(160 days)
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.
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.
The NeoCoil 1.5T 16ch Flex SPEEDER Coil is a receive-only phased array coil system for magnetic resonance imaging. The current submission (K123272) describes an expansion of indications for use to include pediatric populations, with no changes to the physical, performance, design, or material characteristics of the coil itself compared to its legally marketed predicate device (K121362). The primary additions are updated labeling and a Pediatric Stabilizer accessory for head, neck, and spine imaging in pediatric patients.
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 predicate device K121362). |
| 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 (SNR and Uniformity) | Pre-defined performance standards | Pass: SNR and Uniformity are consistent with the requirements for the expanded Indications for Use. (No change from predicate device K121362. 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. |
| IEC 60601-1 (Electromechanical safety) | Pre-defined performance standards | No change: since K121362. |
| IEC 60601-1-2 (ESD) | Pre-defined performance standards | No change: since K121362. |
| IEC 60601-2-33 (Electromechanical safety for MR equipment) | Pre-defined performance standards | No change: since K121362. |
| ISO 10993-1 (Biocompatibility) | Pre-defined performance standards | Additional risk assessment: of Pediatric SPEEDER accessory performed. |
| NEMA MS6 (Characterization of Special Purpose Coils) | Pre-defined performance standards | Characterization: of 1.5T 16ch Flex SPEEDER Large and 1.5T 16ch Flex SPEEDER Medium in conjunction with the Pediatric SPEEDER accessory performed. |
| Clinical Performance | Performance adequate to support Indications for Use | Pass: No adverse events were reported. The coils demonstrated performance adequate to support the Indications for Use for pediatric and adult populations. |
2. Sample size used for the test set and the data provenance:
- Bench Testing: The document does not specify a numerical sample size for the bench tests. These tests would involve specific coil units and test setups. The description notes that "additional SNR and Uniformity measurements demonstrate acceptable performance" with the Pediatric Stabilizer.
- Clinical Testing: The document does not provide a specific numerical sample size (number of patients) for the clinical performance testing. It states that "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." It also confirms that "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."
- Data Provenance: Not explicitly stated, but based on the overall context of a 510(k) submission to the US FDA, it is highly likely to be prospective data collected for the purposes of device clearance. However, the document does not specify the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The clinical images are intended to be "interpreted by a trained physician," but no details are given on the number or qualifications of experts involved in establishing ground truth for the performance testing itself.
4. Adjudication method for the test set:
This information is not provided in the document. The general statement is that images are "interpreted by a trained physician," but no specific adjudication method (e.g., 2+1, 3+1, none) for the test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an MRI coil, not an AI-based diagnostic tool. The document describes the performance of the coil itself, not the impact on human reader performance or the use of AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an MRI coil, a hardware component, and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used:
For the bench testing, the ground truth for parameters like Max B1, Surface Temperature, SNR, and Uniformity would be based on physical measurements against established engineering and clinical performance standards (e.g., NEMA MS 6-2008, IEC 60601 series).
For clinical performance testing, the document implies that the images produced were of diagnostic quality and could be "interpreted by a trained physician." This suggests the ground truth was clinical diagnostic interpretation by physicians, but the specific method of establishing this (e.g., expert consensus, comparison to gold standard pathology, or patient outcomes) is not detailed. The phrase "performance adequate to support the Indications for Use" implies successful visualization of the anatomical regions as intended for diagnosis.
8. The sample size for the training set:
Not applicable. This device is a passive MRI coil, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As stated above, this device does not utilize a training set in the context of machine learning.
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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. .
| STATUS THE THE THE LEAST COLLECTION------------------------------------------------------------------------------------------------------------------------------------------------------------------------------© 2012 NeoCoil11 the 1 1 the been and10.000The first of the county ofA MOND A COLLEGIAN COLLECTION COLLECTION COLLECTION OF CLAIM COLLECTION OF CLAIM CANADIA CONTRACT COLLECTION OF CLAIM CANADIA CONTRACT COLLECTION OF COLLECTION OF COLLECTION------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Company of Children Company of Children1FLA LINE ALL ALER A. L. |
|---|---|
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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 faultconditions | Pre-definedperformance standards | Pass: Coil does not arc or show any signs ofvoltage breakdown.*No change from the legally marketed device,the 1.5T 16ch Flex SPEEDER, K121362, ascleared on 06/15/2012. |
| 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 the expanded Indicationsfor Use.*No change from the legally marketed device,the 1.5T 16ch Flex SPEEDER, K121362, ascleared on 06/15/2012. Additional SNR andUniformity measurements demonstrateacceptable performance when used with thePediatric Stabilizer for head, neck and spineimaging. |
| Unplugged SurfaceTemperature | Acceptable level of risk | Pass: Surface temperature rise results inacceptable residual risk after mitigation. |
Performance testing - Bench:
© 2012 NeoCoil, LLC
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K123272 page 3 of 3
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 formagnetic resonance equipment | No change since K121362 |
| ISO 10993-1 | Biocompatibility | Additional risk assessment of PediatricSPEEDER accessory performed. |
| NEMA MS6 | Characterization of SpecialPurpose Coils for DiagnosticMagnetic Resonance Images | Characterization of 1.5T 16ch FlexSPEEDER Large and 1.5T 16ch FlexSPEEDER Medium in conjunction with thePediatric 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 | ||
|---|---|---|
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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.
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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
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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
Page 1 of
§ 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.