(27 days)
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan Opera MR 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 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.
The system is composed of these main parts:
- Patient positioning table.
- Magnetic unit with the display panel.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
- Electronics box with filter panel.
- Modular shielding box.
This 510(k) summary (K060956) is for the E-scan Opera, a Magnetic Resonance (MR) diagnostic device. It's important to note that this submission is a Special 510(k), meaning it's for modifications to an already cleared device (E-scan XQ K032121), and the changes do not affect the intended use or alter the fundamental scientific technology of the device.
Therefore, the submission focuses on demonstrating that the modified device remains substantially equivalent to the predicate devices and does not introduce new questions of safety or effectiveness. This type of submission typically relies on a comparison of technological characteristics with predicate devices rather than new clinical performance studies with specific acceptance criteria in the same way a de novo device might.
Based on the provided document, the acceptance criteria and study information typically sought for a new or significantly modified device's performance are not explicitly present or detailed because this is a Special 510(k) for minor modifications to an existing technology. The "study" here is essentially the comparison of technical specifications and demonstrating that the changes do not negatively impact performance or safety.
Here's an attempt to answer your questions based on what's available and the nature of a Special 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
For a Special 510(k) like this, specific "acceptance criteria" and "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are generally not required or presented in the same way as for a new device. The "performance" is inherently demonstrated by showing substantial equivalence to the predicate device, which has already established acceptable clinical performance.
The document highlights the changes and compares the technical characteristics of the E-scan Opera to its predicate devices (E-scan XQ K032121 and G-scan K042236, as well as MAGNETOM Vision K945517 for software features). The "acceptance criteria" are implied to be that these changes do not degrade the performance or safety of the device compared to the predicate, and in some cases, improve user experience (e.g., lower patient table).
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (E-scan Opera) |
|---|---|---|
| Patient Table | Max load capacity >= 200 kg; Removable from magnet; Rotatable section; Washable material; Manual positioning. | Max load-bearing capacity = 200 kg (approx. 440 lb); Fixed height (710 cm) (20cm lower than E-scan XQ); Removable from magnet cavity; One section can be rotated; Washable covering material; Manual positioning; Integrated in overall design. |
| Magnetic Unit Display Panel | Function for displaying real-time sequences for patient positioning (Preview, Abort). | Function of Display Panel is displaying real time sequences for patient positioning. Commands: Preview (begins real-time sequence and displays image on LCD panel), Abort (stops running sequence). (Comment: Unlike G-Scan, E-scan Opera has no motorized movement, so its display panel function is limited to verifying correct centering). |
| Electronics Box & Operating Console | Signals via fiber optic; Console powered by mains. | Signals from electronics box to operating console pass through a fiber optic cable; Operating console powered directly by mains. |
| Electronics Box | Unit to supply display/control panel. | ALDIM unit: supplies the Display Panel. (Comment: Contrasts with G-Scan's ALEL unit which also supplied CCE unit for motorized movement, which E-scan Opera does not have). |
| Software Reconstruction | Reconstruction process on Host/DSP. | Reconstruction process on Host instead of on DSP (same as G-scan K042236). |
| Software RF Saturation | Use of RF saturation pulses to suppress flow/motion artifacts; Pre-saturation regions arbitrarily locatable. | RF saturation pulses are used to suppress flow and motion artifacts. Pre-saturation regions may be arbitrarily located in any orthogonal or oblique orientation (same as MAGNETOM Vision K945517). |
| Software TR Setting | Method to avoid electrical/motion artifacts. | The Repetition Time (TR) of each sequence can be set using fixed step so that 50 or 60 Hz artifacts, caused by external magnetic fluctuation, can be avoided. (Comment: Analogous technique to MAGNETOM Vision's physiological control for heart artifacts, but applied to electrical interference). |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this type of submission. As a Special 510(k) for modifications that do not alter the fundamental scientific technology or intended use, a specific clinical "test set" with a defined sample size for performance evaluation (e.g., diagnostic accuracy) is not typically required or performed. The demonstration of substantial equivalence is based on engineering changes and comparisons to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No new clinical performance study requiring expert-established ground truth was detailed in this submission. The device relies on existing MR technology where "medical expert trained in the use of MR equipment" interpret images.
4. Adjudication method for the test set
Not applicable/Not provided. No new clinical performance study requiring adjudication was detailed.
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. This device is a basic MR imaging system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a basic MR imaging system, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For an MR imaging device, the "ground truth" for diagnostic purposes is typically pathology, surgical findings, or clinical follow-up as interpreted by human experts. However, no new clinical study requiring the establishment of ground truth for performance metrics was conducted or reported in this Special 510(k).
8. The sample size for the training set
Not applicable/Not provided. This submission does not involve a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.
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MAY 4 2006 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
| Carri Graham, Official Correspondent | |
|---|---|
| 11460 N. Meridian St., Suite 150 | |
| Carmel, IN 46032 | |
| Phone:(317) 569-9500 x103 | |
| Facsimile:(317) 569-9520 | |
| Contact Person: | Carri Graham |
| Date: | April 4, 2006 |
| 807.92(a)(2) | |
| Trade Name: | E-Scan Opera |
| Common Name: | System, Nuclear Magnetic Resonance Imaging |
| Classification Name(s): | Magnetic Resonance Diagnostic Device |
| Classification Number: | 90LNH |
| 807.92(a)(3) |
Predicate Device(s)
| Esaote | E-Scan XQ | K032121 |
|---|---|---|
| Siemens | Magnetom Vision | K945517 |
| Esaote | G-Scan | K042236 |
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807.92(a)(4)
Device Description
Summary of E-scan XQ modifications
The changes performed on the modified E-scan XQ device (E-scan Opera), with respect to the cleared version - E-scan XQ K032121 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:
-
- A lower patient table.
-
- A panel with a LCD screen on the front of the magnet.
- Some different external covers due to the patient table lowering and for renewing the equipment 3. aesthetics.
-
- Upgrading of the electronics.
-
- A new software release.
E-scan Opera
The system is composed of these main parts:
-
- Patient positioning table.
-
- Magnetic unit with the display panel.
- Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the 3. operating table.
-
- Electronics box with filter panel.
- ડ. Modular shielding box.
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807.92(a)(5)
Intended Use(s)
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan Opera MR 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 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.
807.92(a)(6)
Technological Characteristics
The modifications to the E-scan XQ system, reflected in this Special 510(k), do not alter the fundamental scientific technology of the system.
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:
| Characteristic | E-scan Opera | E-scan XQ K032121 | Comments |
|---|---|---|---|
| Patient table: | Maximum load-bearingcapacity = 200 kg (approx.440 lb)fixed height (710 cm)removable from magnetcavity to facilitate patientpositioningone section of the bed canbe rotated to enable variouspositions in relation to theregion examined (right orleft)washable covering materialmanual positioningintegrated in overall designof equipment. | Maximum load-bearingcapacity = 200 kg (approx.440 lb)fixed height (910 cm)removable from magnetcavity to facilitate patientpositioningone section of the bed can berotated to enable variouspositions in relation to theregion examined (right orleft)washable covering materialmanual positioningintegrated in overall designof equipment. | The patienttable of the E-scan Opera is20 cm lowerthan theunmodified E-scan XQpatient table toallow a moreeasy andcomfortablepatientpositioning(see DeviceModificationDescriptionsection). |
| Characteristic | E-scan Opera | G-scan K042236 | Comments |
|---|---|---|---|
| Magnetic unitdisplay panel: | The function of the DisplayPanel is displaying realtime sequences for patientpositioning.Present commands: | The function of the ControlPanel is managing themovement of the magnet andof the patient table anddisplaying real timesequences for patientpositioning.Besides the movementcommands the followingcommands are also present: | The E-scanOpera system,as theunmodified E-scan XQ, hasno motorizedmovement. Sothe function ofthe DisplayPanel is onlyverifying thecorrectcentering of theregion beingexamined (seeDeviceModificationDescriptionsection). |
| Preview: begins the realtime sequence and displaysthe acquired image on theLCD panel in the selectedorientation (sagittal, axial,coronal). | Preview: begins the real timesequence and displays theacquired image on the LCDpanel in the selectedorientation (sagittal, axial,coronal). | ||
| Abort: stops the runningsequence. | Abort: stops the runningsequence. |
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1
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| Characteristic | E-scan Opera | G-scan K042236 | Comments |
|---|---|---|---|
| Electronicsbox andoperatingconsole: | The signals from theelectronics box to theoperating console passthrough a fiber optic cable.The operating console ispowered directly by themains. | The signals from theelectronics box to theoperating console passthrough a fiber optic cable.The operating console ispowered directly by themains. | See DeviceModificationDescriptionsection. |
| Electronicsbox: | ALDIM unit: supplies theDisplay Panel. | ALEL unit: supplies theControl Panel and the CCEunit, which drives theelectric motor and activatesthe solenoid valves of thehydraulic circuit. | See DeviceModificationDescriptionsection. |
| SW version9.2A: | Reconstruction process onHost instead of on DSP. | Reconstruction process onHost instead of on DSP. | See SoftwareDescriptionsection. |
| Characteristic | E-scan Opera | MAGNETOM VisionK945517 | Comments |
|---|---|---|---|
| SW version9.2A: | RF saturation pulses areused to suppress flow andmotion artifacts. Pre-saturation regions may bearbitrarily located in anyorthogonal or obliqueorientation. | RF saturation pulses areused to suppress flow andmotion artifacts. Pre-saturation regions may bearbitrarily located in anyorthogonal or obliqueorientation. | See SoftwareDescriptionsection. |
| The Repetition Time (TR)of each sequence can beset using fixed step so that50 or 60 Hz artifacts,caused by externalmagnetic fluctuation, canbe avoided. | Physiologically controlledimaging: pseudogating isobtained with a TRcorresponding to the RRinterval in the cardiaccycle. This application isused to prevent flowartifacts (assuming a stableheart rate). | The sametechnique is usedto avoid ACpower lineartifacts (E-scanOpera) andmotion artifactscaused byheartbeat(MAGNETOMVision).See SoftwareDescriptionsection. |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter.
MAY 4 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Esaote, S.p.A. % Ms. Carrie Graham Consultant Anson Group, LLC 11460 N Meridian St., Ste 150 CARMEL IN 46032
Re: K060956
Trade/Device Name: E-scan Opera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 6, 2006 Received: April 7, 2006
Dear Ms. Graham:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/5/Picture/10 description: The image is a circular logo with the text "FDA Centennial 1906-2006" arranged around the perimeter. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are aligned beneath the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: E-scan Opera
Indications for Use:
E-scan Opera is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the leg, including the foot, ankle, calf, knee, thigh and hip.
E-scan Opera MR 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)
David R. Lyman
Page 1 of 1
(Division Sian-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
§ 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.