(114 days)
Not Found
No
The document does not mention AI, ML, or deep learning in the device description, intended use, or performance studies. While it mentions "Medical Image Management and Processing System," this is a broad term that does not necessarily imply AI/ML. The performance studies focus on standard medical device testing and software verification/validation, without mentioning AI/ML-specific evaluation metrics or methodologies.
No
The "Intended Use / Indications for Use" and "Device Description" sections clearly state that the device is for "diagnostic ultrasound imaging and measurement" and "diagnostic imaging system," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement". Additionally, the "Device Description" section refers to it as a "general-purpose diagnostic imaging system".
No
The device description explicitly states 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." This indicates the device includes hardware components (the transducer and cable) in addition to software.
Based on the provided information, the Butterfly iQ3 Ultrasound System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Butterfly iQ3 Ultrasound System is a diagnostic imaging system that uses ultrasound waves to visualize and measure anatomical structures and fluids within the 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 in-vivo imaging, not in-vitro analysis.
- Device Description: The description reinforces that it's a "portable, hand-held, general-purpose diagnostic imaging system" for visualizing structures and fluids on patients.
Therefore, the Butterfly iQ3 Ultrasound System falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
IYN, IYO, ITX, QIH
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 imagery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Adult and Pediatric patients
Intended User / Care Setting
Qualified and trained healthcare professionals
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.
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)
The Butterfly iQ3 Ultrasound System did not require clinical studies to support substantial equivalence for this premarket submission.
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
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).
1
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
2
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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3
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 Processing | ||
| System | 21 CFR 892.2050 | QIH |
4
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.
5
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. 3.2
en: 2020 | Medical Electrical Equipment - Part 1. General
requirements for basic safety and essential performance |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-11 Ed.
2.1 b:2020 | Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
CONSOLIDATED EDITION |
| IEC 60601-1-12 Ed.
1.1 b:2020 | Medical electrical equipment - Part 1-12: General requirements
for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical
services environment CONSOLIDATED EDITION |
| IEC 60601-1-2:
2014/AMD1:2020 | Medical Electrical Equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral
Standard: Electromagnetic disturbances - Requirements and
tests |
6
| IEC 60601-2-37 Ed.
2.0 b: 2007 | Medical Electrical Equipment – Part 2-37. Particular
requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment
CONSOLIDATED EDITION |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | Biological evaluation of medical devices — Part 1: Evaluation
and testing within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for
irritation 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 iQ3
Ultrasound
System (Subject
Device) | Butterfly iQ/iQ+
Ultrasound System
(K220068,
Predicate Device) | Comparison |
|------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------|----------------------|
| Regulatory Information | | | |
| Regulation Number | 892.1550 | 892.1550 | Remains
Unchanged |
7
| Device Classification
Name | Ultrasonic Pulsed
Doppler Imaging
System | Ultrasonic Pulsed
Doppler Imaging
System | Remains
Unchanged |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Remains
Unchanged |
| Product Codes | IYN
IYO
ITX
QIH | IYN
IYO
ITX
QIH | Remains
Unchanged |
| Intended Use | | | |
| 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. | ✓ | ✓ | Remains
Unchanged |
| General Device Description | | | |
| Hand-held portable
diagnostic ultrasound
system. | ✓ | ✓ | Remains
Unchanged |
| Indications for Use | | | |
| Abdominal | ✓ | ✓ | Remains
Unchanged |
| Cardiac | ✓ | ✓ | Remains
Unchanged |
| Lung | ✓ | ✓ | Remains
Unchanged |
| Musculoskeletal
(conventional and
superficial) | ✓ | ✓ | Remains
Unchanged |
| Fetal/Obstetric,
Gynecological | ✓ | ✓ | Remains
Unchanged |
| Peripheral Vessel
(including carotid, deep
vein thrombosis, arterial
studies) | ✓ | ✓ | Remains
Unchanged |
| Procedural Guidance | ✓ | ✓ | Remains
Unchanged |
| Small Organs
(including thyroid,
scrotum, and breast) | ✓ | ✓ | Remains
Unchanged |
| Urology | ✓ | ✓ | Remains
Unchanged |
| Opthalmic | ✓ | ✓ | Remains
Unchanged |
| Imaging Modes/Tools | | | |
| M-Mode | ✓ | ✓ | Remains
Unchanged |
| B-Mode (2D) | ✓ | ✓ | Remains
Unchanged |
| Color Doppler | ✓ | ✓ | Remains
Unchanged |
| Pulsed Wave Doppler | ✓ | ✓ | Remains
Unchanged |
| 3-D | ✓ | ✓ | Remains
Unchanged |
| Harmonic Imaging | ✓ | ✓ | Remains
Unchanged |
| Fetal Heart Sounds | ✓ | ✓ | Remains
Unchanged |
| B-mode + Biplane | ✓ | ✓ | Remains
Unchanged |
| B-mode + Needle Viz
Tool | ✓ | ✓ | Remains
Unchanged |
| B-mode + Biplane +
Needle Viz Tool | ✓ | ✓ | Remains
Unchanged |
| B-mode + Multi-Slice | ✓ | - | Multi-slice
collects and
displays B-
mode images
from different
angles
separately. This
new mode does
not change the
acoustic output
to the normal
B-Mode or 3-D
image, nor
does it
introduce any
new questions
of safety and
effectiveness. |
| B-mode + Sweep | ✓ | - | Sweep collects
and
continuously
displays B-
mode images
from different
angles. This
new mode does
not change the
acoustic output
to the normal
B-Mode or 3-D
image, nor
does it
introduce any
new questions
of safety and
effectiveness. |
| Transducer | | | |
| Type | Single probe 2D
Phased Array | Single probe
2D Phased
Array | Remains
Unchanged |
| 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 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. | 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. | |
| Energy
used/delivered
(MI/TI) | Acoustic will
meet
FDA/AIUM
guidelines | Acoustic will
meet
FDA/AIUM
guidelines | Remains
Unchanged |
| Portable/hand-held | ✓ | ✓ | Remains
Unchanged |
| Biocompatibility | ✓ | ✓ | Remains
Unchanged |
| Sterility | Products not
classified as sterile | Products not
classified as sterile | Remains
Unchanged |
| Cleaning/Reprocessing
Methods | ✓ | ✓ | Remains
Unchanged |
| Electrical safety | Meets electrical
safety standards
for a class II
medical device.
Group 1
Class B (CISPR) | Meets electrical
safety standards
for a class II
medical device.
Group 1
Class B (CISPR) | Remains
Unchanged |
| Mechanical safety | Will meet
mechanical safety
standards for a
class II medical
device | Will meet
mechanical safety
standards for a
class II medical
device | Remains
Unchanged |
| Display | COTS device
display | COTS device
display | Remains
Unchanged |
| Power requirements | Battery | Battery | Remains
Unchanged |
| Real-time Image | ✓ | ✓ | Remains
Unchanged |
| Frozen Image | ✓ | ✓ | Remains
Unchanged |
| Appx. Probe
dimensions (L x W x
D), inches | 6.0 x 2.1 x 1.4 | 6.4 x 2.2 x 1.4 | Change in size
of probe |
| Appx. Probe Weight, lbs. | 8 oz. probe only | 8 oz. probe only | Remains
Unchanged |
8
9
10
11
12
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).