(90 days)
Not Found
Not Found
No
The description focuses on image transfer, display, and basic manipulation (resolution, color, display formats). There is no mention of AI or ML algorithms for image analysis, interpretation, or other advanced functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as software for transferring and displaying medical image data, not for direct therapeutic intervention or treatment.
No
The device is described as software for transferring and displaying Pegasys and DICOM image data to physician workstations for review and interaction. It does not perform any analysis, interpretation, or diagnosis of the images itself; rather, it provides a means for physicians to review existing images.
Yes
The device description explicitly states that Pegasys InTouch™ has been designed to operate on standard, off-the-shelf hardware and software components and is intended to be used on standard WinTel PC systems. The core function described is the transfer and display of image data, which is a software-based operation. While it interacts with imaging systems (which are hardware), the device itself is the software application running on existing hardware.
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.
- Device Function: The Pegasys InTouch™ software is described as a system for transferring and displaying medical images (Pegasys and DICOM data) from various imaging modalities like CT and MRI. It allows physicians to review and interact with these images remotely.
- Lack of Biological Sample Analysis: The device does not perform any analysis on biological samples. Its function is solely related to the handling and display of medical images.
Therefore, the intended use and device description clearly indicate that this is a medical image management and display system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pegasys InTouch™ software is intended to transfer and provide interpretive displays of Pegasys and DICOM image data either compressed or uncompressed to physician workstations via a local area network (LAN) interconnected with Ethernet or via a wide area network (WAN) comprised of two or more LANs in different locations, using a hospital intranet, not the Internet.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Pegasys InTouch™ has been developed to provide a physician with the ability to review Pegasys and DICOM images from locations outside the original study Pegasys InTouch™ has been designed to operate on standard, off-the-area. shelf hardware and software components. Using standard WinTel PC systems and the hospital proprietary LAN/WAN (either local or wide area), physicians will have the ability to review and interact with patient data from their desks.
Pegasys and other digital imaging communications systems consist of a computer with a high speed data modem connected to a standard telephone line or computer network that can transmit or receive digitized images. The system is programmed to send, receive, store, copy and display these images in a manner that assures that images are not altered. Operator interface features are also computer controlled so as to enhance the system's capabilities and make the system more user friendly. Images can be displayed with different resolutions and colors; the same image set can be viewed simultaneously at different locations on designated physician workstations.
The physician has the capability to select a variety of display formats for viewing. For example, the physician may select up to 9 separate datasets to be displayed simultaneously, including whole body and snapshot displays; comparative (tomographic) displays of oblique or transverse files; comparative cardiac SPECT data; and SPECT and gated SPECT data in a 10 frame-persecond cine mode. A brief description of the applications available to the physician workstation follows.
- The physician may select from a number of display formats incorporating from 1 to 9 zones as described previously.
- A Tomographic Display is used to display multiple orientations of the same image set in a comparative manner.
- The Cardiac Stress/Rest Comparative application facilitates the visual comparison of the same cardiac locations during rest and during stress.
- Cardiac Comparatives is similar to the Stress/Rest application above, but displays the stress and rest projections in cine motion.
Pegasys InTouch™ and other currently marketed systems consist of a PC compatible computer with a microprocessor with RAM, monitor, keyboard, mouse/trackball, internal hard drive, modem or Ethernet connection, and Microsoft Internet Explorer 3.0 or Netscape Navigator 3.0.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pegasys and DICOM image data, CT and MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician workstations, hospital intranet
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
An image was generated using a prototype of the display applications. The DICOM-format image was downloaded using standard web-based data transfer and displayed into the image viewer. The same image was displayed in each of the four display regions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
K974474
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
- I. General Information
FEB 2 4 1998
| A. Submitted By: | ADAC Laboratories |
|---|---|
| 540 Alder Drive | |
| Milpitas, CA 95035 | |
| Tel: (408) 321-9100 | |
| Fax: (408) 321-9686 | |
| Contact Person: | Dennis Henkelman at address above |
| B. Device Trade Name: | Pegasys InTouch™ |
| Common Name: | Picture Archive and Communication System |
| (PACS) | |
| Classification Name: | Digital Image Communication System |
| C. Predicate Device: | AVP PACSPRO 640 |
| HyperPACS | |
| AMICAS Web/Intranet Image Server |
D. Device Description:
Pegasys InTouch™ has been developed to provide a physician with the ability to review Pegasys and DICOM images from locations outside the original study Pegasys InTouch™ has been designed to operate on standard, off-thearea. shelf hardware and software components. Using standard WinTel PC systems and the hospital proprietary LAN/WAN (either local or wide area), physicians will have the ability to review and interact with patient data from their desks.
Pegasys and other digital imaging communications systems consist of a computer with a high speed data modem connected to a standard telephone line or computer network that can transmit or receive digitized images. The system is programmed to send, receive, store, copy and display these images in a manner that assures that images are not altered. Operator interface features are also computer controlled so as to enhance the system's capabilities and make the system more user friendly. Images can be displayed with different resolutions and colors; the same image set can be viewed simultaneously at different locations on designated physician workstations.
1
The physician has the capability to select a variety of display formats for viewing. For example, the physician may select up to 9 separate datasets to be displayed simultaneously, including whole body and snapshot displays; comparative (tomographic) displays of oblique or transverse files; comparative cardiac SPECT data; and SPECT and gated SPECT data in a 10 frame-persecond cine mode. A brief description of the applications available to the physician workstation follows.
-
- The physician may select from a number of display formats incorporating from 1 to 9 zones as described previously.
- A Tomographic Display is used to display multiple orientations of the 2. same image set in a comparative manner.
- The Cardiac Stress/Rest Comparative application facilitates the visual 3. comparison of the same cardiac locations during rest and during stress.
- Cardiac Comparatives is similar to the Stress/Rest application above, but 4. displays the stress and rest projections in cine motion.
- E. Indications for Use:
Pegasys InTouch™ software is intended to transfer and provide interpretive displays of Pegasys and DICOM image data either compressed or uncompressed to physician workstations via a local area network (LAN) interconnected with Ethernet or via a wide area network (WAN) comprised of two or more LANs in different locations, using a hospital intranet, not the Internet.
- F. Technological Comparison:
Pegasys InTouch™ is similar to a wide variety of Picture Archive and Communication Systems (PACS) currently on the market. These systems are designed to send, receive, store, copy and display high resolution digitized images. The images can be digitally scanned into the system or captured from various imaging modalities such as CT and MRI. Each system consists of either a single unit or multiple units networked. Image data is sent from a sending unit through digital network lines or through standard telephone lines by a high speed modem to a receiving station. Once the image is received, it can be stored, copied and displayed. Displayed images may be adjusted for user preference to assist in interpretation.
2
Pegasys InTouch™ and other currently marketed systems consist of a PC compatible computer with a microprocessor with RAM, monitor, keyboard, mouse/trackball, internal hard drive, modem or Ethernet connection, and Microsoft Internet Explorer 3.0 or Netscape Navigator 3.0.
II. Testing
An image was generated using a prototype of the display applications. The DICOM-format image was downloaded using standard web-based data transfer and displayed into the image viewer. The same image was displayed in each of the four display regions.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
? 4 1996
Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
K974474 Re:
Pegasys InTouch™ (PACS) Dated: November 25, 1997 Received: November 26, 1997 Regulatory class: Unclassified Procode: 90 LLZ
Dear Mr. Henkelman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we bare determined the device is substantially equivalent (for the indications for use states in the exclosure) to devices marketed in interstate commerce prior to May 28, 1976, the ennotment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Comments Act (Act). You may, therefore, narket the device, subject to the general controls provisions of 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 chass III (Premarket Appoval), it may be subject to such additional controls. Existing major regulations affecting your device can be formal in the Code of Feleval Resultivions, Title 21, Parts 800 to 895, A substantially ecuivaliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (S inspections, the Food and Drug Administration (FDA) will verify auch 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 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 predication 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 vitte 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,
William Li, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Pegasys InTouch™ Device Name:
Sponsor Name: ADAC Laboratories
Indications for Use
Pegasys InTouch™ software is intended to transfer and provide interpretive displays of Pegasys and DICOM image data either compressed or uncompressed to physician workstations via a local area network (LAN) interconnected with Ethernet or via a wide area network (WAN) comprised of two or more LANs in different locations, using a hospital intranet, not the Internet.
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 ()
David A. Syam
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K974174