(107 days)
Not Found
No
The summary describes a wireless audio system for communication and entertainment in MRI environments and does not mention any AI or ML components or functionalities.
No
The device is intended for entertainment and communication purposes in an MRI environment, not for treating or diagnosing a medical condition.
No
The device is intended for entertainment and communication during MRI scans, not for diagnosing medical conditions.
No
The device description explicitly states it is a "modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure," indicating it includes hardware components. The performance testing also includes hardware-related tests like "Max B1 in first fault conditions" and "Surface Temperature."
Based on the provided information, the NeoCoil Wireless Audio System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use is to "provide entertainment and facilitate patient communication in MRI environments." This clearly describes a device used on a patient for comfort and communication during a medical procedure, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on components for audio transmission and reception for patient interaction within the MRI environment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on safety within the MRI environment (RF heating, image quality impact, noise reduction) and communication quality, not on the accuracy or reliability of diagnostic test results.
Therefore, the NeoCoil Wireless Audio System falls under the category of a medical device used for patient comfort and communication during an imaging procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.
The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals / MRI scanner environment
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 NeoCoil Wireless Audio System is safe and effective. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.
Performance Testing - Bench:
- Max B1 in first fault conditions: PASS: Wireless Audio System does not arc or show any signs of voltage breakdown.
- Surface Temperature in normal and first fault conditions: PASS: RF heating is not greater than 41° C.
- NEMA MS 6-2008: PASS: Wireless Audio System does not adversely impact MR image SNR and Uniformity
- Coherent Noise Test: PASS: Wireless Audio System does not introduce image artifacts noise in center frequency range of compatible field strengths.
- Noise Reduction: PASS: ≥29 dBA NRR (ANSI S3.19-1974)
- Quality of Service and Coexistence Test: PASS: Wireless Audio System provides adequate quality of service for patient communication during MRI scanning.
Performance Testing - Clinical:
Clinical data submitted exhibits a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes as recommended in the FDA guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016.
No adverse events were reported during clinical performance testing; the NeoCoil Wireless Audio System does not adversely affect MR image production in the worst-case environment.
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.
Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
February 16, 2018
NeoCoil, LLC Michael Leigh Director. Regulatory Affairs N27 W23910A Paul Rd. Pewaukee, Wisconsin 53072
Re: K173409
Trade/Device Name: Wireless Audio System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: January 22, 2018 Received: January 24, 2018
Dear Michael 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 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);
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Page 2 - Michael Leigh
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K173409
Device Name NeoCoil Wireless Audio System
Indications for Use (Describe)
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
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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 262-347-1250 (office) 261-347-1251 (fax) mike.leigh@neocoil.com
5.3. Preparation Date
5.4. Name of Device
●
●
- Proprietary Name: ● Common Name:
Classification:
NeoCoil Wireless Audio System
- Nuclear Magnetic Resonance System 21 CFR 892.1000, Product Code LNH
- 5.5. Model Numbers
| NeoCoil Model Number | NeoCoil Model Name |
|---|---|
| NC069201 | Technologist Console Interface |
| NC079202 | Penetration Panel Transmitter |
| NC071200 | Wireless Patient Headphones |
| NC075200 | Wireless Audio Interface |
| NC107200 | S1 Audio Interface Module |
| NC130200 | S2 Audio Interface Module |
| NC130202 | P2 Audio Interface Module |
| NC126200 | Scan Room Module |
| NC126201 | Wireless Router |
| NC126202 | Technologist Console Interface |
5.6. Device Description
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.
The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.
5.7. Predicate Device
- . Patient Communication and Entertainment System , K133670, as cleared on 07/24/2014
5.8. Comparison to Predicate
The NeoCoil Wireless Audio System is similar in physical, performance, design and material characteristics to the legally marketed device Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014.
4
Use of the device in conjunction with an MRI scanner is similar.
The NeoCoil Wireless Audio System includes the following differences to the predicate.
- Improved Noise Reduction Rating to 29dBA ●
- Optional Wireless Audio Interface for use with a head coil
- Additional installation options for wired, pneumatic, or wireless communication with ● the control room
Clinical testing demonstrates that use of the NeoCoil Wireless Audio System does not affect the safety and/or the effectiveness of the device when used as labeled.
5.9. Indications for Use
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments at 3 Tesla field strength and below.
5.10. Intended Use
The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate patient communication in MRI environments. The product is not intended for medical diagnosis or treatment.
The product is intended for "MR Conditional" use in MRI environments at 3 Tesla and below. Technologist control units are intended to be used outside the MRI scan room.
Wireless receivers are intended for use outside the imaging field of view.
5.11. Testing
The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil Wireless Audio System 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: Wireless Audio System does not arc or | |
| show any signs of voltage breakdown. | ||
| Surface Temperature | ||
| in normal and first | ||
| fault conditions | Pre-defined | |
| performance standards | PASS: RF heating is not greater than 41° C. | |
| NEMA MS 6-2008 | Pre-defined | |
| performance standards | PASS: Wireless Audio System does not | |
| adversely impact MR image SNR and | ||
| Uniformity | ||
| Coherent Noise Test | Pre-defined | |
| performance standards | PASS: Wireless Audio System does not | |
| introduce image artifacts noise in center | ||
| frequency range of compatible field strengths. | ||
| Noise Reduction | Pre-defined | |
| performance standards | PASS: ≥29 dBA NRR (ANSI S3.19-1974) | |
| Quality of Service | ||
| and Coexistence | ||
| Test | Pre-defined | |
| performance standards | PASS: Wireless Audio System provides | |
| adequate quality of service for patient | ||
| communication during MRI scanning. |
Performance Testing - Bench:
Published Standards Testing:
5
The NeoCoil Wireless Audio System has been evaluated to the following standards:
| Standard | Purpose |
|---|---|
| IEC 60601-1 | Electromechanical safety |
| IEC 60601-1-2 | Electromagnetic Compatibility |
| IEC 60601-1-6 | Usability |
| IEC 60601-2-33 | Electromechanical safety for magnetic resonance equipment |
| IEC 62366 | Guidance on the application of usability engineering to medical devices |
| ISO 10993-1 | Biocompatibility |
| NEMA MS6 | Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance |
| Images |
Performance Testing - Clinical:
Clinical data submitted exhibits a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes as recommended in the FDA guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016.
No adverse events were reported during clinical performance testing; the NeoCoil Wireless Audio System does not adversely affect MR image production in the worst-case environment.
5.12. Conclusion
This submission demonstrates that the Indications for Use associated with the NeoCoil Wireless Audio System are as safe and effective as the predicate device, Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014. As such, the NeoCoil Wireless Audio System is equivalent to its predicate, Patient Communication and Entertainment System, K133670, as cleared on 07/24/2014.