SOMATOM RESPIRATORY GATING

K043086 · Siemens Medical Solutions USA, Inc. · JAK · Dec 23, 2004 · Radiology

Device Facts

• Record ID: K043086
• Device Name: SOMATOM RESPIRATORY GATING
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

Respiratory Gating is an option for CT scanners of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.

Device Story

Respiratory Gating is a software option for Siemens Sensation and Emotion CT scanners; it functions by synchronizing CT image acquisition with the patient's respiratory cycle to mitigate motion artifacts. By visualizing organ or tumor movement relative to respiration phases, the device enhances diagnostic image quality. It is operated by radiology staff in a clinical setting. The output is a motion-corrected CT image, which assists clinicians in more accurate diagnosis and treatment planning by providing clearer visualization of moving anatomical structures.

Technological Characteristics

Software-based respiratory gating option for CT scanners; integrates with Sensation and Emotion family CT systems; utilizes respiratory phase data to gate image acquisition.

Indications for Use

Indicated for patients undergoing CT scanning on Sensation or Emotion family scanners to improve image quality by reducing respiratory motion artifacts.

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 Project P10F (K023687)
• Siemens SOMATOM Project 30F (K040665)
• Siemens SOMATOM Project 30L (K040577)

Submission Summary (Full Text)

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DEC 2 3 2004

K043086
page 1 of 2

## 510(K) SUMMARY FOR SIEMENS RESPIRATORY GATING

Submitted by:

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

November 4, 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.

#### Contact Person: 1.

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: [e-mail]

#### 2. Device Name and Classification

Product Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

SOMATOM Respiratory Gating Accessory to Computed Tomography System Radiology 21 CFR §892.1750 Class II 90 JAK

#### 3. Importer/Distributor Establishment:

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

### 4. Manufacturing Facility: Siemens AG Wittelsbacherplatz 2 D-80333 München, Germany

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*K043286
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#### 5. Substantial Equivalence

Option, addressed in this premarket notification, is The Respiratory Gating substantially equivalent to the following commercially available software package:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|------------------------------|----------------------|--------------------|
| Siemens SOMATOM Project P10F | K023687 | 11/22/2002 |
| Siemens SOMATOM Project 30F | K040665 | 04/02/2004 |
| Siemens SOMATOM Project 30L | K040577 | 03/22/2004 |

#### 6. Device Description

The computed tomography system in combination with a device for Respiratory Gating is intended for the removal of the artifacts caused by respiratory motion. This leads to an increase of the image quality and advancement in diagnosis because the movement of organs or tumors can be visualized against the respiration phases.

#### 7. Indications for Use

Respiratory Gating is an option for CT scanners of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2004

Ms. Debbie Peacock Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355

Re: K043086 Trade/Device Name: Somatom Respiratory Gating Regulation Number: 21 CFR 872.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: November 4, 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 rear 20, 1110, 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 do not require approvisions of the Act. The general controls provisions of the Act include reguirements 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 n your a rise is the 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) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally premaired notification: "The PDF Intentig sification 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 If you desire specifice 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 Also, prease note the regulation on your responsibilities under the Act from the 607.97). " Od may obtain outer gineer ational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.ggv/cdrh/dsmadsmamain.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

KU43086 510(k) Number (if known): Respiratory Gating Device Name:

Respiratory Gating is an option for CT scanner of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.

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

Prescription Use OR Over-The-Counter Use
(Per 21 CFR §801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
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