PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS

K960635 · Siemens Medical Solutions USA, Inc. · JAK · Apr 3, 1996 · Radiology

Device Facts

• Record ID: K960635
• Device Name: PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Apr 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Pulmo CT with Reference Database is intended for diagnostic imaging. It provides highly reproducible CT values for pulmonary tissue, which is essential for follow up examinations and for providing quantitative support for diagnosis.

Device Story

Device is a post-processing software package for SOMATOM Plus and Plus 4 CT scanners; utilizes spirometric control to trigger CT scans at specific respiratory levels (e.g., 50% vital capacity). Inputs: CT image data and patient spirometry signals. Processing: automatic/interactive lung segmentation (entire, central, peripheral); calculation of lung volumes, partial volumes, and density histograms; comparison of patient data against an integrated adult reference database of normal lung function values. Output: statistical parameters, histograms, and volume measurements displayed to the clinician. Used in clinical settings by radiologists/technicians to support pulmonary diagnosis and longitudinal follow-up. Benefits: provides highly reproducible CT values for quantitative assessment of pulmonary tissue.

Clinical Evidence

Multi-center clinical study conducted in Europe to establish the reference database. Data collected from individuals with normal lung functions; statistical analysis performed to generate reference lung CT density values.

Technological Characteristics

Software-based post-processing package for SOMATOM Plus/Plus 4 CT systems. Features spirometric interface for respiratory-gated triggering. Includes database of normal lung density values for comparative analysis. Performs automated/interactive segmentation and statistical quantification of lung volumes and density histograms.

Indications for Use

Indicated for diagnostic imaging of pulmonary tissue in patients requiring quantitative assessment of lung density and volume, including follow-up examinations.

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

• Pulmo CT option in SOMATOM Plus CT (Siemens Medical Systems, Inc.)
• Pulmo CT option in SOMATOM Plus 4 CT (Siemens Medical Systems, Inc.)

Submission Summary (Full Text)

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SIEMENS
K960635

# Appendix 1

## 510(k) Summary
*Pulmo CT with Reference Database Option for SOMATOM CT Systems*

Submitted by:

Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ 08830

February 13, 1996

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

## 1. Contact Person:

Ms. Jing Zhang
Phone: [phone] Fax: [phone]

## 2. Device Name and Classification:

Trade Name: Pulmo CT with Reference Database for the SOMATOM Plus and Plus 4 Computed Tomography Systems
Classification Name: Computed Tomography X-ray System
CFR Section: 21 CFR §892.1750, Class II
Device Code: 90JAK

## 3. Substantial Equivalence:

The Pulmo CT with Reference Database option operating on SOMATOM Plus and Plus 4 CT scanners is substantially equivalent to the following devices:

1) Pulmo CT option in SOMATOM Plus CT Siemens Medical Systems, Inc.
2) Pulmo CT option in SOMATOM Plus 4 CT Siemens Medical Systems, Inc.

Both the Pulmo CT with Reference Database and Pulmo CT options are post-processing evaluation packages that involve respiratory gating, and as such do not affect the dosage characteristics or the imaging performance parameters of the SOMATOM CT scanners.

510(k) for Pulmo CT with Reference Database
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510(k) for Pulmo CT with Reference Database
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# SIEMENS

## 4. Device Description:

The Pulmo CT with Reference Database enables the user to obtain CT scans at defined respiratory levels through spirometric control. The patient is asked to breath through a spirometer and when the inspiration reaches a certain percentage (e.g., 50%) of the patient's vital capacity, the CT scan is triggered.

In addition to respiratory controlled triggering of CT scans, the Pulmo CT option provides the following evaluation capabilities:

- isolation of the left and right lungs
- automatic and interactive segmentation of the entire lung, or of central or peripheral regions,
- calculation and display of statistical parameters, including sub-range statistics (e.g., mean single-slice CT values),
- calculation and display of histograms of the entire lung, as well as the left and right, and
- calculation and display of volumes and partial volumes
- Comparison of the patient's averaged histograms and mean CT values with the adult reference database.

The adult reference database contains a collection of lung CT values (density) acquired using existing Pulmo CT option from patients with normal lung functions.

## 5. Intended Use of the Device:

The Pulmo CT with Reference Database is intended for diagnostic imaging. It provides highly reproducible CT values for pulmonary tissue, which is essential for follow up examinations and for providing quantitative support for diagnosis.

## 6. Summary of Technological Characteristics of the Device Compared to the Predicate Device:

The Pulmo CT with Reference Database has the same technological characteristics as the predicate Pulmo CT option, except the addition of a reference database and the histogram and mean values comparison function. They both control the spirometer, trigger the CT scans at the user defined trigger level, and provide evaluations and statistical analysis to the acquired images. The addition of the reference database and the comparison provides a reference for the clinical evaluation of pulmonary diseases.

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# SIEMENS

## 7. Clinical Study and Conclusion:

A multi-center clinical study was carried out in Europe to collect lung CT images from individuals with normal lung functions. The collected data, after statistical analysis, served as the reference database.


Kathleen Rutherford
Manager, Regulatory Submissions
Siemens Medical Systems, Inc.

510(k) for Pulmo CT with Reference Database