K Number
K051639
Device Name
AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM
Manufacturer
Date Cleared
2005-08-02

(43 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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. 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.
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.
More Information

Not Found

No
The summary describes a system for managing patient information and images, focusing on data handling, communication protocols (DICOM, non-DICOM), and reporting. There is no mention of AI, ML, or any advanced analytical capabilities that would typically involve these technologies. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

No.
The device is an information system for managing patient data and images, not for directly treating or diagnosing medical conditions.

No.
The AS-OBGYN Information System is described as a system for managing patient information, including image acquisition, review, document, storage, archive, and reporting, rather than diagnosing conditions. Its primary function is to automate the management and processing of existing patient and image data from other DICOM modalities.

Yes

The device is described as a "System" that manages patient information and images, communicating with modalities. While it utilizes commercial off-the-shelf hardware, the core functionality and medical device aspects appear to reside solely in the software components for data management, communication, and reporting. The description focuses on software packages (AS-DICOM Server, AS-COMM) and their functions.

Based on the provided information, the AS-OBGYN Information System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
  • Intended Use of AS-OBGYN Information System: The intended use of the AS-OBGYN Information System is to "automate the management of patient information." It focuses on image acquisition, review, documentation, storage, archiving, and reporting of patient data, primarily from DICOM modalities.
  • Lack of Specimen Examination: The system does not perform any examination of biological specimens (blood, tissue, urine, etc.) in vitro. Its function is to manage and process data and images obtained from other medical devices.

The AS-OBGYN Information System is a medical information management system designed to handle and organize patient data and images, which is distinct from the function of an IVD device that analyzes biological samples.

N/A

Intended Use / Indications for 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. 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.

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.

K970402, K000443, K022877

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

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:

ManufacturerDevice Name510(k) NumberClearance Date
Digisonics, Inc.OB-View (Doctors
Review System)K970402Mar. 26 1997
R4 Telemedicine
Systems' Inc.R4's Remote Fetal
Medicine Ultrasound
SystemK000443Apr. 24 2000
Vision Chips, Inc.Observer Ultrasound
Reporting and Imaging
SystemK022877Feb. 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
Other240-276-0100

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:

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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,