(39 days)
Not Found
No
The summary describes a physical coil system for MRI, focusing on hardware specifications and performance testing related to signal reception and safety. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a receive-only coil system designed to produce diagnostic images, not to treat any condition.
No
Explanation: This device is a component (a receive-only coil system) of a Magnetic Resonance Imaging (MRI) system. It is used to produce diagnostic images, but it does not independently interpret or diagnose. The interpretation is done by a trained physician using the images produced in conjunction with a Toshiba Magnetic Resonance Scanner. Therefore, it is a diagnostic imaging accessory, not a diagnostic device itself.
No
The device description explicitly states it is a "receive-only phased array coil system" and lists physical components like "formable, flexible and detachable antennae." 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "receive-only phased array coil system designed to provide high resolution imaging" for various parts of the body using Magnetic Resonance. It is used in conjunction with an MRI scanner to produce images.
- Intended Use: The intended use is to "produce diagnostic images" that are "interpreted by a trained physician." This is a function of an imaging device, not an IVD.
The device is a component of a Magnetic Resonance Imaging (MRI) system, which is a type of medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The NeoCoil 1.5T 16ch Flex SPEEDER is a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. The system consists of:
- Two formable, flexible and detachable antennae of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
- Optional accessories designed for patient comfort and reduced motion artifacts.
The NeoCoil 1.5T 16ch Flex SPEEDER coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following data has been submitted, referenced or relied on to demonstrate that the 1.5T 16ch Flex SPEEDER Coil is safe and effective. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.
Test: Max B1 in first faultconditions; Pass/Fail Criteria: Pre-definedperformance standards; Result: Pass: Coil does not arc or show any signs ofvoltage breakdown.
Test: Surface Temperaturein normal and firstfault conditions; Pass/Fail Criteria: Pre-definedperformance standards; Result: Pass: RF heating is not greater than 39° C innormal or first fault conditions.
Test: NEMA MS 6-2008; Pass/Fail Criteria: Pre-definedperformance standards; Result: Pass: SNR and Uniformity are consistent withthe requirements for indications for use.
Test: Unplugged SurfaceTemperature; Pass/Fail Criteria: Acceptable level of risk; Result: Pass: Surface temperature rise results inacceptable residual risk after mitigation.
Published Standards testing:
Standard: IEC 60601-1; Purpose: Electromechanical safety
Standard: IEC 60601-1-2; Purpose: ESD
Standard: IEC 60601-2-33; Purpose: Electromechanical safety
Standard: ISO 10993-1; Purpose: Biocompatibility
Clinical Performance testing:
Clinical data submitted exhibits a mix of scanner configurations, pulse sequences, imaging options, field of view and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
No adverse events were reported during clinical performance testing; the 1.5T 16ch Flex SPEEDER Large and 1.5T 16ch Flex SPEEDER Medium coils demonstrated performance adequate to support the Indications for Use.
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.
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.
0
JUN 1 5 2012
N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: (262) 347-1250 Fax: (262) 347-1251
5. Abbreviated 510(k) Summary
5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072
5.2. Contact Steven Nichols Chief Operating Officer 262-347-1250 (office) 261-347-1251 (fax) steve.nichols@neocoil.com
5.3. Preparation Date 04/13/2012
5.4. Name of Device
- Proprietary Name: .
- Common Name:
- Classification:
5.5. Model Numbers
| NeoCoil Model Number | NeoCoil Model Name | Toshiba Model |
|---|---|---|
| NC043000 | 1.5T 16ch Flex SPEEDER Coil Large | MJAJ-227A/S1 (Japan) |
| MJAJ-227A/J1 (USA) | ||
| MJAJ-227A/E1 (Europe) | ||
| NC042000 | 1.5T 16ch Flex SPEEDER Coil Medium | MJAJ-217A/S1 (Japan) |
| MJAJ-217A/J1 (USA) | ||
| MJAJ-217A/E1 (Europe) |
1.5T 16ch Flex SPEEDER Coil
Magnetic Resonance Specialty Coil
21 CFR 892.1000, Product Code MOS
5.6. Device Description
The NeoCoil 1.5T 16ch Flex SPEEDER is a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine. The system is compatible with 2D, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction. The system consists of:
- Two formable, flexible and detachable antennae of different size that can be . wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
- . Optional accessories designed for patient comfort and reduced motion artifacts.
The NeoCoil 1.5T 16ch Flex SPEEDER coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
5.7. Predicate Device
- 1.5T GEM Flex Coil (K113474) .
- 5.8. Comparison to Predicate
The NeoCoil 1.5T 16ch Flex SPEEDER coils are identical in physical, performance, design and material characteristics to the legally marketed device, the 1.5T GEM Flex Coil, K113474, as cleared on 03/16/2012.
© 2012 NeoCoil, LLC
NeoCoil, LLC
1
N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: (262) 347-1250 (262) 347-1251 Fax:
The differences introduced in this submission include: '
- . Electrical interface with the MRI scanner, in order to ensure compatibility.
- . Coil cable, cable covering and connector, in order to satisfy Toshiba requirements and achieve MRI scanner compatibility.
- Minor dimensional changes compared to the GEM Flex arrays, resulting from the . elimination of the GEM Flex interface module.
The Indications for Use are consistent with the capabilities of the 1.5T GEM Flex Coil.
Clinical testing demonstrates that the differences in the devices do not affect the safety and/or the effectiveness of the device when used as labeled.
5.9. Indications for Use
To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine that can be interpreted by a trained physician.
5.10. Intended Use
Intended use of the 1.5T 16ch Flex SPEEDER Coil is identical to that of routine MR imaging; specifically to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine.
Use of the device in conjunction with an MRI scanner is unchanged.
5.11. Testing
The following data has been submitted, referenced or relied on to demonstrate that the 1.5T 16ch Flex SPEEDER Coil is safe and effective. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.
| Test | Pass/Fail Criteria | Result |
|---|---|---|
| Max B1 in first faultconditions | Pre-definedperformance standards | Pass: Coil does not arc or show any signs ofvoltage breakdown. |
| Surface Temperaturein normal and firstfault conditions | Pre-definedperformance standards | Pass: RF heating is not greater than 39° C innormal or first fault conditions. |
| NEMA MS 6-2008 | Pre-definedperformance standards | Pass: SNR and Uniformity are consistent withthe requirements for indications for use. |
| Unplugged SurfaceTemperature | Acceptable level of risk | Pass: Surface temperature rise results inacceptable residual risk after mitigation. |
Performance testing - Bench:
© 2012 NeoCoil, LLC
2
N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: (262) 347-1250 Fax: (262) 347-1251
Image /page/2/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular graphic with an arrow pointing to the right, followed by the text "NeoCoil" in a bold, sans-serif font. Above the logo, the text "p. 3 of 3" is written in handwriting.
1121362
Published Standards testing:
| Standard | Purpose |
|---|---|
| IEC 60601-1 | Electromechanical safety |
| IEC 60601-1-2 | ESD |
| IEC 60601-2-33 | Electromechanical safety |
| ISO 10993-1 | Biocompatibility |
Performance testing - Clinical:
Clinical data submitted exhibits a mix of scanner configurations, pulse sequences, imaging options, field of view and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
No adverse events were reported during clinical performance testing; the 1.5T 16ch Flex SPEEDER Large and 1.5T 16ch Flex SPEEDER Medium coils demonstrated performance adequate to support the Indications for Use.
5.12. Conclusion
This submission demonstrates that the Indications for Use are in line with the predicate device to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine and are as safe and effective as the predicate device. As such, 1.5T 16ch Flex SPEEDER coils are equivalent to their predicate, 1.5T GEM Flex Coil, K113474.
| © 2012 NeoCoil, LLC |
|---|
| --------------------- |
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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
Mr. Steven Nichols Chief Operating Officer NeoCoil, LLC N27 W23910A Paul Road PEWAUKEE WI 53072
JUN 1 5 2012
Re: K121362
Trade/Device Name: 1.5T 16ch Flex SPEEDER Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 13, 2012 Received: May 7. 2012
Dear Mr. Nichols:
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 Mav 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
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety. Center for Devices and Radiological Health
Enclosure
5
K12136.2
Indications for Use
510(k) Number (if known):
Device Name: 1.5T 16ch Flex SPEEDER
Indications for Use:
To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)K121362