ATUSA™ Automated 3D Breast Ultrasound System

K213620 · Isono Health, Inc. · IYO · Apr 22, 2022 · Radiology

Device Facts

• Record ID: K213620
• Device Name: ATUSA™ Automated 3D Breast Ultrasound System
• Applicant: Isono Health, Inc.
• Product Code: IYO · Radiology
• Decision Date: Apr 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

Device Story

ATUSA™ is a battery-operated, automated 3D breast ultrasound system. Input: ultrasound echoes captured via automated linear array transducer. Transformation: scanner hardware (transducer, electronics, mechanics) acquires serial 2D grayscale images; software performs 3D reconstruction and visualization. Output: real-time B-mode images and 3D breast volumes displayed on a laptop. Used in clinical settings (hospitals, clinics, mobile units) by trained healthcare professionals. Positioning accessory (expandable cups, straps) ensures reproducible scanning. Healthcare providers use images to visualize breast tissue structures. Benefits: provides automated, reproducible breast ultrasound imaging for diagnostic assessment.

Clinical Evidence

Bench testing only. Includes electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), acoustic output (IEC 60601-2-37, IEC 62359), and biocompatibility (ISO 10993-1). System verification and imaging performance testing completed. Usability and human factors validation conducted in simulated clinical environments. Board-certified radiologists reviewed sample images to confirm adequate quality for visualizing breast tissue structures.

Technological Characteristics

Battery-operated diagnostic ultrasound system. Components: automated scanner, positioning accessory (cups, straps), charger base, laptop-based software. Transducer: automated linear array, 5-10 MHz. Connectivity: USB to laptop. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-1. Software: moderate level of concern.

Indications for Use

Indicated for B-mode ultrasonic imaging of the breast in patients ages 18 and above. Not intended as a replacement for screening mammography. Operator: Trained Healthcare Professional. Environment: Hospitals, clinics, physician offices, mobile care units.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• K080555

Submission Summary (Full Text)

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April 22, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

iSono Health, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Dr. DAYTON OH 45430

Re: K213620

Trade/Device Name: ATUSA™ Automated 3D Breast Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: March 18, 2022 Received: March 21, 2022

# Dear Daniel Lehtonen:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Jessica Lamb, Ph.D. Assistant 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) K213620

### Device Name

ATUSA™ Automated 3D Breast Ultrasound System

### Indications for Use (Describe)

The device is indicated for use as a B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

Operator: Trained Healthcare Professional

Patient Population: Ages 18 and above

Environment of use: Facilities where healthcare is provided - e.g. hospitals, clinics, physician offices, mobile care units.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device Systems Act 1990 and 21 CFR Sec. 807.92

510(k) Number:

K213620

#### a1 APPLICANT INFORMATION:

| Date Prepared: | 22 April 2022 |
|-------------------|--------------------------------------------------------------------------------------------|
| Name:<br>Address: | iSono Health, Inc.<br>395 Oyster Point Blvd.<br>Suite 501<br>South San Francisco, CA 94080 |
| Contact Person: | Shadi Saberi, PhD |
| Title: | Chief Technology Officer |
| Phone Number: | [phone] |
| Email: | [e-mail] |

#### a2 DEVICE:

| Trade Name: | ATUSA™ Automated 3D Breast Ultrasound System |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Ultrasound System |
| Classification Name: | System, Imaging, Pulsed Echo, Ultrasonic<br>21 CFR 892.1560 / 21 CFR 892.1570 |
| Product Code: | IYO. ITX |

#### аЗ PREDICATE DEVICE:

| Predicate Device: | K080555 [Cleared 03 Jun 2008] |
|-------------------|-------------------------------|
|-------------------|-------------------------------|

The FDA database for recalls was searched on 24 Sep 2021 during the preparation of the 510(k) submission and no recalls for the device noted above were found.

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Image /page/4/Picture/0 description: The image shows the logo for Isono Health. The word "isono" is in a teal sans-serif font, with the "o" having a small orange arc above it. Below "isono" is the word "health" in a smaller teal sans-serif font. The logo is simple and modern, with a focus on the company name.

# iSono Health, Inc. ATUSA™ Automated 3D Breast Ultrasound System

#### DESCRIPTION OF THE DEVICE: a4

The ATUSA™ Automated 3D Breast Ultrasound System is a battery operated Track 3 diagnostic ultrasound system intended for imaging of the breast. The device utilizes B-mode grayscale ultrasound via an automated linear transducer and consists of the following components:

- 1) Automated ultrasound scanner that integrates all hardware components including the transducer, electronics, and mechanical parts in a compact form factor. The scanner connects to a laptop via USB cable and automatically captures ultrasound images of the breast volume;
- 2) Positioning accessory that includes a pair of expandable cups, disposable straps, drain bags and mesh. The expandable cups are assembled as a wearable accessory with disposable straps to form the breast tissue conveniently in the field of view of the scanner and facilitate reproducible positioning of the scanner on the breast. The expandable cups come in different sizes to accommodate a range of breast sizes;
- 3) Charger base for wirelessly charging the scanner battery;
- 4) Software application to control the scanner operation, to acquire and display the images in realtime, and to perform advanced image processing, 3D reconstruction and visualization in various image planes.

#### STATEMENT OF INTENDED USE: a5

The device is indicated for use as a B-mode ultrasonic imaging system for imaging of a patient's breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

Operator: Trained Healthcare Professional

Patient population: Ages 18 and above

Environment of use: Facilities where healthcare is provided - e.g. hospitals, clinics, physician offices, mobile care units.

#### TECHNOLOGICAL CHARACTERISTIC COMPARISON: a6

Both the subject and predicate devices are diagnostic ultrasound devices. Ultrasound imaging is based on the use of a device which converts electrical energy to sound, emits the sound waves into the target tissue and 'listens' for the return echo which is converted back to electrical pulses and processed into an image. In both devices the transducer is controlled by a computer via proprietary software.

The subject and predicate devices are based on the following same technological principles:

- . B mode diagnostic ultrasound imaging via the use of an automated linear transducer to acquire serial 2D grayscale images of the entire breast
- . Software controlled ultrasound image capture and processing
- Use previously cleared linear array transducers
- Breast tissue is immersed in fluid environment

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Image /page/5/Picture/0 description: The image shows the logo for Isono Health. The word "isono" is written in a teal color, with the "o" having a curved orange line above it. Below the word "isono" is the word "health" also written in teal.

# iSono Health, Inc. ATUSA™ Automated 3D Breast Ultrasound System

The following technological differences exist between the subject and predicate devices:

- . The subject device scanner powered by a rechargeable battery whereas the predicate device is line powered. The change in energy source does not impact the safety or effectiveness of the device. Compliance with applicable electrical safety standards support equivalence.
- . The subject device transducer operates between 5 and 10 MHz, the predicate device transducer operates at 5 - 13 MHz. The difference in the upper frequency range does not impact the safety or efficacy of the device.
- . The patient is in a supine position for the subject device versus a prone position for the predicate device. A supine positioned patient is common and the difference in patient positioning does not impact the safety or efficacy of the device.

#### b1/2 SAFETY AND PERFORMANCE TESTING AND VALIDATION:

The following system design verification testing was successfully completed:

- . Electrical Safety
- . Electromagnetic compatibility (EMC)
- Acoustic Output Testing .
- Performance Testing

# Referenced Standards:

- IEC 60601-1:2005 +A1:2012 Medical electrical equipment Part 1: General requirements for . basic safety and essential performance
- . IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-2-37 Edition 2.1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 62359 Edition 2.1 2017-09 CSV Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
- ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part 1: Evaluation ● and testing within a risk management process

# Performance Testing

- . ATUSA™ System Requirement Verification Detailed Test Report
- . ATUSA™ Scanner Imaging Performance Test Report

# Software Verification and Validation Testing

Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.

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Image /page/6/Picture/0 description: The image shows the logo for Isono Health. The word "isono" is written in a teal sans-serif font, with the "o" having a curved orange accent mark above it. Below "isono" is the word "health" also in a teal sans-serif font, but smaller in size.

# iSono Health, Inc. ATUSA™ Automated 3D Breast Ultrasound System

# Device Validation Testing

The ATUSA™ System has undergone validation testing including feasibility, and human factors evaluation to validate the ATUSA System and accessories met their respective user requirements. The initial feasibility assessment was performed to validate the design of the ATUSA™ System with respect to the device function and the positioning accessory fit and comfort for the patient. Validation of the usability and human factors considerations consisted of simulated users and simulated patients using the ATUSA™ System and accessories. The testing was conducted in a simulated exam room replicating a typical professional use environment. Sample clinical images were reviewed by board-certified radiologists who validated that the gray scale B-mode images have adequate image quality for visualizing breast tissue structures.

#### b3 CONCLUSIONS DRAWN FROM TESTING:

The safety, performance and validation testing data demonstrate that the ATUSA™ Automated 3D Breast Ultrasound System meets the device requirements supporting its intended use and is substantially equivalent in technological characteristics, principles of operation and indications for use to the predicate device. Any noted differences do not raise any new issues of safety and effectiveness. Therefore, the ATUSA system is as safe and as effective as the predicate device.