Auto 3D Bladder Volume Tool

K200980 · Butterfly Network, Inc. · IYO · Jun 11, 2020 · Radiology

Device Facts

• Record ID: K200980
• Device Name: Auto 3D Bladder Volume Tool
• Applicant: Butterfly Network, Inc.
• Product Code: IYO · Radiology
• Decision Date: Jun 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

Device Story

Software application for Butterfly iQ ultrasound systems; performs non-invasive bladder volume measurement. Clinician acquires 25 2D B-mode ultrasound images of bladder; software uses U-Net deep learning algorithm for automatic bladder segmentation and volume calculation via integration over binary images. Output presented to clinician for diagnostic support. Used by qualified clinicians in clinical settings. Benefits include rapid, automated volume estimation to aid clinical decision-making regarding bladder function.

Clinical Evidence

Non-interventional validation study using representative patient dataset (balanced gender, typical age). Primary endpoint met. Variability testing performed for inter- and intra-operator consistency across image clips/frames. Test datasets strictly segregated from training data. Results demonstrate safety and effectiveness profile equivalent to predicate.

Technological Characteristics

Software-based bladder volume quantification. Uses U-Net convolutional neural network for image segmentation. Operates on Butterfly iQ ultrasound systems (phased array, 100-degree sector). Measurement range 0-740 mL. Accuracy: 0-100mL ±7.5mL; 100-740mL ±7.5%. Non-sterile, battery-powered, B-mode operation.

Indications for Use

Indicated for noninvasive bladder volume measurement in adult populations to support physician diagnosis. Contraindicated for fetal or pediatric use, pregnant patients, patients with ascites, or patients with open skin/wounds in the suprapubic region.

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

• BladderScan Prime PLUS System (K172356)

Submission Summary (Full Text)

{0}------------------------------------------------

June 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font and enclosed in a blue square.

Butterfly Network, Inc. % Mr. Brian Sawin Sr. Regulatory Affairs Manager 530 Old Whitfield Street GUILFORD CT 06437

Re: K200980

Trade/Device Name: Auto 3D Bladder Volume Tool Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: April 8, 2020 Received: April 14, 2020

Dear Mr. Sawin:

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 ([e-mail]) or phone [phone] 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) K200980

Device Name Auto 3D Bladder Volume Tool

#### Indications for Use (Describe)

The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

Type of Use (Select one or both, as applicable):

| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|--------------------------------------------------------------------------------------|
| | <input type="checkbox"/> 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 [e-mail]

"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}------------------------------------------------

K200980

510(k) Summary or Statement

Image /page/3/Picture/2 description: The image shows the logo for Butterfly Network. The logo consists of a blue butterfly icon on the left, followed by the words "Butterfly" and "Network" in black text. The word "Butterfly" is larger and on top, while "Network" is smaller and below it.

510(k) Summary of Safety and Effectiveness

## Submitter Information

### Submitter Name and Address

Butterfly Network, Inc. 530 Old Whitfield St. Guilford, CT 06437 USA (tel.) 855-296-6188 (fax) 203-458-2514 www.butterflynetwork.com

### Contact Person

Brian Sawin Sr. Regulatory Affairs Manager 855-296-6188 [e-mail]

### Date Prepared

June 8, 2020

### Subject Device - Proprietary/Trade Name

Auto 3D Bladder Volume Tool

## Subject Device - Common Name

Diagnostic Ultrasound System with accessories

### Classification Name

| Classification Name | Regulation Number | Product Code |
|---------------------------------------|-------------------|--------------|
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |

## Classification

Class II

{4}------------------------------------------------

## Predicate Device:

K172356 - BladderScan Prime PLUS System. Verathon. Inc. (Clearance Date: 09/15/2017)

### Device Summary:

The Butterfly Auto 3D Bladder Volume Tool is a software application used on Butterfly iQ Ultrasound Systems to provide a non-invasive measurement of bladder volume. The system calculates the bladder volume using proprietary artificial intelligence automatic segmentation and volume measurement algorithms on Butterfly Network ultrasound systems.

The Auto 3D Bladder Volume Tool allows the clinician to calculate bladder volume when using the Bladder preset in B-mode. The tool is used to acquire 25, 2D images of the bladder. Once acquired, a volume estimate is calculated and presented back to the clinician. The clinician can then exit, restart the tool or save the acquisition to the study roll. The information presented is intended as additional input to standard diagnostic pathways and is only to be used by qualified clinicians.

The Auto 3D Bladder Volume Tool is based on the image segmentation method, U-Net', and the volume calculation is computed using the process of integration over binary images.

1. Ronneberger, Olaf, Fischer, Philipp, and Brox, Thomas. "U-net: Convolutional networks for biomedical image segmentation." International Conference on Medical image computing and computer-assisted intervention. Springer, Cham, 2015.

### Indications for Use:

The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

### Summary of Technoloqical Characteristics

The Butterfly Auto 3D Bladder Volume Tool has a substantially equivalent intended use and technological characteristics as the legally marketed predicate device. Quantification and reporting of results of bladder volume is the technological principle for both the subject and predicate devices and are used to aid in diagnosis. The subject and predicate devices are based on the following same technological elements:

- Quantification of bladder volume based on the analysis of on image segmentation data
- Identifying and outlining the bladder
- Auto-contouring of the bladder
- Reporting of bladder volume

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

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

- The Butterfly Auto 3D Bladder Volume Tool uses the machine learning-based . algorithm, U-Net.
- o The predicate has the same intended use and provides machine learningbased algorithms for its bladder volume calculations via patented neural network technology.

A comparison of the proposed Butterfly Auto 3D Bladder Volume Tool to the currently marketed predicate device are provided in the table below:

| Comparison Category | Butterfly Auto 3D<br>Bladder Volume Tool | Predicate Verathon<br>BladderScan Prime PLUS<br>System |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (This submission) | (K172356) |
| Comparison Overview | | |
| Intended Use/Indications<br>For Use | The Butterfly Auto 3D<br>Bladder Volume Tool is a<br>software application<br>package. It is designed to<br>view, quantify and report<br>results acquired on Butterfly<br>Network ultrasound<br>systems for noninvasive<br>volume measurements of<br>the bladder, to support<br>physician diagnosis.<br>Indicated for use in adult<br>populations. | The BladderScan Prime<br>System is an ultrasound<br>device intended to be used for<br>measuring the urine volume in<br>the bladder non- invasively. |
| Contraindications | The Auto 3D Bladder<br>Volume Tool is not<br>intended for fetal or<br>pediatric use or for use on<br>pregnant patients, patients<br>with ascites, or patients<br>with open skin or wounds<br>in the suprapubic region. | The BladderScan Prime<br>System is not intended for fetal<br>use or for use on pregnant<br>patients, patients with ascites,<br>or patients with open skin or<br>wounds in the suprapubic<br>region. |
| Patient/User Characteristics | | |
| Target Population | Male and Female | Male, Female, and Pediatric |
| Anatomical Site | Identical to predicate | Bladder |
| Users | Identical to predicate | Physicians/Medical<br>Professionals |
| Technological Characteristics and Performance | | |
| Technology | Identical to predicate | Neural network technology |
| Sterility | Identical to predicate | Non-sterile |
| Power Source | Identical to predicate | Battery powered |
| Energy Delivered | Identical to predicate | Ultrasound |
| Measurement Accuracy | 0-100mL = ±7.5mL<br>100-740 mL = ±7.5% | 0-100mL = ±7.5mL<br>100-999 mL = ±7.5% |
| Measurement Range | 0 to 740 mL | 0 to 999 mL |
| Modes of Operation | B-mode | B-mode |
| Transducer Type | Electronic Sector Scanning<br>(Phased Array) | Mechanical Sector Probe |
| Sector Angle | 100 degrees | 120 degrees |
| Number of Scan Planes | 25 | 12 |
| Design and Usability Features | | |
| Portable | Identical to predicate | Yes |
| Display | Identical to predicate | LCD |
| Scan Button | Identical to predicate | Yes |
| Touchscreen Operation | Identical to predicate | Yes |
| Selectable Unit Orientation<br>(Patient Right/Left) | No | Yes |
| Live Scan Image | Identical to predicate | Yes |
| Calibration | Identical to predicate | No calibration recommended |

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

# Performance Data

Software Verification and Validation Testing

Software verification and validation testing were conducted, and was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered a "moderate" level of concern, since a failure or latent design flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

{7}------------------------------------------------

## Performance Testing

Butterfly Network's Auto 3D Bladder Volume Tool software was developed and tested in accordance with company design control processes and safety and performance testing. Verification and validation testing established that the device meets its design requirements, intended use and demonstrates substantial equivalence to the predicate. A non-interventional validation study was conducted, where bladder volume was calculated. The patient dataset was constructed to provide a representative range of volume values, in a patient population with a balanced gender proportion and clinically typical age. Variability testing was also performed to demonstrate that the Auto 3D Bladder Volume Tool performs acceptably with a variety of image clips and frames from the same patient. Test datasets were strictly segregated from algorithm training datasets. The primary endpoint was met. Inter and intra-operator variability was assessed between operators processing the same images. Based on the clinical performance as documented in this study, the device has a safety and effectiveness profile that is equivalent to the predicate.

### Summary of Substantial Equivalence:

The Auto 3D Bladder Volume Tool is as safe and effective as the predicate has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences raise no new issues of safety or effectiveness. Performance data, including software verification and validation and performance testing demonstrate that the Butterfly Auto 3D Bladder Volume Tool is safe and effective and therefore, substantially equivalent.