(160 days)
No
The description focuses on the hardware components (coils, antennae) and their physical properties for receiving MR signals. There is no mention of software algorithms, image processing, or any terms related to AI/ML.
No
The device is described as a receive-only phased array coil system used to produce diagnostic images, indicating its purpose is for diagnosis, not treatment.
No
This device is a receive-only coil system for Magnetic Resonance Scanners, designed to produce diagnostic images. The images are then interpreted by a trained physician, indicating that the device itself is an imaging component rather than a diagnostic one.
No
The device description explicitly details physical components like "antennae" and "optional accessories," and the performance studies include bench testing related to physical properties like "Surface Temperature" and "Max B1." This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "receive-only phased array coil system" used in conjunction with an MRI scanner to "produce diagnostic images." It is a component of an imaging system, not a test performed on a biological sample.
- Intended Use: The intended use is to produce images for interpretation by a physician, not to analyze biological samples.
- Lack of Biological Sample Analysis: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
This device is a medical imaging accessory, specifically an MRI coil.
N/A
Intended Use / Indications for Use
To be used in conjunction with Toshiba 1.5T Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine in pediatric and adult populations that can be interpreted by a trained physician.
Product codes
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 in pediatric and adult populations that can be interpreted by a trained physician. 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
pediatric and adult populations
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:
Max B1 in first fault conditions: Pass: Coil does not arc or show any signs of voltage breakdown. *No change from the legally marketed device, the 1.5T 16ch Flex SPEEDER, K121362, as cleared on 06/15/2012.
Surface Temperature in normal and first fault conditions: Pass: RF heating is not greater than 39° C in normal or first fault conditions.
NEMA MS 6-2008: Pass: SNR and Uniformity are consistent with the requirements for the expanded Indications for Use. *No change from the legally marketed device, the 1.5T 16ch Flex SPEEDER, K121362, as cleared on 06/15/2012. Additional SNR and Uniformity measurements demonstrate acceptable performance when used with the Pediatric Stabilizer for head, neck and spine imaging.
Unplugged Surface Temperature: Pass: Surface temperature rise results in acceptable residual risk after mitigation.
Published Standards testing:
The expanded Indications for Use introduced for the 1.5T 16ch Flex SPEEDER Coil in this submission have no impact to the results of standards testing of the predicate device, 1.5T 16ch Flex SPEEDER Coil, K121362, as cleared on 06/15/2012.
Additional standards testing were performed incorporating the added accessory, Pediatric SPEEDER accessory. Standards Data Report Forms (FDA 3654) are included in this submission, as applicable.
NOTE: Where indicated in the table below, new Standards testing was performed, as necessary, to support the expanded Indications for Use for pediatric populations. Standards testing that was not impacted by the introduction of the Pediatric SPEEDER accessory is listed as 'No change'.
Standard: IEC 60601-1, Purpose: Electromechanical safety, Comment: No change since K121362
Standard: IEC 60601-1-2, Purpose: ESD, Comment: No change since K121362
Standard: IEC 60601-2-33, Purpose: Electromechanical safety for magnetic resonance equipment, Comment: No change since K121362
Standard: ISO 10993-1, Purpose: Biocompatibility, Comment: Additional risk assessment of Pediatric SPEEDER accessory performed.
Standard: NEMA MS6, Purpose: Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images, Comment: Characterization of 1.5T 16ch Flex SPEEDER Large and 1.5T 16ch Flex SPEEDER Medium in conjunction with the Pediatric SPEEDER accessory performed.
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, issued November 14, 1998.
Clinical performance testing includes imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Device issued May 14, 2004.
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)
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 Direct: (262) 347-1250 Fax: (262) 347-1251
AR 2 8 2013
5. Abbreviated 510(k) Summary
- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072
- 5.2. Contact Katie Gonzalez Engineering Services Specialist 262-347-1250 (office) 261-347-1251 (fax) katie.gonzalez@neocoil.com
5.3. Preparation Date 9/17/2012
5.4. Name of Device
- Proprietary Name: .
- Common Name: .
- Classification: .
1.5T 16ch Flex SPEEDER Coil Magnetic Resonance Specialty Coil 21 CFR 892.1000, Product Code MOS
5.5. Model Numbers
| NeoCoil Model Number | NeoCoil Model Name | Toshiba Model |
|---|---|---|
| NC043000 | 1.5T 16ch Flex SPEEDER Coil Large | MJAJ-227A/S1 |
| NC042000 | 1.5T 16ch Flex SPEEDER Coil Medium | MJAJ-217A/S1 |
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 in pediatric and adult populations that can be interpreted by a trained physician. 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 16ch Flex SPEEDER Coil (K121362), cleared on 06/15/2012 ●
- 5.8. Comparison to Predicate
The NeoCoil 1.5T 16ch Flex SPEEDER coils are unchanged 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:
- Expanded Indications for Use with specific claims relating to pediatric populations. .
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© 2012 NeoCoil
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K123272 Page 2 of 3
N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/1/Picture/2 description: The image shows the logo for NeoCoil. The logo consists of a circular shape with an arrow pointing to the right, followed by the text "NeoCoil" in a bold, sans-serif font. The circular shape is made up of two concentric circles, with the arrow extending from the inner circle to the outer circle.
- . Updated labeling that includes coil setup and positioning that support the expanded Indications for Use.
Use of the device in conjunction with an MRI scanner is unchanged; the specific claims in the expanded Indications for Use relating to pediatric populations have been added and are consistent with the capabilities of the 1.5T 16ch Flex SPEEDER 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 1.5T Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine in pediatric and adult populations 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.
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 fault | ||
| conditions | Pre-defined | |
| performance standards | Pass: Coil does not arc or show any signs of | |
| voltage breakdown. | ||
| *No change from the legally marketed device, | ||
| the 1.5T 16ch Flex SPEEDER, K121362, as | ||
| cleared on 06/15/2012. | ||
| Surface Temperature | ||
| in normal and first | ||
| fault conditions | Pre-defined | |
| performance standards | Pass: RF heating is not greater than 39° C in | |
| normal or first fault conditions. | ||
| NEMA MS 6-2008 | Pre-defined | |
| performance standards | Pass: SNR and Uniformity are consistent with | |
| the requirements for the expanded Indications | ||
| for Use. | ||
| *No change from the legally marketed device, | ||
| the 1.5T 16ch Flex SPEEDER, K121362, as | ||
| cleared on 06/15/2012. Additional SNR and | ||
| Uniformity measurements demonstrate | ||
| acceptable performance when used with the | ||
| Pediatric Stabilizer for head, neck and spine | ||
| imaging. | ||
| Unplugged Surface | ||
| Temperature | Acceptable level of risk | Pass: Surface temperature rise results in |
| acceptable residual risk after mitigation. |
Performance testing - Bench:
© 2012 NeoCoil, LLC
2
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N27 W23910A Paul Rd Pewaukee, WI 53072 Direct: (262) 347-1250 (262) 347-1251 Fax:
Published Standards testing:
The expanded Indications for Use introduced for the 1.5T 16ch Flex SPEEDER Coil in this submission have no impact to the results of standards testing of the predicate device, 1.5T 16ch Flex SPEEDER Coil, K121362, as cleared on 06/15/2012.
Additional standards testing were performed incorporating the added accessory, Pediatric SPEEDER accessory. Standards Data Report Forms (FDA 3654) are included in this submission, as applicable.
NOTE: Where indicated in the table below, new Standards testing was performed, as necessary, to support the expanded Indications for Use for pediatric populations. Standards testing that was not impacted by the introduction of the Pediatric SPEEDER accessory is listed as 'No change'.
| Standard | Purpose | Comment |
|---|---|---|
| IEC 60601-1 | Electromechanical safety | No change since K121362 |
| IEC 60601-1-2 | ESD | No change since K121362 |
| IEC 60601-2-33 | Electromechanical safety for | |
| magnetic resonance equipment | No change since K121362 | |
| ISO 10993-1 | Biocompatibility | Additional risk assessment of Pediatric |
| SPEEDER accessory performed. | ||
| NEMA MS6 | Characterization of Special | |
| Purpose Coils for Diagnostic | ||
| Magnetic Resonance Images | Characterization of 1.5T 16ch Flex | |
| SPEEDER Large and 1.5T 16ch Flex | ||
| SPEEDER Medium in conjunction with the | ||
| Pediatric SPEEDER accessory performed. |
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, issued November 14, 1998.
Clinical performance testing includes imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Device issued May 14, 2004.
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 expanded Indications for Use associated with pediatric use are as safe and effective as the predicate device, 1.5T 16ch Flex SPEEDER coil, K121362, as cleared on 06/15/2012.
| © 2012 NeoCoil, LLC | ||
|---|---|---|
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28. 2013
NeoCoil, LLC % Ms. Katie Gonzalez Engineering Services Specialist N27 W23910A Paul Road PEWAUKEE WI 53072
Re: K123272
Trade/Device Name: 1.5T 16ch Flex SPEEDER Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 8, 2013 Received: March 13, 2013
Dear Ms. Gonzalez:
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. Ilisting 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.
4
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
5
Indications for Use
510(k) Number (if known): K123272
Device Name: 1.5T 16ch Flex SPEEDER
Indications for Use:
To be used in conjunction with Toshiba 1.5T Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine in pediatric and adult populations 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiologica! Health Office of In Vitro Diagnostics and Radiological Health
510(k) K123272
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