(65 days)
No
The document describes a standard MRI device and its intended use for diagnostic imaging. There is no mention of AI, ML, or advanced image processing techniques that would suggest the incorporation of such technologies. The described changes relate to physical improvements for patient comfort, not technological advancements in image analysis or interpretation.
No.
The device's intended use is for diagnostic nuclear magnetic resonance imaging, specifically to produce images for diagnostically useful information, not to treat or alleviate a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The E-Scan is intended for diagnostic nuclear magnetic resonance imaging..." and "If interpreted by a medical expert, these images can provide diagnostically useful information." The "Device Description" also clearly identifies it as a "Magnetic resonance diagnostic device."
No
The device description explicitly states it is a "Magnetic resonance diagnostic device" and a "System, Nuclear Magnetic Resonance Imaging," which are hardware-based imaging modalities. The changes described relate to the physical gantry for patient comfort, further indicating a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The E-Scan is a Magnetic Resonance Imaging (MRI) device. It uses magnetic fields and radio waves to create images of the internal structures of the body. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended use clearly states it's for "diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand." This involves imaging the patient directly, not analyzing samples taken from the patient.
Therefore, the E-Scan falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
Product codes
90 LNH
Device Description
The E-Scan is a Magnetic Resonance Diagnostic Device. The system commercialized under the trade name "E-Scan" was preliminarily named "Artoscan S". Changes were made to optimize the system, particularly relating to accessibility inside the gantry for greater patient comfort. The modified device's intended use and fundamental scientific technology remain unchanged.
Key specifications compared to the Artoscan S include:
-
slices per echo: 1 - 96 (vs 1 - 128)
- Homogeneity:
§ 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
MAY 2 7 1999
510(k) Summary E-Scan Biosound Esaote
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
| Colleen Hittle, Official Correspondent | |
|---|---|
| 8000 Castleway Drive | |
| Indianapolis, IN 46250 | |
| Phone: | (317) 849-1916 |
| Facsimile: | (317) 577-9070 |
| Contact Person: | Colleen Hittle |
| Date: | March 10, 1999 |
807.92(a)(2)
| Trade Name: | E-Scan |
|---|---|
| Common Name: | Magnetic resonance diagnostic device |
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging |
| Classification Number: |
807.92(a)(3)
Predicate Device(s)
| Esaote | Artoscan S | K981358 |
|---|---|---|
| -------- | ------------ | --------- |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
510(k) Summary E-Scan Biosound Esaote
807.92(a)(5)
Intended Use(s)
The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.
2
510(k) Summary E-Scan Biosound Esaote
| Item | Artoscan S | E-SCAN | Comments |
|---|---|---|---|
| # slices per | |||
| echo | 1 - 128 | 1 – 96 | |
| Homogeneity | Other | ||
| and to introduce the Arm | |||
| data. Now arm is included | |||
| in the standard and most | |||
| common districts to be | |||
| examined with E-scan | |||
| Installation | |||
| area | 3.7 x 3.7 sq. m. | Integrated shielding: 3.7 x | |
| 4 mt |
Shielding box: 4 x 4.5 sq.
m. (min height 2.4 m) | Variation due to the
industrialization of the
system. |
Comparison Chart for Substantial Equivalence
3
510(k) Summary E-Scan Biosound Esaote
Comparison Chart for Substantial Equivalence Continued
.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1099
Colleen Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, Indiana 46250 RE:
K990968 E-Scan Magnetic Resonance Diagnostic Device Dated: March 19, 1999 Received: March 23, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known):
K 99 0968
Device Name:
E-Scan
Indications for Use:
The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
✓
OR
Over-The-Counter Use
David U. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological I 510(k) Number