(22 days)
No
The document describes modifications to hardware components (magnet poles, gradient coils, receiving coils), safety features, and pulse sequences. While a new software release is mentioned, there is no indication or description of AI/ML capabilities within the software or the device's function. The focus is on image acquisition and interpretation by a medical expert.
No
The device is an MR system intended for diagnostic imaging to provide information to a medical expert, not for therapeutic purposes.
Yes
The device produces images that, when interpreted by a medical expert, can provide diagnostically useful information. It is an MR system primarily used for imaging internal structures of limbs, joints, and the spinal column, which is a common diagnostic tool.
No
The device description explicitly lists multiple hardware components that have been modified or added, such as magnet poles, gradient coils, receiving coils, safety devices, and patient table accessories. While there is a new software release, the device is clearly a physical MR system with associated hardware.
Based on the provided information, the G-scan device is not an In Vitro Diagnostic (IVD).
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.
- G-scan's Function: The G-scan is a Magnetic Resonance (MR) system. It produces images of the internal structures of the patient's body (limbs, joints, spinal column) by using magnetic fields and radio waves. It does not analyze 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 and imaging the cervical spine and the lumbar spine sections as portions of the spinal column." This is direct imaging of the patient's anatomy, not analysis of biological samples.
Therefore, the G-scan falls under the category of an imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
G-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 and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
G-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
G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K042236 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
-
- A modified version of the magnet poles and of the gradient coils.
-
- New receiving coils.
-
- Modified pulse sequences.
-
- A new Emergency button procedure.
-
- A new safety device named sensitive edge.
-
- A new safety switch named "Bed in"
-
- A hand protection for patient table.
-
- A head protection for patient table.
-
- An exam positioning indicator kit for patient table.
-
- A new step for patient positioning.
-
- Contraindications have been added in the user manual due to the possibility of patient syncope caused by protracted orthostatic positions required for the examination.
-
- A new software release.
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. 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 and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in the 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)
Not Found
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.
0
510(k) Summary G-Scan Esaote S.p.A.
FEB 17 2011
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
Date: January 21, 2011 Trade Name: G-Scan Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s): Magnetic Resonance Diagnostic Device Classification Number: aornia
Predicate Device(s)
| Trade Name | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| G-scan | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | ESAOTE S.P.A | K042236 | |
| S-scan | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | ESAOTE S.P.A. | K080968 | |
| O-scan | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | ESAOTE S.P.A. | K092469 |
1
Device Description
G-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
The changes performed on the modified G-scan device, with respect to the cleared version – G-scan K042236 –, are due to the improvement of the system safety and performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
-
- A modified version of the magnet poles and of the gradient coils.
-
- New receiving coils.
-
- Modified pulse sequences.
-
- A new Emergency button procedure.
-
- A new safety device named sensitive edge.
-
- A new safety switch named "Bed in"
-
- A hand protection for patient table.
-
- A head protection for patient table.
-
- An exam positioning indicator kit for patient table.
-
- A new step for patient positioning.
-
- Contraindications have been added in the user manual due to the possibility of patient syncope caused by protracted orthostatic positions required for the examination.
-
- A new software release.
Intended Use(s)
G-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 imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
G-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 G-scan system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the G-scan system, the predicate device, cleared via K042236.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus is made up of three wavy lines that represent the three branches of government: the executive, legislative, and judicial.
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 c/o Ms. Allison Scott Regulatory Associate Anson Group, LLC 11460 N Meridian Street, Suite 150 CARMEL IN 46032
FEB 1 7 201
Re: K110238
Trade Name: G-Scan Regulation Number: 21 CFR & 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 21, 2011 Received: January 26, 2011
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
3
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/ReportalProblem/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,
Mary S Postel
Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
KI10238
Indications for Use
510(k) Number (if known):
Device Name: G-Scan MR System
Indications for Use:
G-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 and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
G-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) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hld o thu
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitra Diagnostic Device Evaluation and Safety
510K K110238
Esaote, S.p.A.
G-Scan Special 510(k)
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