(445 days)
Yes
The device description explicitly mentions an "image analysis algorithm" for the "Auto B-line Counter" and performance studies evaluate the algorithm's performance against ground truth and clinician annotators using metrics like ICC and DSC, which are common in evaluating image analysis algorithms, including those based on AI/ML. While the terms AI/ML are not explicitly used, the description of an automated image analysis algorithm with performance evaluation against human experts strongly suggests the use of such technology.
No
The device is described as a "general-purpose diagnostic imaging system" and its intended use is for "diagnostic ultrasound imaging and measurement of anatomical structures and fluids." There is no mention of treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is indicated "to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids." Additionally, the "Device Description" section refers to it as a "general-purpose diagnostic imaging system."
No
The device description explicitly states the system consists of a "single transducer" connected to a mobile device, indicating a hardware component (the transducer) is part of the medical device system. The software component (Auto B-line Counter) is integrated into the mobile application for use with this transducer.
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 Butterfly iQ+ Ultrasound System is a diagnostic imaging system that uses ultrasound waves to visualize anatomical structures and fluids within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes imaging and measurement of anatomical structures and fluids for various clinical applications, all of which involve direct imaging of the patient.
- Device Description: The description focuses on the hardware (transducer) and software (mobile app, Auto B-line Counter) used for generating and analyzing ultrasound images.
- Input Modality: The input modality is Ultrasound, which is an in-vivo imaging technique, not an in-vitro diagnostic method.
While the device performs analysis (the Auto B-line Counter), this analysis is performed on images generated from within the patient's body, not on samples taken from the patient. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Butterfly iQ/iQ+ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep ven thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler.
Product codes
IYN, IYO, ITX, QIH
Device Description
The Butterfly iQ/Butterfly iQ+ Ultrasound System is a hand-held general-purpose diagnostic imaging system for use by trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected to a standard handheld commercial off the shelf (COTS) mobile device compatible with the Butterfly iQ/iQ+ mobile application (app).
The subject device introduces the Auto B-line Counter, a software application backed by an image analysis algorithm. The purpose of the Auto B-line Counter is to provide automated detection and automatic calculation of the number of B-lines to a user in a given rib space and also provides the users the capabilities of reviewing the detected B-lines (via visual overlays). The overlay of B-lines does not mark images for detection of specific pathologies. The Auto B-line Counter enables the automated identification and count of B-lines during a lung scan and is integrated into the existing Butterfly iQ/iQ+ mobile application for use with the Butterfly iQ or iQ+ transducers.
Mentions image processing
Yes, "image analysis algorithm"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Peripheral Vessel (including carotid, deep ven thrombosis and arterial studies), Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Trained healthcare professionals in environments where healthcare is provided.
Description of the training set, sample size, data source, and annotation protocol
The data used for verification is completely distinct from that used during the training process and there is no overlap between the two. Independence of testing and training data was ensured by auditability-each study and associated images had unique dataset identification- and by sequestration-no study or its images could belong to multiple datasets.
Description of the test set, sample size, data source, and annotation protocol
Analytical Validation testing was performed to demonstrate that the Auto B-line Counter algorithm performance is non-inferior to clinician annotators (Ground Truth).
A validation dataset was curated by random selection of 6000 de-identified cines acquired from 253 sites. The datasets spanned many demographic variables including gender (male, female, and unidentified), age (20-90 years), and ethnicity via collection from a multitude of clinical sites with diverse and distinct racial patient populations.
Algorithm performance was verified on all demographic subgroups and clinical subgroups with various confounders present including but not limited to congestive heart failure, heart failure reduced ejection fraction, diabetes with and without chronic complication, myocardial infarction, peripheral vascular disease, renal disease, and many other factors.
The ground truthing for B-line counts was determined by the ICC among expert annotators presented with lung cines and instructions to determine the maximum number of B-Lines using the instant percent method. The ground truth locations of B-lines were then determined by expert annotator segmentations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Testing:
Performance was assessed by the widely accepted metrics, the intraclass correlation coefficient (ICC) between annotators for the Quality Indicator and Dice Coefficient Score (DSC), for the conformance of automatic B-line segmentation to ground truth.
Clinical Performance Evaluation:
The clinical performance was evaluated on 99 subjects and demonstrated that the Auto B-line Counter algorithm performance is non-inferior to clinician annotator ground truth. Performance was assessed by calculating the intraclass correlation coefficient (ICC) between the tool and the ground truth. Additionally, the evaluation concluded that the algorithm's performance was consistent among clinically meaningful subgroups: age, gender, and BMI. Overall, the results support the generalizability of the Auto B-line Counter across the intended patient population.
Non-clinical Evaluation:
The introduction of the Butterfly Auto B-Lines Counter was tested in accordance with internal Butterfly standards for safety and design quality and documentation 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. The activities to ensure safe and effective performance of the subject software revision include but are not limited to Requirements Review, Risk Analysis and Management, Product Specifications, Design Reviews, Product Performance testing. Additional non-clinical evaluation demonstrated that the inclusion of the Auto B-Line Counter did not introduce any additional risks to the previously cleared Butterfly iQ/iQ+ Ultrasound System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Intraclass correlation coefficient (ICC), Dice Coefficient Score (DSC).
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the date March 31, 2023. The text is written in a clear, sans-serif font. The date is written in a standard format, with the month, day, and year clearly indicated. The text is centered and takes up most of the image.
Butterfly Network, Inc. % Lynda Ikejimba Senior Regulatory Affairs Program Manager 1600 District Ave BURLINGTON MA 01803
Re: K220068
Trade/Device Name: Butterfly iQ\ Butterfly iQ+ Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIH Dated: March 6, 2023 Received: March 6, 2023
Dear Lynda Ikejimba:
We have reviewed vour 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
1
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 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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220068
Device Name Butterfly iQ/iQ+ Ultrasound System
Indications for Use (Describe)
The Butterfly iQ+ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep ven thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac,
Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Butterfly Network, a medical imaging company. The logo consists of a blue butterfly icon on the left, followed by the word "Butterfly" in bold, black letters. Below the word "Butterfly" is the tagline "The New Image of Health" in a smaller font.
1600 District Ave Burlington, MA 01803
(781) 557-4800
This 510(k) Summary is submitted in accordance with 21 CFR §807.92 K220068
I. SUBMITTER
Manufacturer:
Butterfly Network, Inc. 1600 District Ave Burlington, MA 01803 Phone: 1-781-557-4800
Contact Person:
Lynda Ikejimba, PhD Senior Regulatory Affairs Program Manager E-mail: likejimba(@butterflynetinc.com
Date Prepared: March 6, 2023
II. DEVICE
Trade Name: Butterfly iQ/ Butterfly iQ+ Ultrasound System Common Name: Ultrasound Imaging System Classification Name(s): Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560) Diagnostic Ultrasound Transducer (21 CFR 892.1570) Automated Radiological Image Processing Software (21 CFR 892.2050) Regulatory Class: II Primary Product Code: IYN Secondary Product Codes: IYO, ITX, QIH Classification Panel: Radiology
III. PREDICATE DEVICE
Primary Predicate: Butterfly iQ Ultrasound System (K202406) This predicate has not been subject to a design-related recall.
Reference Predicates: Philips Lumify Diagnostic Ultrasound System (K203406), GE Venue (K170714)
IV. DEVICE DESCRIPTION
The Butterfly iQ/Butterfly iQ+ Ultrasound System is a hand-held general-purpose diagnostic imaging system for use by trained healthcare professionals in environments where healthcare is provided to enable visualization and measurement of anatomical structures and fluid of adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities
4
connected to a standard handheld commercial off the shelf (COTS) mobile device compatible with the Butterfly iO/iO+ mobile application (app).
The subject device introduces the Auto B-line Counter, a software application backed by an image analysis algorithm. The purpose of the Auto B-line Counter is to provide automated detection and automatic calculation of the number of B-lines to a user in a given rib space and also provides the users the capabilities of reviewing the detected B-lines (via visual overlays). The overlay of B-lines does not mark images for detection of specific pathologies. The Auto B-line Counter enables the automated identification and count of B-lines during a lung scan and is integrated into the existing Butterfly iQ/iQ+ mobile application for use with the Butterfly iQ or iQ+ transducers.
V. INDICATIONS FOR USE
The Butterfly iQ/Butterfly iQ+ Ultrasound System is indicated for use by a trained healthcare professional in an environment where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications:
Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic.
Modes of operation include B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device contains the same hardware technology as the previously cleared predicate device Butterfly iQ/iQ+(K202406), and the subject device is compatible with both the Butterfly iQ and iQ+ Ultrasound systems. There is an addition of "lung" to the Indications For Use statement and Spectral Pulsed Wave Doppler to the modes of operation. These additions do not introduce any additional risks as there have been no changes in the other modes or compatible transducer frequencies and Spectral Pulsed Wave Doppler is a well-established mode of operation. The differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use as a general-purpose diagnostic ultrasound imaging system. A comparison of the proposed Butterfly iQ/Butterfly iQ+ Ultrasound System to the currently marketed predicate is provided in the table below.
5
| Comparison
Category | Butterfly iQ/iQ+
Ultrasound System
(Subject Device) | Butterfly iQ
Ultrasound System
(Primary Predicate)
(K202406) | Comparison |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| General Device
Description | Hand held portable
diagnostic ultrasound
system | Hand held portable
diagnostic ultrasound
system | Remains
Unchanged |
| Indications for
Use | The Butterfly iQ/ iQ+
Ultrasound System is
indicated for use by
trained healthcare
professionals in
environments where
healthcare is provided to
enable diagnostic
ultrasound imaging and
measurement of
anatomical structures and
fluids of adult and
pediatric patients for the
following clinical
applications:
Peripheral Vessel
(including carotid, deep
vein thrombosis and
arterial studies),
Procedural Guidance,
Small Organs (including
thyroid, scrotum and
breast), Cardiac,
Abdominal, Lung,
Urology, Fetal/Obstetric,
Gynecological,
Musculoskeletal
(conventional),
Musculoskeletal
(superficial) and
Ophthalmic.
Modes of operation
include B-mode, B-mode
- M-mode, B-mode +
Color Doppler, B- mode + | The Butterfly iQ
Ultrasound System is
indicated for use by
trained healthcare
professionals in
environments where
healthcare is provided
to enable diagnostic
ultrasound imaging and
measurement of
anatomical structures
and fluids of adult and
pediatric patients for the
following clinical
applications:
Peripheral Vessel
(including carotid, deep
vein thrombosis and
arterial studies),
Procedural Guidance,
Small Organs
(including thyroid,
scrotum and breast),
Cardiac, Abdominal,
Urology,
Fetal/Obstetric,
Gynecological,
Musculoskeletal
(conventional),
Musculoskeletal
(superficial) and
Ophthalmic.
Modes of operation
include B-mode,
B-mode + M-mode,
B-mode + Color | Addition of "lung"
to Indications for
Use and Spectral
Pulsed Wave
Doppler to
operating mode. |
| | Power Doppler, Spectral
Pulsed Wave Doppler. | Doppler, B-mode +
Power Doppler. | |
| Type | Single probe 2D phased
array | Single probe 2D phased
array | Remains
Unchanged |
| Sterility | Non-sterile | Non-sterile | Remains
Unchanged |
| Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Remains
Unchanged |
| Reusable | Yes | Yes | Remains
Unchanged |
| Principles of
Operation
(subject Auto
B-Line Counter) | Automatic detection and
counting of B-lines from
lung ultrasound images | Manual counting of
B-lines from lung
ultrasound images | Auto B-Line
Counter added to
existing Butterfly
iQ/Butterfly iQ+
Ultrasound System
App |
6
VII. PERFORMANCE DATA
Performance Testing
Butterfly Network's iQ/iQ+ Ultrasound System was developed and tested in accordance with company design control processes and safety and performance testing. Relevant non-clinical verification and validation testing was performed to address the introduction of the subject software algorithm for the Auto B-Lines Counter and to assure its safe and effective performance.
Analytical Testing
Analytical Validation testing was performed to demonstrate that the Auto B-line Counter algorithm performance is non-inferior to clinician annotators (Ground Truth). The Auto B-line Counter met the acceptance criteria for all tests. Performance was assessed by the widely accepted metrics, the intraclass correlation coefficient (ICC) between annotators for the Quality Indicator and Dice Coefficient Score (DSC), for the conformance of automatic B-line segmentation to ground truth.
A validation dataset was curated by random selection of 6000 de-identified cines acquired from 253 sites. The datasets spanned many demographic variables including gender (male, female, and unidentified), age (20-90 years), and ethnicity via collection from a multitude of clinical sites with diverse and distinct racial patient populations.
Clinical subgroups and confounders:
The algorithm performance was verified on all demographic subgroups and clinical subgroups with various confounders present including but not limited to congestive heart failure, heart
7
failure reduced ejection fraction, diabetes with and without chronic complication, myocardial infarction, peripheral vascular disease, renal disease, and many other factors,
Truthing process:
The ground truthing for B-line counts was determined by the ICC among expert annotators presented with lung cines and instructions to determine the maximum number of B-Lines using the instant percent method. The ground truth locations of B-lines were then determined by expert annotator segmentations.
The data used for verification is completely distinct from that used during the training process and there is no overlap between the two. Independence of testing and training data was ensured by auditability-each study and associated images had unique dataset identification- and by sequestration-no study or its images could belong to multiple datasets.
Clinical Performance Evaluation
The clinical performance was evaluated on 99 subjects and demonstrated that the Auto B-line Counter algorithm performance is non-inferior to clinician annotator ground truth. Performance was assessed by calculating the intraclass correlation coefficient (ICC) between the tool and the ground truth. Additionally, the evaluation concluded that the algorithm's performance was consistent among clinically meaningful subgroups: age, gender, and BMI. Overall, the results support the generalizability of the Auto B-line Counter across the intended patient population.
Non-clinical Evaluation
The introduction of the Butterfly Auto B-Lines Counter was tested in accordance with internal Butterfly standards for safety and design quality and documentation 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. The activities to ensure safe and effective performance of the subject software revision include but are not limited to Requirements Review, Risk Analysis and Management, Product Specifications, Design Reviews, Product Performance testing. Additional non-clinical evaluation demonstrated that the inclusion of the Auto B-Line Counter did not introduce any additional risks to the previously cleared Butterfly iQ/iQ+ Ultrasound System.
Summary
Based on the clinical performance as documented in the pivotal clinical study, the Butterfly Auto B-Lines Counter was found to have a safety and effectiveness profile that is similar to the predicate device.
VII. CONCLUSIONS
Based on the indications for use, technological characteristics, and performance testing, the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device and does not raise new questions of safety or effectiveness to the predicate device. The subject device was found to have a safety and effectiveness profile that is similar to the predicate device.