(146 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard MRI technology and reconstruction algorithms, with no mention of AI/ML features.
No
The device is described as an MRI system intended for general diagnostic use, producing images that "yield information that can be useful in the determining of a diagnosis," rather than providing a therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Comfort EC710 is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use."
No
The device description explicitly states it is a "1.5T MRI System" which includes hardware components like a magnet, gradients, RF transmission, and coils, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description: The Comfort EC710 is a whole-body magnetic resonance imaging (MRI) system. MRI is an in vivo imaging modality, meaning it acquires images of the inside of the living body directly, without the need for external specimens.
- Intended Use: The intended use is for "general diagnostic use" by producing images that "yield information that can be useful in the determining of a diagnosis." This is consistent with an imaging device, not a device that analyzes specimens.
The information provided clearly describes an imaging system that works directly on the patient's body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Confort EC710 is a whole-body magnetic resonance maging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Comfort EC710 system reflect the spatial distribution for the density of hydrogen muclei (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.
Product codes
LNH
Device Description
The Comfort EC710, a 1.5T MRI System, represents a modification to the previously cleared Echostar Comfort 1.5T MRI system (K141945); both utilize a 1.5T superconducting magnet with a 71cm bore, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images, with a data acquisition system supporting multiple coil elements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
whole-body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
No clinical testing was conducted, however clinical images were obtained to confirm the performance of the knee-foot coil and the new software features.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance nonclinical testing were conducted to the applicable portions of the following standards on the filing device, Comfort EC710:
- NEMA MS-1 2014
- NEMA MS-3 2014
- AAMI ANSI ES 60601-1:2005/(R)2012
- NEMA MS-4 2010
- IEC 60601-2-33:2010
- IEC 60601-1-2:2007
Software verification and validation testing were conducted and documentation provided as recommended by the FDA's Guidance for Industry and Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered a "moderate" level of concern.
No clinical testing was conducted, however clinical images were obtained to confirm the performance of the knee-foot coil and the new software features.
Sample phantom and clinical images, and test data support the safety of the device. Test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device that is marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2017
Alltech Medical Systems America, Inc. % Michaeleen Dom Manager, Quality Systems and Regulatory Affairs 28900 Fountain Parkway Suite A SOLON OH 44139
Re: K163192 Trade/Device Name: Comfort EC710 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 10, 2017 Received: March 15, 2017
Dear Michaeleen 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 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.
Michael D.'Hara
For
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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Image /page/2/Picture/0 description: The image shows the logo for Alltech Medical Systems America. The logo includes the company name in a stylized font. Below the logo is the company's address, which is 28900 Fountain Parkway, Solon, OH 44139. The image also includes the company's telephone and fax numbers, which are 1-440-424-2240 and 1-440-424-2255, respectively.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0810-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Comfort EC710
Indications for Use (Describe)
The Confort EC710 is a whole-body magnetic resonance maging (MRI) system intended for general diagnostic use. Transverse, sagittal, coronal and oblique planes may be imaged. MRI images produced by the Comfort EC710 system reflect the spatial distribution for the density of hydrogen muclei (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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (8/14)
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351 Firefilms brand Season (1) 443-8740;
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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 bold, sans-serif font, with the first letter "a" in lowercase and the rest of the letters in lowercase. Below the logo is the text "Alltech Medical Systems America" followed by the address "28900 Fountain Parkway Solon, OH 44139" and the phone and fax numbers "Tel:1-440-424-2240 Fax: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 Ste. A Solon, OH 44139 Phone: (440) 424-2240 Fax: (440) 424-2255 Contact: Michaeleen Dom Date Prepared: March 10, 2017
21 CFR 807.92 (a)(2) Name of the Device
Trade Name: Comfort EC710 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 Comfort 1.5T MRI System. The Echostar Comfort 1.5T MRI system was cleared by the FDA on February 3, 2015 (K141945).
21 CFR 807.92 (a)(4) Device Description
The Comfort EC710, a 1.5T MRI System, represents a modification to the previously cleared Echostar Comfort 1.5T MRI system (K141945); both utilize a 1.5T superconducting magnet with a 71cm bore, gradients, RF transmission, various sequences and reconstruction algorithms to acquire 2D single slice, multi-slice and 3D volume images, with a data acquisition system supporting multiple coil elements.
21 CFR 807.92 (a)(5) Intended Use
The Comfort EC710 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 Comfort system reflect the spatial distribution for the density of hydrogen nuclei (protons) spin-lattice
4
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.
21 CFR 807.92 (a) (6) Comparison with Predicate Device
The changes to the device. Comfort EC710. reflected in this 510(k) submission do not alter the fundamental scientific technology of the Echostar Comfort 1.5T MRI system that was cleared by the FDA through K141945. The Comfort EC710 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 Comfort 1.5T MRI system. The Comfort EC710 software and sequences were modified for scan performance improvements and included the addition of a Field Echo- Echo Planar Imaging sequence, faster imaging methods, reduction of reconstruction time, reduction of shimming time, improved shimming accuracy, enhanced magnetic field homogeneity and image uniformity, additional imaging techniques for enhanced tissue contrast, reduction in artifacts, improved table control for better images at isocenter and improved workflow. The Comfort EC710 includes the addition of a Knee-Foot coil and 2 positioning pads.
21 CFR 807.92 (b) (1) and (2) Performance Testing - Summary of Test Data
Safety and performance nonclinical testing were conducted to the applicable portions of the following standards on the filing device, Comfort EC710:
- NEMA MS-1 2014
- NEMA MS-3 2014
- AAMI ANSI ES 60601-1:2005/(R)2012
- NEMA MS-4 2010
- IEC 60601-2-33:2010
- •IEC 60601-1-2:2007
Software verification and validation testing were conducted and documentation provided as recommended by the FDA's Guidance for Industry and Staff: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered a "moderate" level of concern.
No clinical testing was conducted, however clinical images were obtained to confirm the performance of the knee-foot coil and the new software features.
Sample phantom and clinical images, and test data support the safety of the device. Test reports are presented for the changes, demonstrating conformance with the standard and equivalent performance with the predicate device that is
5
marketed for the same intended use.
21 CFR 807.92 (b) (3) Conclusion
The intended use, technological characteristics and performance of the Knee-Foot Coil is the same as the predicate Knee Coil.
The enhanced software features do not create a new intended use or alter the fundamental technological characteristics.
Based on the results of the safety and performance testing, it is the opinion of Alltech Medical Systems America, Inc. that the device, Comfort EC710, is substantially equivalent to the Echostar Comfort 1.5T MRI System predicate device. The Comfort EC710, a 1.5T MRI System, has the same fundamental technological characteristics of the predicate device, does not include any new indications for use and no new or additional safety concerns have been raised.
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