(81 days)
Not Found
No
The device description and intended use focus solely on the hardware components (RF coils) for MRI systems and do not mention any software or algorithms that would incorporate AI/ML for image processing, analysis, or interpretation. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a receive-only RF coil used with MRI systems for obtaining diagnostic images, which provide information useful in the determination of a diagnosis. It is not indicated for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images produced by these coils "provide information that can be useful in the determination of the diagnosis," and "When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis." Also, some coils are indicated for "obtaining diagnostic images" or "diagnostic images".
No
The device description explicitly states that these are "receive-only multichannel phased array coils," which are hardware components used in MRI systems. The testing conducted also includes standards related to electrical safety, biological evaluation, and image quality measurements for physical coils.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices are receive-only RF coils used in Magnetic Resonance Imaging (MRI) systems. They are external components that receive the radiofrequency signals emitted by the body during an MRI scan.
- Intended Use: The intended use clearly states that these coils are used for imaging specific anatomical regions of the human body. The images are then interpreted by a trained physician for diagnostic purposes. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
- Lack of Specimen Analysis: There is no mention of these devices being used to analyze any biological specimens.
Therefore, these MRI coils are medical devices used for diagnostic imaging, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Infant Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Foot & Ankle Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Product codes
MOS
Device Description
Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24 are receive-only multichannel phased array coils designed for use with UIH 3T MRI systems. The suffix number in coil name stands for the receive channel of the resonant nucleus is hydrogen protons (1H). All coil elements are protected from transmit field by both active and passive decoupling circuits. Each coil is designed to provide optimum image quality for its dedicated human anatomy region as defined in intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Head, carotid, mandible region, infant's brain, spine, heart, torso and extremities, heart, mediastinum, foot and ankle.
Indicated Patient Age Range
Adult (implied for most coils), Infant (for Infant Coil - 24)
Intended User / Care Setting
Trained physician / Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The following testing was conducted on the proposed devices as the predicate devices:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
The test results demonstrated that the devices performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
Summary of Clinical Tests:
- Sample clinical images were provided to support the ability of the proposed A devices to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163205, K181697, K061952, K133986, K112002, K140998
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Shanghai United Imaging Healthcare Co., Ltd. Xin Gao Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 Cn
February 8, 2019
Re: K183186
Trade/Device Name: Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil -4. Infant Coil - 24. Cardiac Coil - 24. Foot & Ankle Coil - 24 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 15, 2018 Received: November 19, 2018
Dear Xin Gao:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183186
Device Name
Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24
Indications for Use (Describe)
Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Infant Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
Foot & Ankle Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The color of the text and the "U" symbol is a dark gray or blue-gray.
510 (k) SUMMARY
1. Date Prepared [21 CFR 807.92(a)(1)] November 15, 2018
2. General Information [21 CFR 807.92(a)(1)]
| Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd
2258 Chengbei Rd., Jiading District, Shanghai, 201807 |
|-----------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Xin GAO
Regulatory Affairs Specialist |
| | Tel: +86 (21) 67076888-5386 |
| | Fax: +86-021-67076889 |
| | Email: xin.gao@united-imaging.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Head Coil - 12, Head Coil - 32, Carotid Coil - 8,
Temporomandibular Joint Coil - 4, Infant Coil - 24,
Cardiac Coil - 24, Foot & Ankle Coil - 24 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Magnetic Resonance Diagnostic Device |
| Model: | Head Coil - 12, Head Coil - 32, Carotid Coil - 8,
Temporomandibular Joint Coil - 4, Infant Coil - 24,
Cardiac Coil - 24, Foot & Ankle Coil - 24 |
| Product Code: | MOS |
| Regulation Number: | 21 CFR 892.1000 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicate devices within this submission are as follow:
| Predicate Device 1 | |
|---|---|
| Manufacturer: | GE Healthcare Coils (USA Instruments, Inc.) |
| Device Name: | 48CH Head Coil |
| Product Code: | MOS |
| Device Class: | II |
| Regulation Number: | 21 CFR 892.1000 |
| FDA 510 (k) #: | K163205 |
| Predicate Device 2 | |
| Manufacturer: | Quality Electrodynamics, LLC |
| Device Name: | 16ch Foot/ Ankle SPEEDER |
| Product Code: | MOS |
| Device Class: | II |
| Regulation Number: | 21 CFR 892.1000 |
| FDA 510 (k) #: | K181697 |
| Predicate Device 3 | |
| Manufacturer: | INVIVO |
| Device Name: | CARDIOVASCULAR ARRAY COILS |
| Product Code: | MOS |
| Device Class: | II |
| Regulation Number: | 21 CFR 892.1000 |
| FDA 510 (k) #: | K061952 |
| Predicate Device 4 | |
| Manufacturer: | Resonance Innovations LLC |
| Device Name: | Orbit and Mandible Array Family |
| Product Code: | MOS |
| Device Class: | II |
| Regulation Number: | 21 CFR 892.1000 |
| FDA 510 (k) #: | K133986 |
| Predicate Device 5 | |
| Manufacturer: | Shanghai Chenguang Medical Technologies Co., Ltd |
| Device Name: | Carotid Coil |
| Product Code: | MOS |
| Device Class: | II |
| Regulation Number: | 21 CFR 892.1000 |
| FDA 510 (k) #: | K112002 |
| Predicate Device 6 | |
| Manufacturer: | Quality Electrodynamics, LLC |
| Device Name: | Pediatric 16, A 3T Tim Coil |
| Product Code: | MOS |
| Device Class: | II |
| Regulation Number: | 21 CFR 892.1000 |
| FDA 510 (k) #: | K140998 |
4
Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized icon that resembles a shield with a horizontal line through the middle. The logo is simple and modern in design.
5
Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
5. Device Description [21 CFR 807.92(a)(4)]
Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24 are receive-only multichannel phased array coils designed for use with UIH 3T MRI systems. The suffix number in coil name stands for the receive channel of the resonant nucleus is hydrogen protons (1H). All coil elements are protected from transmit field by both active and passive decoupling circuits. Each coil is designed to provide optimum image quality for its dedicated human anatomy region as defined in intended use.
6. Intended Use [21 CFR 807.92(a)(5)]
- Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
- Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
- Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
- Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
- Infant Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
- Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
6
Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, uppercase letters, stacked on top of each other. To the right of the text is a stylized graphic that resembles the letter "U" with a horizontal line through the middle, creating a cross-like shape within the "U".
- Foot & Ankle Coil 24 is a 24 channel receive-only RF coil designed for use ● with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
Head Coil - 12. Head Coil - 32. Carotid Coil - 8. Temporomandibular Joint Coil - 4. Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24 are built with wellestablished technology and design principles in the industry.
All coils are formed with linear loop coils resonant at the MR system frequency into a phased array. Each coil element is connected to an independent low noise amplifier with a low noise figure to maintain optimum SNR.
Two means of protection from RF transmit field are used for each coil element. An active decoupling circuit is controlled by a PIN diode driven by external control signal provided by the MR system. A passive decoupling circuit is also used in case the coil is left unplugged in the system bore.
The rigid coil enclosures are designed with shape matching the anatomy. Flexible flaps are also used in some coils to enhance patient comfort and adjustability. Coil materials are test to be flame and impact resistant, and biocompatible.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
Summary of Non-Clinical Tests:
The following testing was conducted on the proposed devices as the predicate devices:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
-
MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
7
Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized graphic element that resembles the letter "U" or a shield, with a vertical white line running through the center, creating a negative space "I" shape. The color scheme is a muted teal or gray-blue.
The test results demonstrated that the devices performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
Summary of Clinical Tests:
- Sample clinical images were provided to support the ability of the proposed A devices to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
9. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we conclude that the proposed devices substantially equivalent to the predicate devices. They do not introduce new indications for use, and have the same technological characteristics and do not introduce new potential hazards or safety risks.