(48 days)
Not Found
No
The device description and performance testing focus on the hardware components and their physical and electrical properties, with no mention of software algorithms, image processing, or AI/ML techniques.
No
The device is used to produce diagnostic images, which are used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "to produce diagnostic images" which are then "interpreted by a trained physician," explicitly indicating its role in diagnosis.
No
The device description explicitly details physical hardware components: "Two formable, flexible and detachable antennae" and "Optional accessories designed for patient comfort and reduced motion artifacts." The performance testing also includes physical tests like "Unplugged Surface Temperature" and "Surface Temperature," indicating a hardware component.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an MRI coil used to produce diagnostic images of various anatomical sites within the body. It works by receiving RF signals from the patient's body during an MRI scan.
- Intended Use: The intended use is to produce images that are interpreted by a physician, not to analyze biological samples.
- Lack of Specimen Handling: There is no mention of the device interacting with or analyzing any biological specimens.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used in conjunction with Siemens 1.5T MAGNETOM MRI scanners to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis and spine that can be interpreted by a trained physician.
Intended use of the NeoCoil 1.5T 16-Channel Flex Coils for Siemens is identical to that of routine MR imaging; specifically to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis and spine.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is a system of phased array, receiveonly coils. 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 16-Channel Flex Coils for Siemens are tuned to receive RF frequency corresponding to the proton precession in a 1.5 testa magnetic field, which is governed by the Larmor equation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
upper and lower extremities, chest, abdomen, pelvis 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:
Test: Unplugged Surface Temperature, Pass/Fail Criteria: Acceptable level of risk, Result: Pass: Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner.
Test: Surface Temperature, Pass/Fail Criteria: Pre-defined performance standards, Result: Pass: RF and Eddy current heating is not greater than 41℃.
Test: Blocking Network Analysis, Pass/Fail Criteria: Adequate transmit decoupling, Result: Pass: Blocking network demonstrates adequate active and passive transmit decoupling.
Test: B1 Field Distortion, Pass/Fail Criteria: Pre-defined performance standards, Result: Pass: B1 field inhomogeneity meets Siemens performance requirements and demonstrates adequate active and passive transmit decoupling.
Test: NEMA MS 6-2008, Pass/Fail Criteria: Pre-defined performance standards, Result: Pass: SNR and Image Uniformity are consistent with the requirements for indications for use.
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
Standard: NEMA MS-6, Purpose: SNR and Image Uniformity
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 16-Channel Flex Coil, Large and 1.5T 16-Channel Flex Coil, Small 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
DEC 2 6 2013
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/0/Picture/3 description: The image shows the logo for NeoCoil. The logo consists of a stylized circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in a bold, sans-serif font. The logo is black and appears to be on a white background.
5. Abbreviated 510(k) Summary
- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
- 5.2. Contact Katie Gonzalez Engineering Services Specialist 262-522-6124 (direct) 261-347-1251 (fax) Katie. Gonzalez@NeoCoil.com
5.3. Preparation Date 11/07/2013
5.4. Name of Device
- Proprietary Name: .
- Common Name: .
- Classification: .
1.5T 16-Channel Flex Coils Magnetic Resonance Specialty Coil 21 CFR 892.1000, Product Code MOS
5.5. Model Numbers
| NeoCoil Model Number | NeoCoil Model Name |
|---|---|
| NC052000 | 1.5T 16-Channel Flex Coil, Small |
| NC053000 | 1.5T 16-Channel Flex Coil, Large |
5.6. Device Description
The NeoCoil 1.5T 16-Channel Flex Coils for Siemens is a system of phased array, receiveonly coils. 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 16-Channel Flex Coils for Siemens are tuned to receive RF frequency corresponding to the proton precession in a 1.5 testa 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 16-Channel Flex Coils for Siemens 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.
1
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 Fax: (262) 347-1251
Image /page/1/Picture/1 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 word "NeoCoil" in bold, sans-serif font. The logo is black and white.
The differences introduced in this submission include:
- Electrical interface modifications to meet the Siemens MAGNETOM Coil Interface . Description.
- Cable and connector material modifications to utilize Siemens specified materials. . All materials have been evaluated for biocompatibility.
- Minor dimensional changes compared to the 1.5T 16ch Flex SPEEDER, resulting . from the plastic housing modifications to accommodate electrical interface changes.
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 Siemens 1.5T MAGNETOM MRI scanners to produce diacnostic images of the upper and lower extremities, chest, abdomen, pelvis and spine that can be interpreted by a trained physician. -
Intended Use 5.10.
Intended use of the NeoCoil 1.5T 16-Channel Flex Coils for Siemens is identical to that of routine MR imaging; specifically to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis 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 1.5T 16-Channel Flex Coils for Siemens are safe and effective. The devices' performance meets the requirements of pre-defined acceptance criteria 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℃. | ||
| Blocking Network | ||
| Analysis | Adequate transmit | |
| decoupling | Pass: Blocking network demonstrates | |
| adequate active and passive transmit | ||
| decoupling. | ||
| B1 Field Distortion | Pre-defined | |
| performance standards | Pass: B1 field inhomogeneity meets Siemens | |
| 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. |
Performance testing - Bench:
© 2013 NeoCoil, LLC
2
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/2/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a stylized coil symbol with an arrow on the right side, followed by the text "NeoCoil" in a bold, sans-serif font. The coil symbol is made up of three concentric arcs, with the arrow pointing to the right. The logo is black and white.
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:
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 16-Channel Flex Coil, Large and 1.5T 16-Channel Flex Coil, Small 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 and spine and are as safe and effective as the predicate device. As such, NeoCoil 1.5T 16-Channel Flex Coils for Siemens are equivalent to their predicate, 1.5T 16ch Flex SPEEDER Coil, K121362 as cleared on 06/15/2012.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 26, 2013
NeoCoil, LLC % Ms. Katie Gonzalez Engineering Services Specialist N27 W23910A Paul Road PEWAUKEE WI 53072
Re: K133422
Trade/Device Name: 1.5T 16-Channel Flex Coil, (Small-NC052000 and Large-NC05300) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 7, 2013 Received: November 8, 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, 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.
4
Page 2 - Ms. Katie Gonzalez
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/ReportaProblem/default.htmfor 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
FDA
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
نيوني ويوري وي
510(k) Number (if known): K133422
Device Name: 1.5T 16-Channel Flex Coils
Indications for Use:
To be used in conjunction with Siemens 1.5T MAGNETOM MRI scanners to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis 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 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)
Michal FDA Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K133422
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