(16 days)
No
The summary describes a standard MR system and the addition of new coils, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as an imaging system used to produce images for diagnostic purposes, not for treating any condition or disease.
Yes
The device is described as producing images that, when interpreted by a medical expert, can "provide diagnostically useful information." This explicitly states its role in diagnosis.
No
The device is described as a Magnetic Resonance (MR) system and includes the addition of physical coils (4-channels Lumbar Spine coils 17 and 18), indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The S-scan is a Magnetic Resonance (MR) system that produces images of the internal structures of the patient's limbs, joints, and spinal column in vivo (within the body).
- The intended use and device description clearly state it's an imaging system. It produces images based on the magnetic resonance properties of protons within the body.
- There is no mention of analyzing biological specimens.
Therefore, the S-scan is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
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 4-channels Lumbar Spine coils 17 and 18. These are a four channels receiving coils, shaped for suitability to the areas under examination and designed to be matched to the patient's lumbo-sacral vertebrae; the coils are 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
limbs, joints and spinal column, upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, lower limb, including the foot, ankle, calf, knee, thigh and hip, cervical spine and the lumbar spine sections
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)
Non-clinical testing of the S-scan system with the addition of the 4-channels Lumbar Spine Coils 17 and 18 demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
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.
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.
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 4-channels Lumbar Spine Coils 17 and 18 Esaote, S.p.A.
APR - 8 2011
1108
p/2
22
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: | March 23, 2011 |
| Trade Name: | 4-channels Lumbar Spine Coils 17 and 18 |
| 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 |
1
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 4-channels Lumbar Spine coils 17 and 18. These are a four channels receiving coils, shaped for suitability to the areas under examination and designed to be matched to the patient's lumbo-sacral vertebrae; the coils are 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 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 addition of the 4-channels Lumbar Spine Coils 17 and 18 to the S-scan system, reflected in this Special 510(k), does not alter the fundamental scientific technology of the S-scan system cleared via K080968. The technological characteristics of the 4channels Lumbar Spine Coils 17 and 18 are based on the Hitachi Medical Corporation AIRIS Elite Rapid Body Coil (K050307).
Performance Data
Non-clinical testing of the S-scan system with the addition of the 4-channels Lumbar Spine Coils 17 and 18 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
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 Regulatory Consultant Anson Group 11460 N Meridian St., Suite 150 CARMEL IN 46032
APR - 8 2011
Re: K110802
Trade/Device Name: S-Scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 21, 2011 Received: March 23, 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. Iisting 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): K110802
Device Name: S-Scan
Indications for Use:
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 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.
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 In Vitro Diagnostic Devices (OIVD)
Mary S. Posth
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K160802
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