The APAX™ PACS is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

Device Description

The APAX™ PACS system is a general purpose software designed for acquisition/ capture/ view/ archival and transmission of medical images. This device allows easy capturing, selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems such as MRI, CT, CR, etc., and of non-DICOM images from Ultrasound (by capturing) and X-ray Film (by scanning). When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis. The PACS system

AI/ML Overview

The provided 510(k) summary for the APAX™ PACS System (K032760) is primarily focused on demonstrating substantial equivalence to a predicate device based on its intended use and general performance characteristics. It does not present specific acceptance criteria in the form of performance metrics nor does it detail a study proving the device meets such criteria.

The submission is for a Picture Archiving and Communication System (PACS), which is a general-purpose medical image management, communication, storage, archiving, and review system. For such devices, the FDA typically assesses functionality, data integrity, compatibility with DICOM standards, and overall safety and effectiveness for its intended use, rather than specific diagnostic accuracy metrics.

Here's an breakdown of the requested information based on the provided text, highlighting what is not available:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the submission. The submission describes the general functions of the APAX™ PACS, such as acquisition, capture, view, archival, and transmission of medical images, and its ability to handle multi-modality DICOM and non-DICOM images. It states, "When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis." However, no specific performance metrics (e.g., image loading speed, archival success rate, accuracy of image processing algorithms if any were specifically highlighted for diagnostic impact) are mentioned as acceptance criteria or reported as device performance.
Sample Size Used for the Test Set and Data Provenance: This information is not provided. As no specific performance study is detailed, there's no mention of a test set, its size, or the origin of any data that might have been used for testing.
Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. Since there's no diagnostic accuracy study, there's no mention of experts establishing ground truth.
Adjudication Method for the Test Set: This information is not provided.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study was not mentioned or conducted. The submission does not discuss AI assistance or human-in-the-loop performance. The device is described as a system for managing and reviewing images, with diagnosis being performed by a trained physician.
Standalone Performance Study (Algorithm only without human-in-the-loop performance): This information is not provided. The device is a PACS, not an AI or algorithm-based diagnostic tool that would typically have standalone performance metrics. Its function is to facilitate image review by human professionals.
Type of Ground Truth Used: This information is not provided.
Sample Size for the Training Set: This information is not provided. As no specific AI or machine learning algorithm requiring a training set is highlighted or evaluated, this information is not relevant to the submission's content.
How the Ground Truth for the Training Set was Established: This information is not provided.

Summary of Device Capabilities (from text):

Functions: Acquisition/capture/view/archival and transmission of medical images.
Image Modalities: Multi-modality DICOM images (MRI, CT, CR, etc.) and non-DICOM images (Ultrasound by capturing, X-ray Film by scanning).
Users: Authorized staff, including physicians, nurses, and technicians.
Purpose: Medical image management, communications, storage, archiving, and review.
Diagnosis: Filmed images, when interpreted by a trained physician, may be used as a basis for a diagnosis.

Conclusion based on the provided text:

The 510(k) submission for the APAX™ PACS System focuses on demonstrating substantial equivalence to a predicate device (Mediface Co., Ltd. Mediface PACS™ System K010259) primarily based on its intended use and functional capabilities as a general-purpose medical image management system. It does not contain information about specific performance acceptance criteria or a study detailing the device reaching those criteria, as typically seen for devices with explicit diagnostic claims or AI components. The FDA's letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Summary

{0}------------------------------------------------

K032760

SEP 1 7 2003

000024

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Company and Correspondent making the submission:

Name - TIS, Inc.. Address - Suite 602, KWTC, 159-1, Samsung-Dong, Kangnam-Ku, Seoul, 135-729, Korea Telephone — +82-2-6000-8869 – +82-2-6000-8868 Fax – Mr. Sung Ho Byun Contact Internet – http://www.tis21.com

2. Device :

Proprietary Name - - APAX™ - Picture archiving and communication system Common Name Classification Name - Picture archiving and communication system

3. Predicate Device :

Mediface Co., Ltd. Mediface PACS™ System K010259

4. Classifications Names & Citations :

21CFR 820.2050, LLZ, Picture archiving and communication system, Class2 Guidance document for the preparation of premarket notifications [510(k)'s].

1. Description :
  The APAX™ PACS system is a general purpose software designed for acquisition/ capture/ view/ archival and transmission of medical images. This device allows easy capturing, selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems such as MRI, CT, CR, etc., and of non-DICOM images from Ultrasound (by capturing) and X-ray Film (by scanning). When interpreted by a trained

{1}------------------------------------------------

000025

physician, filmed images may be used as a basis for a diagnosis. The PACS system

1. Indication for use :
  The APAX™ PACS is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.
1. Comparison with predicate device :
  TIS, Inc., believes that the APAX™ PACS System is substantially equivalent to the Mediface PACS™ System.
1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification TIS, Inc.. concludes that APAX™ is safe and effective and substantially equivalent to predicate devices as described herein.
1. TIS, Inc.. will update and include in this summary any other information deemed seasonably necessary by the FDA.

END

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, composed of three curved lines that represent the bird's body and wings. The bird is oriented to the right. To the left of the bird, there is a semi-circular arrangement of small dots, which may represent a globe or a partial border. The overall design is simple and abstract.

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 1 7 2003

TIS, Inc. % Mr. Marc M. Mouser Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

Re: K032760

Trade/Device Name: APAX™ PACS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: July 25, 2003 Received: September 5, 2003

Dear Mr. Mouser:

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 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.

{3}------------------------------------------------

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

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): Ko 3 2760

Device Name: APAX™PACS System

Indications for Use:

The Device is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

David R. Leggrm

, i

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number __

(Optional Format 3-10-98)

Regulation Number and Section

§ 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).