Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard Doppler device for blood flow measurement and does not mention any AI or ML capabilities in its description, intended use, or performance studies.

Therapeutic

No
The device is described as a diagnostic tool for measuring blood flow velocities, not for treating conditions.

Diagnostic

Yes.
The "Device Description" section states that the Dolphin systems are "noninvasive peripheral vascular diagnostic systems," and their intended use is for "measurements of blood flow velocities in arteries and veins," which are diagnostic measurements.

SaMD (Software as a Medical Device)

No

The device description explicitly states that both Dolphin/IQ and Dolphin/4D systems share identical Doppler hardware and software, and the Dolphin/4D is a complete integrated system including hardware components like a computer system, hard disk, and touch screen display.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states that the Dolphin systems are for "noninvasive measurements of blood flow velocities in arteries and veins". This involves using ultrasound technology to measure physiological parameters directly from the patient's body.
Device Description: The description details a Doppler system that uses probes to interact with the body and measure blood flow.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is the defining characteristic of an In Vitro Diagnostic device.

IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Dolphin systems are used to directly measure physiological parameters within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Dolphin/IQ and Dolphin/4D are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.

Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications.

Note : The Dolphin is to be used only by trained medical personnel.

Product codes (comma separated list FDA assigned to the subject device)

IYN, ITX

Device Description

Dolphin/IQ and Dolphin/4D systems are part of the Dolphin product family of noninvasive peripheral vascular diagnostic systems. The Dolphin/IQ and the Dolphin/4D are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. Both systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes and integrated computer system with hard disk, and touch screen display. The functionality and performance of both systems is identical. Both systems support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Both support the same accessories: IR wireless remote control, foot switch and monitoring head set.

Wherever the term Dolphin is used in this document, it applies to the Dolphin/IQ and Dolphin/4D products. Otherwise, each product is specifically by name. The Dolphin systems are based on Doppler technology and are designed for standard intended use for Transcranial Doppler systems operated only by experienced medical staff.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic pulsed doppler imaging

Anatomical Site

Arteries and veins (intracranially, extracranially, and in the peripheral circulation)

Indicated Patient Age Range

Adults and Pediatric

Intended User / Care Setting

trained medical personnel; hospitals, clinics and physician offices

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 Dolphin/IQ and Dolphin/4D devices have been thoroughly tested through verification of specifications and validation, including software validation. The following performance verification testing were applied to the development of the system: Acoustic output Measurement, temperature rise and velocity accuracy testing.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060421, K051085

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Viasonix Ltd. Mr. Dan Manor, CEO 10 Hamelacha Street Raanana, 4366105 ISRAEL

November 14, 2017

Re: K170859

Trade/Device Name: Dolphin/IQ and Dolphin/4D Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX Dated: October 19, 2017 Received: October 23, 2017

Dear Mr. Manor:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert 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)

K170859

Device Name Dolphin/IQ and Dolphin/4D

Indications for Use (Describe)

The Dolphin/IQ and Dolphin/4D are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices

Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications.

Note : The Dolphin is to be used only by trained medical personnel.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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:

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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System:	Dolphin/IQ, Dolphin/4D
Transducer:	1.6 MHz Hand Held

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic			x
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic			x
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel			x
	Other (Specify)

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System:	Dolphin/IQ, Dolphin/4D
Transducer:	2 MHz Monitoring

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Combined	Other*
(Track 1 Only)	(Tracks 1 & 3)					Doppler	(Specify)	(Specify)
Ophthalmic	Ophthalmic			x
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal	Pediatric
Imaging
& Other	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic			x
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel			x
Vessel	Other (Specify)

5

System:	Dolphin/IQ, Dolphin/4D
Transducer:	2 MHz Hand Held

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track 1 Only)	(Tracks 1 & 3)
Ophthalmic	Ophthalmic			x
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic			x
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel			x
	Other (Specify)

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System:	Dolphin/IQ, Dolphin/4D
Transducer:	4 MHz Hand Held

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic			X	X
	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel			X	X
	Other (Specify)

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System:	Dolphin/IQ, Dolphin/4D
Transducer:	8 MHz Hand Held

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic			x	x
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel			x	x
	Other (Specify)

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SECTION 5 - 510(K) SUMMARY

5.1 ADMINISTRATIVE INFORMATION

Date:	14-March-2017
Submitter:	Viasonix Ltd.
10 Hamelacha Street
Raanana , ISRAEL 4366105
Phone : 972-9-7441692
Official Correspondent:	Dan Manor, CEO
Trade Name:	Dolphin/IQ and Dolphin/4D
Classification Name:
Classification Number:	Ultrasonic Pulsed Doppler Imaging System
21 CFR 892.1550
Product Code:
Device Class:	IYN, ITX
Class II
Predicate Devices:	Primary:
Sonara and Sonara/Tek
VIASYS Healthcare, Inc,
510(k) Number - K060421

Secondary:
Doppler-Box
COMPUMEDICS GERMANY GMGH - DWL
510(k) Number - K051085 |

5.2 DEVICE DESCRIPTION

Dolphin/IQ and Dolphin/4D systems are part of the Dolphin product family of noninvasive peripheral vascular diagnostic systems. The Dolphin/IQ and the Dolphin/4D are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. Both systems share identical Doppler hardware and software. The Dolphin/IQ is a module, that needs to connect to an external computer and display for its' operation while the Dolphin/4D is a complete integrated system that includes and integrated computer system with hard disk, and touch screen display. The functionality and performance of both systems is identical. Both systems

9

support the same Doppler probes: 1.6 MHz PW hand held probe, 2 MHz PW hand held probe, 2 MHz PW monitoring probe, 4 MHz CW/PW hand held probe and 8 MHz CW/PW hand held probe. Both support the same accessories: IR wireless remote control, foot switch and monitoring head set.

Wherever the term Dolphin is used in this document, it applies to the Dolphin/IQ and Dolphin/4D products. Otherwise, each product is specifically by name. The Dolphin systems are based on Doppler technology and are designed for standard intended use for Transcranial Doppler systems operated only by experienced medical staff.

5.3 INTENDED USE AND INDICATIONS FOR USE

The Dolphin/IQ and Dolphin/4D are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices.

Contraindications: The Dolphin is not intended to be used in fetal or neonatal applications.

Note - The Dolphin is to be used only by trained medical personnel

5.4 SUMMARY OF TECHNICAL CHARACTERISTICS

The Dolphin/IQ and Dolphin/4D are similar to the predicate devices cited above with 1.6MHz, 2MHz, 4MHz and 8MHz transducers intended for transcranial and peripheral Doppler applications.

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, the intended use, use environment and target patient population of the Dolphin/1Q and Dolphin/4D devices are substantially equivalent to the predicate devices cited above.

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5.4.1 Summary table of Comparison

| Specification | Dolphin/4D and
Dolphin/IQ | Sonara and Sonara/tek | Doppler-Box | Differences discussion |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Proposed Device | K060421 | K051085 | NA |
| Manufacturer | VIASONIX LTD. | VIASYS HEALTHCARE, INC | COMPUMEDICS GERMANY
GMGH - DWL | NA |
| Product regulation
and code | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicates |
| | | | | |
| Indications for use | Code: IYN, ITX
The Dolphin/IQ and | Code: IYN, ITX
Sonara and Sonara/Tek | Code: IYN, ITX
The Doppler-Box is a medical | Equivalent. |
| | Dolphin/4D are medical
Doppler devices intended
for noninvasive
measurements of blood
flow velocities in arteries
and veins in adults and
Pediatric. The Dolphin
systems can be used in
hospitals, clinics and
physician offices. | systems are medical
ultrasound Doppler
devices for measuring the
blood flow velocities in
arteries and veins non-
invasively. | ultrasound device for
measuring the blood flow
velocities in arteries and
veins mainly subcutaneously.
The 16MHz probe can also be
used intraoperative. | Intended use, use environment and
target patient population is
substantially equivalent to the
predicate devices. The Dolphin
devices don't include the 16MHz
option for intraoperative use. |
| Clinical Applications | Intracranial
Extracranial
Peripheral | Intracranial
Extracranial
Peripheral | Intracranial
Extracranial
Peripheral
Intraoperative | Identical to Sonara and Sonara/tek |
| Weight (kg) | Dolphin/4D: ~6 Kg
Dolphin/IQ: ~2 Kg | Sonara: 10 Kg
Sonara/tek: 2 Kg | 1.5 Kg | -Dolphin/4D and the predicate,
Sonara have an integrated computer
and display.
-Dolphin/IQ and the predicate,
Sonara/tek to be connected
externally to PC and monitor. |
| Dimensions (cm) | Dolphin/4D: 47x30x7
Dolphin/IQ: 26.5x20.5x5.5 | Sonara: 39x30x26
Sonara/tek: 26.5x22x4 | 27x10.5x9 | -Dolphin/4D and the predicate,
Sonara have an integrated computer
and display.
-Dolphin/IQ and the predicate,
Sonara/tek to be connected
externally to PC and monitor. |
| Frequency modes / | 1.6MHz PW | 2MHz PW | 1MHz PW | The Dolphin 1.6MHz PW doesn't |
| Transducers
(MHz) | 2MHz PW
4MHz PW/CW
8MHz PW/CW | 4MHz PW/CW
8MHz PW/CW | 2MHz PW
4MHz PW/CW
8MHz PW/CW
16MHz PW | adversely impact the substantial
equivalent to the predicate, the
Doppler-Box. |
| Patient surface
contact materials | Compatible | compatible | compatible | Patient surface contact probes
materials are identical to all
predicate devices from the same
material/assembly manufacturer |
| 2 MHz Monitoring
Probe | available | available | available | Identical to the predicate Sonara
device |
| Monitoring headset | available | available | available | Similar to the predicate devices. All
have same look, function and probe
handling. |
| User controls | Remote control, foot
switch, touch screen, key
board, mouse | Remote control, foot
switch, touch screen, key
board, mouse | Remote control, foot switch,
touch screen, key board,
mouse | Identical to the predicate devices |
| Display modes | Unilateral, bilateral,
monitoring, external
channels, HITS | Unilateral, bilateral,
monitoring, external
HITS | Unilateral, bilateral,
monitoring, external
channels, HITS | Identical to Doppler-Box |
| Specification | Dolphin/4D and
Dolphin/IQ | Sonara and Sonara/tek | Doppler-Box | Differences discussion |
| Sample Volume (2 MHz) | 1-20 mm | 1-20 mm | Available, range unknown | Identical to Sonara and Sonara/tek |
| Scale (2 MHz) | Up to 32 KHz depth dependent | Up to 16 KHz depth dependent | Up to 32 KHz depth dependent | Identical to Doppler-Box |
| Power control | 0-100 % of maximal derated Ispta within FDA guidelines | 0-100 % of maximal derated Ispta within FDA guidelines | 0-100 % of maximal derated Ispta within FDA guidelines | Identical to the predicate devices |
| Maximal Acoustic Ispta.3 (mW/cm²) | Below maximal FDA guideline limits | Below maximal FDA guideline limits | Below maximal FDA guideline limits | Equivalent to predicate devices |
| | Comply with FDA limits:
Ispta.3 ≤ 720 mW/cm²
MI ≤ 1.9 or the global maximum derated ISPPA ≤ 190 W/cm². | Comply with FDA limits:
Ispta.3 ≤ 720 mW/cm²
MI ≤ 1.9 or the global maximum derated ISPPA ≤ 190 W/cm² | Comply with FDA limits:
Ispta.3 ≤ 720 mW/cm²
MI ≤ 1.9 or the global maximum derated ISPPA ≤ 190 W/cm² | |
| M-mode display | available | available | available | Identical to the predicate devices |
| Multi-gate windows | Up to 8 | Up to 8 | Available, # not known | Identical to Sonara and Sonara/tek |
| HITS detection | Available | Available | Available | Similar to predicate devices |
| Velocity profile display | Available | Available | Not available | Similar to Sonara and Sonara/tek |
| Cursors | Available | Available | Available | Identical to the predicate devices |
| Audio replay | Available | Available | Available | Identical to the predicate devices |
| Sweep time display | Up to 3 minutes | Up to 2 minutes | Available, sweep time not known | The sweep time display is only a display option with no impact on intended use |
| Parameters | Peak velocity, mean velocity, end diastolic velocity, pulsatility Index, resistance index, systolic to diastolic ratio, rise time, heart rate | Peak velocity, mean velocity, end diastolic velocity, pulsatility Index, resistance index, systolic to diastolic ratio, heart rate | Peak velocity, mean velocity, end diastolic velocity, pulsatility Index, resistance index, systolic to diastolic ratio, rise time, heart rate | Identical to the predicate devices |
| Measurement accuracy | ± 10% accuracy | ± 10% accuracy | ± 10% accuracy | Identical to the predicate devices |
| accessories | Remote control, foot switch, monitoring head set | Remote control, foot switch, monitoring head set | Remote control, foot switch, monitoring head set | Equivalent |
| Velocity units | Cm/sec or KHz | Cm/sec or KHz | Cm/sec or KHz | Identical to the predicate devices |
| Summary screens | available | available | available | Identical to the predicate devices |
| Patient database | available | available | available | Identical to the predicate devices |
| Patient search options | available | available | available | Identical to the predicate devices |
| Spectrum color palette selection | available | available | Not available | Identical to Sonara and Sonara/tek |
| Insonation angle | User defined | User defined | User defined | Identical to the predicate devices |
| Database backup options | available | available | available | Identical to the predicate devices |
| Database statistics | available | available | Not available | Identical to Sonara and Sonara/tek |
| Export | Multiple formats | Multiple formats | Multiple formats | Identical to the predicate devices |
| Analog input channels | 8 | Not available | 8 | Identical to Doppler-Box |
| Analog output channels | 4 | Not available | 4 | Identical to Doppler-Box |
| Configurable protocols | available | available | available | Identical to the predicate devices |
| Specialty tests | available | available | available | Identical to the predicate devices |
| Connectivity to PACS systems | available | available | available | Identical to the predicate devices |
| Printer support | available | available | available | Identical to the predicate devices |
| Standards Compliance | IEC 60601-1 , 3.1 Ed.
IEC 60601-1-2. 4 Ed.
IEC 60601-2-37. 2.1 Ed. | IEC 60601-1 , 3.0 Ed.
IEC 60601-1-2. 3 Ed.
IEC 60601-2-37. 2.0 Ed. | IEC 60601-1 , 3.0 Ed.
IEC 60601-1-2. 2.0 Ed.
IEC 60601-2-37. 2.0 Ed. | Dolphin/4D and Dolphin/IQ complies with the most recent standards editions |

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5.5 UTILIZATION OF STANDARDS AND GUIDANCE'S:

The Dolphin/IQ and Dolphin/4D meets the following standards and guidance's:

1. IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
1. IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
1. IEC 60601-2-37: 2007(AMD1:2015) [Edition 2.1] Medical Electrical Equipment -Part 2-37: Particular Requirements for The Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
1. NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
1. UD 3-2004 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. Revision 2.
1. Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: September 9, 2008

5.6 Summary of Non-Clinical Performance Testing

Summary of Non-Clinical Tests:

The Dolphin/IQ and Dolphin/4D devices have been thoroughly tested through verification of specifications and validation, including software validation. The following performance verification testing were applied to the development of the system: Acoustic output Measurement, temperature rise and velocity accuracy testing.

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5.7 Summary of Clinical Performance Data

No clinical study was conducted to support this application.

5.8 CONCLUSIONS

Based on its underlying technology and bench tests performed, the Dolphin/IQ and Dolphin/4D are substantially equivalent to the predicate devices.