(114 days)
The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals 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, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep.
The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.
The Butterfly iQ3 Ultrasound System is a portable, hand-held, general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging.
The user interface includes touch screen menus, buttons, controls, indication icons that allow the operator to control the system and to view and measure ultrasound imagerv.
The provided text is a 510(k) summary for the Butterfly iQ3 Ultrasound System. This document does not describe acceptance criteria for an AI/CADe device or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate ultrasound system (Butterfly iQ/iQ+ Ultrasound System, K220068) based on technological characteristics and non-clinical performance testing of the ultrasound system itself.
Here's why the requested information cannot be extracted from this document:
- No AI/CADe Acceptance Criteria: The document describes a general diagnostic ultrasound imaging system. While it mentions the "Bladder Volume and B-lines tools remain compatible with the images generated with the iQ3," these are presented as features of the ultrasound system's software compatibility, not as separate AI/CADe functions with specific performance acceptance criteria. There's no mention of a standalone AI algorithm, human-in-the-loop performance, or specific metrics like sensitivity, specificity, or AUC that would be associated with an AI/CADe device.
- No Clinical Study for Substantial Equivalence: The document explicitly states: "The Butterfly iQ3 Ultrasound System did not require clinical studies to support substantial equivalence for this premarket submission." This indicates that the substantial equivalence was demonstrated through non-clinical testing (e.g., electrical safety, biocompatibility, mechanical safety, software verification and validation) and comparison of technical specifications to the predicate device, not through a clinical performance study involving human readers or AI algorithms with associated ground truth.
- No Ground Truth Information: Since no clinical studies were performed, there is no discussion of how ground truth was established, the number of experts, their qualifications, or adjudication methods.
- No Training Set Information: Without a clinical performance study involving AI/CADe, there's no mention of a training set or how its ground truth was established.
Therefore, based on the provided text, it is not possible to fill out the requested table or answer the specific questions about acceptance criteria, clinical study details, sample sizes, expert involvement, or ground truth for an AI/CADe device.
The document primarily focuses on demonstrating that the Butterfly iQ3 Ultrasound System, as a whole, is safe and effective and substantially equivalent to its predecessor for various human body applications, based on its hardware and software functionalities for image acquisition and display, not on the performance of a specific AI algorithm designed to interpret those images for diagnostic purposes.
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January 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Butterfly Network, Inc. % Nathan Sabich Senior Director, Head of Global Regulatory Affairs 1600 District Ave BURLINGTON MA 01803
Re: K232808
Trade/Device Name: Butterfly iQ3 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: December 1, 2023 Received: December 4, 2023
Dear Nathan Sabich:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
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
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Indications for Use
Submission Number (if known)
Device Name
Butterfly iQ3 Ultrasound System
Indications for Use (Describe)
The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals 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, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep.
The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic. hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.
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 of Safety and Effectiveness Butterfly Network, Inc.
K232808
This 510(k) summary is submitted in accordance with 21 CFR Part 807.92:
Date Prepared: September 8, 2023
Submitter Name and Address:
Butterfly Network, Inc. 1600 District Ave Burlington, MA 01803 Phone: 1-781-557-4800
Primary Contact:
Nathan Sabich Senior Director, Head of Global Regulatory Affairs E-mail: nsabich@butterflynetinc.com
Subject Device - Proprietary/Trade Name:
Butterfly iQ3 Ultrasound System
Subject Device - Common/Usual Name:
Diagnostic Ultrasound Imaging System
Device Classification:
Class II
Regulation Description:
| Classification Name(s) | Regulation Number | Product Code |
|---|---|---|
| Primary | ||
| Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 | IYN |
| Secondary | ||
| Ultrasonic Pulsed Echo Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 21 CFR 892.1570 | ITX |
| Medical Image Management and ProcessingSystem | 21 CFR 892.2050 | QIH |
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Predicate Device Information:
| Device Trade Name: | Butterfly iQ/iQ+ Ultrasound System |
|---|---|
| 510(k) Number: | K220068 |
| Submitter: | Butterfly Network, Inc. |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System |
| Primary Product Code: | IYN - 21 CFR 892.1550 |
| Secondary Product Code(s): | IYO - 21 CFR 892.1560 |
| ITX – 21 CFR 892.1570 | |
| QIH – 21 CFR 892.2050 |
Note: The predicate device has not been subject to a design-related recall.
Device Description:
The Butterfly iQ3 Ultrasound System is a portable, hand-held, general-purpose diagnostic imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients. The system consists of a single transducer with broad imaging capabilities connected via a USB cable to a standard handheld commercial off the shelf (COTS) mobile device. In addition to M-mode and B-mode imaging the instrument also supports Color Flow Doppler imaging.
The user interface includes touch screen menus, buttons, controls, indication icons that allow the operator to control the system and to view and measure ultrasound imagerv.
Indications for Use:
The Butterfly iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diaqnostic 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, Fetal Heart Sounds, B-mode + Biplane, B mode + Needle Viz Tool, B-mode + Biplane + Needle Viz Tool, B-mode + Multi-Slice, B-mode + Sweep.
The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.
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Summary of Technological Characteristics:
There are no technological characteristics and features that change the indications for use in this submission that are not previously evaluated and cleared in the predicate device. The iQ3 represents a new Butterfly iQ App compatible transducer.
As with the iQ and iQ+, the iQ3 uses a capacitive micromachined ultrasonic transducer (CMUT) array rather than a traditional crystalline piezoelectric array. The system remains battery operated and all image interaction and capture is with the existing iOS and Android host applications. The Bladder Volume and B-lines tools remain compatible with the images generated with the iQ3.
As with the iQ+. the iQ3 includes new printed circuit board assemblies and a next generation release of the CMUT array. Additionally, the iQ3 uses a new custom battery, a new lens material (butadiene synthetic rubber), and replaces the induction coil charging method with a direct contact charqing system.
Summary of Safety and Non-Clinical Performance:
The Butterfly iQ3 Ultrasound System was developed and tested in accordance with internal procedures for safety, design quality, and documentation.
Verification and validation activities were designed and performed to demonstrate that the Butterfly iQ3 Ultrasound System meets predetermined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the safe and effective performance of the device:
| IEC 60601-1 Ed. 3.2en: 2020 | Medical Electrical Equipment - Part 1. Generalrequirements for basic safety and essential performance |
|---|---|
| IEC 60601-1-11 Ed.2.1 b:2020 | Medical electrical equipment - Part 1-11: General requirementsfor basic safety and essential performance - Collateral Standard:Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environmentCONSOLIDATED EDITION |
| IEC 60601-1-12 Ed.1.1 b:2020 | Medical electrical equipment - Part 1-12: General requirementsfor basic safety and essential performance - Collateral Standard:Requirements for medical electrical equipment and medicalelectrical systems intended for use in the emergency medicalservices environment CONSOLIDATED EDITION |
| IEC 60601-1-2:2014/AMD1:2020 | Medical Electrical Equipment – Part 1-2: General requirementsfor basic safety and essential performance – CollateralStandard: Electromagnetic disturbances - Requirements andtests |
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| IEC 60601-2-37 Ed.2.0 b: 2007 | Medical Electrical Equipment – Part 2-37. Particularrequirements for the basic safety and essential performance ofultrasonic medical diagnostic and monitoring equipmentCONSOLIDATED EDITION |
|---|---|
| ISO 10993-1 | Biological evaluation of medical devices — Part 1: Evaluationand testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
| ISO 14971:2019 | Application of risk management to medical devices |
Software Verification and Validation Testing for the Butterfly iQ3 Ultrasound System was also conducted and provided in accordance with recommended FDA guidance documentation for Industry and FDA Staff.
Relevant non-clinical verification and validation testing was performed to address the introduction of the subject hardware and its compatibility with the cleared Butterfly iQ App and to assure its safe and effective performance. Verification and validation testing established that the device meets its design requirements, intended use, and demonstrates substantial equivalence to the predicate.
Summary of Clinical Tests:
The Butterfly iQ3 Ultrasound System did not require clinical studies to support substantial equivalence for this premarket submission.
Summary of Substantial Equivalence:
The Butterfly iQ3 Ultrasound System is substantially equivalent to the predicate device (K220068). The following table below provides an overview of the comparison between the subject device and the predicate device.
| Model | Butterfly iQ3UltrasoundSystem (SubjectDevice) | Butterfly iQ/iQ+Ultrasound System(K220068,Predicate Device) | Comparison |
|---|---|---|---|
| Regulatory Information | |||
| Regulation Number | 892.1550 | 892.1550 | RemainsUnchanged |
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| Device ClassificationName | Ultrasonic PulsedDoppler ImagingSystem | Ultrasonic PulsedDoppler ImagingSystem | RemainsUnchanged |
|---|---|---|---|
| Classification | Class II | Class II | RemainsUnchanged |
| Product Codes | IYNIYOITXQIH | IYNIYOITXQIH | RemainsUnchanged |
| Intended Use | |||
| Intended for use byqualified and trainedhealthcare professionalsto enable diagnosticultrasound imaging andmeasurement ofanatomical structures andfluids of adult andpediatric patients. | ✓ | ✓ | RemainsUnchanged |
| General Device Description | |||
| Hand-held portablediagnostic ultrasoundsystem. | ✓ | ✓ | RemainsUnchanged |
| Indications for Use | |||
| Abdominal | ✓ | ✓ | RemainsUnchanged |
| Cardiac | ✓ | ✓ | RemainsUnchanged |
| Lung | ✓ | ✓ | RemainsUnchanged |
| Musculoskeletal(conventional andsuperficial) | ✓ | ✓ | RemainsUnchanged |
| Fetal/Obstetric,Gynecological | ✓ | ✓ | RemainsUnchanged |
| Peripheral Vessel(including carotid, deepvein thrombosis, arterialstudies) | ✓ | ✓ | RemainsUnchanged |
| Procedural Guidance | ✓ | ✓ | RemainsUnchanged |
| Small Organs(including thyroid,scrotum, and breast) | ✓ | ✓ | RemainsUnchanged |
| Urology | ✓ | ✓ | RemainsUnchanged |
| Opthalmic | ✓ | ✓ | RemainsUnchanged |
| Imaging Modes/Tools | |||
| M-Mode | ✓ | ✓ | RemainsUnchanged |
| B-Mode (2D) | ✓ | ✓ | RemainsUnchanged |
| Color Doppler | ✓ | ✓ | RemainsUnchanged |
| Pulsed Wave Doppler | ✓ | ✓ | RemainsUnchanged |
| 3-D | ✓ | ✓ | RemainsUnchanged |
| Harmonic Imaging | ✓ | ✓ | RemainsUnchanged |
| Fetal Heart Sounds | ✓ | ✓ | RemainsUnchanged |
| B-mode + Biplane | ✓ | ✓ | RemainsUnchanged |
| B-mode + Needle VizTool | ✓ | ✓ | RemainsUnchanged |
| B-mode + Biplane +Needle Viz Tool | ✓ | ✓ | RemainsUnchanged |
| B-mode + Multi-Slice | ✓ | - | Multi-slicecollects anddisplays B-mode imagesfrom differentanglesseparately. Thisnew mode doesnot change theacoustic outputto the normalB-Mode or 3-Dimage, nordoes itintroduce anynew questionsof safety andeffectiveness. |
| B-mode + Sweep | ✓ | - | Sweep collectsandcontinuouslydisplays B-mode imagesfrom differentangles. Thisnew mode doesnot change theacoustic outputto the normalB-Mode or 3-Dimage, nordoes itintroduce anynew questionsof safety andeffectiveness. |
| Transducer | |||
| Type | Single probe 2DPhased Array | Single probe2D PhasedArray | RemainsUnchanged |
| Frequency | 1.0 - 12 MHz | 1.0 - 10 MHz | Similar. The subject device remains within the boundaries of the predicate device and does not introduce any new questions of safety and effectiveness. |
| Software Features | |||
| Auto B-Lines Counter | ✓ | ✓ | Remains Unchanged |
| Auto Bladder Volume | ✓ | ✓ | Remains Unchanged |
| Patient Data Entry | ✓ | ✓ | Remains Unchanged |
| Patient Database and Storage | ✓ | ✓ | Remains Unchanged |
| Generic Measurement Tools | ✓ | ✓ | Remains Unchanged |
| Analysis and Calculation Packages | ✓ | ✓ | Remains Unchanged |
| Annotations | ✓ | ✓ | Remains Unchanged |
| Other | |||
| Target Population | Adult and Pediatric | Adult and Pediatric | Remains Unchanged |
| Device Use Settings | Professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office) | Professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office), home healthcare | Remains Unchanged |
| home healthcareenvironment,ambulancesand/or accidentsites, and otherenvironmentswhere healthcareis provided. Usersmay also includemedical studentsworking under thesupervision orauthority of aphysician duringtheir education/training. | environment,ambulances and/oraccident sites, andother environmentswhere healthcare isprovided. Usersmay also includemedical studentsworking under thesupervision orauthority of aphysician duringtheir education/training. | ||
| Energyused/delivered(MI/TI) | Acoustic willmeetFDA/AIUMguidelines | Acoustic willmeetFDA/AIUMguidelines | RemainsUnchanged |
| Portable/hand-held | ✓ | ✓ | RemainsUnchanged |
| Biocompatibility | ✓ | ✓ | RemainsUnchanged |
| Sterility | Products notclassified as sterile | Products notclassified as sterile | RemainsUnchanged |
| Cleaning/ReprocessingMethods | ✓ | ✓ | RemainsUnchanged |
| Electrical safety | Meets electricalsafety standardsfor a class IImedical device.Group 1Class B (CISPR) | Meets electricalsafety standardsfor a class IImedical device.Group 1Class B (CISPR) | RemainsUnchanged |
| Mechanical safety | Will meetmechanical safetystandards for aclass II medicaldevice | Will meetmechanical safetystandards for aclass II medicaldevice | RemainsUnchanged |
| Display | COTS devicedisplay | COTS devicedisplay | RemainsUnchanged |
| Power requirements | Battery | Battery | RemainsUnchanged |
| Real-time Image | ✓ | ✓ | RemainsUnchanged |
| Frozen Image | ✓ | ✓ | RemainsUnchanged |
| Appx. Probedimensions (L x W xD), inches | 6.0 x 2.1 x 1.4 | 6.4 x 2.2 x 1.4 | Change in sizeof probe |
| Appx. Probe Weight, lbs. | 8 oz. probe only | 8 oz. probe only | RemainsUnchanged |
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Conclusion:
Based on the subject device's intended use, design similarities, technological characteristics, mode of operation, conformance to recognized performance standards, and relevant performance testing, the Butterfly iQ3 Ultrasound System does not introduce any new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device (K220068).
§ 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.