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.

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.

AI/ML Overview

The Resoundant Acoustic Driver System is not an AI/ML device but an acoustic driver system used in Magnetic Resonance Elastography (MRE). Therefore, the typical acceptance criteria and study designs associated with AI/ML devices do not apply. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance metrics against a clinical ground truth.

However, based on the provided text, we can extract the verification and validation information to describe how the device (not an AI algorithm) meets its acceptance criteria.

1. Table of Acceptance Criteria (from Verification and Validation) and Reported Device Performance

Acceptance Criteria Category	Specific Tests/Standards Met	Reported Device Performance
Mechanical Performance	Dimensional, operational performance, material testing.	Compliance to specifications (exact specifications not detailed).
Electrical Safety	IEC ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012	Verified compliance to product specifications and international standards for Safety for Medical Electrical Equipment.
	IEC 60601-1-2:2014 (Fourth Edition)	Verified compliance to product specifications and international standards for Safety for Medical Electrical Equipment.
Firmware Functionality	Firmware developed and tested	Assured compliance to specifications (exact specifications not detailed).
Packaging Integrity	Simulated distribution testing per ASTM D4169-16 Distribution Cycle 13	Verified that packaging and product were not damaged during processing, shipping, or storage.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and not provided in the document. The device is a hardware accessory, not a diagnostic algorithm that processes data to produce a result. Its "performance" is evaluated through engineering and safety tests rather than analysis of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. Ground truth in the context of diagnostic algorithms refers to a confirmed diagnosis or condition. For a hardware device, ground truth would relate to measurable physical properties or compliance with engineering standards, which are typically assessed by engineers and testing personnel, not medical experts establishing diagnostic ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, particularly in studies involving diagnostic accuracy algorithms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of an AI system on human reader performance. The Resoundant Acoustic Driver System is a hardware component for MRE, not an AI system.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone performance study was not done because this is not an algorithm. The device's function is to generate acoustic vibrations, which is a physical process, not a computational one.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on engineering specifications, international safety standards (e.g., IEC 60601 series), and functional design requirements. For example, the "ground truth" for electrical safety is compliance with specific clauses of IEC 60601-1-2014. For mechanical performance, it would be adherence to defined dimensional tolerances or operational parameters. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would.

8. The Sample Size for the Training Set

This information is not applicable. The Resoundant Acoustic Driver System is a hardware device; it does not utilize a training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for a hardware device.

Summary

{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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201389

Device Name

Resoundant Acoustic Driver System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Resoundant Acoustic Driver System

Date Prepared:	7 July 2020
Submitter:	Resoundant Inc.421 First Ave SWSuite 204WRochester, MN 55902Telephone: 507-322-0011
Contact:	John Hartigan, DRSc., MBAVP QA/RA421 First Ave SW, Suite 204WRochester, MN 55902Telephone: 507-322-0011
Proprietary Name:	Resoundant Acoustic Driver System
Common/Usual Name:	Acoustic Driver SystemAccessory for Magnetic Resonance Image System for MRE
Regulation Name:	Magnetic Resonance Image System21 CFR 892.1000, Class IIProduct 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).

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:

DeviceParameter	Resoundant Acoustic DriverSystem	GE Mr-Touch Option	Difference ifany
510(k)		K083421	NA
Classification	21 CFR 892.1000, Class II	21 CFR 892.1000, Class II	Same
Product Code	Product Code – LNHMagnetic ResonanceDiagnostic Device,Radiological	Product Code – LNH MagneticResonance Diagnostic Device,Radiological	Same
Indicationsfor Use	The Resoundant AcousticDriver System is intended foruse with magnetic resonancediagnostic devices (MRDD)that include legally marketedMR elastography capabilities.It is indicated for generatingacoustic vibrations in the bodyduring an MRI exam, in orderto assess tissue elasticity fordiagnostic purposes as part of	MR-TouchTM is a software andhardware option intended foruse with GE Signa® MRsystems. it is indicated formagnetic resonance imaging ofthe human body.MR-TouchTM generatestransverse sectional informationrelated to the relative stiffnessof soft tissue. It consists ofhardware as well as acquisition	OverallIntended Useis substantiallyequivalent; theacousticvibrationgeneration isidentical. TheAcousticDriver Systemis 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

{5}------------------------------------------------

{6}------------------------------------------------

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.

Regulation Number and Section

§ 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.