SOMATOM CARE CONTRAST CT

K043087 · Siemens Medical Solutions USA, Inc. · JAK · Dec 15, 2004 · Radiology

Device Facts

• Record ID: K043087
• Device Name: SOMATOM CARE CONTRAST CT
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended 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.

Device Story

CARE Contrast CT is an optional hardware and software extension for Siemens SOMATOM CT scanners. It functions as a communication interface between the CT scanner and a contrast media injector. By enabling synchronized operation, the device allows a clinician to initiate both the CT scan and the contrast injection simultaneously using a single start button located at either the scanner console or the injector. This integration streamlines the workflow for contrast-enhanced CT examinations, ensuring precise timing between contrast delivery and image acquisition. It is intended for use in clinical radiology settings by trained medical personnel.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hardware and software interface extension for Siemens SOMATOM CT scanners. Facilitates communication between CT scanner and contrast injector via a standardized interface. Operates as an integrated component of the CT system.

Indications for Use

Indicated for patients undergoing contrast-enhanced CT examinations requiring synchronized operation between the CT scanner and contrast injector.

Regulatory Classification

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.

Predicate Devices

• Siemens SOMATOM Emotion 6 (P10F) (K023687)
• Siemens SOMATOM Sensation 64 (P30F) (K040665)
• Siemens SOMATOM Sensation Open (P30L) (K040577)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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<br>(P30F) | K040665 | 04/02/2004 |
| Siemens SOMATOM Sensation Open<br>(P30L) | K040577 | 03/22/2004 |

#### ર્ડ. 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.

#### 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 [phone] or [phone] 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

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.

(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)

OR

Over-The-Counter Use

David A. Lyman

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

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