(272 days)
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Not Found
No
The summary focuses on acquiring and providing physiological signals for MRI gating and does not mention any AI/ML processing or analysis of these signals.
No
The device explicitly states, "This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment." Its purpose is to acquire physiologic signals to trigger gated MRI acquisitions, not to provide therapy.
No
Explanation: The 'Intended Use / Indications for Use' section explicitly states, "This product is not intended for the diagnosis, treatment, or prevention of any disease... This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring."
No
The description explicitly states the device "acquires physiologic signals, comprising ECG, PP, and RESP," which implies the use of hardware sensors to collect this data. While software is likely involved in processing and providing the reference outputs, the core function relies on hardware signal acquisition.
Based on the provided information, the Ivy MR Wireless Gating System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to acquire physiologic signals (ECG, PP, RESP) to trigger the acquisition of gated images during MRI scanning. It explicitly states it is not intended for the diagnosis, treatment, or prevention of any disease and not intended to provide diagnostic clinical information.
- IVD Definition: IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ivy MR Wireless Gating System does not process or analyze such specimens.
Therefore, the device's function is to facilitate the imaging process by providing timing signals based on physiological data, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Ivy MR Wireless Gating System's intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
Product codes
LNH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
MRI
Anatomical Site
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Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
trained and qualified medical professionals
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text.
Ivy Biomedical Systems, Inc. Nicole Bush Director of Regulatory 11 Business Park Drive Branford, Connecticut 06405
Re: K171778
Trade/Device Name: MR Wireless Gating System, Model WGS-100 Regulation Number: 21 CFR 892,1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: February 7, 2018 Received: February 13, 2018
Dear Nicole Bush:
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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 medical devices and radiation-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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171778
Device Name MR Wireless Gating System, Model WGS-100
Indications for Use (Describe)
The Ivy MR Wireless Gating System's intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition of gated images during MRI scanning in systems operating at 3.0 Tesla in strength.
The MR Wireless Gating System is intended for use on adult and pediatric patients.
This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring.
The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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