SOMATOM SPIRIT

K042328 · Siemens Medical Systems, Inc. · JAK · Sep 14, 2004 · Radiology

Device Facts

• Record ID: K042328
• Device Name: SOMATOM SPIRIT
• Applicant: Siemens Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The SOMATOM Spirit system 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

Whole body X-ray computed tomography scanner; utilizes continuously rotating tube-detector system; functions via fan beam principle. System software (SOMARIS/5.5) manages patient control, image reconstruction, and image archive/evaluation. Operated by clinical staff in radiology settings. Produces cross-sectional images of body; assists physicians in diagnostic decision-making. Benefits patient through non-invasive visualization of internal anatomy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Whole body X-ray CT scanner; fan beam geometry; continuously rotating tube-detector system. Operates with SOMARIS/5.5 software. Complies with 21 CFR Subchapter J (Federal Diagnostic X-ray Equipment Standard) and electrical/mechanical safety standards.

Indications for Use

Indicated for patients requiring cross-sectional diagnostic imaging of the body via computer-reconstructed X-ray transmission data.

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 Emotion Duo (K003014)
• General Electric's HiSpeed NX/i (K991716)

Submission Summary (Full Text)

{0}------------------------------------------------

K042328

### 510(K) SUMMARY FOR SOMATOM PROJECT P 1 5

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

August 27, 2004

# Summary of Safety and Effectiveness

SEP 1 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.

#### General Information I.

# Device Name and Classification:

| Product Name: | SOMATOM Project P15 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Trade Name: | SOMATOM Spirit |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
| Establishment Registration Number: | 2240869 |
| Performance Standards: | 21 CFR Subchapter J, Federal<br>Diagnostic X-ray Equipment Standard |
| Address: | Siemens Shanghai Medical<br>Equipment Ltd. No.278,<br>Jin Hu Rd. 201206, Shanghai, PRC |
| Contact Person: | Ms. Nealie Hartman<br>Technical Specialist, Regulatory Affairs Submissions<br>Siemens Medical Solutions, Inc. USA<br>51 Valley Stream Parkway E-50<br>Malvern, PA 19355<br>Phone:[phone]; Fax: [phone] |

{1}------------------------------------------------

# II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

### Device Description:

Device Description:
The Siemens SOMATOM Spirit is a whole body X-ray computed tomography stanners, The Siemens SOMATOM 'Spint is a 'Wiole' 600' whole '600' '1. tem'
which features a continuously rotaing tube-detector system and functions according to the fan which features a coliminously folling tabe accords of program used for patient beam principle. The system soltware is a control, image reconstruction, and image archive/evaluation.

### Indication for Use:

The SOMATOM Spirit is intended to produce cross-sectional images of the body by computer The SUMATOM Spint is mended to produce of cours and 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.)

### Technological Characteristics:

Technological Characteristics.
The SOMATOM Spirit systems are whole body X-ray computed tomography status for hear The SUMATOM Spirit systems are which body is not one functions according to the family features a continuously rouaing tabe decision by Amotion Duo system (for further principle. The System is Cassetem will operate with SOMARIS/5.5 software.

## General Safety and Effectiveness Concerns:

General Safety and Ellectreness Concerns.
All components of the SOMATOM Spirit subject to the Federal Diagnostic Equipment All components of the SOMITION bplicable regulations of 21CFR § 1020.33 are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be certified with the Center for Devices and Radiological Health (CDRH). To minimize electrical, filed with the Center for Devices and Acades and established industry mechanical, and Tatlanon nazards, bromets accisions accisions and MECHANCAL
Practice. The SOMATOM is designed to meet the ELECTRICAL AND FOR practice. The SOMATOM is designed to thee the EAY EQUIPMENT STANDARD FOR SAFETY.

#### Substantial Equivalence:

Substantial Equivalence.
The SOMATOM Spirit systems operating with SOMARIS/5.5 software are substantially equivalent to the following systems:

| Product Name | 510(k) | Clearance Date |
|---------------------------------|---------|----------------|
| Siemens Emotion Duo | K003014 | 10/12/00 |
| General Electric's HiSpeed NX/i | K991716 | 06/18/99 |

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 4 2004

Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 MALVERN PA 19355

· Re: K042328

Trade/Device Name: SOMATOM Spirit Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: August 27, 2004 Received: August 27, 2004

Dear Ms. Hartman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regally annual date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Foreign of D conimer & prior to Hay 20, 2778, waccordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval approval application (PMA). and Cosmetic Act (1107 that do not required to the general controls provisions of the Act. The I ou may, therefore, market the est include requirements for annual registration, listing of Echeral controls provision 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 If your device is classinod (soc as or of als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may ou found in the 0000 cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Nasc oc advised that I Dri a lossante at your device complies with other requirements of the Act that I DX has made a determinations administered by other Federal agencies. You must comply or any it cachares and regainstilling, but not limited to: registration and listing (21 CFR Part with an the Tree 3 requirements, measurements of active requirements as set forth in the 001); laboring (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin hanketing your and equivalence of your device to a legally premarket notification. The PDA inisms of backence of the sice 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 specific advice for your de tee 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 Additionally, for questions on the promotions. Also, please note the regulation entitled, "Misbranding Other of Comphance at (301) 97 - 100 (21CFR Part 807.97) you may obtain. Other general by relevence to premarket nonitour (21 Connect the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the mormation on your responsionities and creating 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. Brogdon

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

Enclosure

{4}------------------------------------------------

### Indications For Use

510(k) Number (if known):

KO42328

Device Name:

SOMATOM Spirit

Indication for use:

The SOMATOM Spirit system is intended to produce cross-sectional images of the body by
the are a The SOMATOM Spirit system is mission data from either the same axial plane taken at
computer reconstruction of x-ray transmission data from either the same axial plane taken computer reconstruction of the states at different angles.

(*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray in
t the axial planes with and the of the sations of the sations of the same of (" Spiral planes. the axial p translation of the patient.)

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

(Please do not Wille below this mo - online - one ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prescription Use V (Per 21 CFR §801.109)

Over-The-Counter Use OR

David R. Hynson