(65 days)
Not Found
No
The summary describes a receive-only phased array coil for MRI systems and focuses on its physical design, intended use for imaging, and performance metrics like SNR and uniformity. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as an imaging device that produces images to aid in diagnosis and determine therapy options, rather than providing therapy itself.
Yes
The device produces images that, "When interpreted by a trained physician, ... provide information that can be useful in determining a diagnosis and therapy options." It is also explicitly stated that the coils "can also be used as standard diagnostic head coils for diagnostic examinations."
No
The device description explicitly states that the device is a "receive-only eight channel phased array coil" and describes its physical components and how it is used in conjunction with MRI systems. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IMRIS Flex coils are described as imaging devices used in conjunction with MR systems. They produce images of the human head and upper C-spine internal structures.
- Intended Use: The intended use is for clinical procedures, including intra-operative, interventional, and diagnostic examinations, where the images are interpreted by a trained physician to aid in diagnosis and therapy options.
- Lack of Sample Testing: There is no mention of the device performing any tests on biological samples. Its function is solely to acquire images.
Therefore, the IMRIS Flex coils are imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
IMRIS Flex coils HC150 (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures.
IMRIS Flex coils produce images of the human head and upper C-spine internal structures. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The IMRIS 1.5T Head Coil (HC150) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC150 is a pair of receive-only phased array coils designed for use with the IMRIS 1.5T system. The IMRIS 1.5T (Neuro II-SE) uses the Siemens MAGNETOM 1.5T MRI system (MAGNETOM Espree).
The IMRIS 3T Head Coil (HC300) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC300 is a pair of receive-only phased array coils designed for use with the IMRIS 3T system. The IMRIS 3T (Neuro III-SV) uses the Siemens MAGNETOM 3T MRI system (MAGNETOM Verio).
The IMRIS HC150/HC300 head coils balance surgical requirements with the MRI reguirements to provide MR imaging in intra-operative and interventional procedures. Coils are used to acquire MR images of the head and upper C-spine during intra-operative /interventional procedures. The IMRIS HC150/HC300 head coils can also be used as standard diagnostic head coils for diagnostic examinations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
Human head and upper C-spine internal structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / intra-operative, interventional procedures, diagnostic examinations
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)
Signal to Noise Ratio (SNR) and image uniformity tests according to NEMA standard are performed for the new HC150/HC300 coils and the results presented in this submission show that they are equivalent with the predicate devices.
The IMRIS coils HC150/HC300 verification/validation results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate devices, the SAH coil 1.5T and SAH coil 3T.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K091166, K083137, K061916, K071099
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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FEB - 2 201
510(k) SUMMARY FOR HC150/HC300
1. GENERAL INFORMATION
| Establishment: | IMRIS Inc. |
|---|---|
| Address: | 100-1370 Sony Place |
| Winnipeg, Manitoba | |
| Canada, R3T 1N5 | |
| Registration Number: | 3003807210 |
| Contact Person: | Mr. Sanjay Shah |
| QA and Regulatory Engineer | |
| Email: sshah@imris.com | |
| Phone: 1-204-480-7070, | |
| Fax: 1-204-480-7071 | |
| Date of Summary | |
| Preparation: | September 30, 2010 |
| Device Name/Trade name | 1.5T Head Coil (HC150) |
| 3T Head Coil (HC300) | |
| Classification Name: | Coil, magnetic resonance, specialty |
| Classification Panel: | Radiology |
| Classification (CFR section): | 21 CFR 892.1000 |
| Class: | Class II |
| Product Code: | MOS |
2. INDICATION FOR USE
IMRIS Flex coils HC150 (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures.
IMRIS Flex coils produce images of the human head and upper C-spine internal structures. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.
3. DEVICE DESCRIPTION
The IMRIS 1.5T Head Coil (HC150) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC150 is a pair of receive-only phased array coils designed for use with the IMRIS 1.5T system. The IMRIS 1.5T (Neuro II-SE) uses the Siemens MAGNETOM 1.5T MRI system (MAGNETOM Espree).
The IMRIS 3T Head Coil (HC300) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC300 is a pair of receive-only phased array coils designed for use with the IMRIS 3T system. The IMRIS 3T (Neuro III-SV) uses the Siemens MAGNETOM 3T MRI system (MAGNETOM Verio).
The IMRIS HC150/HC300 head coils balance surgical requirements with the MRI reguirements to provide MR imaging in intra-operative and interventional procedures. Coils are used to acquire MR images of the head and upper C-spine during intra-operative /interventional
1
procedures. The IMRIS HC150/HC300 head coils can also be used as standard diagnostic head coils for diagnostic examinations.
4. SUBSTANTIALLY EQUIVALENT
HC150/HC300 coils are substantially equivalent to the 1.5T/3T Split Array Head (SAH) coil components of the following Medical device systems.
| Name of the Device | 510(k) Number | Date of Clearance |
|---|---|---|
| IMRIS iMRX system | ||
| (SAH Coil-1.5T) | K091166 | Sep 2, 2009 |
| IMRIS 3T Intra-operative MRI System | ||
| (Neuro III-SV) | ||
| (SAH Coil-3T) | K083137 | Dec 16, 2008 |
| IMRIS 1.5T Intra-operative MRI | ||
| System (Neuro II-SE) | ||
| (SAH Coil-1.5T) | K061916 | |
| K071099 | Aug 11, 2006 | |
| May 22, 2007 |
5. SAFETY & EFFECTIVENESS
The HC150/HC300 coils have the same intended use and indications for use as the IMRIS 1.5T SAH coil / 3T SAH coil. Performance data demonstrate safety and effectiveness of the HC150/HC300 with the new characteristics.
Signal to Noise Ratio (SNR) and image uniformity tests according to NEMA standard are performed for the new HC150/HC300 coils and the results presented in this submission show that they are equivalent with the predicate devices
The IMRIS coils HC150/HC300 verification/validation results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate devices, the SAH coil 1.5T and SAH coil 3T.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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
IMRIS, Inc. % Mr. Thomas M. Tsakeris President Devices & Diagnostic Consulting Group, Inc. 16809 Briardale Road ROCK VILLE MD 20855
FEB -- 2 20H
Re: K103506
Trade/Device Name: HC150 (1.5T Head Coil) and HC300 (3T Head Coil) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 24, 2010 Received: November 29, 2010
Dear Mr. Tsakeris:
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
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Mary S. Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
HC150 (1.5T Head coil) and HC300 (3T Head coil)
Indications For Use:
IMRIS Flex coils HC150 (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures.
IMRIS Flex coils produce images of the human head and upper C-spine internal structures.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological O
510K K103506
IMRIS 510(k) Premarket Notification HC150/HC300
September 28, 2010