(159 days)
Not Found
No
The description focuses on data entry, storage, retrieval, and basic research functions using standard hardware and software. There is no mention of AI, ML, or advanced image processing that would typically indicate such technology.
No.
The device is described as an ultrasound reporting and imaging system intended to automate and enhance the process of entering ultrasound examination information and storing/reviewing images. Its primary function is data management and visualization, not directly treating a disease or condition.
No
This device is described as an "Ultrasound Reporting and Imaging System" that automatizes and enhances the process of entering ultrasound examination information and storing/reviewing ultrasound images. It also enables report generation and research, utilizing standard images received from ultrasound machines. Its function is to manage and present data from diagnostic exams, not to perform the diagnostic exam itself.
No
The device description explicitly states that "All hardware required for the system, including computers, storage devices, monitors and frame grabbers, consists of standard, off the shelf components." While these are off-the-shelf, they are still hardware components that are part of the system, making it not solely software.
Based on the provided information, the OBserver Ultrasound Reporting and Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for automating and enhancing the process of entering ultrasound examination information, storing and reviewing ultrasound images, and providing research data. It focuses on managing and presenting data generated by an ultrasound machine.
- Device Description: The description reinforces this by detailing its function as reporting and image archiving software. It receives data and images from an ultrasound machine and allows for viewing and reporting.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The OBserver system does not perform any analysis on biological specimens. It processes and manages data from an in vivo imaging modality (ultrasound).
In summary, the OBserver system is a medical image management and reporting system that supports the use of ultrasound, which is an in vivo diagnostic imaging modality. It does not perform in vitro diagnostic tests itself.
N/A
Intended Use / Indications for Use
OBserver Ultrasound Reporting and Imaging System is intended to automate and enhance the process by which ultrasound examination information is entered and by which ultrasound images are stored and reviewed by physicians in the field of maternal-fetal medicine. The system also provides significant research data for academic institutions.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The Vision Chips ultrasound reporting and imaging system consists of comprehensive reporting and image archiving software for use in the field of obstetrics and gynecology. It enables physicians to generate reports documenting the results of ultrasound exams and to view the images that were captured during those exams. The system also enables physicians to perform research on all data that have been entered into the program.
Ultrasound machines may transfer ASCII text based information to the system by means of a serial interface. Ultrasound images are received either by means of a standard frame grabber connected to the ultrasound video output or directly across the network using DICOM protocols. Still images are stored as standard jpegs or in DICOM format, cine loops are stored as mpegs, AVIs or in multi frame DICOM format.
All hardware required for the system, including computers, storage devices, monitors and frame grabbers, consists of standard, off the shelf components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
perinatologists, obstetricians, gynecologists, radiologists and ultrasound technicians
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
510(k) Summary K022877
Vision Chips, Inc. OBserver™ OB/GYN Ultrasound Reporting and Imaging System
Name of Submitter:
Vision Chips, Inc. 27111 Aliso Creek Road, Suite 120 Aliso Viejo, CA 92656 (949) 362-0565 (949) 362-0591 Fax
Contact Person:
Ronald "Jock" Philip, President
Date of Summary:
August 29, 2002/Revised 11/25/02
Device and Common Names:
Name of Device: OBserver OB/GYN Ultrasound Reporting, Information & Imaging System Common Name: Image Acquisition, Review and Reporting System Classification Name: Picture Archiving and Communications System
Device Description:
General Description
The Vision Chips ultrasound reporting and imaging system consists of comprehensive reporting and image archiving software for use in the field of obstetrics and gynecology. It enables physicians to generate reports documenting the results of ultrasound exams and to view the images that were captured during those exams. The system also enables physicians to perform research on all data that have been entered into the program.
Ultrasound machines may transfer ASCII text based information to the system by means of a serial interface. Ultrasound images are received either by means of a standard frame grabber connected to the ultrasound video output or directly across the network using DICOM protocols. Still images are stored as standard jpegs or in DICOM format, cine loops are stored as mpegs, AVIs or in multi frame DICOM format.
All hardware required for the system, including computers, storage devices, monitors and frame grabbers, consists of standard, off the shelf components.
Indications for Use
OBserver Ultrasound Reporting and Imaging System is intended to automate and enhance the process by which ultrasound examination information is entered and by which ultrasound images are stored and reviewed by physicians in the field of maternal-fetal medicine. The system also provides significant research data for academic institutions.
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User Characteristics
OBserver is a comprehensive Ob/Gyn Ultrasound and Antepartum surveillance(NST, CST, BPP & AFI) information reporting system. It allows perinatologists, obstetricians, gynecologists, radiologists and ultrasound technicians to capture examination data and images from ultrasound machines and to generate electronic and printed medical reports from them.
Substantial Equivalence:
OBserver Ultrasound Reporting and Imaging System is substantially equivalent to the following legally-marketed devices:
1) ALI Ultras PACS and comPACS (K963610)
OBserver Ultrasound Reporting & Imaging System, like R4's Remote Fetal
Medicine Ultrasound System, Digisonics' OB-View, and ALL's includes review and reporting capabilities, ob/gyn calculations, and digital imaging. Vision Chips' OBserver, like R4's Fetal Ultrasound Reporting and ALI's comPACS, performs ob/gyn reporting and includes calculations to convert fetal measurements to gestational ages. They all have the ability to review ultrasound images captured during the course of the examination. The ultrasound images are captured and converted to digital format with the use of a frame grabber. They are saved as JPEG files on standard computer storage media. The Vision Chips and ALI systems will also accept images and other data that have been transmitted across a network in DICOM format. All of the systems run on Microsoft operating systems although the text reporting section of Vision Chips' system will also run on Macintosh operating systems.
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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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three parallel lines forming its body and wings, suggesting movement or flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2003
Mr. Ronald Philip President Vision Chips, Inc. 27111 Aliso Creek Road #120 VIEJO CA 92656
Re: K022877
Trade/Device Name: Observer Ultrasound Reporting and Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 26, 2002 Received: November 26, 2002
Dear Mr. Philip:
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. Iisting 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 (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,
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This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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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Page 1 of 1
510(k) Number (if known): K 0 2 2 8 77 Device Name: ORS Ultrasound Indications For Use:
OBserver Ultrasound Reporting and Imaging System is intended to automate and enhance the process by which ultrasound examination is entered and reported and by which ultrasound images are stored and reviewed by physicians in the field of maternal-fetal medicine. The system also provides significant research data for academic institutions.
David M. Seaman
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)