(27 days)
S-scan is a Magnetic Resonance (MR) system that produces transversal, 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 portions of the spinal column, including the cervical and lumbo-sacral sections.
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.
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 DPA cervical coil. This is a dual phased array receiving coil, shaped for suitability to the areas under examination and designed to the patient's cervical vertebrae.
This 510(k) summary is for the addition of a DPA cervical coil to the Esaote S-Scan MR System, not for a new device requiring a comprehensive study to prove its acceptance criteria. Therefore, the document primarily focuses on demonstrating substantial equivalence to a predicate device (K080968) rather than providing extensive details about a performance study with acceptance criteria in the manner requested.
Based on the provided text, a detailed table of acceptance criteria and reported device performance, or a standalone study as typically seen for new AI/CADe devices, is not present. The submission focuses on demonstrating that the addition of a new coil does not alter the fundamental scientific technology or intended use of the already cleared S-Scan system.
Here's an attempt to address your requests based only on the provided text, acknowledging that many points cannot be fully answered due to the nature of this particular 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a specific table detailing "acceptance criteria" for the device's diagnostic performance and "reported device performance" against those criteria. This 510(k) submission is for an accessory (DPA cervical coil) to an already cleared MR system (S-Scan, K080968). The primary "acceptance" is demonstrating that the new coil does not materially change the safety and effectiveness of the existing device.
The "performance" described is in the context of the overall S-Scan MR system, which "produces transverse, sagittal and oblique cross-section images of the limbs, joints and spinal column." The images "can provide diagnostically useful information when interpreted by a medical expert trained in the use of MR equipment." This implies that the image quality with the new coil is expected to be sufficient for expert interpretation, consistent with the predicate device.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy for the addition of the DPA cervical coil. This 510(k) focuses on the technological characteristics and substantial equivalence to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No test set requiring expert ground truth establishment is described for this 510(k) submission.
4. Adjudication method for the test set
Not applicable/Not provided. No test set requiring adjudication is described.
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
Not applicable. This device is a Magnetic Resonance (MR) system with an added coil, not an AI or CADe device. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MR imaging system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. As no specific clinical performance study with ground truth is described, this information is not available in the document. The general implication for the S-Scan system is that "diagnostically useful information" comes from images "interpreted by a medical expert trained in the use of MR equipment," suggesting clinical diagnosis as the ultimate truth.
8. The sample size for the training set
Not applicable/Not provided. This submission does not describe an algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of the Study (or lack thereof) Proving Acceptance Criteria:
The document states: "The addition of the DPA Cervical Spine Coil to the S-scan system... does not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K080968."
This statement is the core of the "proof" for this particular 510(k). The regulatory acceptance criteria for this submission are primarily met by demonstrating:
- Substantial Equivalence: The new DPA cervical coil, when added to the S-Scan system, is substantially equivalent to the predicate S-Scan system (K080968) in terms of its technological characteristics and intended use.
- No new questions of safety or effectiveness: The addition of the coil does not raise new questions of safety or effectiveness that were not addressed by the predicate device.
The study proving this involved a comparison of "Technological Characteristics" between the modified device (S-Scan with DPA cervical coil) and its predicate. This is typically achieved through engineering design verification and validation, ensuring that the new component integrates safely and produces images of comparable quality and diagnostic utility to what the original system was cleared for. No specific clinical trial or performance study with detailed metrics against acceptance criteria is described in this summary because the change is limited to an accessory and its impact on the fundamental technology.
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Kioo620
510(k) Summary S-Scan Esaote S.p.A.
APR - 5 2010
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 P: 317.569.9500 x106 F: 317.569.9520 ascott@ansongroup.com
.
Date: March 5, 2010 Trade Name: S-Scan . Common Name: System, Nuclear Magnetic Resonance Imaging Classification Name(s): Magnetic Resonance Diagnostic Device Classification Number: 90LNH
Predicate Device(s)
| Tradename | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| S-scan | System, nuclear magneticresonance imaging | II | LNH | ESAOTE S.P.A. | K080968 |
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510(k) Summary S-Scan 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 DPA cervical coil. This is a dual phased array receiving coil, shaped for suitability to the areas under examination and designed to the patient's cervical vertebrae.
Intended Use(s)
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal 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 portions of the spinal column, including the cervical and lumbo-sacral sections.
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 DPA Cervical Spine Coil to the S-scan system, reflected in this Special 510/k), does not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K080968.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
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
APR - 5 2010
Esaote S.p.A. % Ms. Allison Scott, RAC Regulatory Associate Anson Group, LLC 11460 N. Meridian Street, Suite 150 CARMEL IN 46032
Re: K100670
Trade/Device Name: Esaote S-Scan MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 5, 2010 Received: March 9, 2010
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
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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.
Donald J. Trump
Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100670
Device Name: Esaote S-Scan MR System
Indications for Use:
"S-scan is a Magnetic Resonance (MR) system that produces transversal, 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 portions of the spinal column, including the cervical and lumbo-sacral sections.
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 In Vitro Diagnostic Devices (OIVD) | |
|---|---|
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
1100670 510(k) Number
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§ 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.