(57 days)
Not Found
No
The summary describes a standard MR imaging system and a new coil. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
The device produces images that provide "diagnostically useful information" when interpreted by a medical expert. Its purpose is to image internal structures for medical evaluation, fitting the definition of a diagnostic device.
No
The device description explicitly states that S-scan is a Magnetic Resonance (MR) system and describes a physical coil (Temporomandibular Coil) as a component being added. This indicates the device includes hardware.
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 S-scan system and its temporomandibular coil are used for in vivo imaging. They produce images of the internal structures of the patient's body using magnetic resonance technology. This is a non-invasive imaging technique performed directly on the patient, not on a sample taken from the patient.
- Intended Use: The intended use clearly states "MR imaging of the temporomandibular joint" and other anatomical sites. This is a diagnostic imaging procedure, not an in vitro test.
Therefore, the S-scan system with the temporomandibular coil falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The S-scan Temporomandibular Coil is to be used in MR imaging of the temporomandibular joint.
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. S-scan 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 (TI), 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
MOS
Device Description
S-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
This 510(k) is to add the Temporomandibular coil. This is a single channel surface receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's temporomandibular joint; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Temporomandibular joint, limbs, joints, spinal column, hand, wrist, forearm, elbow, arm, shoulder, foot, ankle, calf, knee, thigh, hip, cervical spine, lumbar spine.
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
Non-clinical testing of the S-scan system with the addition of the Temporomandibular Coil demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K110373
APR - 6 2011
510(k) Summary Temporomandibular coil 15 Esaute, 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
Donatella Ragghianti Esaote S.p.A. Via Siffredi 58 Genova 16153 Italy
| Contact Person: | Allison Scott, RAC |
|---|---|
| Phone: | (317) 569-9500 x 106 |
| Facsimile: | (317) 569-9520 |
| ascott@ansongroup.com | |
| Date: | February 7, 2011 |
| Trade Name: | Temporomandibular Coil 15 |
| Common Name: | Coil, Magnetic Resonance, Specialty |
| Classification Name(s): | Magnetic resonance diagnostic device |
| Classification Number: | 90MOS |
Predicate Device(s)
| Tradename | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| S-scan | System, nuclear | ||||
| magnetic resonance | |||||
| imaging | II | LNH | Esaote S.p.A. | K080968 | |
| Magnetom | |||||
| Avanto 1.5 T | |||||
| Loop coil | Coil, Magnetic | ||||
| Resonance, Specialty | II | MOS | SIEMENS AG | ||
| MEDICAL | |||||
| SOLUTIONS | K070629 |
1
510(k) Summary Temporomandibular coil 15 Esaote, S.p.A.
Device Description
S-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
This 510(k) is to add the Temporomandibular coil. This is a single channel surface receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's temporomandibular joint; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
Intended Use(s)
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
S-scan 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.
Technological Characteristics
The technological characteristics of the S-scan system with the addition of the Temporomandibular Coil, reflected in this Traditional 510(k), are substantially equivalent to those of the predicate devices.
Performance Data
Non-clinical testing of the S-scan system with the addition of the Temporomandibular Coil demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Esaote, S.p.A. % Ms. Allison Scott, RAC Official Correspondent The Anson Group 11460 N Meridian St., Ste 150 CARMEL IN 46032
APR - 6 2011
Re: K110373
Trade/Device Name: Temporomandibular coil 15 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 7, 2011 Received: February 8, 2011
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. 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Temporomandibular coil 15
Indications for Use:
The S-scan Temporomandibular Coil is to be used in MR imaging of the temporomandibular joint.
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. S-scan 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 (TI), 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)
Mary Stoll
Page 1 of 1
Division of Radiological Office of In Vitro
510K K110323
TemporomandIbular Coil 510(k)