(44 days)
Not Found
No
The description focuses on the electro-mechanical components and firmware for generating acoustic vibrations, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as a diagnostic tool used to assess tissue elasticity for diagnostic purposes as part of magnetic resonance elastography (MRE). It does not provide treatment.
Yes
The device is described as generating acoustic vibrations during an MRI exam "in order to assess tissue elasticity for diagnostic purposes" and states that "When interpreted by a trained physician, this information can be useful in determining a diagnosis." This clearly indicates its role in providing information for diagnostic purposes.
No
The device description explicitly states that the system includes an "Active Driver" which is an electro-mechanical device with hardware components like a function generator, power-amplifier, linear motor, pump head, microprocessor-based controller, and power supply electronics. It also includes a "Passive Driver" which is a lightweight enclosure with a diaphragm. The performance studies also include mechanical and electrical testing, further indicating the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Resoundant Acoustic Driver System generates acoustic vibrations in the body during an MRI exam. It does not analyze samples taken from the body.
- Intended Use: The intended use is to generate vibrations for assessing tissue elasticity within the body as part of an MRE procedure.
- Device Description: The description details a system that applies physical vibrations to the patient, not a system that analyzes biological samples.
The device is a medical device used in conjunction with an imaging modality (MRI) to provide diagnostic information, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Resoundant Acoustic Driver System is intended for use with magnetic resonance diagnostic devices (MRDD) that include legally marketed MR elastography capabilities. It is indicated for generating acoustic vibrations in the body during an MRI exam, in order to assess tissue elasticity for diagnostic purposes as part of magnetic resonance elastography (MRE). When interpreted by a trained physician, this information can be useful in determining a diagnosis.
Product codes
LNH
Device Description
The Resoundant Acoustic Driver System includes an Active Driver, connective tubing and a Passive Driver. The system generates transverse acoustic waves in the low-audio frequency range in the body during an MRI exam. This allows assessment of elastic properties of soft tissue to aid in medical diagnosis as part of magnetic resonance elastography (MRE).
The Active Driver component is an electro-mechanical device that consists of a function generator, power-amplifier, linear motor and pump head, along with a microprocessor-based controller and power supply electronics, in an enclosure. The Passive Driver component is connected to the Active Driver through flexible tubing and is used to induce small vibrations in the scan subject. The Passive Driver is a lightweight enclosure containing no electrical components. It features a connection for flexible tubing and a diaphragm that is placed securely over patient clothing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance diagnostic devices (MRDD)
Anatomical Site
Body / soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MRE-trained technician or radiologist
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)
- Mechanical Testing: Dimensional, operational performance, and material testing was performed to assure compliance to specifications.
- Electrical Testing: Testing was conducted by an authorized third party laboratory to verify compliance of the Acoustic Driver System to product specifications as well as the following international standards for Safety for Medical Electrical Equipment: IEC ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-1-2:2014 (Fourth Edition).
- Firmware: The firmware utilized in the Active Driver microprocessor was developed and tested to assure compliance to specifications.
- Packaging: The packaged Acoustic Driver System was tested to verify that the packaging and product was not damaged during processing, shipping, or storage when subjected to simulated distribution testing per ASTM D4169-16 Distribution Cycle 13.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
July 10, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Resoundant, Inc. % John Hartigan, DRSc. MBA VP QA/RA 421 First Avenue SW, Suite 204W ROCHESTER MN 55902
Re: K201389
Trade/Device Name: Resoundant Acoustic Driver System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: May 21, 2020 Received: May 27, 2020
Dear Mr. Hartigan:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-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) K201389
Device Name
Resoundant Acoustic Driver System
Indications for Use (Describe)
The Resoundant Acoustic Driver System is intended for use with magnetic resonance diagnostic devices (MRDD) that include legally marketed MR elastography capabilities. It is indicated for generating acoustic vibrations in the body during an MRI exam, in order to assess tissue elasticity for diagnostic purposes as part of magnetic resonance elastography (MRE). When interpreted by a trained physician, this information can be useful in determining a diagnosis.
| 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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3
510(k) Summary
Resoundant Acoustic Driver System
| Date Prepared: | 7 July 2020 |
|---|---|
| Submitter: | Resoundant Inc. |
| 421 First Ave SW | |
| Suite 204W | |
| Rochester, MN 55902 | |
| Telephone: 507-322-0011 | |
| Contact: | John Hartigan, DRSc., MBA |
| VP QA/RA | |
| 421 First Ave SW, Suite 204W | |
| Rochester, MN 55902 | |
| Telephone: 507-322-0011 | |
| Proprietary Name: | Resoundant Acoustic Driver System |
| Common/Usual Name: | Acoustic Driver System |
| Accessory for Magnetic Resonance Image System for MRE | |
| Regulation Name: | Magnetic Resonance Image System |
| 21 CFR 892.1000, Class II | |
| Product Code – LNH, Magnetic Resonance Image System, Radiological |
Description: The Resoundant Acoustic Driver System includes an Active Driver, connective tubing and a Passive Driver. The system generates transverse acoustic waves in the low-audio frequency range in the body during an MRI exam. This allows assessment of elastic properties of soft tissue to aid in medical diagnosis as part of magnetic resonance elastography (MRE).
The Active Driver component is an electro-mechanical device that consists of a function generator, power-amplifier, linear motor and pump head, along with a microprocessor-based controller and power supply electronics, in an enclosure. The Passive Driver component is connected to the Active Driver through flexible tubing and is used to induce small vibrations in the scan subject. The Passive Driver is a lightweight enclosure containing no electrical components. It features a connection for flexible tubing and a diaphragm that is placed securely over patient clothing.
Indications for Use: The Resoundant Acoustic Driver System is intended for use with magnetic resonance diagnostic devices (MRDD) that include legally marketed MR elastography capabilities. It is indicated for generating acoustic vibrations in the body during an MRI exam, in order to assess tissue elasticity for diagnostic purposes as part of magnetic resonance
4
elastography (MRE). When interpreted by a trained physician, this information can be useful in determining a diagnosis.
Substantial Equivalence:
The Resoundant Acoustic Driver System is substantially equivalent to the following predicate device:
Primary Predicate: GE MR-Touch Option 510(k): K083421 GE Medical Systems This predicate has not been subject to a design related recall.
Comparison with Predicate:
The predicate, MR-Touch from GE Medical Systems, consists of the Resoundant Active Acoustic Driver System and acquisition/processing software in its MRI system. The hardware portion of the MR-Touch option is the Resoundant Acoustic Driver System, which is identical in intended use and technology/configuration.
All electro-mechanical functional specifications of the proposed Resoundant Acoustic Driver System remain the same as the original Acoustic Driver System utilized in the predicate MR-Touch.
A comparison of the devices is provided in the following table:
| Device
Parameter | Resoundant Acoustic Driver
System | GE Mr-Touch Option | Difference if
any |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K083421 | NA |
| Classification | 21 CFR 892.1000, Class II | 21 CFR 892.1000, Class II | Same |
| Product Code | Product Code – LNH
Magnetic Resonance
Diagnostic Device,
Radiological | Product Code – LNH Magnetic
Resonance Diagnostic Device,
Radiological | Same |
| Indications
for Use | The Resoundant Acoustic
Driver System is intended for
use with magnetic resonance
diagnostic devices (MRDD)
that include legally marketed
MR elastography capabilities.
It is indicated for generating
acoustic vibrations in the body
during an MRI exam, in order
to assess tissue elasticity for
diagnostic purposes as part of | MR-TouchTM is a software and
hardware option intended for
use with GE Signa® MR
systems. it is indicated for
magnetic resonance imaging of
the human body.
MR-TouchTM generates
transverse sectional information
related to the relative stiffness
of soft tissue. It consists of
hardware as well as acquisition | Overall
Intended Use
is substantially
equivalent; the
acoustic
vibration
generation is
identical. The
Acoustic
Driver System
is the same |
| | magnetic resonance | and reconstruction software. | hardware |
| | elastography (MRE). | The hardware components | device that |
| | | induce vibrations into the scan | generates the |
| | When interpreted by a trained | subject. The MR-Touch™ | acoustic |
| | physician, this information can | acquisition software is an | vibrations, |
| | be useful in determining a | evolutionary improvement to | enabling MR |
| | diagnosis. | the gradient echo sequence. The | Elastography. |
| | | sequence synchronizes the | |
| | | induced vibrations to acquire a | |
| | | series of phase-contrast images | |
| | | over time. The phase-contrast | |
| | | imaging technique measures | |
| | | motion or displacement. The | |
| | | displacement from the induced | |
| | | vibrations is detected using the | |
| | | time-series of phase-contrast | |
| | | images. The displacement | |
| | | information is | |
| | | reconstructed and presented as | |
| | | strain wave and relative | |
| | | stiffness images. | |
| | | When used with a GE Signa® | |
| | | MR system, MR-Touch™ is | |
| | | capable of producing transverse | |
| | | images of internal body | |
| | | structures such as muscle and | |
| | | liver. | |
| | | When interpreted by a trained | |
| | | physician, these images may | |
| | | provide information that can be | |
| | | useful in determining a | |
| | | diagnosis. | |
| Vibration | The Resoundant Acoustic | The Resoundant Acoustic | Same |
| Product | Driver System includes the | Driver System includes the | |
| Configuration | Active Driver, tubing and | Active Driver, tubing and | |
| | Passive Driver. | Passive Driver. | |
| Output | Nominally 60 Hz with a range | Nominally 60 Hz with a range | Same |
| | of 20-350 Hz | of 20-350 Hz | |
| Intended | MRE-trained technician or | MRE-trained technician or | Same |
| User | radiologist | radiologist | |
Feature and Technical Characteristic Comparison
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Verification and Validation:
The Resoundant Acoustic Driver System has been extensively tested through the design verification and system validation phases of its development. The following provides an overview of the testing successfully performed:
- Mechanical Testing: Dimensional, operational performance, and material testing was . performed to assure compliance to specifications.
- Electrical Testing: Testing was conducted by an authorized third party laboratory to . verify compliance of the Acoustic Driver System to product specifications as well as the following international standards for Safety for Medical Electrical Equipment: IEC ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-1-2:2014 (Fourth Edition).
- Firmware: The firmware utilized in the Active Driver microprocessor was developed and ● tested to assure compliance to specifications.
- Packaging: The packaged Acoustic Driver System was tested to verify that the packaging ● and product was not damaged during processing, shipping, or storage when subjected to simulated distribution testing per ASTM D4169-16 Distribution Cycle 13.
Conclusion:
Through the data and information presented. Resoundant Inc. considers the Acoustic Driver System substantially equivalent to the predicate device already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design, and functional performance and presents no new concerns about safety and effectiveness. The verification and validation tests conducted demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device for its intended use.