The SOMATOM Emotion 6 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

The Siemens SOMATOM Emotion 6 systems are a whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

AI/ML Overview

This document is a 510(k) summary for the Siemens SOMATOM Emotion 6 Computed Tomography X-ray System. It focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study to prove meeting detailed acceptance criteria for a new device's performance.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be fully answered from the provided text because these elements are typically part of a performance study demonstrating novel functionality or a new medical claim, which is not the primary purpose of this 510(k) submission.

However, I can extract and infer some information based on the context of a 510(k) for a CT scanner.

1. Table of acceptance criteria and the reported device performance:

Since this is a submission demonstrating substantial equivalence of a new model of an existing device type (CT scanner), the "acceptance criteria" are implicitly met by demonstrating that the device performs at least as well as and no worse than the predicate devices in terms of its fundamental technical characteristics and safety. The document does not provide specific quantitative performance metrics comparing the SOMATOM Emotion 6 to predicate devices.

Acceptance Criteria Category	Reported Device Performance (as inferred from document)
Intended Use Equivalence	"The SOMATOM Emotion 6 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles." This is stated as equivalent to predicate devices.
Technological Characteristics Equivalence	"The SOMATOM Emotion 6 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Emotion systems... The system will operate with SOMARIS/5 software." Stated as substantially equivalent to Siemens SOMATOM Emotion Duo and Somatom Sensation 4 CT scanners.
Safety Standards Compliance	"All components... certified to meet those requirements [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33]... designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY."
Performance Standard	Meets 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. This document does not detail a clinical performance study using a test set of patient data, but rather focuses on technical specifications and safety standards for demonstrating substantial equivalence.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical test set with human-established ground truth is described. The "ground truth" here is the established performance and safety profile of the predicate devices.

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

Not applicable.

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 MRMC study is mentioned. This device is a CT scanner, not an AI-assisted diagnostic tool.

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

Not applicable. This is a CT imaging system.

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

For this 510(k), the "ground truth" is primarily implicit: the established safety, effectiveness, and technical performance of the predicate devices (Siemens SOMATOM Emotion Duo and Somatom Sensation 4 CT scanners). The substantial equivalence claim is based on the new device having similar fundamental technology and meeting the same safety and performance standards as these already legally marketed devices.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm or a training set.

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

Not applicable.

Summary

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NOV 22 2002

Attachment 1

Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information I.

Device Name:	SOMATOM Emotion 6 Computed Tomography X-raySystems
Classification Name:	§ 892.1750:Computed tomography X-ray system
Proprietary Trade Name:	SOMATOM Emotion 6
Classification:	Class II
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard
Registration Number:	2240869
Address:	Siemens Medical Systems, Inc.186 Wood Avenue SouthIselin, N.J. 08830
Contact Person:	Praveen NadkarniTechnical Specialist, Regulatory Submissions(732) 321-4950

Date of Summary Preparation: 10/29/02

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II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

Device Description:

Intended Use:

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Technological Characteristics:

The SOMATOM Emotion 6 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Emotion systems (for further details see chapter 2). The system will operate with SOMARIS/5 software.

General Safety and Effectiveness Concerns:

All components of the SOMATOM Emotion 6 systems subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be filed with the Center for Devices and Radiological Health (CDRH). To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice. The SOMATOM Emotion Duo is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 60601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY.

Substantial Equivalence:

Siemens believes that within the meaning of the Safe Medical Device Act of 1990, the SOMATOM Emotion 6 systems operating with SOMARIS/5 software are substantially equivalent to the Siemens SOMATOM Emotion Duo and Somatom Sensation 4 CT scanners in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 top half of the circle. Inside the circle is an abstract symbol that resembles three stylized human profiles or birds in flight, stacked on top of each other.

ood and Drug Administration 0 Corporate Boulevard

Mr. Praveen Nadkarni Technical Specialist, Regulatory Submissions SIEMENS Medical Systems, Inc. 186 Wood Avenue South ISELIN NI 08830

Re: K023687 Trade/Device Name: SOMATOM Emotion 6 CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: October 29, 2002 Received: November 1, 2002

Dear Mr. Nadkarni:

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.

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Page 2

This letter will allow you to begin marketing your device as described in your 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:

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" (21 CFR Part 807.97). 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. Snogdon

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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SIEMEN

Attachment 2

Indication for use

510(k) Number (if known):

K023687

Device Name:

SOMATOM Emotion 6 systems

Indication for use:

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Prescription Use

Daniel A. Layne

Attachment

510(k)

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.