(24 days)
Not Found
No
The description focuses on the hardware components (coils, antennae) and their physical properties (flexibility, tuning frequency). While it mentions "coil signal intensity correction," this is a standard image processing technique in MRI and doesn't inherently imply AI/ML. There is no mention of AI, ML, deep learning, or any related terms, nor is there any description of training or test sets which are typical for AI/ML-based devices.
No
The device is described as producing "diagnostic images", which are used for diagnosis, not therapy. Its function is to assist in image acquisition for interpretation by a physician.
No
The device produces diagnostic images, but it does not interpret them or provide a diagnosis itself. Its function is to assist in the creation of images that are then interpreted by a trained physician.
No
The device description explicitly details hardware components (antennae, accessories) and physical properties (tuned to receive RF frequency, 3 tesla magnetic field). It is a physical coil system, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
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 NeoCoil 3T 16ch Flex SPEEDER Coils are accessories for a Magnetic Resonance (MR) scanner. Their purpose is to receive radiofrequency signals from the patient's body during an MR scan to produce diagnostic images. They do not analyze biological specimens.
- Intended Use: The intended use clearly states the device is used "to produce diagnostic images... that can be interpreted by a trained physician." This is consistent with the function of an imaging accessory, not an IVD.
The device is a component of a medical imaging system used for diagnostic imaging in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
N/A
Intended Use / Indications for Use
To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU 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
MOS
Device Description
The NeoCoil 3T 16ch Flex SPEEDER Coils are 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 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 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)
Performance testing - Bench:
Unplugged Surface Temperature: Pass: Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner.
Surface Temperature: Pass: RF and Eddy current heating is not greater than 41°C.
Blocking Network Analysis: Pass: Blocking network demonstrates adequate active and passive transmit decoupling.
B1 Field Distortion: Pass: B1 field inhomogeneity meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling.
NEMA MS 6-2008: Pass: SNR and Image Uniformity are consistent with the requirements for indications for use.
Performance testing - Clinical:
The clinical data in this section exhibits a mix of technical factors 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, issued November 14, 1998. No adverse events were reported during clinical performance testing; the 3T 16ch Flex SPEEDER Coil, Large and 3T 16ch Flex SPEEDER Coil, Medium demonstrated performance adequate to support the Indications for 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.
0
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/0/Picture/1 description: The image shows the logo for NeoCoil, which is a black circle with a white swirl inside and the word "NeoCoil" in bold black letters. Above the logo, there is handwritten text that reads "K141832 page 1 of 3". The text is written in black ink and appears to be a document identifier or page number.
JUL 3 1 2014
5. Traditional 510(k) Summary
- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
- 5.2. Contact Michael Leigh Director, Regulatory/Quality 262-522-6127 (direct) 261-347-1251 (fax) Mike.leigh@neocoil.com
5.3. Preparation Date 07/03/2014
- 5.4. Name of Device
- Proprietary Name: .
- Common Name: .
- . Classification:
3T 16ch Flex SPEEDER Coils Magnetic Resonance Specialty Coil
- 21 CFR 892.1000, Product Code MOS
- 5.5. Model Numbers
| NeoCoil Model Number | NeoCoil Model Name | Toshiba Model Number |
|---|---|---|
| NC045000 | 3T 16ch Flex SPEEDER Coil, Medium | MJAJ-212A |
| NC046000 | 3T 16ch Flex SPEEDER Coil, Large | MJAJ-222A |
5.6. Device Description
The NeoCoil 3T 16ch Flex SPEEDER Coils are 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 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.
5.7. Predicate Device
- . 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.
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| ARLE IN ARE E BELANDER AN AND AND | |||
| MARK | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
ANNUALIER A L C CHINA A
1.8 1.8 1.0 mm .
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NeoCoil, LLC
1
N27 W23910A Paul Rd Pewaukee. WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/1/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a circular graphic on the left and the word "NeoCoil" on the right. The graphic is a black circle with a white crescent shape inside and a small arrow pointing to the right. The word "NeoCoil" is written in a bold, sans-serif font.
5.8. Comparison to Predicate
The NeoCoil 3T 16ch Flex SPEEDER Coils are similar in physical, performance, design and material characteristics to the legally marketed device, the 1.5T 16ch Flex SPEEDER, K121362, as cleared on 06/15/2012.
The differences introduced in this submission include:
- DC and RF chains have been modified to meet the Toshiba Vantage Titan 3T Coil . Interface Description.
- Additional decoupling circuit in the 3T 16ch Flex SPEEDER Large compared to the . 1.5T 16ch Flex SPEEDER Large for the purpose of improved uniformity.
- . Compared to the 1.5T 16ch Flex SPEEDER, the preamplifier circuitry was moved from the antenna housing, to the cable, within a pre-amp cover located further away from the imaging volume to improve stability.
The Indications for Use are consistent with the capabilities of the predicate device, the NeoCoil 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.
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 3T Magnetic Resonance Scanners with ODU 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 3T 16ch Flex SPEEDER Coils 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 NeoCoil 3T 16ch Flex SPEEDER Coils are safe and effective. The devices' performance meets the requirements of pre-defined acceptance cnteria and intended uses.
| Test | Pass/Fail Criteria | Result |
|---|---|---|
| Unplugged Surface | ||
| Temperature | Acceptable level of risk | Pass: Surface temperature is not greater than |
| 41°C when the coil is left unplugged in the MRI | ||
| scanner. | ||
| Surface Temperature | Pre-defined | |
| performance standards | Pass: RF and Eddy current heating is not | |
| greater than 41°C. | ||
| Blocking Network | ||
| Analysis | Adequate transmit | |
| decoupling | Pass: Blocking network demonstrates | |
| adequate active and passive transmit | ||
| decoupling. |
Performance testing - Bench:
2
Page 3 of 3
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/2/Picture/2 description: The image shows the logo for NeoCoil. The logo consists of a stylized, circular graphic to the left of the word "NeoCoil". The graphic appears to be a coil shape with an arrow incorporated into the design. The text "NeoCoil" is in a bold, sans-serif font.
| Test | Pass/Fail Criteria | Result |
|---|---|---|
| B1 Field Distortion | Pre-defined | |
| performance standards | Pass: B1 field inhomogeneity meets Toshiba | |
| performance requirements and demonstrates | ||
| adequate active and passive transmit | ||
| decoupling. | ||
| NEMA MS 6-2008 | Pre-defined | |
| performance standards | Pass: SNR and Image Uniformity are | |
| consistent with the requirements for indications | ||
| for use. |
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 |
| NEMA MS-6 | SNR and Image Uniformity |
Performance testing - Clinical:
The clinical data in this section exhibits a mix of technical factors 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, issued November 14, 1998.5
No adverse events were reported during clinical performance testing; the 3T 16ch Flex SPEEDER Coil, Large and 3T 16ch Flex SPEEDER Coil, Medium 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, the 3T 16ch Flex SPEEDER Coils are equivalent to their predicate, 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.
@ 2014 NeoCoil, LLC
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2014
NEOCOIL. LLC MICHAEL LEIGH N27 W23910A PAUL RD. PEWAUKEE WI 53072
Re: K141832
Trade/Device Name: 3t 16ch Flex Speeder, Medium , 3t 16ch Flex Speeder, Large Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 3, 2014 Received: July 7, 2014
Dear Mr. Leigh:
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.
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
4
Page 2-Mr. Leigh
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. O'Hara
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K141832 |
|---|---|
| Device Name | 3T 16ch Flex SPEEDER Coils |
| Indications for Use (Describe) | To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU 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. |
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
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| FORM FDA 3881 (1/14) | Page 1 of 1 | |
|---|---|---|
| NeoColl, LLC | 3T 16ch Flex SPEEDER Colls - 510k Submission | Page 37 of 1021 |