(81 days)
Not Found
No
The document describes image processing and calculation of curves based on signal intensity, but there is no mention of AI, ML, or related terms. The improvements focus on automation and robustness of existing calculations, not learning from data.
No
The device is described as an imaging system (MR system) and software for image analysis, intended to provide diagnostically useful information and not to treat or cure any condition.
Yes
The device produces images (MR system) and processes them (software option) that "When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information." This explicitly states its purpose in providing information for diagnosis.
No
The device is described as a software option for an existing MRI system (S-scan Esaote MRI systems). While the submission focuses on the software's functionalities, it is explicitly stated to be used on a hardware medical device (the MRI system) and enhances its capabilities. It is not a standalone software device.
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 S-scan system and its software option are used to produce and analyze images of the human body (limbs, joints, spinal column) using Magnetic Resonance technology. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient.
Therefore, the S-scan system and its associated software are considered medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
MRI Dynamic Analysis Plus is the Esaote commercial name of a software option intended for use on S-scan Esaote MRI systems; this option allows the extension of the functionalities of the option MRI Dynamic Analysis (cleared for S-scan K080968). MRI Dynamic Analysis enables the acquisition of a set of dynamic images and subsequent display of the time varying signals that is due to absorption of the contrast agent over time in the image series acquired. The software described above provides values of signal intensity over time and calculates the interpolation curve of these values, the maximum slope and the asymptotic value. The MRI Dynamic Analysis Plus software option has been implemented to enhance the performance of the MRJ Dynamic Analysis in terms of ease of use, reliability (operator independence) of the uptake-curves calculation, productivity and robustness. The MRI Dynamic Analysis Plus software option enhances performance of the existing MRI Dynamic Analysis (K080968) software in the following regard:
- Evolution of the available and consolidated Uptake Curve ●
- . Enabled by the options «MRI Dynamic Analysis» + «MRI Dynamic Analysis Plus»
- . Reliability (Operator independence) - Curve is automatically evaluated pixel on the whole image, instead of on an averaged ROI
- . Productivity - An intensity reference on images (vial placed alongside the wrist) is no more required
- . Robustness - Image data in extended scale is used, that is before "intensity normalization", in order to eliminate RF perturbations effects and to ensure that the pixel intensities along different series of dynamic examination are homogenous
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Upper limb (hand, wrist, forearm, elbow, arm, shoulder), lower limb (foot, ankle, calf, knee, thigh, hip), temporomandibular joint, spinal column (cervical, thoracic, lumbosacral sections).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical expert trained in use of MR equipment
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)
No clinical tests were performed.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2016
Esaote S.p.A. % Ms. Allison Scott Senior Regulatory Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K153039
Trade/Device Name: S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 15, 2015 Received: December 16, 2015
Dear Ms. Scott:
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.
1
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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
UNKNOWN
Device Name
S-scan
Indications for Use (Describe)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images
can provide diagnostically useful information.
Type of Use (Select one or both, as applicable)
X 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)
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510(k) Submission S-scan Esaote, S.p.A.
Special 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.
Submitter Information
Esaote S.p.A. Via Siffredi 58 16153 Genova - Italy
Contact Person:
Allison Scott, RAC Managing Regulatory Consultant Tel. 317.228.8719 Fax 317.228.8701 allison.scott@navigant.com
| Date: | October 15, 2015 |
|---|---|
| Tradename: | S-scan |
| Common name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name: | Radiology |
| Classification Number: | 90LNH |
Predicate Devices
| Trade name | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A | K151668 |
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A | K080968 |
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Device Description
MRI Dynamic Analysis Plus is the Esaote commercial name of a software option intended for use on S-scan Esaote MRI systems; this option allows the extension of the functionalities of the option MRI Dynamic Analysis (cleared for S-scan K080968). MRI Dynamic Analysis enables the acquisition of a set of dynamic images and subsequent display of the time varying signals that is due to absorption of the contrast agent over time in the image series acquired. The software described above provides values of signal intensity over time and calculates the interpolation curve of these values, the maximum slope and the asymptotic value. The MRI Dynamic Analysis Plus software option has been implemented to enhance the performance of the MRJ Dynamic Analysis in terms of ease of use, reliability (operator independence) of the uptake-curves calculation, productivity and robustness. The MRI Dynamic Analysis Plus software option enhances performance of the existing MRI Dynamic Analysis (K080968) software in the following regard:
- Evolution of the available and consolidated Uptake Curve ●
- . Enabled by the options «MRI Dynamic Analysis» + «MRI Dynamic Analysis Plus»
- . Reliability (Operator independence) - Curve is automatically evaluated pixel on the whole image, instead of on an averaged ROI
- . Productivity - An intensity reference on images (vial placed alongside the wrist) is no more required
- . Robustness - Image data in extended scale is used, that is before "intensity normalization", in order to eliminate RF perturbations effects and to ensure that the pixel intensities along different series of dynamic examination are homogenous
Intended Use
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
Technological Characteristics
The technological characteristics of the S-scan systems with the addition of the MRI Dynamic Analysis Plus software option, reflected in this Special 510(k), do not alter the scientific technology of the S-scan system and are substantially equivalent to those of the predicate devices.
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Summary of Non-Clinical Tests
The devices have been evaluated for biocompatibility, electrical, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.
- . IEC 60601-1
- IEC 60601-1-2 ●
- IEC 60601-1-6 ●
- IEC 60601-2-33 ●
- IEC62304
- IEC62366 ●
- ISO10993-1
- NEMA MS-1 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic ● Resonance Imaging
- NEMA MS-3 Determination of Image Uniformity in Diagnostic Resonance ● Images
Summary of Clinical Tests
No clinical tests were performed.
Conclusion
The changes proposed to the S-scan System are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.