(247 days)
The intended use of the ClearMRI Helios-RG8 Coil Accessory Kit is to enable the GE Signa Horizon Cx MR System to perform MR scans of the head or body utilizing newer FDA-cleared coils (up to 8 channels), without hindering its current capability utilizing the legacy GE FDA-cleared 4-channel coils. The ClearMRI Helios-RG8 Coil Accessory Kit inherits the same limitations of the GE Signa Horizon Cx MR system. The ClearMRI Helios-RG8 Coil Accessory Kit has only been validated for and is for use strictly with the GE Signa Horizon Cx MR System, software build 9.1.0311b. The ClearMRI Helios-RG8 Coil Accessory Kit allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body with the GE Signa Horizon Cx MR System. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The Helios-RG8 Coll Accessory Kit will support coil anatomies from Resonance Innovations, LLC: Long Bone Array in large (model 168GE1501).
Accessories to medical devices are regulated under the same classification regulation as the device(s) with which they are intended to be used. The ClearMRI Helios-RG8 Coil Accessory Kit is intended to be used strictly as an accessory to the GE Signa Horizon Cx MR System, software build 9.1.0311b, and does not change the existing indications for the GE Signa Horizon Cx MR System (K962061).
The ClearMRI Solutions, Inc. Helios-RG8 Coil Accessory Kit is designed as an accessory to a previously cleared GE Signa Horizon Cx MR (K962061), software build 9.1.0311b, receiver subsystem with the main modification allowing the operator to use newer RF receive coils with up to 8 channels. The accessory includes a digital receiver, multi-coil driver, and a computer system containing the ClearMRI software and functions in a similar way to the predicate device's comparable subsystem. The ClearMRI hardware is seamlessly background-driven from the GE Signa Horizon Cx system'.
The ClearMRI Solutions Helios-RG8 Coil Accessory Kit includes a digital receiver, multi-coil driver and a computer system containing the ClearMRI software. The accessory kit is available as an add-on to a GE Signa Horizon Cx MR, software build 9.1.0311b, receiver subsystem that allows the operator to scan using a digital imaging system resulting in the benefits of newer multi-channel RF coils. The ClearMRI hardware is controlled by software running independently and in parallel with the GE Signa Horizon Cx System. It does not alter the existing operator workflow. The Helios-RG8 has no new technological characteristics that raise new safety or effectiveness questions.
The provided document describes the ClearMRI Helios-RG8 Coil Accessory Kit, an accessory designed to enable the GE Signa Horizon Cx MR System to utilize newer RF receive coils (up to 8 channels). However, it does not contain a specific study designed to prove the device meets explicit acceptance criteria in terms of clinical performance or image quality, as would typically be seen for an AI-powered diagnostic device.
Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device (GE Signa Horizon Cx Magnetic Resonance System K962061) by asserting that the accessory does not significantly affect the performance of the legally marketed predicate system and adheres to safety and regulatory standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic performance of the ClearMRI Helios-RG8 Coil Accessory Kit, nor does it present a study with reported device performance against such criteria. The focus is on demonstrating that the accessory does not negatively impact the existing capabilities and safety of the MR system.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards | Evaluated to appropriate NEMA standards and IEC 60601 medical device safety standards, as well as IEC 60601-1-2 EMI/EMC standards. |
| Functional Equivalence | "Does not change the existing indications for the GE Signa Horizon Cx MR System.""Does not significantly affect the performance of the legally marketed GE Signa Horizon Cx System.""Functions in a similar way to the predicate device's comparable subsystem." |
| Image Production | "Allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body." |
| New Technological Characteristics | "The Helios-RG8 has no new technological characteristics that raise new safety or effectiveness questions." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy or image quality evaluation for the accessory. Instead, the evaluation seems to have focused on engineering and regulatory compliance, such as NEMA and IEC standards. Therefore, information on sample size and data provenance for a test set for diagnostic performance is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a clinical performance study with a diagnostic test set and ground truth establishment is not described, this information is not available in the provided text.
4. Adjudication Method for the Test Set
As no clinical performance study with expert-adjudicated ground truth is described, the adjudication method is not applicable or mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
No MRMC comparative effectiveness study is mentioned. This device is an accessory to an existing MR system, not an AI diagnostic algorithm, so a study comparing human readers with and without AI assistance is not relevant to its intended function as described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is not an algorithm that performs diagnostic analysis; it's a hardware accessory. Therefore, a standalone performance study for an algorithm is not applicable and not mentioned.
7. The Type of Ground Truth Used
No clinical performance study requiring a specific type of ground truth (e.g., expert consensus, pathology, outcomes data) is described for this accessory. The evaluation appears to be based on technical standards and functional equivalence.
8. The Sample Size for the Training Set
This device is a hardware accessory and not an AI algorithm that requires a training set. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this device does not involve an AI algorithm with a training set, the establishment of ground truth for a training set is not applicable.
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510(k) Summary
K132381
Page 1 of 2
APR 0 4 2014
510(k) Summary
| Sponsor: | ClearMRI Solutions, Inc.W315 S3283 Harvest View DriveWaukesha WI 53189 |
|---|---|
| Contact: | Mary Ann Ferguson, Project ManagerClearMRI Solutions, Inc.W315 S3283 Harvest View DriveWaukesha WI 53189Telephone: (978)-578-1196 |
| Date Prepared: | October 15, 2013 |
| Subject Device: | Trade Name: ClearMRI Helios-RG8 Coil Accessory KitCommon/Usual Name: MRI Coil Accessory KitClassification Name: Magnetic resonance diagnostic device.Regulation: 21 CFR §892.1000; Classification: II; Product Code: LNH |
| Predicate Devices: | General Electric Signa Horizon Cx Magnetic Resonance System(K962061) |
Device Description:
The ClearMRI Solutions, Inc. Helios-RG8 Coil Accessory Kit is designed as an accessory to a previously cleared GE Signa Horizon Cx MR (K962061), software build 9.1.0311b, receiver subsystem with the main modification allowing the operator to use newer RF receive coils with up to 8 channels. The accessory includes a digital receiver, multi-coil driver, and a computer system containing the ClearMRI software and functions in a similar way to the predicate device's comparable subsystem. The ClearMRI hardware is seamlessly background-driven from the GE Signa Horizon Cx system'.
Intended Use:
The intended use of the ClearMRI Helios-RG8 Coil Accessory Kit is to enable the GE Signa Horizon Cx MR System to perform MR scans of the head or body utilizing newer FDA-cleared coils (up to 8 channels), without hindering its current capability utilizing the legacy GE FDAcleared 4-channel coils. The ClearMRI Helios-RG8 Coil Accessory Kit inherits the same limitations of the GE Signa Horizon Cx MR system. The ClearMRI Helios-RG8 Coil Accessory Kit has only been validated for and is for use strictly with the GE Signa Horizon Cx MR System, software build 9.1.0311b. The ClearMRI Helios-RG8 Coil Accessory Kit allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body with the GE Signa Horizon Cx MR System. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (TI), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
ClearMRI Helios-RG8 Coil Accessory Kit
Page | 1
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KT32381
Page 2 of 2
The Helios-RG8 Coil Accessory Kit will support coil anatomies from Resonance Innovations, LLC: Long Bone Array in large (model 168GE1501).
Accessories to medical devices are regulated under the same classification regulation as the device(s) with which they are intended to be used. The ClearMRI Helios-RG8 Coil Accessory Kit is intended to be used strictly as an accessory to the GE Signa Horizon Cx MR System, software build 9.1.0311b, and does not change the existing indications for the GE Signa Horizon Cx MR System (K962061).
Technological Characteristics:
The ClearMRI Solutions Helios-RG8 Coil Accessory Kit includes a digital receiver, multi-coil driver and a computer system containing the ClearMRI software. The accessory kit is available as an add-on to a GE Signa Horizon Cx MR, software build 9.1.0311b, receiver subsystem that allows the operator to scan using a digital imaging system resulting in the benefits of newer multi-channel RF coils. The ClearMRI hardware is controlled by software running independently and in parallel with the GE Signa Horizon Cx System. It does not alter the existing operator workflow. The Helios-RG8 has no new technological characteristics that raise new safety or effectiveness questions.
Performance Data:
The ClearMRI Helios-RG8 device will support up to eight channel coils. The accessory kit was evaluated to the appropriate NEMA standards and IEC 60601 medical device safety standards as well as IEC 60601-1-2 EMI/EMC standards.
Substantial Equivalence:
The ClearMRI Solutions, Inc. (CMS) Helios-RG8 Coil Accessory Kit is designed as an add-on accessory to a GE Signa Horizon Cx MR, software build 9.1.0311b. receiver subsystem that allows the operator the use of newer RF coils (up to 8-channels). Accessories to medical devices are regulated under the same classification regulation as the device(s) with which they are intended to be used. The accessory kit does not significantly affect the performance of the legally marketed GE Signa Horizon Cx System, software build 9.1.0311b, and is therefore substantially equivalent. Nonclinical test data demonstrate that the device is safe and is substantially equivalent to the legally marketed predicate device.
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Image /page/2/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2014
ClearMRI Solutions, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25" Street NW BUFFALO MN 55313
Rc: K132381
Trade/Device Name: ClearMRI Helios-RG8 Coil Accessory Kit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 20, 2014 Received: March 21. 2014
Dear Mr. Job:
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 docs 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 I'DA '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 (OS) 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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Page 2-Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources.forYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara For
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Indications for Use
510(k) Number: K132381
Device Name:
ClearMRI Helios-RG8 Coil Accessory Kit
Indications for Use:
The intended use of the ClearMRI Helios-RG8 Coil Accessory Kit is to enable the GE Signa Horizon Cx MR System to perform MR scans of the head or body utilizing newer FDA-cleared coils (up to 8 channels), without hindering its current capability utilizing the legacy GE FDA-cleared 4-channel coils. The ClearMRI Helios-RG8 Coil Accessory Kit inherits the same limitations of the GE Signa Horizon Cx MR system. The ClearMRI Helios-RG8 Coil Accessory Kit has only been validated for and is for use strictly with the GE Signa Horizon Cx MR System, software build 9.1.0311b. The ClearMRI Helios-RG8 Coil Accessory Kit allows the GE Signa Horizon Cx MR System to continue to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body with the GE Signa Horizon Cx MR System. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T ), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The Helios-RG8 Coll Accessory Kit will support coil anatomies from Resonance Innovations, LLC: Long Bone Array in large (model 168GE1501).
Accessories to medical devices are regulated under the same classification regulation as the device(s) with which they are intended to be used. The ClearMRI Helios-RG8 Coil Accessory Kit is intended to be used strictly as an accessory to the GE Signa Horizon Cx MR System, software build 9.1.0311b, and does not change the existing indications for the GE Signa Horizon Cx MR System (K962061).
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 Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K132381 510(k)
ClearMRI Helios-RG8 Coil Accessory Kit
Page | I
§ 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.