(62 days)
Not Found
No
The summary describes a standard PACS system for image management and display, with no mention of AI/ML capabilities or related performance metrics.
No.
The device is a PACS product that transmits, receives, displays, and stores medical images for clinical evaluation and diagnosis; it does not provide any therapeutic function.
Yes
Explanation: The device is a PACS product that displays medical images for "clinical evaluation and diagnosis," and its user interface is explicitly for "processing of medical images for primary image diagnosis." This indicates its role in a diagnostic workflow where medical professionals use the displayed images to make diagnoses.
No
While the device is described as "software based," the description explicitly states that the manufacturer "provides and installs off the shelf hardware including a hospital and central server" to support the software's functionality. This indicates the device includes hardware components provided by the manufacturer, not just software running on user-provided hardware.
Based on the provided text, 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.
- StatPacs™ function: The description clearly states that StatPacs™ is a software-based PACS product that transmits, receives, displays, and stores medical images (CT, MRI, Ultrasound, etc.) for clinical evaluation and diagnosis. It operates on specified off-the-shelf hardware and interfaces with imaging modalities.
- No mention of biological samples: There is no indication that StatPacs™ interacts with or analyzes biological samples from patients. Its function is solely related to the management and display of medical images.
Therefore, StatPacs™ falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StatPacs™ is a software based PACS product, intended to be used by radiologists technologists and clinicians, to operate on specified off the shelf hardware (OTS) that will provide teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.
Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The StatPacs™ is a software based PACS product, intended to be used by radiologists technologists and clinicians, to operate on specified off the shelf hardware (OTS) that will provide teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.
Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists technologists and clinicians / hospitals/clinics and remote site use
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)
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.
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
SEP 1 5 2009
510k Summary of Safety & Effectiveness
K092134
P. 1 of 2
This summary of 510k Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | (updated 8/04/09) |
|---|---|
| Submitter/Mfg: | StatRad, LLC |
| Company Contact: | Joe Moock, CEO |
| Preparer/510k Contact: | Linda J. Moore, Regulatory Consultant, 408-504-0565 lindajm@aol.com |
| Device Name | |
| Common/usual name: | |
| Proprietary Name: | Picture Archiving & Communications System (PACS) |
| Medical Imaging Processing/Teleradiology System | |
| StatPacs™ | |
| Predicate device(s): | Virtual Radiologic Corporation |
| 11995 Singletree Lane | |
| Minneapolis, MN 55344 vRad PACS K090649 | |
| Mercury Computer Systems Inc. | |
| 199 Riverneck Rd. | |
| Chelmsford, MA 01824-2820 VISAGE PACS/CS K062490 | |
| VISAGE IMAGING, INC | |
| 1815 ASTON AVENUE, SUITE 107 | |
| CARLSBAD, CALIFORNIA, 92008 VISAGE PACS/CS K082269 |
Description/Intended use:
The StatPacs™ is a software based PACS product, intended to be used by radiologists technologists and clinicians, to operate on specified off the shelf hardware (OTS) that will provide teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.
Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.
1
Technical Characteristics:
This is a medical imaging software device that is used with OTS computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. The technical characteristics are similar in design, technical requirements and intended use to predicate devices.
Substantial Equivalence Summary
The StatPacs™ is substantially equivalent in design, technical requirements, and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. The predicate device comparison clearly demonstrates that StatPacs™ is substantially equivalent in all areas such as functionality, user/software features, OTS hardware components and connectivity.
Conclusions:
Based on the information provided in this premarket notification submission, StatPacs™ is substantially equivalent to predicate devices and raises no new issues of safety or effectiveness from its predicate devices.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP 15 2009
StatRad LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K092134
Trade/Device Name: StatPacs™ Picture Archiving and Communications Systems (PACS) Software Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system
Regulatory Class: II
Product Code: LLZ
Dated: September 1, 2009
Received: September 2, 2009
Dear Mr. Job:
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 mav 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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.html
Sincerely yours,
Lucia M. Merritt
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510k # K 09 21 34
Device Name:
StatPacs™ Picture Archiving and Communications Systems (PACS) Software
Indications for Use
The StatPacs™ is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM allowing StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatView™ with the Exam Manager™ application, is a primary user interface for processing of medical images for primary image diagnosis. Image compression and encryption adhere to standard industry protocol. StatPacs™, is not to be used for mammography imaging.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence or CDRH, Office of Device Evaluation (ODE)
lankh
Dimiti Voikore
(Division Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
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