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.

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:

1. A new Bilateral TMJ Coil
1. Introduction of the thoracic spine section examination
1. A new software version including the following features:
- Customization of Image Enhancement ●
- Overlay sending to PACS
- Isotropic 3D acquisition ●

AI/ML Overview

This document describes a 510(k) submission for the Esaote S-Scan Magnetic Resonance (MR) system. The submission, K151668, pertains to improvements made to the S-Scan, specifically the introduction of a new Bilateral TMJ Coil, thoracic spine section examination, and new software features (Customization of Image Enhancement, Overlay sending to PACS, Isotropic 3D acquisition).

However, the provided text explicitly states that no clinical tests were performed to prove that the device meets acceptance criteria. Instead, the submission relies on the substantial equivalence to a previously cleared device, the G-Scan Brio (K142421), which already incorporated these changes.

Therefore, many of the requested details regarding acceptance criteria and a study proving their fulfillment cannot be extracted directly from this document.

Here's the information that can be gleaned and a table summarizing the explicitly requested points, with "N/A" where the information is not provided because no specific clinical study was conducted for this submission:

1. A table of acceptance criteria and the reported device performance

Since no new clinical tests were performed for this 510(k) submission, specific acceptance criteria and performance metrics for the S-Scan (K151668) are not detailed in the provided text. The submission argues that the changes do not alter the fundamental scientific technology and that the image quality performance has already been cleared via K142421 (G-Scan Brio).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A - No clinical tests were performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A - No clinical tests were performed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A - No clinical tests were performed for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A - This document describes an MR system, not an AI-assisted device. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A - This document describes an MR system, not an algorithm, and no standalone performance study was mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

N/A - No clinical tests were performed for this submission.

8. The sample size for the training set

N/A - No clinical tests or machine learning training were described for this submission.

9. How the ground truth for the training set was established

N/A - No clinical tests or machine learning training were described for this submission.

Summary Table:

Feature	Reported Information / Status
1. Acceptance Criteria & Device Performance	Acceptance Criteria: Not explicitly stated as new clinical tests were not performed for this submission. The submission relies on substantial equivalence to a previously cleared device (G-Scan Brio K142421). The "Indications for Use" section implies that the device must produce images that, "When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information." Reported Device Performance: The document states that "The image quality performance of the modified S-scan equipment has been cleared via G-scan Brio K142421." It asserts that S-scan and G-scan Brio have similar core components (magnet, RF and gradient coils, MRI sequences, software, and electronics).
2. Sample Size (Test Set) & Data Provenance	N/A - No clinical tests were performed for this 510(k) submission.
3. Number & Qualifications of Experts (Ground Truth)	N/A - No clinical tests were performed for this 510(k) submission.
4. Adjudication Method (Test Set)	N/A - No clinical tests were performed for this 510(k) submission.
5. MRMC Comparative Effectiveness Study (AI improvement)	N/A - Not applicable; this device is an MR system, not an AI-assisted diagnostic tool.
6. Standalone Algorithm Performance	N/A - Not applicable; this device is an MR system, not an algorithm.
7. Type of Ground Truth Used	N/A - No clinical tests were performed for this 510(k) submission. For the general functionality of an MR system, the ground truth would typically be established by diagnostic interpretation by trained medical experts (e.g., radiologists), potentially correlated with other imaging modalities or pathology if available.
8. Sample Size for Training Set	N/A - No clinical tests or machine learning training were described for this submission.
9. Ground Truth for Training Set Establishment	N/A - No clinical tests or machine learning training were described for this submission.

Summary

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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.

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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)

K151668

Device Name

S-Scan

Indications for Use (Describe)

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 ScottP: 317.228.8719F: 317.228.8701allison.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)

TradeName	Common Name	Class	ProductCode	Owner	510(k)
S-Scan	System, NuclearMagnetic ResonanceImaging;	Class II	LNH	EsaoteS.P.A.	K131996
G-Scan	System, NuclearMagnetic ResonanceImaging	Class II	LNH	EsaoteS.P.A.	K142421

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Device Description

1. A new Bilateral TMJ Coil
1. Introduction of the thoracic spine section examination
1. A new software version including the following features:
- Customization of Image Enhancement ●
- Overlay sending to PACS
- Isotropic 3D acquisition ●

Intended Use

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

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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.

Regulation Number and Section

§ 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.