Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.

Device Description

The Hipax Medical Imaging Software is an autonomous software with the exception of a dongle for copy protection. It is running under Microsoft Windows 2000/XP operating system. The Hipax Medical Imaging Software has an open system architecture consisting of a basic module and modules for the research and the image acquisition, storage and communication to be added as an option. The functions of the Hipax Medical Imaging Software correspond to the features described for the Predicate Devices. Displaying any medical image, for example, from CT, MRI, CR, US, endoscopy, gastroscopy, and other medical specialists (e.g. window leveling, ROIs, edge enhancement, scaling, cine-loop, measurement, writing and marking, Child-Pugh score, histogram etc.). Multiplanar Reconstruction is available as an option. Like the Predicate Devices, the Radworks Medical Imaging Software or the eFilm Workstation, the Hipax Medical Imaging Software offers modules for image acquisition from video sources (Video Module), digitizers (X-ray Digitizing Module), or CR systems (CR-Connection Module). Within a network DICOM worklists can be received and images can be sent and received using the DICOM protocol. Image exchange between two remote Hipax workstations or other Hipax programs via phone lines, broadband, satellite, etc. can be carried out using the Hipax DICOM Communication Software. The DICOM Email module, which is also part of the Radworks Modules, is available to transmit images as Emails. Images can be compressed and encrypted. The DICOM Print Module supports DICOM 3.0 primary. Using the Patient CD Module, images can be written on CD to be handed out to patients on digital media, e.g. DVD. To burn CDs or DVDs automatically, a CD/DVD robot can be connected.

AI/ML Overview

This 510(k) submission (K052411) for the Hipax Medical Imaging Software does not contain a study that proves the device meets specific acceptance criteria.

Instead, this submission is a Premarket Notification (510k) Summary which aims to demonstrate substantial equivalence to existing, legally marketed predicate devices rather than proving a device meets predefined acceptance criteria through a specific performance study.

Therefore, many of the requested sections below cannot be fully populated as there is no performance study detailed in this document.

Here's the breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not describe specific acceptance criteria or report performance metrics from a formal study. It primarily focuses on comparing the Hipax software's functions and technological characteristics to its predicate devices to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided. There is no mention of a test set, sample size, or data provenance in the context of a performance study. The document mentions "Testing is an integral part of the software development process of Steinhart Medizinsysteme GmbH (see documents in G 2 and G 4)," but details of this testing are not included in the provided summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. Since no specific test set or ground truth establishment is described, details about experts cannot be extracted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided. No adjudication method is mentioned as there is no described test set with ground truth establishment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The Hipax Medical Imaging Software is a Picture Archiving Communications System (PACS) component used for processing and displaying medical images, not an AI-powered diagnostic tool. The document does not describe any AI component or human-in-the-loop performance study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable in the context of a diagnostic algorithm. The device is "autonomous software" for image management and display. While it performs functions independently, it is not a standalone diagnostic algorithm in the way that would typically be evaluated for performance metrics like sensitivity or specificity. Its "performance" is about its functional capabilities matching the predicate devices (e.g., displaying images, performing measurements).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided. No ground truth is described as no performance study is detailed.

8. The sample size for the training set

Cannot be provided. No training set is mentioned, as the device is not described as involving machine learning or AI models that require specific training data.

9. How the ground truth for the training set was established

Cannot be provided. No training set or associated ground truth establishment is mentioned.

Summary of Device and its Basis for Substantial Equivalence:

The Hipax Medical Imaging Software is a Picture Archiving Communication System (PACS). Its submission for 510(k) clearance relies on demonstrating substantial equivalence to two predicate devices: Radworks Medical Imaging Software (K962699) and eFilm Workstation (K012211).

The core argument for substantial equivalence is based on the device having:

Same indications for use: Medical image processing and communication.
Same target population: Trained medical professionals (radiologists, orthopedists, clinicians, technologists, etc.).
Same technological characteristics: Autonomous software for displaying and managing medical images, offering features like window leveling, ROIs, measurements, MPR, etc., similar to the predicate devices.
Compliance with general controls: The FDA letter confirms the device can be marketed under the general controls provisions of the Act.

The document states, "The Hipax Medical Imaging Software is tested according to the specifications that are documented in an own description (Description of the software test procedures) and the corresponding Softwaretest forms. Testing is an integral part of the software development process of Steinhart Medizinsysteme GmbH (see documents in G 2 and G 4)." However, the specifics of these tests, including acceptance criteria and detailed results, are not part of the provided 510(k) Summary. Their purpose would likely be to confirm functional requirements and safety rather than clinical performance against specific metrics.

Summary

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Kc52411

SEP 2 1 2005

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Steinhart Medizinsysteme GmbH

510(k) Summary

Summary of functions of the device and its major components provided as part of the Device Summary of functions of the device and its major componing to the Guidance for the Submission of Description for Thir 70 : Modical Image Management Devices, 2000.

Date:	July 27th 2005
Company Name:	Steinhart Medizinsysteme GmbH
Address:	Grubstrasse 6-8D-79279 VoerstettenGermany
Contact Person:	Martina Steinhart
E-Mail:	sales@hipax.de
Phone:	+49-(0)-7666-90070
Fax:	+49-(0)-7666-900711
Device Trade Name:	HIPAX Medical Imaging Software
Device Common Name:	Picture Archiving Communications System (PACS
Product Code:	LLZ
Regulation No.	892.2050
Device Classification:	Class II
Predicate Devices:	Radworks Medical Imaging Software (K962699)eFilm Workstation (K012211)

Device Description

The Hipax Medical Imaging Software is an autonomous software with The Hipax Medical Imaging Soltware is an autonomicas oringer Microsoft Windows 2000/XP
the exception of a dongle for copy protection. It is running under requirements and the exception of a dongle for oopy protocion. It is ranimaly inimum system requirements and supporting the Windows 2000/XP operating system.

The Hipax Medical Imaging Software has an open system architecture consisting of a basic The Hipax Medical miaging Ooltware his an open of the research and the mage acquisition, storage and communication to be added as an option.

The functions of the Hipax Medical Imaging Software correspond to the features described for the The functions of the Hipax Medical image, for example, from CT, MRI, CR, US, Predicate Devices. Displaying any medical Imaging Software offers features endoscopy, gastroscopy, and other medical specialists (e.g. window leveling, ROIs, edge routinely used by Tadiologists and other modifal op Scalless, cine-loop, measurement, writing and marking, Childrioument, 2001Itiplanar Reconstruction is available as an option.

histogram etc.). Multipland Reconstruction is division as an Sparare or the eFilm Workstation, the Like the Predicale Devices, the Rudions Moulan mage acquisition from video sources (Video Hipax Medical Innaging Soltware onero for Intege beep.
Module) digitizers (X-ray Digitizing Module), or CR systems (CR-Connection Module), Within a Module) digitzels (X-ray Digitzing Modic, of UN costs and received using the DICOM
network DICOM worklists can be received and images can be sent and liney programs was nework DICOM worklists can be recorved and inisges who inistations or other Hipax programs via protocol. Image exchange between two remote hipax of using the Hipax DICOM Communication phone lines, broadband, salente, cle. can be carrou out as oftware. The DICOM Email module, which is a modile, which is also part of the Nadworks Modes can be compressed and encrypted. The DICOM
is available to transmit images as Emails. Images can be images an he virithe is available to transmit mages as Emails: images can be written in the written Print Module supports DICOM 3.0 primary. Osing the Patient Station of Children on CD to be handed out to

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510(k) Summary

on digital media, e.g. DVD. To burn CDs or DVDs automatically, a CD/DVD robot can be connected.

Intended Use

The Hipax Medical Imaging Software is intended to be used for medical image processing and communication. Medical Images (single images, series or sequences) and corresponding patient data can be received from various sources, e.g. from CR, CT, MRI, US, R/F units, secondary capture devices as scanners, video sources, etc. Images can be administrated, displayed, transmitted and stored on the local disk of a workstation as well as on distributed locations across a network, or on optical or digital media, e.g. CD or DVD. Lossy compressed mammographic mages and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using the Hipax Medical Imaging Software are, for example, but not limited to, adjustment of window leveling, defining region of interest, image stacking, MPR, rotation, zoom, measurements. The Hipax Medical Imaging Software can be integrated into a patient administration system.

Users of the Hipax Medical Imaging Software are typically trained medical professionals, for example, radiologists, orthopedists, clinicians, technologists, and others.

Technological Characteristics

The Hipax Medical Imaging Software is a stand-alone software, like the Predicate Devices. It can be used on more than one hardware platform. As long as minimum hardware requirements are met, the user is free to choose his/her own hardware platform.

The Hipax Medical Imaging Software as well as the Predicate Devices allow digital image processing and measurement capability.

The Hipax Medical Imaging Software nor contacts the patient, neither controls any life-sustaining devices. Physicians providing the adequate expert knowledge for competent human intervention interpret images and information being displayed and/or printed.

Testing

The Hipax Medical Imaging Software is tested according to the specifications that are documented in an own description (Description of the software test procedures) and the corresponding Softwaretest forms. Testing is an integral part of the software development process of Steinhart Medizinsysteme GmbH (see documents in G 2 and G 4).

Conclusion

The Hipax Medical Imaging Software is a medical device. It has the same indications for use and target population as the legally marketed Predicate Devices.

The Hipax Medical Imaging Software has the same technological characteristics as the Predicate Devices.

This premarket notification describes the characteristics of the Hipax Medical Imaging Software in sufficient detail to assure substantial equivalence.

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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Steinhart Medizinsysteme GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 · Re: K052411 Trade/Device Name: Hipax Medical Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2005 Received: August 29, 2005

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w ove 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 the chercours) to e enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1770, and characteriting 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 do not require upproval or a 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 (Premarket If your de riot is onestilia (200 as 10) additional controls. Existing major regulations affecting your Apple rally it after 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 I tease or as not is a determination that your device complies with other requirements of the Act or any I Drinas made 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)
Continued and consequence The PDA finding of substantial courvalence of your dev This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FD finding of substantial equivalence of your premarket notification. The FDA finding of substantial equivalence of your device to angle your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling regulation (1) - 11 Feb 2017)
contact the Office of Compliance at one of the following numbers, based on the reg 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 information on your responsibilities under the Act from the 807.97). You may obtain other general information on your responsible in the more
Division of Small Manufacturers, International and Consumer Assistance at its toll-free num Division of Small Manafastar at its Internet address. 036-2041 of (501) of (501) 11301) or vindex.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Nancy of Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Office of Devices and Radiological Health

Enclosure

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Indications for Use

Kosta di li 510(k) Number (if known):

Hipax Medical Imaging Software

Indications for Use:

Device Name:

. . .
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Users of the Hipax Medical Imaging Software are typically trained medical professionals, for example, radiologists, orthopedists, clinicians, technologists, and others.

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Syverson

Page 1 of 1

(Division Sign-Off) #
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052411

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).