(129 days)
Not Found
No
The description focuses on standard image processing techniques and spectral analysis of MR data to characterize bone structure, without mentioning AI or ML algorithms. The validation section also describes traditional software verification and validation, not AI/ML model training or testing.
No
The device is described as a non-invasive device that processes MR images to generate reports providing information about structural features in bone, specifically for characterizing trabecular bone microarchitecture. It is an image processing system for diagnostic interpretation, not a device that directly treats or prevents disease.
Yes
The device processes MR images to generate reports that provide information about the structural features in bone, specifically bone microarchitecture, which is used for characterization of trabecular bone. This information is intended for viewing and interpretation by medical professionals to aid in understanding the patient's condition.
Yes
The device description explicitly states, "fineSA is a software only image processing system that can be installed on any network computer that meets the specified minimum hardware and operating system requirements." While it processes data from an MRI scanner, the device itself is the software component that performs the analysis and report generation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The fineSA software processes MR images of bone. It analyzes the structural features within the bone based on the MR data.
- Input Data: The input data is MR data acquired directly from the patient's body using an MRI scanner. It is not a sample taken from the body.
- Output: The output is a report providing information about the structural features in bone, not a diagnostic result based on analyzing a biological sample.
The device is a software tool for analyzing medical images (MRI) to characterize bone structure, which falls under the category of medical image processing software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
fineSA software is intended for use as a non-invasive device that processes designated MR images using the 2-D pulse sequence incorporated on Siemens Medical 3T MAGNETOM systems running syngo MR software versions B17 and D13. This includes the Aera, Skyra, Avanto and Verio models.
fineSA software generates reports that provide information about the structural features in bone. The MR data, in the form of spectra or spectral images, reflect the spacing of structural features at a scale of approximately 500 microns or larger.
Product codes
LLZ, LNH
Device Description
fineSA is a tool for the characterization of trabecular bone microarchitecture using magnetic resonance data. fineSA analyzes data acquired from a region of interest with a 2-D pulse sequence. The result is a spectrum that shows not chemical information, but the average spacing of the structural elements within the region of interest. fineSA provides the ability to identify repetitive structural features as small as 500 um.
Compatible MRI scanners, acquire one-dimensional data along the length of a defined region of interest in the anatomical region using a standard pulse sequence available on the OEM scanner. The additional acquisition time required to collect the fineSA compatible data is less than 2 minutes. The resulting DICOM data object is transferred to a network personal computer loaded with fineSA software for processing and report generation.
The DICOM input data is received from the MRI scanner via standard DICOM protocols. The processing performed is driven by the received data content, and at the completion of data processing and analysis, a PDF formatted report is generated and transferred to a designated DICOM destination as a DICOM encapsulated PDF document for viewing and interpretation.
fineSA is a software only image processing system that can be installed on any network computer that meets the specified minimum hardware and operating system requirements. The system can be deployed on the radiology internal network or at a remote location with secure access to radiology internal network.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
bone
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)
Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern, since a malfunction or latent flaw in the software could delay delivery of appropriate medical care that would likely lead to minor injury.
The fineSA processing software was fully tested, verified and validated by Acuitas as part of its internal design control requirements to ensure it meets defined specifications using phantom and clinical data. Formal test plans were executed to confirm that fineSA meets its formal requirements. This submission includes the verification and validation plan, test results, and verification report confirming the fineSA meets its intended use and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Acuitas Medical Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW WASHINGTON DC 20004
Re: K150069
Trade/Device Name: Fine Structure Analysis (fineSA) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, LNH Dated: April 22, 2015 Received: April 22, 2015
Dear Dr. Smith:
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. 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 either 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 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); 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.
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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.
Michael D.'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K150069
Device Name
Fine Structure Analysis (fineSA) Software
Indications for Use (Describe)
fineSA software is intended for use as a non-invasive device that processes designated MR images using the 2-D pulse sequence incorporated on Siemens Medical 3T MAGNETOM systems running syngo MR software versions B17 and D13. This includes the Aera, Skyra, Avanto and Verio models.
fineSA software generates reports that provide information about the structural features in bone. The MR data, in the form of spectra or spectral images, reflect the spacing of structural features at a scale of approximately 500 microns or larger.
Type of Use (Select one or both, as applicable)Z Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Acuitas Medical. The word "ACUITAS" is written in purple, with a small green square on top of the "I". The word "medical" is written in green and is smaller than the word "ACUITAS". The logo is simple and modern.
Fine Structure Analysis (fineSA)
510(K) SUMMARY (K150069) AS REQUIRED BY 21 CFR 807.92(c)
1. Submitter
Acuitas Medical Ltd. 12 Technium One, Kings Road Swansea Waterfront SA1 8PH Wales UK
Phone: (970) 472-0613 Fax: (970) 416-8896
Contact Person: John Heinrich, Ph.D. Chief Executive Officer Phone: (970) 472-0613 Fax: (970) 416-8896 Email: jheinrich@acuitasmedical.com
2. Date Prepared
May 20, 2015
3. Device
- . Trade Name: Fine Structure Analysis (fineSA)
- Common Name: System, Image Processing, Radiological ●
- Classification Name: Picture Archiving and Communication System (21 CFR 892.2050) ●
- Regulatory Class: II ●
- . Product Code: LLZ, LNH
4. Predicate Device
The predicate device for the Fine Structure Analysis (fineSA) software is the syngo.MR General, which was cleared under 510(k) K130749.
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5. Device Description
fineSA is a tool for the characterization of trabecular bone microarchitecture using magnetic resonance data. fineSA analyzes data acquired from a region of interest with a 2-D pulse sequence. The result is a spectrum that shows not chemical information, but the average spacing of the structural elements within the region of interest. fineSA provides the ability to identify repetitive structural features as small as 500 um.
Compatible MRI scanners, acquire one-dimensional data along the length of a defined region of interest in the anatomical region using a standard pulse sequence available on the OEM scanner. The additional acquisition time required to collect the fineSA compatible data is less than 2 minutes. The resulting DICOM data object is transferred to a network personal computer loaded with fineSA software for processing and report generation.
The DICOM input data is received from the MRI scanner via standard DICOM protocols. The processing performed is driven by the received data content, and at the completion of data processing and analysis, a PDF formatted report is generated and transferred to a designated DICOM destination as a DICOM encapsulated PDF document for viewing and interpretation.
fineSA is a software only image processing system that can be installed on any network computer that meets the specified minimum hardware and operating system requirements. The system can be deployed on the radiology internal network or at a remote location with secure access to radiology internal network.
6. Indications for Use
fineSA software is intended for use as a non-invasive device that processes designated MR images using the 2-D pulse sequence incorporated on Siemens Medical 3T MAGNETOM systems running syngo MR software versions B17 and D13. This includes the Aera, Skyra, Avanto and Verio models.
fineSA software generates reports that provide information about the structural features in bone. The MR data, in the form of spectral images, reflect the spacing of structural features at a scale of approximately 500 microns or larger.
7. Predicate Device Comparison
The fineSA software is substantially equivalent to the syngo.MR General post-processing application (K130749).
A summary comparison of characteristics is provided in Table 1.
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Fine Structure Analysis (fineSA)
| Characteristic | Fine Structure Analysis (fineSA) | PREDICATE
syngo.MR General |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Clearance | K150069 | K130749 |
| Imaging Modality | MRI | MRI |
| Product Code | LLZ | LLZ |
| Intended Use | fineSA software is intended for use as a non-
invasive device that processes designated MR
images using the 2-D pulse sequence incorporated
on Siemens Medical 3T MAGNETOM systems
running syngo MR software versions B17 and D13.
This includes the Aera, Skyra, Avanto and Verio
models.
fineSA software generates reports that provide
information about the structural features in bone.
The MR data, in the form of spectra or spectral
images, reflect the spacing of structural features at a
scale of approximately 500 microns or larger. | Post processing software / applications to be used
for viewing and evaluating the designated images
provided by a magnetic resonance device.
syngo.MR General is a syngo based post-processing
software for viewing, manipulating, and evaluating
MR images. |
| Software Device | Yes | Yes |
| Patient Contact | No | No |
| Graphical User
Interface (GUI) | No | Yes |
| Data Interchange | DICOM | DICOM |
| Data Acquisition | Data acquired for fineSA processing uses spin echo
and gradient echo sequences. | Data acquired uses spin echo and gradient echo
sequences. |
| Data Analysis | Data analyzed using standard data analysis
techniques including Fourier and inverse Fourier
transformations and windowing. | Data analyzed using standard data analysis
techniques including Fourier and inverse Fourier
transformations and windowing. |
| Data Presentation | Data presented in conjunction with MR images. | Data presented as or in conjunction with MR
images. |
| Data Types | Spacings of anatomical elements in bone. | Various, including anatomical, relaxation time,
diffusion rate, spectroscopic. and chemical shift. |
Table 1 - fineSA & Predicates Comparative Analysis
8. Performance Data
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern, since a malfunction or latent flaw in the software could delay delivery of appropriate medical care that would likely lead to minor injury.
The fineSA processing software was fully tested, verified and validated by Acuitas as part of its internal design control requirements to ensure it meets defined specifications using phantom and clinical data. Formal test plans were executed to confirm that fineSA meets its formal requirements. This submission includes the verification and validation plan, test results, and verification report confirming the fineSA meets its intended use and performance requirements.
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9. Risk Management
Product risk management activities were performed in accordance with ISO 14971:2007 throughout the product development process. Risk management verification consisted of both a desk audit and software testing to ensure the implementation of all risk mitigations for the device.
10. Substantial Equivalence Conclusion
As noted previously, the fineSA and its predicate devices have similar intended use for viewing and evaluating the designated images provided by a magnetic resonance device. While there are some differences between fineSA and its predicates, these differences are minor and do not raise different questions of safety and effectiveness. Performance data and software verification and validation demonstrate that the fineSA software should perform as intended in the specified use conditions.
Therefore, Acuitas Medical believes that the fineSA software is substantially equivalent to the predicate devices identified in this submission.