(138 days)
Not Found
No
The summary describes a wireless audio system for entertainment and communication in an MRI environment, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is intended to provide entertainment and facilitate communication, not to treat or diagnose a medical condition.
No
Explanation: The device is described as providing entertainment and facilitating communication, and its performance studies focus on safety and effectiveness in the MRI environment, not on diagnosing medical conditions.
No
The device description explicitly states it is a "multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre)," indicating it includes hardware components.
Based on the provided information, the Innovision Audio system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as providing entertainment and facilitating communication to the patient during an MRI. This is a supportive function for the patient's comfort and communication during a medical procedure, not a diagnostic test performed on a sample from the body.
- Device Description: The description details a system for audio and communication, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Innovision Audio system does not fit this description.
N/A
Intended Use / Indications for Use
The Innovision Audio system is intended to provide entertainment and facilitate communication from the MRS scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.
Product codes
LNH
Device Description
Innovision Audio is a wireless device intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The Innovision Audio system is intended to be used by healthcare professionals.
Innovision Audio is a multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Bench testing demonstrates that the use of the Innovision Audio system is safe and effective and does not affect the safety or effectiveness of the MRI system when used as intended.
Test: MR safety
Pass/Fail Criteria: Pre-defined performance standards
Results: PASS RF, gradient and combined fields heating of applied parts is not greater than 41°C.
Test: NEMA MS 1 NEMA MS 2 NEMA MS 3
Pass/Fail Criteria: Pre-defined performance standards
Results: PASS Innovision Audio has no appreciable effect on MR image quality through assessment of image SNR, signal uniformity, geometric distortion.
Test: MR Immunity
Pass/Fail Criteria: Pre-defined performance standards
Results: PASS Innovision Audio is immune to the fields generated during MR imaging.
Test: Usability of device
Pass/Fail Criteria: Pre-defined performance standards
Results: PASS Innovision Audio is usable and minimally disruptive to the MRI workflow.
Key Metrics
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue and includes the words "U.S. Food & Drug Administration."
April 7, 2020
Innovere Medical Inc. % Ms. Lynsie Thomason Regulatory & Operations Lead 6-250 Shields Court Markham, Ontario L3R 9W7 CANADA
Re: K193218
Trade/Device Name: Innovision Audio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: March 6, 2020 Received: March 9, 2020
Dear Ms. Thomason:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Innovision Audio
Indications for Use (Describe)
The Innovision Audio system is intended to provide entertainment and facilitate communication from the MRS scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5 : 510(k) Summary
5.1 Applicant/Submitter
| Company Name | Innovere Medical Inc. |
|---|---|
| Establishment Registration Number | |
| Phone Number | 1-888-262-0408 |
| Company Street Address | 6-250 Shields Court |
| Fax Number | |
| City | Markham |
| State | ON |
| Country | Canada |
| Zip Code | L3R 9W7 |
| 5.2 Contact Person | |
| Full Name | Lynsie Thomason |
| Job Title | Regulatory & Operations Lead |
| Phone | 1-888-262-0408 (x104) |
| lynsie.thomason@innoveremedical.com |
5.3 Date of Preparation
| Date of Preparation | : 12/13/2019 |
|---|---|
| --------------------- | -------------- |
5.4 Device Information
Table - 5.1 Device Information
| Trade Name | Innovision Audio |
|---|---|
| Common or Usual Name | Magnetic resonance diagnostic device. |
| Classification Name | 21 CFR 892.1000 |
| Regulatory Class | 2 |
| Product Code | LNH |
5.5 Device Description
Innovision Audio is a wireless device intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The Innovision Audio system is intended to be used by healthcare professionals.
Innovision Audio is a multi-component system comprised of a wireless patient pillow, wireless bridges (data relays), and a Console Unit (entertainment control centre).
5.6 Predicate Device(s)
Table - 5.2 Predicate Device(s)
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| Predicate Type | 510(k) Number | Device Name | Manufacturer |
|---|---|---|---|
| Primary Device | K173409 | Wireless Audio System | NeoCoil, LLC |
5.7 Comparison of Technological Characteristics with Predicate
Based on the evidence provided, the Innovision Audio System is substantially equivalent to the legally marketed device NeoCoil Wireless Audio System (K173409, cleared on 02/16/2018).
Use of the devices with the MRI scanner is similar.
The Innovision Audio system differs from the predicate in the following ways:
- · Innovision Audio has a higher Noise Reduction Rating of >32dB
- · Innovision Audio delivers audio to the patient through a pillow instead of traditional headphones/earbuds
- · Innovision Audio includes an entertainment audio source with the device
Bench testing demonstrates that the use of the Innovision Audio system is safe and effective and does not affect the safety or effectiveness of the MRI system when used as intended.
5.8 Indications for Use
The Innovision Audio system is intended to provide entertainment and facilitate communication from the operator to the patient in the MRI scanner environment. The system is intended for "MR Conditional" use during supine MRI examinations at 1.5T and 3.0T.
5.9 Testing
The testing summarized in Table - 5.3 Performance Testing - Bench and Table - 5.4 Published Standards Testing have been submitted, referenced or relied on to demonstrate the safety and effectiveness of Innovision Audio. The device performs as intended.
| Test | Pass/Fail Criteria | Results |
|---|---|---|
| MR safety | Pre-defined performance standards | PASS |
| RF, gradient and combined fields | ||
| heating of applied parts is not greater | ||
| than 41°C. | ||
| NEMA MS 1 | ||
| NEMA MS 2 | ||
| NEMA MS 3 | Pre-defined performance standards | PASS |
| Innovision Audio has no appreciable | ||
| effect on MR image quality through | ||
| assessment of image SNR, signal | ||
| uniformity, geometric distortion. | ||
| MR Immunity | Pre-defined performance standards | PASS |
| Innovision Audio is immune to the | ||
| fields generated during MR imaging. | ||
| Usability of device | Pre-defined performance standards | PASS |
| Innovision Audio is usable and | ||
| minimally disruptive to the MRI | ||
| workflow. |
Table - 5.3 Performance Testing - Bench
Table - 5.4 Published Standards Testing
Standard
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| IEC 60601-1 | Electrical safety |
|---|---|
| IEC 60601-1-2 | Electromagnetic compatiblity |
| ISO 10993-1 | Biocompatiblity |
| NEMA MS 1 | Signal-to-Noise Ratio (SNR) in MR images |
| NEMA MS 2 | 2-Dimensional geometric distortions in MR images |
| NEMA MS 3 | Image uniformity of MR images |
5.10 Conclusion
This submission demonstrates that for the specified indications for use the Innovision Audio system is as safe and effective as the predicate device, NeoCoil Wireless Audio System, K173406, as cleared on 02/16/2018.