(81 days)
SOMATOM AR family, Plus 4 CT scanners
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on quantitative CT technology and a reference database, not AI/ML algorithms.
No
The device is described as an assessment tool for bone mineral content and density, not a treatment device.
Yes
The device is intended for "routine assessment of bone mineral content," which implies detecting or determining the presence and extent of insufficient bone mineral content, fitting the definition of a diagnostic device.
No
The device description explicitly lists several hardware components included in the Osteo package (reference calibration phantom, tabletop pad, coupling pad, foam insert, pad insert) in addition to the software.
Based on the provided information, the Osteo CT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Osteo CT Function: The Osteo CT directly assesses bone mineral content within the patient's body using a CT scanner. It does not examine specimens in vitro (outside the body). It uses imaging technology to analyze the bone structure directly.
Therefore, the Osteo CT falls under the category of an imaging device used for diagnostic purposes in vivo (within the living body), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Osteo CT is intended to be used for routine assessment of bone mineral content in cortical and trabecular bone. It is also applicable to assess changes in bone mineral content over time.
The Osteo CT is intended to be used for routine assessment of bone mineral content in the vertebral bodies of the lumbar and thoracical spine with high precision through the use of SOMATOM CT scanners. It is also applicable to assessment of changes in bone mineral content over time.
Product codes (comma separated list FDA assigned to the subject device)
90JAK, 90KGI
Device Description
OSTEO CT is a scan/evaluation option added to the SOMATOM AR family, and Plus 4 CT scanners. It provides assessment of the bone mineral density (BMD) through the use of single energy quantitative CT technology.
An Osteo package contains 1 reference calibration phantom designed for all SOMATOM CT systems, 1 tabletop pad specially designed for housing the reference phantom, 1 coupling pad designed to eliminate possible air bubbles between the patient and the reference phantom, 1 foam insert to prevent the phantom from moving vertically within the tabletop pad and to eliminate possible air bubbles between the table and the reference phantom, 1 pad insert to prevent the phantom from moving longitudinally within the tabletop pad, and the bone mineral density scanning/evaluation software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
cortical and trabecular bone, vertebral bodies of the lumbar and thoracical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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 cortical and trabecular bone CT images from individuals with normal bone mineral density. The collected data, after statistical analysis, served as the reference database.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3D QCT Bone Mineral Densitometry, Siemens Medical Systems, Inc., SOMATOM AR family, and Plus 4 CT scanners
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.
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Image /page/0/Picture/0 description: The image contains the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, filling most of the frame. The font appears to be sans-serif, and the overall impression is one of clarity and prominence.
Appendix 1
510(k) Summary Osteo CT Option for SOMATOM CT Systems
Submitted by:
JUN 1 3 1997
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
March 21, 1997
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
- Contact Person: 1. Ms. Jing Zhang Fax: (908)321-4841 Phone: (908)321-4927
Device Name and Classification: 2.
Osteo CT for SOMATOM AR family, and Trade Name: Plus 4 Computed Tomography Systems Computed Tomography X-ray System Classification Name: 21 CFR §892.1750, Class II CFR Section: 90JAK Device Code:
3. Substantial Equivalence:
The Osteo CT option operating on SOMATOM AR family, and Plus 4 CT scanners is substantially equivalent to the following devices:
- 3D QCT Bone Mineral Densitometry 1) MindWaves Software, for assessing BMD
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- SOMATOM AR family, and Plus 4 CT scanners 2) Siemens Medical Systems, Inc., for scanning and image analysis
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Device Description: 4.
OSTEO CT is a scan/evaluation option added to the SOMATOM AR family, and Plus 4 CT scanners. It provides assessment of the bone mineral density (BMD) through the use of single energy quantitative CT technology.
An Osteo package contains 1 reference calibration phantom designed for all SOMATOM CT systems, 1 tabletop pad specially designed for
1
SIEMENS
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housing the reference phantom, 1 coupling pad designed to eliminate possible air bubbles between the patient and the reference phantom, 1 foam insert to prevent the phantom from moving vertically within the tabletop pad and to eliminate possible air bubbles between the table and the reference phantom, 1 pad insert to prevent the phantom from moving longitudinally within the tabletop pad, and the bone mineral density scanning/evaluation software.
5. Intended Use of the Device:
The Osteo CT is intended to be used for routine assessment of bone mineral content in cortical and trabecular bone. It is also applicable to assess changes in bone mineral content over time.
6. Summary of Technological Characteristics of the Device Compared to the Predicate Device:
The Osteo CT has the same technological characteristics as the predicate 3D QCT Bone Mineral Densitometry, except the Osteo CT is written for Siemens line of CT scanners while the predicate can take images from any CT scanners. They both use reference phantom, calculate the patient's bone mineral density (BMD) with reference to the phantom, offer a reference database, and provide BMD results in both tabular and graphical forms. The reference database and the comparison provide a reference for the clinical evaluation of bone diseases.
The Osteo software operates independent of the SOMATOM CT scanners reconstruction software, does not influence the determination of the CT numbers by the scanners, and does not affect the dosage characteristics or the imaging performance parameters of the SOMATOM CT scanners.
7. Clinical Study and Conclusion:
A multi-center clinical study was carried out in Europe to collect cortical and trabecular bone CT images from individuals with normal bone mineral density. The collected data, after statistical analysis, served as the reference database.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Jing Zhang Technical Specialist Siemens Medical Systems, Inc. 186 Wood Ave. South Iselin, NJ 08830
Re: K971054
Osteo CT for the SOMATOM AR family and Plus 4 CT X-Ray Systems Dated: March 21, 1997. - .. Received: March 24, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK 21 CFR 892.1170/Procode: 90 KGI
Dear Ms. Zhang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 egainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,
This letter will allow you to begin marketing your device as described in your 510(x) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please ontact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address ﺗﻜﻠﻴ "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Y
Lilian Yin, Ph.D. Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix 2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Osteo CT for the SOMATOM AR family, and Plus 4 CT Scanners
Indications for Use:
The Osteo CT is intended to be used for routine assessment of bone mineral content in the vertebral bodies of the lumbar and thoracical spine with high precision through the use of SOMATOM CT scanners. It is also applicable to assessment of changes in bone mineral content over time.
| Concurrence of the CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971054 |
Prescription Use
OR Over-The-Counter Use __________
(per 21 CFR 801.109)