The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning (excluding screening and primary diagnosis of mammography images).

Therefore CHILI PACS supports the following generic imaging workflow:

Receive scheduled exams from IS at the CHILI PACS archiving component CHILI . Server
Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces
Receive and store new exams from the Modalities at the CHILI Server
· Prepare images for reading
Report new images, if required by comparing them with prior exams and reports
· Demonstrate exams at Radiological Demos
View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).

Note: The workstation deployment CHILI 3D-Plugln is not intended for primary diagnosis.

Device Description

CHILI PACS is a "software only" - solution. It is a modular system, consisting of modules which can be combined for the specific needs of a customer, including a backend communication and storage component and different workplace deployments for medical imaging tasks and applications.

CHILI PACS is the integrated radiology suite for radiological practices and community hospitals. Important factors are the centralized server structure, the wide-ranging data distribution and the overall integrated concept, ranging from reporting and archiving as well as image and report distribution.

The three CHILI PACS workplace deployments

a) CHILI Web for image distribution (web-based viewing application suited for primary diagnosis)
b) CHILI Workstation for reporting, inside as well as outside of the radiology (standalone workstation or client workstation connected to server)
c) CHILI 3D-Plugln (optional) for 3D- and 4D reconstructions of image slices generated by digital modalities and stored in the DICOM format (not intended for primary diagnosis)

are medical diagnostic and viewing workstations intended for manipulating, reading, reporting, viewing and communicating / distributing of radiological softcopy images and so allows radiologists, radiological technicians and health care professionals to receive and process all data needed.

Data Management: CHILI Server.
Ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy.

The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports.

Integration: CHILI Workflow Integration.
The Workflow Management enables by integration of any HL7- / DICOM-compatible HIS, RIS (IHE Year 5) and other information systems to the CHILI PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.

AI/ML Overview

The medical device being described is "CHILI PACS," a Picture Archiving and Communication System (PACS). This submission does not include a study or acceptance criteria related to device performance in diagnosing or treating conditions, as it is a PACS system primarily focused on image management, display, and distribution, rather than diagnostic AI capabilities.

The primary objective of this 510(k) submission (K070796) is to establish substantial equivalence to an existing legally marketed device (syngo Imaging Version V20A K052461), implying that the new device meets the same safety and effectiveness standards without introducing new risks. Therefore, the "acceptance criteria" here relate more to regulatory compliance and equivalence to the predicate device, rather than specific performance metrics for a diagnostic algorithm.

Here's the breakdown based on the provided text, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a PACS system designed for image management and viewing, rather than a diagnostic AI, there are no specific performance metrics like sensitivity, specificity, or AUC provided in the submission for a diagnostic task. The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and adhering to general safety and effectiveness standards.

Acceptance Criterion (Implicit for PACS)	Reported Device Performance (Implied by Substantial Equivalence)
Functional Equivalence	CHILI PACS performs functions similar to predicate device (image display, processing, reading, reporting, communication, distribution, storage, archiving).
Technical Characteristics Equivalence	CHILI PACS has similar technical characteristics to predicate device (software-only, supports DICOM, client/server architecture).
Safety - No new potential safety risks introduced	Risk analysis conducted, hazards controlled via software development, verification, and validation testing. Adherence to recognized industry practices and standards.
Effectiveness - Safe and effective use provided by labeling	Device labeling contains instructions for use, cautions, and warnings.
Compliance with Regulatory Standards	Adheres to guidance documents for medical image management devices and software, and off-the-shelf software use.
Intended Use Equivalence	Intended use is consistent with the predicate device for enhancing imaging workflow and assisting physicians in diagnosis/treatment planning (excluding mammography primary diagnosis/screening).

2. Sample Size Used for the Test Set and Data Provenance

This submission does not describe a clinical performance study using a "test set" in the context of diagnostic accuracy. The testing mentioned refers to "verification and validation testing" which is standard software quality assurance, not device performance testing on patient data for diagnostic accuracy.

Sample Size for Test Set: Not applicable in the context of a diagnostic performance study.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no diagnostic performance study on a test set with expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable, as no diagnostic performance study on a test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate PACS system for image management and viewing, not on the comparative diagnostic performance of human readers with or without AI assistance.

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

No, a standalone performance study in the context of a diagnostic algorithm was not done. CHILI PACS is a "software only" solution for image management and viewing, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

Not applicable, as no diagnostic performance study requiring clinical ground truth (like pathology, expert consensus, or outcomes data) is described. The device is a PACS system for managing medical images.

8. The Sample Size for the Training Set

Not applicable. CHILI PACS is an image viewing and management system and does not mention any machine learning or AI components that would require a "training set" for diagnostic algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a diagnostic algorithm is described.

Summary

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K070796

3 510(k) Summary

APR - 6 2007

3.1 Owner Information

Owner's Name:	CHILI GmbH
Owner's Address:	Burgstrasse 61D-69121 Heidelberg, GermanyPhone: (+49) 6221 1 80 79 - 10Fax: (+49) 6221 1 80 79 - 11
Representative:	Peter Kayser (CEO)Burgstrasse 61D-69121 Heidelberg, GermanyPhone: +49 6221 180 79 10Fax: +49 6221 180 79 11
Date prepared:	March 12, 2007

3.2 Device name

Trade Name:	will be first marketed as CHILI PACS Version 2006-09
Common Name:	PACS
Classification Name:	Picture Archiving and Communication System
Classification Number:	Class II
Classification Code:	21 CFR §892.2050
Classification Panel:	Radiology
Predicate Device:	syngo Imaging Version V20A (K052461)
Reason for the 510 (k):	New device

3.3 Device Description and Intended Use

This premarket notification covers CHILI's PACS system "CHILI PACS".

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CHILI PACS Integrated Workplaces / CHILI PACS Image Distribution.

The three CHILI PACS workplace deployments

a) CHILI Web for image distribution (web-based viewing application suited for primary diagnosis)
b) CHILI Workstation for reporting, inside as well as outside of the radiology (standalone workstation or client workstation connected to server)
c) CHILI 3D-Plugln (optional) for 3D- and 4D reconstructions of image slices generated by digital modalities and stored in the DICOM format (not intended for primary diagnosis)

Data Management: CHILI Server.

Ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy.

The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports.

Integration: CHILI Workflow Integration.

The Workflow Management enables by integration of any HL7- / DICOM-compatible HIS, RIS (IHE Year 5) and other information systems to the CHILI PACS a consistent workflow - from patient registration to requirement scheduling to a personal worklist and supports therefore reporting, documentation or administrative tasks.

3.4 Device Technological Characteristics

CHILI PACS is a "software only"-system, which will be delivered on CD-ROM / DVD and installed by service engineers. Hardware requirements to be met are therefore defined.

The backend communication and storage solution is based on the SuSE Linux operating system. The workplaces are based on Windows XP or SuSE Linux operating system, or MacOS X in case of CHILI Web.

The herewith described CHILI PACS supports DICOM formatted images and objects.

3.5 Testing and Equivalence

The CHILI PACS, addressed in this premarket notification, is substantially equivalent to the following commercially available device:

. syngo Imaging Version V20A K052461

The CHILI PACS described in this 510(k) has the same intended use and similar technical characteristics as the devices listed above.

In summary, CHILI is of the opinion that CHILI PACS does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices.

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3.6 General Safety and Effectiveness Concerns

The device labelling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, CHILI GmbH adheres to recognized and established industry practice and standards.

3.7 Guidance Documents

· Guidance for the Submission of Premarket Notification for Medical Image Management Devices, July 27, 2000.
Guidance for the Content for Premarket Submissions for Software Contained in Medi-. cal Devices, May 11, 2005.
· Off-The-Shelf Software Use in Medical Devices, September 9, 1999

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Third Party Review Quality Assessment

Section 1 - Submission Information

510(k) No.:	K070796
Third Party Organization:	TÜV SÜD America.

Third Party's Primary Reviewer(s): Stefan Preiss

ODE/OIVD Division: DRARD Branch/Team: Radiological Devices Branch

Section 2 - 510(k) Decision

_ NSE ________________________________________________________________________________________________________________________________________________________________________ Other (specify): Third party recommendation: SE V______________________________________________________________________________________________________________________________________________ SE NSE NSE SE ODE/OIVD final decision: Other (specify): _____________________________________________________________________________________________________________________________________________________________

Section 3 - Assessment of Third Party Review

Review Element	Rating (check one)
	Adequate	Minor Issue(s)	Major Issue(s)
a. Determination of device eligibility for third party review	√
b. Extent of pre-submission consultation with ODE/OIVD division
c. Organization and format of review documentation	√
d. Determination of 510(k) administrative completeness (screening review)	√
e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission	√
f. Comparison to legally marketed devices—identification and analysis of key similarities and differences	√
g. Rationale for conclusions and recommendation	√
h. Use of guidance documents and standards
i. Resolution of 510(k) deficiencies and FDA requests for additional information
j. Scope of reviewer expertise and use of consulting reviewers
k. Other (specify):

Comments (explanation of ratings/issues): ____________________________________________________________________________________________________________________________________

Section 4 - ODE/OIVD Assessor Information

Sunder Rajan_ Date: April 5, 2007 Tel. No.: 240 276 3968 Assessed by:

Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k). DMC -- Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402).

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Image /page/4/Picture/0 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged vertically along the left side. To the right of the text is a stylized graphic consisting of three abstract figures or shapes stacked vertically. The figures appear to be interconnected or overlapping, creating a sense of unity or collaboration. The logo is simple and uses a monochromatic color scheme.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Chili GmbH c/o Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Hwy 8 NW, Ste. 104 NEW BRIGHTON MN 55112-1891

APR 6 2007

Re: K070796

Trade/Device Name: CHILI PACS Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 21, 2007 Received; March 23, 2007

Dear Mr. Preiss:

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 in the Medical in the Nate 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 registrations, 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 may publich further and of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

Image /page/4/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The text around the circle is difficult to read.

Protecting and Promoting Public Health

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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.

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 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 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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Indications for Use 2

510(k) Number (if known):

Device Name:

CHILI PACS

Indications For Use:

The CHILI PACS is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e.

Displaying
Processing
Reading
Reporting
Communicating / distributing
Storing / archiving of radiological softcopy images and
Storing / archiving of structured (DICOM) reports.

The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning (excluding screening and primary diagnosis of mammography images).

Therefore CHILI PACS supports the following generic imaging workflow:

Receive scheduled exams from IS at the CHILI PACS archiving component CHILI . Server
Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces
Receive and store new exams from the Modalities at the CHILI Server
· Prepare images for reading
Report new images, if required by comparing them with prior exams and reports
· Demonstrate exams at Radiological Demos
View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).

Note: The workstation deployment CHILI 3D-Plugln is not intended for primary diagnosis.

AND/OR Prescription Use _ Over-The-Counter Use (Part 21 CFR 801 Subpart D)

21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymann

n of Reproductive, Abdomina

Page 5

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).