(67 days)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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 the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral 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 spinlatice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
The change performed on the modified S-scan, with respect to the cleared version, S-scan K153039, is due to the improvement of the system performance. This modification, which does not affect the intended use or alter the fundamental scientific technology of the device, is the introduction of the Shoulder Coil 20 code 130000014. The Shoulder Coil N.20 is a three channels receiving coil. Its intended use is for shoulder examination on the S-scan. The Shoulder Coil is a wearable rigid coil equipped with an adaptor for fast placement in the patient table. The same adaptor matches for patient laterality (left /right shoulder).
This document, K161238, is a Special 510(k) submission for the ESAOTE S.p.A. S-scan Magnetic Resonance (MR) system, specifically regarding the addition of a new Shoulder Coil 20. The submission states that no clinical tests were performed to prove the device meets acceptance criteria. Instead, the submission relies on the concept of substantial equivalence to a previously cleared device (S-scan K153039) and non-clinical testing.
Therefore, many of the requested details related to acceptance criteria, device performance, and clinical study specifics are not available in this document.
However, based on the provided text, here's what can be extracted and inferred regarding the "study" that proves the device meets "acceptance criteria" through non-clinical means:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics for the device itself or the new shoulder coil. Instead, the "acceptance criteria" are implied to be adherence to recognized safety and performance standards and demonstrating improved image quality/performance of the new coil compared to the previous one.
| Acceptance Criteria (Implied) | Reported Device Performance (for Shoulder Coil 20) |
|---|---|
| Biocompatibility | Evaluated; found to conform to ISO10993-1 |
| Electrical safety | Evaluated; found to conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33 |
| Electromagnetic compatibility (EMC) | Evaluated; found to conform to IEC 60601-1-2 |
| Mechanical safety | Evaluated; found to conform to IEC 60601-1 |
| Software lifecycle process | Evaluated; found to conform to IEC62304 |
| Usability/Human factors | Evaluated; found to conform to IEC62366 |
| Risk management | Evaluated; found to conform to ISO 14971-2 |
| Image Quality: Signal-to-Noise Ratio (SNR) | Increased (compared to 2Ch Shoulder Coil 7) as per NEMA MS-1 standards. |
| Image Quality: Uniformity | Evaluated as per NEMA MS-3 standards. (Specific performance not detailed, but implied to be acceptable) |
| Increased number of possible patient examinations (due to coil size) | Designed to allow this |
| Increased receiving channels | 3 channels (compared to 2 channels in the previous coil) |
| Substantial Equivalence to Predicate Device (S-scan K153039) | Claimed and accepted by FDA. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical tests were performed with human subjects. The "test set" here refers to non-clinical evaluations against engineering standards and specifications within the manufacturer's testing environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as no clinical data or expert consensus was used for ground truth in this non-clinical submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical data requiring expert adjudication was involved.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. This submission is for an MR system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The S-scan is a diagnostic imaging system, not an algorithm. Its performance is evaluated based on its ability to produce diagnostically useful images when interpreted by a medical expert. The "standalone" performance here refers to the engineering validation of the system and its components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was based on established engineering and safety standards and specifications. For example, the Signal-to-Noise Ratio (SNR) was determined according to NEMA MS-1, and image uniformity according to NEMA MS-3. These standards define the acceptable performance characteristics for MR devices.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this submission, as it does not involve machine learning or artificial intelligence.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
ESAOTE S.p.A. % Ms. Allison Scott Senior Regulatory Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268
Re: K161238
Trade/Device Name: S-scan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 8, 2016 Received: June 9, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Odle
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161238 UNKNOWN
Device Name
S-Scan
Indications for Use (Describe)
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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 the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral 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 spinlatice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Submission S-scan Esaote, S.p.A.
Special 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.
Submitter Information
Esaote S.p.A. Via Siffredi 58 16153 Genova - Italy
Contact Person: Allison Scott, RAC Senior Regulatory Consultant Tel. 317.228.8719 Fax 317.228.8701 allison.scott@navigant.com
June 9, 2016 Date:
Tradename: S-scan
Classification Name: Magnetic Resonance Diagnostic Device
Classification Panel: Radiology
Classification Number: 90LNH
Predicate Devices
| Trade name | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| S-scan | System, nuclear magnetic resonance imaging | II | LNH | ESAOTE S.P.A | K153039 |
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510(k) Submission S-scan Esaote, S.p.A.
Device Description
The change performed on the modified S-scan, with respect to the cleared version, S-scan K153039, is due to the improvement of the system performance. This modification, which does not affect the intended use or alter the fundamental scientific technology of the device, is the introduction of the Shoulder Coil 20 code 130000014. The Shoulder Coil N.20 is a three channels receiving coil. Its intended use is for shoulder examination on the S-scan. The Shoulder Coil is a wearable rigid coil equipped with an adaptor for fast placement in the patient table. The same adaptor matches for patient laterality (left /right shoulder).
Intended Use
S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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 the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral 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 spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.
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510(k) Submission S-scan Esaote, S.p.A.
Technological Characteristics
The technological characteristics of the S-scan systems with the addition of the Shoulder Coil 20 option, reflected in this Special 510(k), do not alter the scientific technology of the S-scan system and are substantially equivalent to those of the predicate devices.
The Shoulder Coil 20 has been designed in order to have bigger dimension (to allow an increased number of possible patient examinations and an extra receiving channel) and increased image quality than the 2Ch Shoulder Coil 7 (already cleared for the S-scan system).
The 3Ch Shoulder Coil and 2Ch Shoulder Coil have a similar shape, can be tilted on their base to allow left or right shoulder examination and both are embraced by the patient during examination.
Summary of Non-Clinical Tests
The devices have been evaluated for biocompatibility, electrical, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.
- IEC 60601-1 ●
- IEC 60601-1-2 ●
- IEC 60601-1-6 ●
- IEC 60601-2-33 ●
- IEC62304 ●
- IEC62366 ●
- ISO10993-1 ●
- ISO 14971-2 ●
- NEMA MS-1 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic ● Magnetic Resonance Imaging
- NEMA MS-3 Determination of Image Uniformity in Diagnostic Magnetic ● Resonance Images
Summary of Clinical Tests
No clinical tests were performed.
Conclusion
The changes proposed to the S-scan System are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.
§ 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.