K Number
K163510
Device Name
Poseidon Ultrasound System
Date Cleared
2017-09-06

(265 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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).
Device Description
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.
More Information

Not Found

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and user interface controls.

No
The device is described as a "general-purpose diagnostic imaging system" and its intended use is for "diagnostic ultrasound imaging and measurement of anatomical structures and fluids." There is no mention of treating conditions or providing therapy.

Yes
The device description explicitly states, "The Poseidon Ultrasound System is a general-purpose diagnostic imaging system." Additionally, the "Intended Use / Indications for Use" section highlights its purpose of enabling "diagnostic ultrasound imaging and measurement of anatomical structures and fluids."

No

The device description explicitly states that the system consists of a single transducer connected via a USB cable to a mobile device. This indicates the presence of hardware components (transducer and cable) beyond just software.

Based on the provided information, the Poseidon Ultrasound System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body. They perform tests outside the body (in vitro) to diagnose conditions.
  • The Poseidon Ultrasound System is a diagnostic imaging system. It uses ultrasound waves to visualize structures within the body (in vivo). It does not analyze specimens.

The description clearly states its purpose is for "diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients" and that it "enabling visualization and measurement of anatomical structures and fluid on adult and pediatric patients." This is the core function of an ultrasound machine, which is not an IVD.

N/A

Intended Use / 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 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).

Product codes

IYN, IYO, ITX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

qualified and trained healthcare professionals

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 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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162549

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

Public Health Service

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CER 801 Subpart C)

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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 ApplicationMode of Operation
General (Track 1
Only)Specific (Tracks 1 & 3)BMPWDCWDColor
DopplerCombined
(Specify)Other*
(Specify)
OphthalmicOphthalmic
Fetal Imaging &
OtherFetal/ObstetricNNNB mode + M
mode
AbdominalNNNB mode + M
mode
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
PediatricNNNB mode + M
mode
Small Organ (including
thyroid)NNNB mode + M
mode
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Superficial)NNNB mode + M
mode
Intravascular
Other (Musculo-skeletal -
Conventional)NNNB mode + M
mode
Other (Gynecological)NNNB mode + M
mode
Other (Urology)NNNB mode + M
mode
Other (Specify)
CardiacCardiac AdultNNNB mode + M
mode
Cardiac PediatricNNNB mode + M
mode
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral VesselPeripheral vesselNNNB mode + M
mode
Other (Carotid, arterial
studies)NNNB mode + M
mode
Other (Procedural Guidance)NNNB mode + M
mode

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

5

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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 bsawin@butterflynetinc.com

Date Prepared

August 9, 2017

Subject Device - Proprietary/Trade Name

Poseidon Ultrasound System

Subject Device - Common Name

Ultrasound Imaging System

Classification Name

Regulation NumberProduct Code
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX

Classification

Class II

Predicate Device:

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

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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.