(15 days)
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No
The document describes a medical image display workstation with workflow and connectivity features. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The device is a medical image display workstation used for review and interpretation of medical images/data. It does not directly treat or diagnose conditions but rather provides tools for interpretation, which assists qualified healthcare professionals.
Yes
The device is described as a "medical image display workstation" used for "review and interpretation of medical images/data" and the "results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures." This clearly indicates its use in diagnostic processes.
Yes
The device is described as a "Windows®-based physician workstation" and its features are focused on software applications for image review, interpretation, and reporting. While it interacts with medical image data, the description does not mention any specific hardware components included as part of the device itself, only the software functionality and its operating environment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Physician's Desktop Review is described as a medical image display workstation used for the review and interpretation of medical images/data. It processes and displays images obtained from various medical imaging procedures.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the patient. The input is image data, not biological specimens.
Therefore, the device falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Physician's Desktop Review is a medical image display workstation that provides software applications used for review and interpretation of medical images/data. The results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician's Desktop Review system should only be operated by qualified healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Physician's Desktop Review (PDT) is a Windows®-based physician workstation. The product's design and features improve physician workflow by integrating image and information into his/her desktop environment. The comprehensive tools and features provided with this product allow the physician to review, interpret, and report results and not have to leave the office environment. The connectivity package allows the physician to download image data to his/her location reducing the time for travel and improving turn-around time for patient results.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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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| ADAC Laboratories | K02 1669 | ||||
|---|---|---|---|---|---|
| Physician's Desktop Review | CONFIDENTIAL | 510(k) Premarket Notification | |||
| Section B. Administrative Information | |||||
| JUN 5 2002 | ADMINISTRATIVE INFORMATION | ||||
| I. | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | ||||
| A. | Submitted By: | ADAC Laboratories A Philips Medical | |||
| Systems Company | |||||
| 540 Alder Drive | |||||
| Milpitas, California 95035 | |||||
| Tel: | (408) 468-3051 | ||||
| Fax: | (408) 468-3050 | ||||
| Contact Person: | Coleen Coleman | ||||
| At address above | |||||
| B. | Device Trade Name: | Physician's Desktop Review | |||
| Common Name: | Picture Archive and Communication | ||||
| Systems (PACS) | |||||
| Classification Name: | Image Processing System | ||||
| C. | Predicate Device(s): | ||||
| Manufacturer | Product Name | 510(k) No. | |||
| ADAC Laboratories | Pegasys Ultra™ | K993946 | |||
| ADAC Laboratories | Pegasys InTouch (WebView™) | K974474 | |||
| D. | Device Description: | Physician's Desktop Review (PDT) is a Windows®-based physician | |||
| workstation. The product's design and features improve physician | |||||
| workflow by integrating image and information into his/her desktop | |||||
| environment. The comprehensive tools and features provided with this | |||||
| product allow the physician to review, interpret, and report results and not | |||||
| have to leave the office environment. The connectivity package allows the | |||||
| physician to download image data to his/her location reducing the time for | |||||
| travel and improving turn-around time for patient results. | |||||
| E. | Indications for Use: | Physician's Desktop Review is a medical image display workstation that | |||
| provides software applications used for review and interpretation of |
provides software applications used for review and interpretation of medical images/data. The results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician's Desktop Review system should only be operated by qualified
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healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.
- F. Technological Comparison:
The Physician's Desktop Review, Pegasys Ultra™ (K993946), and Pegasys InTouch (WebView™) (K974474) have similar indications for use and overall function and perform in a similar manner with respect to, display, review applications, data storage, and system utilities.
II. CONCLUSION
Physician's Desktop Review is substantially equivalent to the predicate devices the Pegasys Ultra™ (K993946) and InTouch (Webview™ K974474) based on similar intended use, technological comparison, and system performance.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. 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 human profiles facing to the right, with three lines above them. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2002
ADAC Laboratories % Ms. Elizabeth Drew Reviewer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K021669
Trade/Device Name: Physician's Desktop Review Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: May 17, 2002 Received: May 21, 2002
Dear Ms. Drew:
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 (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); 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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ko 2 166 9 - ------
Device Name: Physician's Desktop Review
Sponsor Name: ADAC Laboratories A Philips Medical Systems Company
Indications for Use:
Physician's Desktop Review is a medical image display workstation that provides software applications used for review and interpretation of medical images/data. The results obtained may be used as a tool in interpretation of data derived from any medical imaging procedures. The Physician's Desktop Review system should only be operated by qualified healthcare professionals (e.g., radiologists, cardiologists, oncologists, or general nuclear medicine physicians) trained in the use of medical imaging equipment.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021669