(49 days)
Pulmo CT option in SOMATOM Plus CT Siemens Medical Systems, Inc., Pulmo CT option in SOMATOM Plus 4 CT Siemens Medical Systems, Inc.
No
The description focuses on image processing, segmentation, statistical analysis, and comparison to a reference database, none of which inherently require AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as intended for "diagnostic imaging" to provide "highly reproducible CT values for pulmonary tissue" and "quantitative support for diagnosis," with no mention of treating or alleviating any disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Pulmo CT with Reference Database is intended for diagnostic imaging." Additionally, it provides "quantitative support for diagnosis."
No
The device description explicitly mentions "respiratory controlled triggering of CT scans" through a spirometer, indicating interaction with hardware (the spirometer and the CT scanner) beyond just software processing. The predicate devices are also described as "Pulmo CT option in SOMATOM Plus CT Siemens Medical Systems, Inc." and "Pulmo CT option in SOMATOM Plus 4 CT Siemens Medical Systems, Inc.", which are CT scanner systems, further suggesting a hardware component.
Based on the provided information, the Pulmo CT with Reference Database is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The Pulmo CT system analyzes images of the lungs within the body (in vivo) using a CT scanner.
- The intended use is diagnostic imaging and providing quantitative support for diagnosis based on imaging data. This aligns with the function of a medical imaging device, not an IVD.
- The device description focuses on image acquisition (CT scans), image processing (segmentation, calculation of parameters), and comparison with a reference database of imaging data. This is characteristic of an imaging analysis tool.
The device is clearly a medical imaging device used for diagnostic purposes, specifically for analyzing pulmonary tissue through CT scans.
N/A
Intended Use / Indications for 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.
Product codes
90JAK
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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-ray System
Anatomical Site
Pulmonary tissue (lungs)
Indicated Patient Age Range
adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
A multi-center clinical study was carried out in Europe to collect lung CT images from individuals with normal lung functions.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pulmo CT option in SOMATOM Plus CT Siemens Medical Systems, Inc., Pulmo CT option in SOMATOM Plus 4 CT Siemens Medical Systems, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The font is bold and sans-serif. The letters are black against a white background.
APR - 3 -996
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: (908)321-4927 Fax: (908)321-4841
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:
-
- Pulmo CT option in SOMATOM Plus CT Siemens Medical Systems, Inc.
-
- 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.
1
SIEMENS
Device Description: এ.
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.
2
SIEMENS
Clinical Study and Conclusion: 7.
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
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.