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.

Device Description

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.

AI/ML Overview

The provided text describes the Butterfly iQ Ultrasound System and establishes its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or an analytical study proving that the device meets those criteria.

The document discusses:

Indications for Use: The system is for diagnostic ultrasound imaging and measurement of anatomical structures and fluids in adult and pediatric patients for various clinical applications (Peripheral Vessel, Procedural Guidance, Small Organs, Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal, Ophthalmic).
Technological Characteristics: It's a general-purpose diagnostic imaging system consisting of a single transducer connected to a mobile device, supporting B-mode, M-mode, Color Doppler, and Power Doppler.
Comparison to Predicate Devices: It highlights similarities and differences with the Butterfly Poseidon Ultrasound System (K163510) and GE Venue (K170714) regarding intended use, general device description, clinical applications, target population, usage environment, energy output, regulatory classification, portability, biocompatibility, sterility, electrical and mechanical safety, product codes, transducer type, and display.
Summary of Safety and Performance: It states that verification and validation activities were performed to demonstrate that the device meets predetermined performance specifications and lists various IEC, ISO, and NEMA standards used for evaluation (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993, NEMA UD-2).
Conclusion of Substantial Equivalence: It concludes that the Butterfly iQ Ultrasound System is as safe and effective as the predicate, with similar intended uses, indications, technological characteristics, and principles of operation, and that minor technological differences raise no new issues of safety or effectiveness. Performance data, including software verification and validation and performance testing, are mentioned as demonstrating safety and effectiveness.

However, the document does not provide the following specific information:

A table of acceptance criteria and the reported device performance. While it mentions "predetermined performance specifications" and "performance data," it doesn't quantify what those specifications were or the results achieved.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance. The device is an ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the prompt.
If a standalone (algorithm only without human-in-the-loop performance) was done. Again, the prompt describes AI/algorithm performance, which is not the focus of this 510(k) for an ultrasound system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

In summary, the provided text confirms the general safety and performance evaluation undertaken for the Butterfly iQ Ultrasound System to establish substantial equivalence but lacks the detailed metrics, study design, and results typically found in a clinical study report for specific acceptance criteria.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K202406

Device Name Butterfly iQ Ultrasound System

Indications for Use (Describe)

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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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

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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 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 .

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Commercial off the shelf display vs. LCD display •

Device Comparison Table:

Butterfly iQUltrasound System(This submission)	Butterfly PoseidonUltrasound System510(k): K163510	Venue510(k): K170714
FDA Clearance	No - original submission	Yes (September 6, 2017)	Yes (June 22, 2017)
Intended Use	Intended for use by trainedhealthcare professionals inenvironments wherehealthcare is provided toenable diagnostic ultrasoundimaging and measurementof anatomical structures andfluids of adult and pediatricpatients for the followingclinical applications:Peripheral Vessel (includingcarotid, deep veinthrombosis and arterialstudies), ProceduralGuidance, Small Organs(including thyroid, scrotumand breast), Cardiac,Abdominal, Urology,Fetal/Obstetric,Gynecological,Musculoskeletal(conventional),Musculoskeletal (superficial)and Ophthalmic. Modes ofoperation include B-mode,B-mode + M-mode, B-mode+ Color Doppler, B-mode +Power Doppler.	Intended for use by qualifiedand trained healthcareprofessionals to enablediagnostic ultrasound imagingand measurement ofanatomical structures andfluids of adult and pediatricpatients for the following clinicalapplications: Peripheral Vessel(including carotid, deep veinthrombosis and arterial studies),Procedural Guidance, SmallOrgans (including thyroid,scrotum and breast), Cardiac,Abdominal, Urology,Fetal/Obstetric, Gynecological,Musculoskeletal (conventional)and Musculoskeletal(superficial).	Intended for ultrasoundimaging, measurement andanalysis of the human bodyand fluid for multiple clinicalapplications including:abdominal (GYN andUrology), thoracic/pleural,ophthalmic, Fetal/OB, SmallOrgan (including breast,testes, thyroid), Peripheralvascular, neonatal and adultcephalic, pediatric,musculoskeletal (conventionaland superficial), cardiac(adults and pediatric),Transrectal, Transvaginal,and imaging guidance ofinterventional procedures(e.g. Nerve block, vascularaccess).
General Device Description	Hand held portable diagnosticultrasound system.	Hand held portable diagnosticultrasound system.	Mobile diagnostic ultrasoundsystem.
Clinical Applications

	Ophthalmic	Not Applicable	Ophthalmic
	Abdominal	Abdominal	Abdominal
	Cardiac	Cardiac	Cardiac
	Carotid	Carotid	Carotid
	Musculo-skeletal(conventional andsuperficial)	Musculo-skeletal(conventional and superficial)	Musculo-skeletal(conventional and superficial)
	Fetal/Obstetric,Gynecological	Fetal/Obstetric, Gynecological	Fetal/Gynecological
	Peripheral Vessel(including carotid, deepvein thrombosis, arterialstudies)	Peripheral Vessel (includingcarotid, deep vein thrombosis,arterial studies)	Peripheral Vessel
	Procedural Guidance	Procedural Guidance	Imaging guidance ofinterventional procedures
	Small Organs includingthyroid, scrotum, andbreast	Small Organs includingthyroid, scrotum, and breast	Small Organs includingthyroid, 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
TargetPopulation	Fetal, Pediatric, Adult,Male, Female	Fetal, Pediatric, Adult, Male,Female	Fetal, Pediatric, Adult, Male,Female
Where used	Professional healthcaresettings	Professional healthcaresettings	Environments wherehealthcare is provided byhealthcare professionals
Energyused/delivered(MI/TI)	Meets FDA/AIUMguidelines	Meets FDA/AIUM guidelines	Meets FDA/AIUM guidelines
FDA RegulatoryClassification	Class II	Class II	Class II
510(k) Track	Track 3	Track 3	Track 3
Portable/hand-held	Yes	Yes	Yes
Biocompatibility	Yes	Yes	Yes
Sterility	Products not classified assterile	Products not classified assterile	Products not classified assterile
Electrical safety	Meets electrical safetystandards for a class IImedical device.	Meets electrical safetystandards for a class IImedical device.	Meets electrical safetystandards for a class II medicaldevice.
Mechanicalsafety	Meets mechanical safetystandards for a class IImedical device	Meets mechanical safetystandards for a class IImedical device	Meets mechanical safetystandards for a class IImedical device
FDA ProductCodes	IYN, IYO, ITX	IYN, IYO, ITX	IYN, IYO, ITX
Transducer
Type	Single probe 2D PhasedArray	Single probe 2D Phased Array	Multiple probes including,convex, linear and phasedArray
Pan/Zoom
Real-time image	Yes	Yes	Yes
Frozen image	Yes	Yes	Yes
Miscellaneous
Display	COTS device display	COTS device display	LCD device display
Scan time	Battery (120 minutescontinuous scan time)	Battery (120 minutescontinuous scan time)	Battery (240 minutescontinuous scan time)

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Summary of Safety and Performance

Verification and validation activities were designed and performed to demonstrate that the Butterfly iQ Ultrasound System meets predetermined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:

IEC 60601-1:Edition 3.0 – 2005 (3.0 2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012). Medical Electrical Equipment - Part 1: General Requirements for Safety.

IEC 60601-1-2:Edition 4.0 - 2014, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.

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IEC 60601-2-37:Edition 2.0 Am 1 – 2015, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment.

ISO 10993:2009 Biological Evaluation of Medical Devices. Part 1

NEMA UD-2: 2004 Rev 3, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.

Summary of Substantial Equivalence:

The Butterfly iQ Ultrasound System 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 iQ Ultrasound System is safe and effective and therefore, substantially equivalent.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.