CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.

Device Description

CARE Contrast CT for the SOMATOM CT Systems includes both hardware and software components. CARE Contrast CT is an optional extension to the functionality of Siemens SOMATOM Emotion and Sensation CT scanners and is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. The addition of the CARE Contrast CT option to the SOMATOM scanners simply implements an interface between CT scanners and an injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens CARE Contrast CT, which is an accessory to Computed Tomography Systems. The primary purpose of this device is to facilitate contrast-enhanced CT examinations by connecting CT and injector systems.

Based on the document, there is no acceptance criteria or study outlined to prove the device meets specific performance criteria in the traditional sense of a clinical or performance study for diagnostic accuracy.

The 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The review process for substantial equivalence typically involves demonstrating that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement is not available or applicable in this specific 510(k) summary because a performance study with such details was not presented.

Here's an analysis of the requested information based on the provided text:

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

Not applicable / Not provided. The document describes a device designed to facilitate CT examinations by connecting a CT scanner and an injector. It does not present specific performance criteria or metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic task for which acceptance criteria would typically be set. The device's "performance" is its ability to establish communication and allow synchronized operation, which is assumed to be functional.

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

Not applicable / Not provided. The submission does not detail a "test set" or any data collection for a performance study. Its focus is on establishing substantial equivalence based on the device's functional description and comparison to existing predicate devices.

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)

Not applicable / Not provided. Since no "test set" is described, there's no mention of experts or ground truth establishment.

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

Not applicable / Not provided. No test set or corresponding adjudication method is discussed.

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 device, CARE Contrast CT, is an interface solution between a CT scanner and an injector, not an AI-assisted diagnostic tool.

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

Not applicable / Not provided. This device is not an algorithm that performs a standalone diagnostic task. It's an accessory that enables communication and workflow for contrast-enhanced CT.

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

Not applicable / Not provided. No ground truth for diagnostic performance is mentioned as no such study was presented.

8. The sample size for the training set

Not applicable / Not provided. As this is not an AI/ML diagnostic device, there is no mention of a training set.

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

Not applicable / Not provided. No training set is mentioned.

Summary

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K04 3087

DEC 1 5 2004

510(K) SUMMARY FOR SIEMENS CARE CONTRAST CT

Submitted by:

Siemens Medical Solutions, Inc. 51Valley Stream Parkway Malvern, PA 19355

November 3, 2004

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.

1. Contact Person:

Ms. Debbie Peacock Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 Malvern, PA 19355 Phone: (610) 448-1773 Fax: (610) 448-1787 Email: debra.peacock(@siemens.com

2. Device Name and Classification

Product Name:	SOMATOM CARE Contrast CT
Classification Name:	Accessory to Computed Tomography System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90 JAK

3. Importer/Distributor Establishment:

Registration Number: 2240869 Siemens Medical Solutions, Inc. USA 51 Valley Stream Pkwy Malvern, PA 19355

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Manufacturing Facility:

Siemens AG Wittelsbacherplatz 2 DE- 80333 Muenchen Germany

4. Substantial Equivalence

The CARE Contrast CT package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens SOMATOM Emotion 6 (P10F)	K023687	11/22/2002
Siemens SOMATOM Sensation 64(P30F)	K040665	04/02/2004
Siemens SOMATOM Sensation Open(P30L)	K040577	03/22/2004

ર્ડ. Device Description

6. Indications for Use

CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast-enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.

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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 consists of a stylized eagle with three wavy lines representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2004

Ms. Debbie Peacock Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355

Re: K043087 Trade/Device Name: CARE Contrast CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray sytem Regulatory Class: II Product Code: 90 JAK Dated: November 3, 2004 Received: November 8, 2004

Dear Ms. Peacock:

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 (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.

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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/dsmadsmam.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

510(k) Number (if known): _ Ko Y Jo8 7

Device Name:

CARE Contrast CT

(Please do not write below this line - continue on another page if needed)

============================================================================================================================================================================== Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR §801.109)

Over-The-Counter Use

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ROH 308 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 13

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.