(11 days)
Not Found
No
The summary describes a standard MR system and a receiving coil. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No
The device is an MR imaging system and a coil for it, intended for diagnosis by producing images, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images produced by the device, "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." This indicates its purpose is to aid in diagnosis.
No
The device description explicitly details a physical component, the "DPA Shoulder Coil," which is a hardware receiving coil used with an MR system. This indicates the device is not software-only.
Based on the provided information, 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 XQ is a magnetic resonance (MR) system that produces images of the limbs and joints. It works by using magnetic fields and radio waves to create images of the internal structures of the body.
- Nature of the Output: The output of the device is images, which are then interpreted by a medical expert. This is a form of in vivo imaging, meaning it is performed on a living organism.
Therefore, since the device operates on the patient directly to produce images rather than analyzing samples taken from the patient, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique images of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ 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.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
The DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving coil and is the result of the combination of two different coils. The first is coil designed to be "wom" by are patient and lonected in a series with 4 tuning capacitors positioned under the the printary con and is composed of - cans ocists of 3 turns designed to improve the image homogenery and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder; Lower limb, including the foot, ankle, calf, knee, thigh and hip.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical expert trained in the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032121, K990968, K001894, K012728
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary E-scan XQ Biosound Esaote
MAY 1 4 2004
K041145
Page 1 of 3
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
8000 Castleway Drive
Indianapolis, IN 46250
(317) 849-1916
Phone:
(317) 577-9070
| Facsimile: | ||||
|---|---|---|---|---|
| Carri Graham | ||||
| Contact Person: | ||||
| Date: | April 30, 2004 | |||
| 807.92(a)(2) | ||||
| Trade Name: | E-Scan XQ | |||
| Common Name: | Magnetic resonance diagnostic device | |||
| Classification Name(s): | System, Nuclear Magnetic Resonance Imaging | |||
| Classification Number: | 90LNI-I | |||
| 807.92(a)(3) | Predicate Device(s) | |||
| Esaote | E-Scan | K990968 | ||
| Esaote | E-Scan | K001894 | ||
| Esaote | Hip Coil | K012728 | ||
| Esaote | E - Scan XQ | K020164 | ||
| Esaote | E-Scan XQ | K032121 |
1
510(k) Summary E-scan XQ Biosound Esaote
K041145
Pengelup
01.92(a)(4)
Device Description
The DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving THE DF A Shoulder Con is to be asou with and is the result of the combination of two different coils. The first is con designed to be "wom" by are patient and lonected in a series with 4 tuning capacitors positioned under the the printary con and is composed of - cans ocists of 3 turns designed to improve the image homogenery and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.
807.92(a)(5)
Intended Use(s)
E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique L-scall AQ is a maginent resumbled for imaging the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the lower limb, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ 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 magine resolutios proportion (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a I II, Spin Telandien and ( of MR equipment, the images can provide diagnostically useful information.
2
Image /page/2/Picture/0 description: The image contains text that appears to be from a document. The text includes "510(k) Summary", "E-scan XQ", and "Biosound Esaote". There is also some illegible handwriting on the right side of the image.
807.92(a)(6)
Technological Characteristics
Comparison to the cleared device E-scan XQ K032121
| Characteristics | E-scan XQ
K032121 | Modified
E-scan XQ | Comments |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DPA receiving
coils | 2 Knee coil: 22.5 x
21.0 x 18.3 cm (h x w x d) external; 14.3 x
16.0 x 18.3 cm (h x w x d) internal
3 Hand coil: 17.8 x
17.5 x 20 cm (h x w x
d) external; 11.9 x 7.2
x 20 cm (h x w x d)
internal
4 Foot/Ankle coil: 22.0
x 19.2 x 28.5 cm (h x
w x d) external; 14.6 x
10.0 x 28.5 cm (h x w
x d) internal | 2 Knee coil: 22.5 x
21.0 x 18.3 cm (h x w x d) external; 14.3 x
16.0 x 18.3 cm (h x w x d) internal
3 Hand coil: 17.8 x
17.5 x 20 cm (h x w x
d) external; 11.9 x 7.2
x 20 cm (h x w x d)
internal
4 Foot/Ankle coil: 22.0
x 19.2 x 28.5 cm (h x
w x d) external; 14.6 x
10.0 x 28.5 cm (h x w
x d) internal
7 Shoulder coil: 25.5 x
18.5 cm (larger
opening)
13.3 x 13.3 cm
(smaller opening) | The technological
characteristics of the
DPA 7 Shoulder coil
are similar to the
characterisitics of the
predicate device DPA
receiving coils.
The coil is designed to
be morphologically
adapted to the
examined area for
increasing the Signal-
to-Noise Ratio.
See section "DPA
Shoulder Coil
Description". |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
MAY 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Esaote S.p.A. % Ms. Carri Graham Official Correspondent The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K041145
Trade/Device Name: E-scan XQ MRI System Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 MOS Dated: April 30, 2004 Received: May 3, 2004
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 (PMA), 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.
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 clectronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050
4
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogden
Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
Indications for Use
510(k) Number (if known): ΚοΨ 114)
Device Name: E-scan XQ MR System
Indications for Use:
E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and L-scan AQ is a inaginene resources of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and maging portions of the apper will the lower limb, including the foot, ankle, calf, knee, thigh and hip.
E-scan XQ 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) AP/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 h. Lyonn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
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