(26 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or components that would indicate the use of AI or ML.
No
The device is described as a "general-purpose diagnostic imaging system" used to "enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids," indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is indicated "to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids." Additionally, the "Device Description" section refers to it as a "general-purpose diagnostic imaging system."
No
The device description explicitly states that the system consists of a "single transducer" which is a hardware component. The performance studies also reference standards related to hardware safety and performance (IEC 60601 series, NEMA UD-2).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Butterfly iQ Ultrasound System is a diagnostic imaging system that uses ultrasound waves to visualize internal anatomical structures and fluids directly within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients." This describes an in-vivo (within the living organism) diagnostic method, not an in-vitro one.
Therefore, based on the provided information, the Butterfly iQ Ultrasound System is a diagnostic imaging device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
IYN, IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
trained healthcare professionals in environments where healthcare is provided
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were designed and performed to demonstrate that the Butterfly iQ Ultrasound System meets predetermined performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
| 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
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
Ultrasound System
(This submission) | Butterfly Poseidon
Ultrasound System
510(k): K163510 | Venue
510(k): K170714 | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | No - original submission | Yes (September 6, 2017) | Yes (June 22, 2017) |
| Intended Use | Intended 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 Doppler, B-mode +
Power Doppler. | Intended 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),
Procedural Guidance, Small
Organs (including thyroid,
scrotum and breast), Cardiac,
Abdominal, Urology,
Fetal/Obstetric, Gynecological,
Musculoskeletal (conventional)
and Musculoskeletal
(superficial). | Intended for ultrasound
imaging, measurement and
analysis of the human body
and fluid for multiple clinical
applications including:
abdominal (GYN and
Urology), thoracic/pleural,
ophthalmic, Fetal/OB, Small
Organ (including breast,
testes, thyroid), Peripheral
vascular, neonatal and adult
cephalic, pediatric,
musculoskeletal (conventional
and superficial), cardiac
(adults and pediatric),
Transrectal, Transvaginal,
and imaging guidance of
interventional procedures
(e.g. Nerve block, vascular
access). |
| General Device Description | Hand held portable diagnostic
ultrasound system. | Hand held portable diagnostic
ultrasound system. | Mobile diagnostic ultrasound
system. |
| Clinical Applications | | | |
| | | | |
| | Ophthalmic | Not Applicable | Ophthalmic |
| | Abdominal | Abdominal | Abdominal |
| | Cardiac | Cardiac | Cardiac |
| | Carotid | Carotid | Carotid |
| | Musculo-skeletal
(conventional and
superficial) | Musculo-skeletal
(conventional and superficial) | Musculo-skeletal
(conventional and superficial) |
| | Fetal/Obstetric,
Gynecological | Fetal/Obstetric, Gynecological | Fetal/Gynecological |
| | Peripheral Vessel
(including carotid, deep
vein thrombosis, arterial
studies) | Peripheral Vessel (including
carotid, deep vein thrombosis,
arterial studies) | Peripheral Vessel |
| | Procedural Guidance | Procedural Guidance | Imaging guidance of
interventional procedures |
| | Small Organs including
thyroid, scrotum, and
breast | Small Organs including
thyroid, scrotum, and breast | Small Organs including
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
Population | Fetal, Pediatric, Adult,
Male, Female | Fetal, Pediatric, Adult, Male,
Female | Fetal, Pediatric, Adult, Male,
Female |
| Where used | Professional healthcare
settings | Professional healthcare
settings | Environments where
healthcare is provided by
healthcare professionals |
| Energy
used/delivered
(MI/TI) | Meets FDA/AIUM
guidelines | Meets FDA/AIUM guidelines | Meets FDA/AIUM guidelines |
| FDA Regulatory
Classification | 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 as
sterile | Products not classified as
sterile | Products not classified as
sterile |
| Electrical safety | Meets electrical safety
standards for a class II
medical device. | Meets electrical safety
standards for a class II
medical device. | Meets electrical safety
standards for a class II medical
device. |
| Mechanical
safety | Meets mechanical safety
standards for a class II
medical device | Meets mechanical safety
standards for a class II
medical device | Meets mechanical safety
standards for a class II
medical device |
| FDA Product
Codes | IYN, IYO, ITX | IYN, IYO, ITX | IYN, IYO, ITX |
| Transducer | | | |
| Type | Single probe 2D Phased
Array | Single probe 2D Phased Array | Multiple probes including,
convex, linear and phased
Array |
| 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 minutes
continuous scan time) | Battery (120 minutes
continuous scan time) | Battery (240 minutes
continuous scan time) |
6
7
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.
8
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.