SOMATOM SENSATION 64 AND SENSATION CARDIAC

K040665 · Siemens Medical Solutions USA, Inc. · JAK · Apr 2, 2004 · Radiology

Device Facts

• Record ID: K040665
• Device Name: SOMATOM SENSATION 64 AND SENSATION CARDIAC
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The SOMATOM P30 is 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 Story

The SOMATOM Project P30F (Sensation 64/Sensation Cardiac) is a whole-body X-ray computed tomography (CT) system. It utilizes a continuously rotating tube-detector assembly operating on the fan beam principle to acquire X-ray transmission data. The system performs computer reconstruction of this data to generate cross-sectional images of the patient. Operated by trained clinical staff in a radiology setting, the device includes software (SOMARIS/5) for patient management, scan control, image reconstruction, and archiving. The output images are used by physicians to assist in clinical diagnosis and decision-making. The device benefits patients by providing diagnostic imaging capabilities for various body regions.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by hazard analysis, software verification, and validation testing.

Technological Characteristics

Whole-body CT system; fan beam principle; continuously rotating tube-detector assembly. Software: SOMARIS/5. Connectivity: Data management and image archiving. Safety: Adherence to recognized industry standards for electrical, mechanical, and radiation hazards.

Indications for Use

Indicated for producing cross-sectional body images via computer reconstruction of X-ray transmission data acquired through axial or spiral scanning. Intended for prescription use.

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 P30 (K013522)

Submission Summary (Full Text)

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K040665

APR - 2 2004

510(K) SUMMARY FOR SOMATOM PROJECT P30F

Submitted by: Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway Malvern, PA 19355

March 1, 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. Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway J-15 Malvem, PA 19355 Phone:[phone] Fax: [phone]

#### Device Name and Classification 2.

| Product Name: | SOMATOM Project P30F |
|-----------------------|----------------------------|
| Classification Name: | Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

#### 3. Substantial Equivalence:

Siemens SOMATOM P30F Computed Tomography X-ray systems, contigured with software version SOMARIS/5 is substantially equivalent to the following medical device in commercial distribution:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|-----------------------|----------------------|--------------------|
| Siemens SOMATOM P30 | K013522 | 11/07/2001 |

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## Device Description: 4.

The Sicmens SOMATOM P30F is a whole body X-ray computed tomography systems, 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.

## 5. Indications for Use:

The SOMATOM P30 is 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 angels 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.)

# General Safety and Effectiveness Concerns: 6.

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

Risk management is ensured via a hazard 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, Siemens adheres to recognized and established industry practice and standards.

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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 curved lines representing its body and wings. The eagle faces to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2004

Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway J-15 MALVERN PA 19355

Re: K040665 Trade/Device Name: SOMATOM Project P30F (Sensation 64/Sensation Cardiac) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: March 1, 2004 Received: March 4, 2004

Dear Ms. Hartman:

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 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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# SECTION 3 INDICATION FOR USE

510(k) Number (if known):

K040445

Device Name:

SOMATOM Project P30F (Sensation 64 / Sensation Cardiac)

The Siemens SOMATOM P30F 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.)

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

Prescription Use

(Per 21 CFR §801.109)

ાર Over-The-Counter Use

: 110(k) Number

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