Who is the manufacturer of Butterfly iQ/iQ+ Ultrasound System?

Butterfly Network, Inc. filed the 510(k) submission for Butterfly iQ/iQ+ Ultrasound System (K220068).

What is the FDA product code for Butterfly iQ/iQ+ Ultrasound System?

IYO. It is classified under 21 CFR 892.1560 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Butterfly iQ/iQ+ Ultrasound System?

510(k) clearance (submission type: Traditional).

Does Butterfly iQ/iQ+ Ultrasound System use AI or machine learning?

Yes. Butterfly iQ/iQ+ Ultrasound System (K220068) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Butterfly iQ/iQ+ Ultrasound System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Butterfly iQ/iQ+ Ultrasound System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Butterfly iQ/iQ+ Ultrasound System

Q: What are the predicate devices for Butterfly iQ/iQ+ Ultrasound System?

Butterfly iQ Ultrasound System (K202406).

K220068 · Butterfly Network, Inc. · IYO · Mar 31, 2023 · Radiology

Device Facts

Record ID	K220068
Device Name	Butterfly iQ/iQ+ Ultrasound System
Applicant	Butterfly Network, Inc.
Product Code	IYO · Radiology
Decision Date	Mar 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1560
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

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.

Device Story

Hand-held diagnostic ultrasound system; consists of single transducer connected to COTS mobile device running Butterfly iQ/iQ+ app. System captures ultrasound signals; processes data for B-mode, M-mode, Color/Power Doppler, and Spectral Pulsed Wave Doppler. New feature: Auto B-line Counter; uses image analysis algorithm to detect and count B-lines in lung ultrasound images; provides visual overlays for user review. Used by trained healthcare professionals in clinical environments. Output displayed on mobile device screen; assists clinicians in lung assessment. Benefits include automated, objective quantification of B-lines, potentially aiding in rapid clinical decision-making for conditions like pulmonary edema or interstitial lung disease.

Clinical Evidence

Clinical evaluation performed on 99 subjects. Primary endpoint: Intraclass Correlation Coefficient (ICC) between Auto B-line Counter and expert clinician annotator ground truth. Results demonstrated non-inferiority of algorithm to human annotators. Performance consistent across demographic subgroups (age, gender, BMI). Analytical validation used 6,000 de-identified cines from 253 sites, utilizing ICC and Dice Coefficient Score (DSC) for segmentation conformance. Testing data was independent and sequestered from training data.

Technological Characteristics

Hand-held 2D phased array transducer; COTS mobile device host. Modes: B-mode, M-mode, Color/Power Doppler, Spectral Pulsed Wave Doppler. Software-based Auto B-line Counter algorithm. Non-sterile, reusable, limited duration (≤ 24 hours).

Indications for Use

Indicated for trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids in adult and pediatric patients. Clinical applications: Peripheral Vessel (carotid, DVT, arterial), Procedural Guidance, Small Organs (thyroid, scrotum, breast), Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional/superficial), and Ophthalmic. No specific contraindications listed.

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

Butterfly iQ Ultrasound System (K202406)

Reference Devices

Philips Lumify Diagnostic Ultrasound System (K203406)
GE Venue (K170714)

Related Devices

K203406 — Lumify Diagnostic Ultrasound System · Philips Ultrasound, Inc. · Feb 23, 2021
K223771 — Lumify Diagnostic Ultrasound System · Philips Ultrasound · May 4, 2023
K252557 — Lumify Diagnostic Ultrasound System · Philips Ultrasound, LLC · Dec 22, 2025
K232808 — Butterfly iQ3 Ultrasound System · Butterfly Network, Inc. · Jan 4, 2024
K202406 — Butterfly iQ Ultrasound System · Butterfly Network, Inc. · Sep 16, 2020

Submission Summary (Full Text)

{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. 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) | #### 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ 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.