(58 days)
Not Found
Yes
The device description explicitly states that the system calculates bladder volume using "proprietary artificial intelligence automatic segmentation and volume measurement algorithms" and that it uses the "machine learning-based algorithm, U-Net". The comparison to the predicate device also mentions "machine learning-based algorithms" and "patented neural network technology".
No.
The device is described as a tool to support physician diagnosis by providing noninvasive measurements of bladder volume, rather than directly treating a condition.
Yes
The device is designed to view, quantify, and report results to support physician diagnosis and states that the information presented is intended as additional input to standard diagnostic pathways.
No
The device is described as a "software application package" and a "software application used on Butterfly iQ Ultrasound Systems". While the core functionality is software-based (AI algorithms for segmentation and volume calculation), it explicitly states it operates on Butterfly Network ultrasound systems, which are hardware devices. The software is an application for a hardware system, not a standalone software-only medical device.
Based on the provided information, the Butterfly Auto 3D Bladder Volume Tool 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 Butterfly Auto 3D Bladder Volume Tool uses ultrasound imaging to non-invasively measure the volume of the bladder. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis." This clearly describes an imaging-based diagnostic aid, not an in vitro test.
Therefore, while it is a diagnostic tool, it falls under the category of medical imaging devices rather than In Vitro Diagnostics.
No
The input states "Control Plan Authorized (PCCP) and relevant text: Not Found", which means the letter does not explicitly mention FDA review, approval, or clearance of a PCCP for this device.
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Bladder
Indicated Patient Age Range
Adult populations
Intended User / Care Setting
Physicians/Medical Professionals
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
Test datasets were strictly segregated from algorithm training datasets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Accuracy: 0-100mL = ±7.5mL; 100-740 mL = ±7.5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
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 (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) 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):
| 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 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 bsawin@butterflynetwork.com
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.
- 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
Bladder Volume Tool | Predicate Verathon
BladderScan Prime PLUS
System |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (This submission) | (K172356) |
| Comparison Overview | | |
| Intended Use/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. | The BladderScan Prime
System is an ultrasound
device intended to be used for
measuring the urine volume in
the bladder non- invasively. |
| Contraindications | The Auto 3D Bladder
Volume Tool is not
intended for fetal or
pediatric use or for use on
pregnant patients, patients
with ascites, or patients
with open skin or wounds
in the suprapubic region. | The BladderScan Prime
System is not intended for fetal
use or for use on pregnant
patients, patients with ascites,
or patients with open skin or
wounds in the suprapubic
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
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
100-740 mL = ±7.5% | 0-100mL = ±7.5mL
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
(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
(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.