Butterfly iQ Ultrasound System

{0}------------------------------------------------ September 16, 2020 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. Butterfly Network, Inc. % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 Re: K202406 Trade/Device Name: 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 Dated: August 18, 2020 Received: August 21, 2020 Dear Prithul Bom: 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/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 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 {1}------------------------------------------------ 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 mediation-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) K202406 Device Name Butterfly 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 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 + M-mode, B-mode + Color Doppler, B-mode + Power Doppler. Type of Use (Select one or both, as applicable) | <span></span> | <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |---------------|-----------------------------------------------------------------------------------------------------| | <span></span> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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}------------------------------------------------ # 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 and the words "Butterfly Network" in black on the right. The word "Butterfly" is in a larger font than the word "Network", and there is a trademark symbol next to the word "Butterfly". 530 Old Whitfield Street Guilford, CT 06437 (203) 458-7100 ## 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 July 20, 2020 # Subject Device - Proprietary/Trade Name Butterfly iQ Ultrasound System ### Subject Device - Common Name Ultrasound Imaging System #### Classification Name | | Regulation Number | Product Code | |------------------------------------------|-------------------|--------------| | Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN | | Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO | | Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX | ### Classification Class II {4}------------------------------------------------ # Predicate Device: K163510 - Poseidon Ultrasound System, Butterfly Network, Inc. (Clearance Date: 09/06/2017) K170714 - Venue, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Clearance Date: 06/22/2017) # Device Summary: The Butterfly iQ Ultrasound System is a general-purpose diagnostic imaging system for use by qualified and 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. In addition to M-mode imaging the instrument also supports Color Doppler and Power Doppler imaging. The user interface includes touchscreen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery. ## Indications for Use: 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, Uroloqy, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include Bmode, B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler. ### Summary of Technological Characteristics The Butterfly iQ Ultrasound System has a substantially equivalent intended use, imaging capability, technological characteristics and safety and effectiveness as the legally marketed predicate device and is used to aid in diagnosis. The subject and predicate devices are based on the following substantially equivalent clinical and technological elements: - . Diaqnostic ultrasound system - Ophthalmic clinical application The following clinical and technological differences exist between the subject and predicate: - Transrectal, Transvaginal, Neonatal and adult cephalic, Thoracic/pleural and . Cardiac Fetal Echo clinical applications - . Handheld vs. mobile - Single probe vs. multiple . {5}------------------------------------------------ - Commercial off the shelf display vs. LCD display • # Device Comparison Table: | Butterfly iQ<br>Ultrasound System<br>(This submission) | Butterfly Poseidon<br>Ultrasound System<br>510(k): K163510 | Venue<br>510(k): K170714 | | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Clearance | No - original submission | Yes (September 6, 2017) | Yes (June 22, 2017) | | Intended Use | Intended for use by trained<br>healthcare professionals in<br>environments where<br>healthcare is provided to<br>enable diagnostic ultrasound<br>imaging and measurement<br>of anatomical structures and<br>fluids of adult and pediatric<br>patients for the following<br>clinical applications:<br>Peripheral Vessel (including<br>carotid, deep vein<br>thrombosis and arterial<br>studies), Procedural<br>Guidance, Small Organs<br>(including thyroid, scrotum<br>and breast), Cardiac,<br>Abdominal, Urology,<br>Fetal/Obstetric,<br>Gynecological,<br>Musculoskeletal<br>(conventional),<br>Musculoskeletal (superficial)<br>and Ophthalmic. Modes of<br>operation include B-mode,<br>B-mode + M-mode, B-mode<br>+ Color Doppler, B-mode +<br>Power Doppler. | Intended for use by qualified<br>and trained healthcare<br>professionals to enable<br>diagnostic ultrasound imaging<br>and measurement of<br>anatomical structures and<br>fluids of adult and pediatric<br>patients for the following clinical<br>applications: Peripheral Vessel<br>(including carotid, deep vein<br>thrombosis and arterial studies),<br>Procedural Guidance, Small<br>Organs (including thyroid,<br>scrotum and breast), Cardiac,<br>Abdominal, Urology,<br>Fetal/Obstetric, Gynecological,<br>Musculoskeletal (conventional)<br>and Musculoskeletal<br>(superficial). | Intended for ultrasound<br>imaging, measurement and<br>analysis of the human body<br>and fluid for multiple clinical<br>applications including:<br>abdominal (GYN and<br>Urology), thoracic/pleural,<br>ophthalmic, Fetal/OB, Small<br>Organ (including breast,<br>testes, thyroid), Peripheral<br>vascular, neonatal and adult<br>cephalic, pediatric,<br>musculoskeletal (conventional<br>and superficial), cardiac<br>(adults and pediatric),<br>Transrectal, Transvaginal,<br>and imaging guidance of<br>interventional procedures<br>(e.g. Nerve block, vascular<br>access). | | General Device Description | Hand held portable diagnostic<br>ultrasound system. | Hand held portable diagnostic<br>ultrasound system. | Mobile diagnostic ultrasound<br>system. | | Clinical Applications | | | | | | | | | | | Ophthalmic | Not Applicable | Ophthalmic | | | Abdominal | Abdominal | Abdominal | | | Cardiac | Cardiac | Cardiac | | | Carotid | Carotid | Carotid | | | Musculo-skeletal<br>(conventional and<br>superficial) | Musculo-skeletal<br>(conventional and superficial) | Musculo-skeletal<br>(conventional and superficial) | | | Fetal/Obstetric,<br>Gynecological | Fetal/Obstetric, Gynecological | Fetal/Gynecological | | | Peripheral Vessel<br>(including carotid, deep<br>vein thrombosis, arterial<br>studies) | Peripheral Vessel (including<br>carotid, deep vein thrombosis,<br>arterial studies) | Peripheral Vessel | | | Procedural Guidance | Procedural Guidance | Imaging guidance of<br>interventional procedures | | | Small Organs including<br>thyroid, scrotum, and<br>breast | Small Organs including<br>thyroid, scrotum, and breast | Small Organs including<br>thyroid, scrotum, and breast | | | Urology | Urology | Urology | | | Not Applicable | Not Applicable | Transrectal | | | Not Applicable | Not Applicable | Transvaginal | | | Not Applicable | Not Applicable | Neonatal and adult cephalic | | | Not Applicable | Not Applicable | Thoracic/pleural | | | Not Applicable | Not Applicable | Cardiac Fetal Echo | | | Relevant Similarities | | | | Target<br>Population | Fetal, Pediatric, Adult,<br>Male, Female | Fetal, Pediatric, Adult, Male,<br>Female | Fetal, Pediatric, Adult, Male,<br>Female | | Where used | Professional healthcare<br>settings | Professional healthcare<br>settings | Environments where<br>healthcare is provided by<br>healthcare professionals | | Energy<br>used/delivered<br>(MI/TI) | Meets FDA/AIUM<br>guidelines | Meets FDA/AIUM guidelines | Meets FDA/AIUM guidelines | | FDA Regulatory<br>Classification | Class II | Class II | Class II | | 510(k) Track | Track 3 | Track 3 | Track 3 | | Portable/hand-<br>held | Yes | Yes | Yes | | Biocompatibility | Yes | Yes | Yes | | Sterility | Products not classified as<br>sterile | Products not classified as<br>sterile | Products not classified as<br>sterile | | Electrical safety | Meets electrical safety<br>standards for a class II<br>medical device. | Meets electrical safety<br>standards for a class II<br>medical device. | Meets electrical safety<br>standards for a class II medical<br>device. | | Mechanical<br>safety | Meets mechanical safety<br>standards for a class II<br>medical device | Meets mechanical safety<br>standards for a class II<br>medical device | Meets mechanical safety<br>standards for a class II<br>medical device | | FDA Product<br>Codes | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX | | Transducer | | | | | Type | Single probe 2D Phased<br>Array | Single probe 2D Phased Array…