICTools Medical Compression Toolkit are substantially wquivalent to those in WinRad Teleradiology System (K936179). The clinical functionalities of the three devices are compared below.
| Wavelet imagecompression | JPEG imagecompression | |
|---|---|---|
| PICTools MedicalCompression Toolkit | X | X |
| Access Radiology(Framewave) (K972925) | X |
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Image /page/2/Picture/0 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 symbol that resembles three overlapping human figures or abstract shapes. The symbol is black, and the text is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Andrew Hudson Director of Corporate Development Pegasus Imaging Corporation 4010 Boy Scout Blvd., Suite 400 Tampa, FL 33607
Re:
K982146 PICTools Medical Compression Toolkit Dated: June 10, 1998 Received: June 17, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Hudson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K982146
PICTools Medical Compression Toolkit Device Name:
Indications For Use:
PICTools Medical Compression Toolkit is intended to be used by software developers ITC I ouls Medical Compression Foother is and in digital medical images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal, ENT and Radiological I
510(k) Number K982146
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).