Butterfly iQ/iQ+ Ultrasound System

{0}------------------------------------------------ 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. 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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) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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<br>Category | Butterfly iQ/iQ+<br>Ultrasound System<br>(Subject Device) | Butterfly iQ<br>Ultrasound System<br>(Primary Predicate)<br>(K202406) | Comparison | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | General Device<br>Description | Hand held portable<br>diagnostic ultrasound<br>system | Hand held portable<br>diagnostic ultrasound<br>system | Remains<br>Unchanged | | Indications for<br>Use | The Butterfly iQ/ iQ+<br>Ultrasound System is<br>indicated for use by<br>trained healthcare<br>professionals in<br>environments where<br>healthcare is provided to<br>enable diagnostic<br>ultrasound imaging and<br>measurement of<br>anatomical structures and<br>fluids of adult and<br>pediatric patients for the<br>following clinical<br>applications:<br>Peripheral Vessel<br>(including carotid, deep<br>vein thrombosis and<br>arterial studies),<br>Procedural Guidance,<br>Small Organs (including<br>thyroid, scrotum and<br>breast), Cardiac,<br>Abdominal, Lung,<br>Urology, Fetal/Obstetric,<br>Gynecological,<br>Musculoskeletal<br>(conventional),<br>Musculoskeletal<br>(superficial) and<br>Ophthalmic.<br>Modes of operation<br>include B-mode, B-mode<br>+ M-mode, B-mode +<br>Color Doppler, B- mode + | The Butterfly iQ<br>Ultrasound System is<br>indicated for use by<br>trained healthcare<br>professionals in<br>environments where<br>healthcare is provided<br>to enable diagnostic<br>ultrasound imaging and<br>measurement of<br>anatomical structures<br>and fluids of adult and<br>pediatric patients for the<br>following clinical<br>applications:<br>Peripheral Vessel<br>(including carotid, deep<br>vein thrombosis and<br>arterial studies),<br>Procedural Guidance,<br>Small Organs<br>(including thyroid,<br>scrotum and breast),<br>Cardiac, Abdominal,<br>Urology,<br>Fetal/Obstetric,<br>Gynecological,<br>Musculoskeletal<br>(conventional),<br>Musculoskeletal<br>(superficial) and<br>Ophthalmic.<br>Modes of operation<br>include B-mode,<br>B-mode + M-mode,<br>B-mode + Color | Addition of "lung"<br>to Indications for<br>Use and Spectral<br>Pulsed Wave<br>Doppler to<br>operating mode. | | | Power Doppler, Spectral<br>Pulsed Wave Doppler. | Doppler, B-mode +<br>Power Doppler. | | | Type | Single probe 2D phased<br>array | Single probe 2D phased<br>array | Remains<br>Unchanged | | Sterility | Non-sterile | Non-sterile | Remains<br>Unchanged | | Duration of Use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Remains<br>Unchanged | | Reusable | Yes | Yes | Remains<br>Unchanged | | Principles of<br>Operation<br>(subject Auto<br>B-Line Counter) | Automatic detection and<br>counting of B-lines from<br>lung ultrasound images | Manual counting of<br>B-lines from lung<br>ultrasound images | Auto B-Line<br>Counter added to<br>existing Butterfly<br>iQ/Butterfly iQ+<br>Ultrasound System<br>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.