(99 days)
No
The document describes a standard MR imaging system and its modifications (new coils and expanded indications). There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of such technologies. The performance studies focus on safety standards, software verification, and image quality, without any metrics typically associated with AI/ML performance (e.g., AUC, sensitivity, specificity).
No
The device is described as an MR system producing images for diagnostic purposes, with no mention of therapeutic function.
Yes
The device produces images that, when interpreted by a medical expert, can provide "diagnostically useful information." This explicitly states its role in aiding diagnosis.
No
The device is described as a Magnetic Resonance (MR) system, which is a hardware-based imaging modality. The description also mentions physical components like coils (Shoulder Coil 20, Head Coil 16). While software is involved (as indicated by the mention of "software verification"), the core device is a hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body).
- This device is a Magnetic Resonance (MR) system. MR systems are imaging devices that produce images of the inside of the body in vivo (within the body) using magnetic fields and radio waves. They do not analyze samples taken from the body.
The intended use and device description clearly state that it produces images of various anatomical sites within the body for diagnostic purposes, which is characteristic of an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, limbs, joints and spinal column. It is intended for imaging the head, 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 lumbosacral sections as portions of the spinal column.
G-scan Brio 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.
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, 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 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 Brio 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
LNH, MOS
Device Description
The change performed on the modified G-scan Brio, with respect to the cleared version - G-scan Brio K142421 - are due to the improvement of the system performance. This modification is for the introduction of the new Shoulder Coil 20 code 130000014 (already cleared with S-scan K161238), the Head Coil 16 code 13000100, and the head indication for use.
The change performed on the modified S-scan, with respect to the cleared version – S-scan K161238 – are due to the improvement of the system performance. This modification is the introduction of the new Head Coil 16 code 13000100 and the head indication for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, limbs, joints, spinal column, upper limb (hand, wrist, forearm, elbow, arm, shoulder), lower limb (foot, ankle, calf, knee, thigh, hip), temporomandibular joint, cervical, thoracic, lumbosacral sections of the spinal column.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in 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)
Summary of Non-Clinical Tests:
The G-scan Brio and S-scan have been evaluated to demonstrate substantial equivalence related to biocompatibility, medical electrical equipment, risk management, software verification, and image quality and has 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
- ISO 14971
- ISO 62304
- IEC 62366
- NEMA MS-1
- NEMA MS-3
Summary of Clinical Tests:
Sample clinical images and attestation from a U.S. Board-Certified Diagnostic Radiologist that the images are of good diagnostic quality were provided as part of this submission.
Conclusion:
The non-clinical testing demonstrates that the G-scan are as safe, as effective, and performs as well as or better than the predicate. G-scan are substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
Esaote S.p.A % Allison Scott, RAC Managing Regulatory Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K161973
Trade/Device Name: G-scan Brio. S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Dated: September 23, 2016 Received: September 26, 2016
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. O'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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Indications for Use
510(k) Number (if known) K161973
Device Name G-scan Brio and S-scan
Indications for Use (Describe)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, limbs, joints and spinal column. It is intended for imaging the head, 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 lumbosacral sections as portions of the spinal column.
G-scan Brio 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.
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, 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 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 Brio 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary G-scan Brio and S-scan Esaote S.p.A.
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Submitter Information
Maria Marzapane Esaote, S.p.A. Via Siffredi 58 Genova 16153 Italy
-
Contact Person: Allison Scott, RAC P: 317.228.8719 F: 317.228.8701 Allison.Scott@navigant.com
Date: September 20, 2016 -
Trade Name: G-scan Brio and S-scan
-
Classification Panel: Radiology
-
Classification Name(s): Magnetic Resonance Diagnostic Device
-
LNH, MOS Classification Number:
Predicate Device(s)
| Trade Name | Common name | Class | Product
code | Manufacturer | K
number |
|-------------|-----------------------------------------------|-------|-----------------|---------------|-------------|
| G-scan Brio | System, nuclear magnetic
resonance imaging | II | LNH | ESAOTE S.P.A. | K142421 |
| S-scan | System, nuclear magnetic
resonance imaging | II | LNH | ESAOTE S.P.A. | K161238 |
Reference Device(s)
| Trade Name | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| IRIS II | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | Hitachi Medical | ||
| Systems America | K994378 | ||||
| MAGNETOM | |||||
| Concerto | System, nuclear magnetic | ||||
| resonance imaging | II | LNH | SIEMENS | K003192 |
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Device Description
The change performed on the modified G-scan Brio, with respect to the cleared version - G-scan Brio K142421 - are due to the improvement of the system performance. This modification is for the introduction of the new Shoulder Coil 20 code 130000014 (already cleared with S-scan K161238), the Head Coil 16 code 13000100, and the head indication for use.
The change performed on the modified S-scan, with respect to the cleared version – S-scan K161238 – are due to the improvement of the system performance. This modification is the introduction of the new Head Coil 16 code 13000100 and the head indication for use.
Intended Use(s)
G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging the head, 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.
G-scan Brio 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 "chift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging the head, 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 Brio 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.
5
Technological Characteristics
The technological characteristics of the G-scan Brio and S-scan systems with the addition of the Shoulder Coil 20, Head Coil 16, and Head indication, reflected in this 510(k), do not alter the scientific technology of the G-scan Brio and S-scan systems and are substantially equivalent to those of the predicate devices.
The Shoulder Coil 20 has been designed in order to have bigger dimension (to allow an increased number of possible patient examinations and an extra receiving channel) and increased image quality than the 2Ch Shoulder Coil 7 (already cleared for the G-scan Brio and S-scan systems). The Head Coil 16 has been designed in order to allow head imaging.
The 3Ch Shoulder Coil and 2Ch Shoulder Coil have a similar shape, can be tilted on their base to allow left or right shoulder examination and both are embraced by the patient during examination.
Summary of Non-Clinical Tests
The G-scan Brio and S-scan have been evaluated to demonstrate substantial equivalence related to biocompatibility, medical electrical equipment, risk management, software verification, and image quality and has 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
- ISO 14971
- ISO 62304
- IEC 62366
- NEMA MS-1 ●
- NEMA MS-3
Summary of Clinical Tests
Sample clinical images and attestation from a U.S. Board-Certified Diagnostic Radiologist that the images are of good diagnostic quality were provided as part of this submission.
Conclusion
The non-clinical testing demonstrates that the G-scan are as safe, as effective, and performs as well as or better than the predicate. G-scan are substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.