(25 days)
Unknown
The feature "AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)" could potentially utilize AI/ML for image analysis and positioning, but the description is not detailed enough to confirm this. The document does not explicitly mention AI, ML, or related terms.
No
The device is described as an MR system that produces images for diagnostic purposes, not for treating conditions or diseases.
Yes
The "Intended Use / Indications for Use" section states that the images produced by the device, "When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information." This explicitly indicates its role in providing information for diagnosis.
No
The device description explicitly states that O-scan is a Magnetic Resonance (MR) system, which is a hardware device. The 510(k) is for software modifications to an existing MR system.
Based on the provided text, 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 O-scan is a Magnetic Resonance (MR) system. It produces images of limbs and joints by detecting the spatial distribution of protons within the body. This is an in vivo imaging technique, meaning it is performed on a living organism, not on a specimen outside the body.
- Intended Use: The intended use is to produce images that, when interpreted by a medical expert, can provide diagnostically useful information. This is consistent with medical imaging devices, not IVDs.
Therefore, the O-scan is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
LNH
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:
-
- AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
-
- 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)
-
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical expert trained in 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
No clinical tests are included within this submission.
Key Metrics
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K183685
Device Name O-Scan
Indications for Use (Describe)
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 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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3
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 | Product
code | Manufacturer | K
number |
|------------|-----------------------------------------------|-------|-----------------|---------------|-------------|
| O-scan | System, nuclear magnetic
resonance imaging | II | LNH | ESAOTE S.P.A. | K092469 |
Reference Device(s)
| ACHIEVA
1.0T | System, nuclear magnetic
resonance Imaging | II | LNH | PHILIPS MEDICAL
SYSTEMS | K052078 |
|-----------------|-----------------------------------------------|----|-----|----------------------------|---------|
| G-scan Brio | System, nuclear magnetic
resonance imaging | II | LNH | ESAOTE S.P.A. | K180592 |
4
510(k) Summary O-scan Esaote S.p.A.
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:
-
- AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist)
-
- 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 ●
5
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.