(43 days)
The AS-OBGYN Information System is intended to automate the management of patient information. The system allows image acquisition, review, document, storage, archive and reporting.
The AS-OBGYN Information System is intended for use by obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.
The AS-OBGYN Information System consists of robust and comprehensive patient information. The system allows the management of patient clinical data and image management (communication, review, storage and archiving). The system provides the capability to edit patient information and clinical data as well as the generation of electronic and printed reports. The device is available in a variety of configurations depending on specific requirements.
The AS-OBGYN Information System communicates with DICOM modalities devices. In the case of DICOM sessions the communication is handled through the AS-DICOM Server package (for TCP/IP connections). For non-DICOM sessions, the communication is handled through the AS-COMM package (for TCP/IP, RS-232 and USB connections). The AS-OBGYN Information System receives single and multi-frame images from devices over the network using the DICOM communication, while additional descriptive data may be received through DICOM session or non-DICOM sessions.
All the hardware used by AS-OBGYN Information System (including computers, storage drives, network interface, monitor and printer) is commercial off-the-shelf equipment.
The provided text is a 510(k) summary for the AS-OBGYN Information System. It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input.
This 510(k) summary focuses on demonstrating substantial equivalence to existing devices, which is a common pathway for medical device clearance, especially for information systems. It doesn't typically require extensive clinical performance studies in the same way a novel diagnostic or therapeutic device might. The "performance" in this context is likely related to its functionality as an information system (e.g., ability to acquire, review, store, and report data), which would be assessed through software verification and validation, rather than clinical efficacy or accuracy metrics against a ground truth.
{0}------------------------------------------------
Kos 1639
AUG 2 - 2005
510(k) Summary
AS Software Inc. AS-OBGYN Information System
The below summary is provided as part of this abbreviated Premarket Notification 110(k) in compliance with 21CFR807.92 Content and format of a 510(k) summary.
Name of Submitter:
AS Software, Inc. 80 South Woodland St. Englewood, NJ 07631 (201) 541-1900 (201) 541-1199 Fax
Contact Person:
Kim A. Nathanson, Chief Operating Officer
Date of Summary:
June, 14 2005
Device Name:
AS-OBGYN Information System
Other Device Proprietary Name:
AS-EMR System
Common or Usual Names:
Common Name: Image Acquisition, Review and Reporting System Classification name: Picture Archiving and Communications System
Substantial Equivalence:
| Manufacturer | Device Name | 510(k) Number | Clearance Date |
|---|---|---|---|
| Digisonics, Inc. | OB-View (DoctorsReview System) | K970402 | Mar. 26 1997 |
| R4 TelemedicineSystems' Inc. | R4's Remote FetalMedicine UltrasoundSystem | K000443 | Apr. 24 2000 |
| Vision Chips, Inc. | Observer UltrasoundReporting and ImagingSystem | K022877 | Feb. 5 2003 |
{1}------------------------------------------------
Device Description:
The AS-OBGYN Information System consists of robust and comprehensive patient information. The system allows the management of patient clinical data and image management (communication, review, storage and archiving). The system provides the capability to edit patient information and clinical data as well as the generation of electronic and printed reports. The device is available in a variety of configurations depending on specific requirements.
The AS-OBGYN Information System communicates with DICOM modalities devices. In the case of DICOM sessions the communication is handled through the AS-DICOM Server package (for TCP/IP connections). For non-DICOM sessions, the communication is handled through the AS-COMM package (for TCP/IP, RS-232 and USB connections). The AS-OBGYN Information System receives single and multi-frame images from devices over the network using the DICOM communication, while additional descriptive data may be received through DICOM session or non-DICOM sessions.
All the hardware used by AS-OBGYN Information System (including computers, storage drives, network interface, monitor and printer) is commercial off-the-shelf equipment.
Intended Use:
The AS-OBGYN Information System is intended to automate the management of patient information. The system allows image acquisition, review, document, storage, archive and reporting.
User Characteristics:
The AS-OBGYN Information System is intended for use by obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.
{2}------------------------------------------------
Comparison to Predicate Devices:
The AS-OBGYN Information System is substantially equivalent to the following legally marketed devices:
- Digisonics, Inc., OB-View (Doctors Review System) .
- R4 Telemedicine Systems, Inc., R4's Remote Fetal Medicine Ultrasound . System
- Vision Chips, Inc., Observer Ultrasound Reporting and Imaging System .
Like all of the above devices, the AS-OBGYN Information System allows for the management of patient information, examination data and medical images. All these devices as well as the AS-OBGYN Information System run on Microsoft operating systems.
The R4's Remote Fetal Medicine Ultrasound System also allows for a ● telemedicine sessions which the AS-OBGYN Information System does not.
The R4's and Digisonics devices also exercise framegrabber digitizers, . which the AS-OBGYN Information System does not.
Like the R4's and the Vision Chips's Observer, the AS-OBGYN . Information System includes calculations to convert fetal measurements to gestational ages.
The main difference and advantage of the AS-OBGYN Information . System over the other abovementioned devices is its powerful user interface and ease of operation.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized eagle emblem. The eagle is depicted with three wavy lines forming its body and wings, giving it a modern and abstract appearance. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim A. Nathanson Chief Operations Officer AS Software, Inc. 80 South Woodland Street ENGLEWOOD NJ 07631 Re: K051639 Trade/Device Name: AS-OBGYN Information System Regulation Number: 21 CFR 892. 2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ
Dated: June 14, 2005 Received: June 20, 2005
Dear Ms. Nathanson:
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 reguirements 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 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.
AUG 2 - 2005
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k)
The Baying The Callery Collection of selection and source of your device to Jega This letter will allow you to begin maketing of substantial equivalence of your device to a legally premarket notification. The FDA midnig of Sacsantial office and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Park 801), please If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Fridoriana on your responsibilities under the Act from the 807.97). You may obtain other general mornation on your of your of its toll-free number (800) Division of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
165 1639
Indications for Use Statement
Device Name:
AS-OBGYN Information System
Indications for Use:
$\vec{z}*1 = \vec{z}*2$
The AS-OBGYN Information System is intended to automate the management The AS-OBOTTY Information. The system allows image acquisition, review, document, storage, archive and reporting.
The AS-OBGYN Information System is intended for use by obstetricians, The AS-OD I N imoniation Ordiologists and cardiologists. The system is designed for use in hospitals and medical offices.
Prescription Use
Nancy C. Brogdon
(Division Sianion of Reproductive, Abdominal,
§ 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).