(55 days)
With the post-processing application syngo® Dual Energy it is possible to obtain additional information about the chemical composition of body materials. CT images taken at the same time with two different kV levels from the same patient and the same anatomical region are used and the differences in the energy dependence of the attenuation coefficients of different materials are exploited. These images will be combined and analyzed to visualize information about anatomical and pathological structures.
Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.
Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy. The postprocessing application Syngo Dual Energy uses this additional information to improve the visualization of various energy dependent materials in the human body.
This 510(k) summary for Syngo® Dual Energy does not contain enough information to complete the requested table and study details. Minimal information about validation or verification testing is provided. Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on device description, indications for use, and substantial equivalence, not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance
This information is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided.
4. Adjudication method
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. The document describes a post-processing application, not specifically an "AI" device as might be understood today. It does not mention any human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly provided. The document states that "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." This vague statement could imply standalone testing, but no details are given about the nature or results of such testing.
7. The type of ground truth used
This information is not provided.
8. The sample size for the training set
This information is not provided.
9. How the ground truth for the training set was established
This information is not provided.
Summary of Available Information:
The document primarily serves as a 510(k) submission for substantial equivalence, focusing on:
- Device Name: Syngo® Dual Energy
- Classification: Accessory to Computed Tomography System, Class II, Product Code 90 JAK
- Indications for Use: To obtain additional information about the chemical composition of body materials by analyzing CT images taken at two different kV levels, to visualize information about anatomical and pathological structures.
- Predicate Devices: Several Siemens products including Leonardo (syngo Fused Vision 3D), InSpace 4D, Body Perfusion, and SOMATOM DR I.
- General Safety and Effectiveness: Stated to be ensured via risk management, hazard analysis, software development, verification, and validation testing, adhering to industry practice and standards. However, no specific results or methods of these tests are detailed.
In conclusion, this regulatory submission focuses on justifying the device's substantial equivalence to existing products rather than providing detailed performance data from a specific study that meets the acceptance criteria directly.
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510(K) SUMMARY FOR Syngo® Dual Energy
OCT -5 2006
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
August 9, 2006
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.
1. Contact Person:
Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355 Phone: (610) 448-1778 (610) 448-1787 Fax:
2. Device Name and Classification
| Product Name: | syngo® Dual Energy |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
3. Substantial Equivalence:
The syngo® Dual Energy software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available Siemens Medical Systems devices:
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| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens | Leonardo(syngo Fused Vision 3D) | K040970 | 07/08/04 |
| 2. Siemens | InSpace 4D | K043469 | 02/03/05 |
| 3. Siemens | Body Perfusion | K050867 | 04/14/05 |
| 4. Siemens | SOMATOM DR I | K837107 | 03/09/83 |
| Remark: | The referenced Predicate Device of the SOMATOM DHR has beencleared with a non-filing-justification in October 10, 1984 ! ) |
4. Device Description:
Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy. The postprocessing application Syngo Dual Energy uses this additional information to improve the visualization of various energy dependent materials in the human body.
ર્ડ. Indications for Use:
With the post-processing application syngo® Dual Energy it is possible to obtain additional information about the chemical composition of body materials. CT images taken at the same time with two different kV levels from the same patient and the same anatomical region are used and the differences in the energy dependence of the attenuation coefficients of different materials are exploited.
These images will be combined and analyzed to visualize information about anatomical and pathological structures.
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 seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT - 5-2006
Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 MALVERN PA 19355
Re: K062351
Trade/Device Name: Syngo® Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Accessory to computed tomography system Regulatory Class: II Product Code: JAK Dated: August 9, 2006 Received: August 11, 2006
Dear Mr. Johnson:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 3 INDICATION FOR USE
510(k) Number (if known):
Device Name:
Syngo® Dual Energy
Kol 2351
Syngo Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials.
The images are combined to visualize and analyze information about anatomical and pathological structures
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use 区 | OR | Over-The-Counter Use □ |
|---|---|---|
| (Per 21 CFR §801.109) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
§ 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.