(78 days)
PACScache is an integrated client server software system designed to allow rapid access to radiographic data (specifically high resolution images) through out the radiology department as well as the entire hospital or clinical setting. The product is intended to enable review of images through clinical information systems and allow review of images on a digital picture archiving and communication system (PACS) network using a personal computer or workstation configured for standard internet access.
PACScache is an imaging software program used to view medical images on a personal computer. The software is designed to function with off-the-shelf hardware and software products including standard communications products. Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the scanner.
The provided document is a 510(k) summary for the PACScache device, an imaging software program for viewing medical images. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way that would typically be expected for demonstrating the safety and effectiveness of a device using a formal study.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices (Articas Web/Intranet Server K970064 and RSTAR's Image Management System K925994). This regulatory pathway for low-risk devices often relies on comparisons to existing technology rather than requiring de novo studies with specific performance targets.
Therefore, many of the requested categories of information cannot be extracted from this document, as they were likely not part of the submission for this particular device.
Here's a breakdown of what can be inferred or directly stated, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of quantitative metrics for accuracy, sensitivity, specificity, etc. The submission focuses on substantial equivalence to predicate devices. | The document states PACScache has "Indications for Use similar to other image viewing software products such as AMICAS (510k # K970064)." It also notes it "uses the same target endusers (competent health professionals)" and "is designed to operate with off-the-shelf hardware and systems" like the predicate devices. It "employs JPEG image compression to remove redundant or unimportant information in the original data," similar to predicate devices that use JPEG and wavelet compression. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned. The document states it views "files generated by a medical scanning device and acquired according to the dominant industry standard communications format (DICOM 3.0)," but doesn't detail any specific dataset used for testing. The "test set" in the context of this submission would likely refer to internal verification and validation against software requirements, rather than a clinical dataset for performance evaluation against a gold standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. It's unlikely such ground truth establishment was required or performed for this type of software's 510(k) submission, which emphasizes "viewing" and "imaging software program" functionality rather than diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is described as "imaging software program used to view medical images," and explicitly states "It does not provide a diagnosis. It only provides information/data. It is a stand-alone system and not a part of a regulated classified device or accessory to it." The concept of "human readers improve with AI" is not applicable, as this device is a viewing platform, not an AI-powered diagnostic aid. This predates widespread AI in medical imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense, the device is standalone in its function of displaying images. The document states: "It is a stand- alone system and not a part of a regulated classified device or accessory to it." However, this refers to its independence as a software product, not necessarily an "algorithm only" performance study in the modern sense of a diagnostic AI algorithm. Its performance is related to its ability to correctly display medical images from DICOM data, not to interpret them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not mentioned for performance evaluation in a clinical sense. For this type of software, "ground truth" would likely involve ensuring accurate display of DICOM data as per standards, and verification/validation against specified software requirements.
8. The sample size for the training set
- Not applicable/Not mentioned. This device is described as an "imaging software program" for viewing, operating with "off-the-shelf hardware and software products." It does not appear to involve machine learning or AI models that require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set or AI model development.
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Image /page/0/Picture/3 description: The image shows the logo for Dome Imaging Systems. The logo features a black background at the top, with a white dome shape underneath. Below the dome, the word "DOME" is written in large, bold, black letters. Underneath the word "DOME", the words "imaging systems" are written in a smaller, less bold font.
JAN 1 4 1999
510(K) SUMMARY K983812
Submitter: Dome imaging systems inc. 400 fifth avenue, Waltham, MA 02154 Contact name: Morteza Minaee Phone number: (781) 895-1155 Fax number: (781) 895-1133 Device trade name: PACScache Product code: 90LMD Legally marketed device to which Dome imaging systems inc., is claiming equivalence: Articas Web/Intranet Server (K970064) and RSTAR's Image Management System (K925994)
Safety and Effectiveness Information
PACScache is an imaging software program used to view medical images on a personal computer. The software is designed to function with off-the-shelf hardware and software products including standard communications products.
Image acquisition is via the industry standard DICOM 3.0 protocol allowing the images to be produced from the digital data originated by the scanner.
List of hazards related to the functions performed by the software and means taken to mitigate these hazards:
This product falls in the "Low Level of Concern" category.
Intended Use: The software is to be used for the remote viewing of files generated by a medical scanning device and acquired according to the dominant industry standard communications format (DICOM 3.0).
System and Software Requirements: The software will run on standard off-the shelf hardware and system configurations.
Hazard Analysis: The loss or corruption of patient demographics, study information and image data is the basic hazard related to any PACS. Incorrect display of the image data is possible due to incorrect data produced
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by the scanner or from a software malfunction. The mitigation is through the FDA's regulation of these devices, and through the QA system and the verification and validation test procedures adhered to during development and testing stages of the software product prior to its release. Additional control is the intended use of the product with properly regulated devices, and timely identification and correction of any potential software problems and subsequent testing procedures.
Among factors considered in this hazard analysis were the risk or danger to the patient. The software can not immediately threaten the patient's life nor directly cause any irreversible illness or permanent injury. It only deals with data gathered and processed by FDA regulated devices and viewed by a competent medical professional.
Degree of influence on therapy or diagnosis was also considered in the hazard analysis. The software product does not control the delivery of energy, administration of parenteral drugs, or devices with life-sustaining functions. It does not provide a diagnosis. It only provides information/data. It is a stand- alone system and not a part of a regulated classified device or accessory to it (It may be offered for use by OEM customers for integration into their product).
Competent health professionals would reasonably be expected to use judgement and professional expertise in the use and interpretation of the information.
PACScache has Indications for Use similar to other image viewing software products such as AMICAS (510k # K970064). It uses the same target endusers (competent health professionals). Also, as in the above claimed equivalent devices, it is designed to operate with off-the-shelf hardware and systems.
Like the RSTAR Image management system, it employs JPEG image compression to remove redundant or unimportant information in the original data. Autocyte group's AMICAS and RSTAR's Image Management System also utilize wavelet compression which has been found to be substantially equivalent to previously cleared devices using JPEG compression techniques.
The table in exhibit F of our submission compares PACScache to AMICAS. Although technical differences can be noted on the following comparison chart, we believe that these differences are minor and that none of them affect the safety and efficacy of the PACScache product.
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Re:
JAN 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Morteza Minaee Director, Quality Assurance Dome Imaging Systems® 400 Fifth Avenue Waltham, MA 02451-8738
K983815 PACScache Dated: October 21, 1998 Received: October 28, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Minaee:
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 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). 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 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 requlation (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 requlatory 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 531 through 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D.
Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices · Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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k983815_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):
Device Name: PACScache
Indication for use:
PACScache is an integrated client server software system designed to allow rapid access to radiographic data (specifically high resolution images) through out the radiology department as well as the entire hospital or clinical setting. The product is intended to enable review of images through clinical information systems and allow review of images on a digital picture archiving and communication system (PACS) network using a personal computer or workstation configured for standard internet access.
(PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) ✓ | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K983815 |
|---|---|
| --------------- | --------- |
§ 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).