O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nucleus 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 on the modified O-scan, with respect to the cleared version – O-scan K092469 are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

A new Software version (EVO'18) including the following features:
- 1. AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
- 1. 3D Viewer; this is an option that starting from the acquired data cube allows the running of a 3D viewer in which to reconstruct the desired 3D series, both using the three projections of the acquired package and generating a special MPR curve as reference. (Previously cleared by FDA via K180592 on G-Scan Brio)

AI/ML Overview

This FDA 510(k) summary for the Esaote O-Scan device does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness in a clinical setting.

The submission focuses on establishing substantial equivalence to previously cleared devices based on software modifications and compliance with safety standards rather than clinical performance claims.

Here's a breakdown of the requested information based on the provided text:

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

No acceptance criteria for diagnostic performance or reported clinical device performance are mentioned in this document. The submission states "No clinical tests are included within this submission."

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

Not applicable. No clinical tests or test sets are described.

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)

Not applicable. No clinical tests or ground truth establishment for a test set are described.

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

Not applicable. No clinical tests or adjudication methods are described.

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

Not applicable. No MRMC study is mentioned. The software modifications are described as improvements for display, analysis, and comparison, but no quantification of reader improvement is provided. The document mentions "AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)" and "3D Viewer," which might relate to AI or image processing, but no comparative effectiveness study with human readers is presented.

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

Not applicable. No standalone algorithm performance study is mentioned. The device is an MR system that produces images "When interpreted by a medical expert trained in use of MR equipment."

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

Not applicable. No ground truth for clinical performance is described.

8. The sample size for the training set

Not applicable. No training set for a clinical performance study is described.

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

Not applicable. No ground truth for a training set is described.

Summary of what the document does include regarding device evaluation:

The submission focuses entirely on non-clinical tests to demonstrate substantial equivalence:

Software Verification: The new software version (EVO'18) with AGilExam and 3D Viewer features was evaluated for verification.
Compliance with Safety Standards: The O-Scan was found to conform to various medical device safety standards, including:
- IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-6 (Usability)
- IEC 60601-2-33 (Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis)
- ISO 14971 (Medical devices - Application of risk management to medical devices)
- ISO 62304 (Medical device software - Software life cycle processes)
- IEC 62366 (Medical devices - Application of usability engineering to medical devices)
- NEMA MS-1 (Magnetic Resonance Terminology)
- NEMA MS-3 (Quality Control Procedures for Magnetic Resonance Imaging Devices)

The conclusion states that "The non-clinical testing demonstrates that the O-Scan is as safe, as effective, and performs as well as or better than the predicate." This "effectiveness" is inferred from compliance with standards and the nature of the software modifications, not from clinical performance data.

Summary

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January 22, 2019

Esaote S.p.A % Allison Scott, RAC Associate Director Navigant Consulting, Inc 9100 Keystone Crossing, Suite 500 INDIANAPOLIS IN 46240

Re: K183685

Trade/Device Name: O-Scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: December 27, 2018 Received: December 28, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K183685

Device Name O-Scan

Indications for Use (Describe)

protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spinlattice relaxation time (T1), spin-spin relaxation time (T2), nucleus 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)

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510(k) Summary O-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

Esaote, S.p.A. Via E. Melen 77 Genoa 16152 Italy

Allison Scott, RAC Contact Person: P: 317.272.5419 F: 317.217.5361 Allison.Scott@navigant.com

Date: December 21, 2018

Trade Name: O-scan

Classification Panel: Radiology

Classification Name(s): Magnetic Resonance Diagnostic Device

90LNH Classification Number:

Predicate Device(s)

Trade Name	Common name	Class	Productcode	Manufacturer	Knumber
O-scan	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K092469

Reference Device(s)

ACHIEVA1.0T	System, nuclear magneticresonance Imaging	II	LNH	PHILIPS MEDICALSYSTEMS	K052078
G-scan Brio	System, nuclear magneticresonance imaging	II	LNH	ESAOTE S.P.A.	K180592

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510(k) Summary O-scan Esaote S.p.A.

Device Description

A new Software version (EVO'18) including the following features:
- 1. AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
- 1. 3D Viewer; this is an option that starting from the acquired data cube allows the running of a 3D viewer in which to reconstruct the desired 3D series, both using the three projections of the acquired package and generating a special MPR curve as reference. (Previously cleared by FDA via K180592 on G-Scan Brio)

Intended Use(s)

O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spin-lattice relaxation time (T1), spinspin relaxation time (T2), nucleus 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.

Technological Characteristics

The technological characteristics of the O-scan systems with the addition of AgilExam and 3D Viewer, reflected in this 510(k), do not alter the scientific technology of the O-Scan systems and are substantially equivalent to those of the predicate devices. The modification are implemented in order to improve display, analysis and comparison of Magnetic Resonance images.

Summary of Non-Clinical Tests

The O-Scan has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, and software verification 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 ●

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510(k) Summary O-scan Esaote S.p.A.

Summary of Clinical Tests

No clinical tests are included within this submission.

Conclusion

The non-clinical testing demonstrates that the O-Scan is as safe, as effective, and performs as well as or better than the predicate. O-Scan is substantially equivalent to the legally marketed devices and conforms 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.