(34 days)
No
The document describes performance improvements and new features related to image acquisition, processing, and workflow management, but none of the listed modifications or descriptions explicitly mention or imply the use of AI or ML technologies. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is intended for imaging and providing diagnostically useful information, not for treatment or therapy.
Yes
The S-scan system produces images (e.g., cross-section images of limbs, joints, and spinal column) using magnetic resonance. These images, when interpreted by a medical expert, are explicitly stated to "provide diagnostically useful information." This indicates its role in aiding diagnosis.
No
The device description explicitly states it is a Magnetic Resonance (MR) system, which is a hardware-based imaging modality. The modifications listed are improvements to the system's performance, including hardware-related aspects like patient positioning kits and coil usage, in addition to software updates.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The S-scan is a Magnetic Resonance (MR) system. It produces images of internal body structures (limbs, joints, spinal column) by using magnetic fields and radio waves. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use clearly states it is 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column." This is consistent with an imaging device, not an IVD.
- Device Description: The description focuses on the technical aspects of the MR system and modifications to improve performance, all related to image acquisition and processing, not analysis of biological specimens.
Therefore, the S-scan is an imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 the use of MR equipment, the images can provide diagnostically useful information.
Product codes
LNH
Device Description
The changes performed on the modified S-scan device, with respect to the cleared version – S-scan K110802 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
- A new step for patient positioning.
- A kit for patient positioning during hip examination using 4-channels lumbar spine coil 17 and 18.
- Geometric distortion correction.
- FSE parameters optimization
- FSE acceleration and improving.
- FSE sampling frequency management.
- Streaming acquisition performance increasing.
- Configurable send and export of XBONE echoes.
- Environment for the management of the virtual film.
- Data matching for patient coming from a worklist server.
- SpeedUp technique introduction, cleared via K120748.
- A new software version.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
limbs, joints and spinal column, upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, lower limb, including the foot, ankle, calf, knee, thigh and hip, temporomandibular joint, cervical spine, lumbar spine sections.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in the use of MR equipment / 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
9 2012 JUL
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Submitter Information
Donatella Ragghianti Esaote, S.p.A. Via Siffredi 58 Genova 16153 Italy
Contact Person: Allison Scott, RAC P: 317.569.9500 x106 F: 317.569.9520 ascott@ansongroup.com
June 1, 2012 Date:
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 | Manufacturer | K number |
|---|---|---|---|---|---|
| S-scan | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | ESAOTE S.P.A. | K110802 |
1
Device Description
The changes performed on the modified S-scan device, with respect to the cleared version – S-scan K110802 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
-
- A new step for patient positioning.
-
- A kit for patient positioning during hip examination using 4-channels lumbar spine coil 17 and 18.
-
- Geometric distortion correction.
-
- FSE parameters optimization
.
.
-
- FSE acceleration and improving.
-
- FSE sampling frequency management.
-
- Streaming acquisition performance increasing.
-
- Configurable send and export of XBONE echoes.
-
- Environment for the management of the virtual film.
-
- Data matching for patient coming from a worklist server.
- SpeedUp technique introduction, cleared via K120748.
-
- A new software version.
Intended Use(s)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 the use of MR equipment, the images can provide diagnostically useful information.
Technological Characteristics
The changes to the S-scan system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K110802.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Esaote S.p.A % Ms. Allison Scott, RAC Regulatory Associate · Anson Group, LLC 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K121650
Trade/Device Name: S-Scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 1, 2012 Received: June 5, 2012
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of t
9 2012 JUL
3
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: S-Scan MR System
Indications for Use:
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and 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 of the temporomandibular joint and imaging the cervical spine and the lumbar spine 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 the use of MR equipment, the images can provide diagnostically useful information.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
(Division Sign-C
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
919K K121650
S-Scan E-MRI Brio 2.0 510(k)