(205 days)
Not Found
No
The description focuses on iterative reconstruction algorithms and image processing techniques, which are traditional methods in medical imaging and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts like training data or models.
No.
The device is described as CT reconstruction software that improves image quality and allows for reduced radiation dose in CT scans, which are diagnostic tools. It does not directly treat or alleviate a disease or condition.
No
ADMIRE is a CT reconstruction software that improves image quality or allows for reduced radiation dose. It processes acquired raw data to produce images, but it does not directly diagnose conditions.
Yes
The device is described as a "software option for CT operating systems" and its function is to perform image reconstruction, which is a software-based process. There is no mention of any hardware component being part of the device itself.
Based on the provided information, ADMIRE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, or tissue outside of the body to provide information about a person's health.
- ADMIRE is CT reconstruction software. It processes raw data acquired from a CT scan (which is an in vivo imaging technique, meaning it's performed on a living person) to create images. It does not analyze biological specimens.
- The intended use is for image reconstruction and quality improvement. The description clearly states its purpose is to process CT data to improve image quality, reduce dose, and reduce artifacts.
Therefore, ADMIRE falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.
Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
Siemens ADMIRE is an extension of the previously cleared Sinogram Affirmed Iterative Reconstruction (SAFIRE) reconstruction algorithm. ADMIRE is a software option for CT operating systems that provides an improved image quality or reciprocally can allow the physician to acquire scans with reduced radiation dose without reduction of image quality compared to today's standard.
ADMIRE is designed to improved reconstructed image quality through the integration of additional processing steps in image reconstruction. These additional steps result in the following improvements in image quality:
- . Higher pixel noise reduction
- A noise texture closer to filtered back projection (FBP) .
- . Improved resolution for high contrast edges
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Not Found
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)
Non clinical tests (integration and functional) and phantom testing were conducted for ADMIRE during product development. The modifications described in this Premarket Notification were supported with verification/validation testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. In addition to successful completion of verification and validation testing, additional bench testing was performed to substantiate performance claims and demonstrate substantial equivalence to the predicate device SAFIRE. Sample clinical images were also provided within the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 2 0 2014
K133646
page 1 of 5
510(K) SUMMARY FOR ADMIRE
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: May 5, 2014
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
SIEMENS
- General Information
Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number: 2240869
Manufacturing Site: SIEMENS AG, MEDICAL SOLUTIONS Siemensstrasse 1 91301 Forchheim, GERMANY
Establishment Registration Number: 3004977335
2. Contact Person:
Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Fax: (610) 448-1778 Phone: (610) 448-1772 Email: kimberly.mangum@siemens.com
- Device Name and Classification 3.
| Product Name: | ADMIRE |
|---|---|
| Propriety Trade Name: | ADMIRE |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
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Device Class: Class II Product Code: 90JAK
Legally Marketed Predicate Devices Trade Name: SAFIRE 510(k)#: K103424 Clearance Date: Clearance Date: Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: . Product Code: 90 JAK
4. Substantial Equivalence:
Siemens ADMIRE is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| SAFIRE | K103424 | November 22, 2011 |
5. Device Description:
Siemens ADMIRE is an extension of the previously cleared Sinogram Affirmed Iterative Reconstruction (SAFIRE) reconstruction algorithm. ADMIRE is a software option for CT operating systems that provides an improved image quality or reciprocally can allow the physician to acquire scans with reduced radiation dose without reduction of image quality compared to today's standard.
ADMIRE is designed to improved reconstructed image quality through the integration of additional processing steps in image reconstruction. These additional steps result in the following improvements in image quality:
- . Higher pixel noise reduction
- A noise texture closer to filtered back projection (FBP) .
- . Improved resolution for high contrast edges
Summary of Technical Characteristics of the Subject Device as 6. Compared with the Predicate Device:
ADMIRE reconstruction software do not have significant changes in the indications for use, materials, energy source, or technological characteristics when compared to the predicate device.
The additional/extended algorithm processing steps result in the following improvements in reconstructed image quality for ADMIRE in comparison to the predicate device SAFIRE:
2
- Higher pixel noise reduction in thicker slices (for example 3mm and . 5mm)
- Less outliers in the noise texture resulting in a noise texture closer to . that of filtered back projection (FBP)
- Improved Resolution at High Contrast Edges compared to weighted . filtered back projection (WFBP)
The intended use and fundamental scientific technology are similar to the predicate device; therefore Siemens believes that they are substantially equivalent to the predicate device.
7. Nonclinical Testing:
ADMIRE is designed to fulfill the requirements of following safety and performance standards:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
Edition 2007-
03-01 | 08/20/2012 | ISO |
| 13-8 | Software | Medical device software -
Software life cycle processes | 62304 First
edition 2006-05 | 08/20/2012 | IEC |
| 5-41 | General | Medical electrical equipment -
Part 1-4: General requirements
for safety - Collateral standard:
Programmable electrical medical
systems, edition 1.1 | 60601-1-4:
2000
Consol.Ed 1.1 | 09/08/2009 | IEC |
| | General | Medical electrical equipment -
Part 1-6: General requirements
for basic safety and performance | 60601-1-6 | 2006 | IEC |
| 12-218 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) | PS 3.1 - 3.18
(2008) | 2008 | NEMA |
3
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom testing were conducted for ADMIRE during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Summary of Additional Testing
In addition to successful completion of verification and validation testing, additional bench testing was performed to substantiate performance claims and demonstrate substantial equivalence to the predicate device SAFIRE. Sample clinical images were also provided within the submission.
8. Indications for Use:
ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter back-projection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.
ADMIRE at highest noise reduction strength for thin (0.6 mm) reconstruction slices in simulated body and head phantoms for low contrast objects with different contrasts.
Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.
4
K133646
Page 5 of 5
9. General Safety and Effectiveness Concerns:
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 during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards. Siemens adheres to recognized and established industry practice and standards.
10. Conclusion as to Substantial Equivalence
In summary, Siemens is of the opinion that the ADMIRE does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
June 20, 2014
Siemens Medical Systems, Inc. % Ms. Kimberlv Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19301
K133646 Rc:
Trade/Device Name: ADMIRE Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: H Product Code: JAK Dated: May 8, 2014 Received: May 13, 2014
Dear Ms. Mangum:
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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
6
Page 2 - Ms. Kimberly Mangum
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133646
Device Name ADMIRE
Indications for Use (Describe)
ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter backprojection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space.
Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
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