Poseidon Ultrasound System

K163510 · Butterfly Network, Inc. · IYN · Sep 6, 2017 · Radiology

Device Facts

• Record ID: K163510
• Device Name: Poseidon Ultrasound System
• Applicant: Butterfly Network, Inc.
• Product Code: IYN · Radiology
• Decision Date: Sep 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Poseidon 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 and arterial studies), Procedural Guidance, Small Organs (including thyroid), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional) and Musculoskeletal (superficial).

Device Story

Poseidon Ultrasound System is a general-purpose diagnostic imaging system; consists of a single transducer with broad imaging capabilities; connects via USB to a standard handheld commercial off-the-shelf (COTS) mobile device. Device uses capacitive micromachined ultrasonic transducer (CMUT) array technology to capture ultrasound signals; transforms inputs into B-mode, M-mode, and Color Flow Doppler imagery. Operated by qualified healthcare professionals in clinical settings. User interface on mobile device provides touchscreen menus, buttons, and navigation icons for system control, image viewing, and measurement. Output assists clinicians in visualizing anatomical structures and fluids, supporting diagnostic decision-making and procedural guidance. Benefits include portable, broad-capability diagnostic imaging.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to demonstrate compliance with predetermined performance specifications and safety standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and NEMA UD-2.

Technological Characteristics

System utilizes a capacitive micromachined ultrasonic transducer (CMUT) array. Supports B-mode, M-mode, and Color Flow Doppler imaging. Connectivity via USB to a COTS mobile device. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound safety), ISO 10993 (biocompatibility), and NEMA UD-2 (acoustic output).

Indications for Use

Indicated for diagnostic ultrasound imaging and measurement of anatomical structures and fluids in adult and pediatric patients across peripheral vessel, procedural guidance, small organs, cardiac, abdominal, urology, fetal/obstetric, gynecological, and musculoskeletal applications.

Regulatory Classification

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.

Predicate Devices

• Philips Healthcare, Lumify Ultrasound System (K162549)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2017

Butterfly Network, Inc. % Mr. Brian Sawin Sr. Regulatory Affairs Manager 530 Old Whitfield Street GUILFORD CT 06437

Re: K163510

Trade/Device Name: Poseidon 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 9, 2017 Received: August 10, 2017

Dear Mr. Sawin:

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. 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

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara

Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K163510

Device Name Poseidon Ultrasound System

#### Indications for Use (Describe)

The Poseidon 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 pediativ for the following clinical applications: Peripheral Vessel (including carotid and arterial studies), Procedural Guidance, Small Organs (including thyroid), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional) and Musculoskeletal (superficial).

Type of Use (Select one or both, as applicable)

| <div> <span>☑</span> <span>Prescription Use (Part 21 CER 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------|
| <div> <span>☐</span> <span>Over-The-Counter Use (21 CER 801 Subpart C)</span> </div> |

#### 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}------------------------------------------------

#### Diagnostic Ultrasound Indications For Use Table

System: Poseidon Ultrasound System

#### Transducer: Poseidon Ultrasound System transducer

#### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|--------------------------------------------|-------------------|---|-----|-----|--------------------|-----------------------|---------------------|
| General (Track 1<br>Only) | Specific (Tracks 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging &<br>Other | Fetal/Obstetric | N | N | | | N | B mode + M<br>mode | |
| | Abdominal | N | N | | | N | B mode + M<br>mode | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | N | B mode + M<br>mode | |
| | Small Organ (including<br>thyroid) | N | N | | | N | B mode + M<br>mode | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | N | N | | | N | B mode + M<br>mode | |
| | Intravascular | | | | | | | |
| | Other (Musculo-skeletal -<br>Conventional) | N | N | | | N | B mode + M<br>mode | |
| | Other (Gynecological) | N | N | | N | B mode + M<br>mode | | |
| | Other (Urology) | N | N | | N | B mode + M<br>mode | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N | N | | N | B mode + M<br>mode | | |
| | Cardiac Pediatric | N | N | | N | B mode + M<br>mode | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral Vessel | Peripheral vessel | N | N | | N | B mode + M<br>mode | | |
| | Other (Carotid, arterial<br>studies) | N | N | | N | B mode + M<br>mode | | |
| | Other (Procedural Guidance) | N | N | | N | B mode + M<br>mode | | |

{4}------------------------------------------------

N = new indication; P = previously cleared by FDA; E = added under this appendix

{5}------------------------------------------------

Image /page/5/Picture/0 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".

## 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.) 203.204.6600 (fax) 203.458.2514 www.butterflynetwork.com

#### Contact Person

Brian Sawin Sr. Requlatory Affairs Manager 203.204.6600 [e-mail]

#### Date Prepared

August 9, 2017

### Subject Device - Proprietary/Trade Name

Poseidon 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

#### Predicate Device:

K162549 - Philips Healthcare, Lumify Ultrasound System (Clearance Date:

{6}------------------------------------------------

## 10/03/2016)

## Device Summary:

The Poseidon Ultrasound System is a 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 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 Poseidon 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 and arterial studies), Procedural Guidance, Small Organs (including thyroid), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional) and Musculoskeletal (superficial).

## Summary of Technological Characteristics

There are no technological characteristics, features or indications for use in this submission that are not previously evaluated and cleared in the predicate device, with the exception of utilizing a capacitive micromachined ultrasonic transducer (CMUT) array rather than a traditional crystalline piezoelectric array. This technology meets the same intended use and performs the same actions as piezoelectric material.

## Summary of Safety and Performance

Verification and validation activities were designed and performed to demonstrate that the Poseidon Ultrasound System meets predetermined performance specifications. The following standards were used to determine appropriate methods for evaluating the performance of the device:

IEC 60601-1: Medical Electrical Equipment – Part 1: General Requirements for Safety.

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

IEC 60601-2-37: Medical Electrical Equipment – Part 2-37: Particular

{7}------------------------------------------------

Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment.

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

NEMA UD-2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.

## Summary of Substantial Equivalence:

Based on the indications for use, technological characteristics, and safety and performance testing, the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device.