(201 days)
The Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.
The Echostar Comfort 1.5T MRI System and Echostar Spica 1.5T MR system are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis.
The Echostar Comfort 1.5T MRI System represents a modification to the previously cleared Echostar Spica 1.5T MR system (K113511); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including a body coil, head coil, spine coil, cspine (neck) coil, shoulder coil, knee coil, small-4 element torso coil, large-12 element torso coil, wrist coil, medium-8 element torso coil, small flex coil and large flex coil.
This document describes the Echostar Comfort 1.5T MRI System, which is a modification of a previously cleared device (Echostar Spica 1.5T MR system). The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo performance study with specific acceptance criteria directly related to clinical diagnostic accuracy.
Therefore, much of the requested information regarding clinical study design, sample sizes, expert adjudication, MRMC studies, and standalone performance for diagnostic tasks is not explicitly available within this 510(k) summary. The summary focuses on engineering and regulatory compliance, ensuring the modified device maintains the same safety and effectiveness as its predicate.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for a specific condition) for the Echostar Comfort 1.5T MRI System. Instead, the acceptance criteria are based on technical and safety standards compliance and equivalence to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (Echostar Comfort 1.5T MRI System) |
|---|---|
| Substantial Equivalence (Overall) | The device is substantially equivalent to the Echostar Spica 1.5T MR system (K113511), sharing the same classification, intended use, indications for use, design principles, similar product design and specifications, and comparable performance for effectiveness and safety. |
| Technical Standards Compliance | Conformance with the following standards demonstrated: - AAMI ANSI ES 60601-1:2005/(R)2012 - IEC 60601-1-2:2007 - IEC 60601-2-33:2010 - NEMA MS-1 2008 - NEMA MS-2 2008 - NEMA MS-3 2008 - NEMA MS-4 2010 - NEMA MS-5 2010 - NEMA MS-6 2008 - NEMA MS-8 2008 |
| Image Quality & Functionality | Sample phantom and clinical images, and test reports were presented to demonstrate conformance with standards and equivalent performance with the predicate device. The system can acquire 2D single slice, multi-slice and 3D volume images, and images reflect spatial distribution for hydrogen nuclei density, T1, T2, and flow. |
| Safety | Nonclinical testing for safety was conducted. No new or additional safety concerns have been raised compared to the predicate device. |
| RF Coils & System Components | Modifications include: - Additional RF coils. - Magnet modifications for a 70+ cm clear bore opening. - RF transmit components specified for required RF transmit performance. - Gradient subsystem specified for higher gradient strength and slew rate. These modifications are designed to maintain or improve performance while ensuring equivalence. |
| Software Sequences & Applications | Includes the same software sequences and applications, modified for scan performance improvements. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Sample phantom and clinical images, and test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device."
- Sample Size for Test Set: Not specified quantitatively. It mentions "sample phantom and clinical images," implying a limited set used for technical verification rather than a large-scale clinical trial to establish diagnostic accuracy against a ground truth.
- Data Provenance: Not explicitly stated (e.g., country of origin). It mentions "clinical images," suggesting real patient data, but whether it was retrospective or prospective is not detailed. Given the context of a 510(k) for a modified device, it's likely images were collected to demonstrate equivalence, possibly from a mix of retrospective and prospective technical validation scans.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The assessment appears to be primarily technical validation (phantom images, engineering tests) and a comparison of image characteristics to the predicate device, rather than a clinical study requiring expert diagnosis against a clinical ground truth for the new device. The Indications for Use state, "When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis," implying that the interpretation relies on existing medical expertise once the image quality is deemed acceptable.
4. Adjudication Method for the Test Set
Since a formal clinical study with a diagnostic ground truth is not detailed, an adjudication method is not applicable or described in this summary. The assessment focuses on meeting technical standards and demonstrating image quality equivalence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described. This submission is for an MRI system, not an AI-powered diagnostic algorithm alongside human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study for an algorithm was not done or described. This device is an MRI hardware and basic software system, not an AI or standalone diagnostic algorithm.
7. The Type of Ground Truth Used
For the technical performance aspects, the "ground truth" would be established through:
- Physical Phantoms: Known physical properties and structures within phantoms are used to assess image quality metrics (signal-to-noise ratio, spatial resolution, contrast, uniformity, etc.) according to NEMA standards.
- Predicate Device Performance: The primary "ground truth" for the new device's performance is its substantial equivalence to the performance of the legally marketed predicate device (Echostar Spica 1.5T MR system), which itself would have demonstrated diagnostic capability in general use.
- Clinical Image Evaluation: As mentioned, "clinical images" were presented, which would implicitly be evaluated by qualified personnel for acceptable diagnostic quality, even if not against a specific pathological ground truth within this particular submission.
8. The Sample Size for the Training Set
Not applicable/Not mentioned. This document describes an MRI hardware system, not a device that relies on a trained algorithm or AI model. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not mentioned. As there is no training set for an AI model, this question does not apply to this submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2015
Alltech Medical Systems America, Inc. % Michaeleen Dom Manager, Quality Systems and Regulatory Affairs 28900 Fountain Parkway SOLON OHIO 44139
Re: K141945
Trade/Device Name: Echostar Comfort 1.5T MRI System Regulation Number: 21 CFR Regulation Name: Magnetic Resonance Imaging System Regulatory Class: Class II Product Code: LNH Dated: December 26, 2014 Received: January 6, 2015
Dear Ms. Dom:
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 devicerelated 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/ResourcesforYou/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,
Michael D'Hara
For
Robert Ochs. Ph.D Acting 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
510(k) Number (if known) K141945
Device Name Echostar Comfort 1.5T MRI System
Indications for Use (Describe)
The Echostar Comfort 1.5T MRI System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Echostar Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Alltech Medical Systems America. The logo consists of the word "alltech" in a stylized font, with the "e" in "tech" having a unique design. Below the logo is the company name, address (28900 Fountain Parkway, Solon, OH 44139), telephone number (1-440-424-2240), and fax number (1-440-424-2255).
510(k) Summary
In accordance with 21 CFR 807.92. the following summary is provided:
21 CFR 807.92 (a)(1) Submitter
Alltech Medical Systems America, Inc. 28900 Fountain Parkway Solon, OH 44139 Phone: (440) 424-2240 Fax: (440) 424-2255 Contact: Michaeleen Dom Date Prepared: December 19, 2014
21 CFR 807.92 (a)(2) Name of the Device
Trade Name: Echostar Comfort 1.5T MRI System Common Name: Magnetic Resonance Imaging System Classification Name: Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Product Code LNH)
21 CFR 807.92 (a)(3) Legally Marketed Device
Alltech Medical Systems America, Inc. is claiming substantial equivalence to a device that has been found to be substantially equivalent through the 510(k) premarket notification process, the Echostar Spica 1.5T MR System. The Echostar Spica 1.5T MR system was cleared by the FDA on May 2, 2012 (K113511).
21 CFR 807.92 (a)(4) Device Description
The Echostar Comfort 1.5T MRI System represents a modification to the previously cleared Echostar Spica 1.5T MR system (K113511); both utilize a superconducting magnet, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images. The data acquisition system supports multiple coil elements including a body coil, head coil, spine coil, cspine (neck) coil, shoulder coil, knee coil, small-4 element torso coil, large-12 element torso coil, wrist coil, medium-8 element torso coil, small flex coil and large flex coil.
21 CFR 807.92 (a)(5) Intended Use
The Echostar Comfort 1.5T MRI System and Echostar Spica 1.5T MR system are indicated for use as a whole body magnetic resonance diagnostic device (MRDD) that uses transverse, sagittal, coronal and oblique planes to image internal structures or functions of the body including head and extremities. MRI images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic
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Image /page/4/Picture/0 description: The image shows the logo for Alltech Medical Systems America. The logo consists of the word "alltech" in a bold, sans-serif font, with the "e" slightly stylized. Below the logo is the company name, address (28900 Fountain Parkway Solon, OH 44139), telephone number (1-440-424-2240), and fax number (1-440-424-2255).
resonance (NMR). The NMR properties of body tissues and fluids are hydrogen density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow dynamics. These images, when interpreted by a trained physician, yield information that can be useful in diagnosis.
21 CFR 807.92 (a) (6) Comparison with Predicate Device
The changes to the device, Echostar Comfort 1.5T MRI System reflected in this 510(k) submission do not alter the fundamental scientific technology of the Echostar Spica 1.5T MR system that was cleared by the FDA through K113511. The Echostar Comfort 1.5T MRI System has the same classification information, the same intended use, the same indications for use, the same design principles, similar product design and specifications, the same performance of effectiveness and safety as the predicate Echostar Spica 1.5T MR system. The main modifications include additional RF coils, modifications to the magnet to accommodate a 70+ cm clear bore opening. RF transmit components specified to provide RF transmit performance required for all specified sequences, gradient subsystem specified to provide higher gradient strength and slew rate. The Echostar Comfort 1.5T MRI System includes the same software sequences and applications modified for scan performance improvements.
21 CFR 807.92 (b) (1) and (2) Performance Testing - Summary of Test Data
Safety and performance nonclinical testing were conducted to the appropriate standards on the filing device, Echostar Comfort 1.5T MRI System, that were used in the testing of the Echostar Spica 1.5T MR system, to verify and validate its substantial equivalence. Sample phantom and clinical images, and test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device. Testing was conducted as applicable to the following standards:
- AAMI ANSI ES 60601-1:2005/(R)2012
- •IEC 60601-1-2:2007
- IEC 60601-2-33:2010
- NEMA MS-1 2008
- NEMA MS-2 2008
- NEMA MS-3 2008
- NEMA MS-4 2010
- NEMA MS-5 2010
- NEMA MS-6 2008
- NEMA MS-8 2008
21 CFR 807.92 (b) (3)Conclusion
Based on the results of the safety and performance testing, it is the opinion of Alltech Medical Systems America, Inc. that the device, Echostar Comfort 1.5T MRI System, is substantially equivalent to the Echostar Spica 1.5T MR System predicate device. The Echostar Comfort 1.5T MRI System has the same technological characteristics of the predicate device, does not include any new indications for use and no new or additional safety concerns have been raised.
N/A