(81 days)
No
The document describes improvements to system performance and software features like image enhancement customization and 3D acquisition, but there is no mention of AI or ML algorithms being used for image analysis, interpretation, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is an MR imaging system intended for diagnostic purposes, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "the images can provide diagnostically useful information" when interpreted by a medical expert. This indicates its role in aiding diagnosis.
No
The device description explicitly mentions hardware components, specifically a "new Bilateral TMJ Coil," indicating it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The intended use and device description clearly state that the S-scan is a Magnetic Resonance (MR) system that produces images of the limbs, joints, and spinal column. It works by detecting the spatial distribution of protons within the body, not by analyzing samples like blood, urine, or tissue outside the body.
- The output is images for interpretation. The device produces images that are then interpreted by a medical expert. IVDs typically provide results in the form of measurements, concentrations, or qualitative findings from a specimen analysis.
The S-scan is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo (within the living body) diagnostic imaging, not in vitro diagnostic.
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 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.
Product codes
LNH
Device Description
The changes performed to S-scan, with respect to the cleared version – S-scan K131996 – are due to the improvement of the system performance. These modifications, which do not alter the fundamental scientific technology of the device, are the following and all have been cleared with G-scan Brio via K142421:
-
- A new Bilateral TMJ Coil
-
- Introduction of the thoracic spine section examination
-
- A new software version including the following features:
- Customization of Image Enhancement ●
- Overlay sending to PACS
- Isotropic 3D acquisition ●
Mentions image processing
Customization of Image Enhancement
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
limbs, joints and spinal column. 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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
When interpreted by a 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)
Non-Clinical Tests: The devices have been evaluated for biocompatibility, 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 6060 1-2-33
- 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 Magnetic Resonance Images
Clinical Tests: No clinical tests were performed.
Key results: The image quality performance of the modified S-scan equipment has been cleared via Gscan Brio K142421. G-scan Brio and S-scan devices have the same magnet, the same RF and gradient coils, the same MRI sequences contained into the same software and similar electronics. The rotation movement of the G-scan Brio does not impact in any way the image quality, because a hydraulic mechanism rotates both the magnetic system and the patient table from horizontal to vertical position and therefore, during the MR examination, the electromagnetic configuration of the system remains the same. 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.
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
§ 892.1000 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 Department of Health & Human Services - USA. The logo is 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 right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2015
Esaote S.p.A. % Kelli Anderson, M.S., Regulatory Affairs Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K151668 Trade/Device Name: S-Scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 24, 2015 Received: June 25, 2015
Dear Ms. Anderson:
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)
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)
See PRA Statement on last page.
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)
FORM FDA 3881 (1/14)
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510(k) Submission S-Scan Esaote, S.p.A.
Traditional 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 Genova, Italy 16153
| Contact Person: | Allison Scott
P: 317.228.8719
F: 317.228.8701
allison.scott@navigant.com |
|-------------------------|-----------------------------------------------------------------------------------|
| Date: | August 27, 2015 |
| Trade Name: | S-Scan |
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name(s): | Magnetic Resonance Diagnostic Device |
Classification Number: 90LNH
Predicate Device(s)
| Trade
Name | Common Name | Class | Product
Code | Owner | 510(k) |
|---------------|---------------------------------------------------|----------|-----------------|------------------|---------|
| S-Scan | System, Nuclear
Magnetic Resonance
Imaging; | Class II | LNH | Esaote
S.P.A. | K131996 |
| G-Scan | System, Nuclear
Magnetic Resonance
Imaging | Class II | LNH | Esaote
S.P.A. | K142421 |
5
Device Description
The changes performed to S-scan, with respect to the cleared version – S-scan K131996 – are due to the improvement of the system performance. These modifications, which do not alter the fundamental scientific technology of the device, are the following and all have been cleared with G-scan Brio via K142421:
-
- A new Bilateral TMJ Coil
-
- Introduction of the thoracic spine section examination
-
- A new software version including the following features:
- Customization of Image Enhancement ●
- Overlay sending to PACS
- Isotropic 3D acquisition ●
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.
The indications for use statement has been updated to add the thoracic imaging capability.
Technological Characteristics
The changes to the S-scan system, reflected in this Traditional 510(k), do not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K131996.
Summary of Non-Clinical Tests
The devices have been evaluated for biocompatibility, 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 6060 1-2-33
6
510(k) Submission S-Scan Esaote, S.p.A.
- 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 Magnetic Resonance Images
Summary of Clinical Tests
No clinical tests were performed.
Conclusion
The image quality performance of the modified S-scan equipment has been cleared via Gscan Brio K142421. G-scan Brio and S-scan devices have the same magnet, the same RF and gradient coils, the same MRI sequences contained into the same software and similar electronics. The rotation movement of the G-scan Brio does not impact in any way the image quality, because a hydraulic mechanism rotates both the magnetic system and the patient table from horizontal to vertical position and therefore, during the MR examination, the electromagnetic configuration of the system remains the same.
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.