Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard Doppler system and a robotic accessory for probe positioning. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No.
The device is used for noninvasive measurements of blood flow velocities, which indicates a diagnostic or monitoring function, not a therapeutic one.

Diagnostic

Yes

The device is intended for noninvasive measurements of blood flow velocities in arteries and veins, which are measurements taken to provide information for diagnosis. The "Intended Use" section states: "The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Dolphin systems include "identical Doppler hardware" and describes different configurations (module, integrated system with computer/display, system with battery) that involve physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device Function: The Dolphin systems are described as "medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins". This involves using ultrasound technology to directly measure physiological parameters within the body.
Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The measurements are performed directly on the patient's body.

Therefore, the Dolphin systems fall under the category of in vivo diagnostic devices (devices used to diagnose conditions within the living body), not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Dolphin/Q, Dolphin/4D and Dolphin/MAX 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.

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity.

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

IYN, ITX, OQQ

Device Description

Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of transcranial Doppler systems. The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. All 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 an integrated computer system with hard disk, and touch screen display. Dolphin/Max is similar to the Dolphin/4D system, except that it also has an internal rechargeable battery and an external power supply. The functionality and performance of Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems is identical. Dolphin 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. Dolphin systems support the same accessories: IR wireless remote control, External Channels connection box, wired remote control, foot switch, monitoring head set and Dolphin/XF robot.

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

The Dolphin supports the Dolphin/XF robot accessory. The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity. This accessory can be unilateral or bilateral, and is attached to the head with a dedicated headset. It is software controlled, and allows scanning in two angular directions in order to assists the user in the acquisition of the cerebral blood flow velocity.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Doppler/Ultrasound

Anatomical Site

arteries and veins, intracranial, extracranial, peripheral circulation, cerebral blood flow

Indicated Patient Age Range

adults and Pediatric

Intended User / Care Setting

hospitals, clinics and physician offices / trained medical personnel

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)

Summary of Non-Clinical Tests:
The Dolphin/IQ, Dolphin/4D and Dolphin/MAX devices with Dolphin/XF robot accessory have been thoroughly tested through verification of specifications and validation, including software validation.

No clinical study was conducted to support this application.

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

± 10% accuracy

Predicate Device(s)

K191023

Reference Device(s)

K122710

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

January 29, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized eagle emblem. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

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

Re: K202742

Trade/Device Name: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF Robot Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ

Dear Dan Manor:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 25, 2021. Specifically, FDA is updating this SE Letter as an administrative correction because the 510(k) Summary was not included in the SE package.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health by email (Thalia.Mills @fda.hhs.gov) or phone (301-796-6641).

Sincerely,

Michael D. O'Hara 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

1

January 25, 2021

Image /page/1/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in smaller blue letters below.

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

Re: K202742

Trade/Device Name: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF Robot Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, OQQ Dated: December 23, 2020 Received: December 30, 2020

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. 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

2

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 medical devices and radiation-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,

Michael D. O'Hara

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

3

Indications for Use

510(k) Number (if known) K202742

Device Name Dolphin/IQ, Dolphin/4D and Dolphin/MAX with the Dolphin/XF robot accessory

Indications for Use (Describe)

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

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity.

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)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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4

System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 1.6 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)
Fetal
Imaging
& Other	Ophthalmic			X
	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)
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
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)
Clinical Application		Mode of Operation
General	Specific
(Tracks 1 & 3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
(Track 1 Only)	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)
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)
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			×	×
	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			×	×
	Other (Specify)

5

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

6

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

7

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

8

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

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SECTION 5 - 510(K) SUMMARY

5.1 ADMINISTRATIVE INFORMATION	K202742
Date:	22-January-2021
Submitter:	Viasonix Ltd.
10 Hamelacha Street
Raanana, ISRAEL 4366105
Phone : 972-9-7441692
Official Correspondent:	Dan Manor, CEO
Trade Name:	Dolphin/IQ, Dolphin/4D and Dolphin/MAX with
Dolphin/XF robot accessory
Primary Classification:
Regulation Name:	Ultrasonic Pulsed Doppler Imaging System
Regulation Number:	21 CFR 892.1550, Product Code: IYN
Secondary Classification:
Regulation Name:	Diagnostic Ultrasonic Transducer,
Regulation Number:	21 CFR 1570, Product Codes: ITX, OQQ
Device Class:	Class II
Primary Predicate Device:	Dolphin/IQ, Dolphin/4D and Dolphin/MAX, K191023
Reference Device:	EMS9UA, K122710

5.2 DEVICE DESCRIPTION

Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of transcranial Doppler systems. The Dolphin/IQ, Dolphin/4D and Dolphin/MAX are transcranial Doppler (TCD) systems for measurement of blood flow velocity intracranially, extracranially and in the peripheral circulation. All 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 an integrated computer system with hard disk, and touch screen display. Dolphin/Max is similar to the Dolphin/4D system, except that it also has an internal rechargeable battery and an external power supply. The functionality and performance of Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems is identical. Dolphin 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. Dolphin systems support the same accessories: IR wireless remote control, External Channels connection box, wired remote control, foot switch, monitoring head set and Dolphin/XF robot.

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

The Dolphin supports the Dolphin/XF robot accessory. The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity. This accessory can be unilateral or bilateral, and is attached to the head with a dedicated headset. It is software controlled, and allows scanning in two angular directions in order to assists the user in the acquisition of the cerebral blood flow velocity.

5.3 INTENDED USE AND INDICATIONS FOR USE

The Dolphin/IQ, Dolphin/4D and Dolphin/MAX 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.

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity

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, Dolphin/4D and Dolphin/MAX devices are similar to the predicate devices cited above with 1.6MHz, 2MHz, 4MHz and 8MHz transducers intended for transcranial and peripheral vascular Doppler applications and with the Dolphin/XF robot accessory.

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/4D and Dolphin/MAX devices with the Dolphin/XF robot accessory is substantially equivalent to the predicate devices cited above.

11

5.4.1 Summary table of Comparison

| Specification | Dolphin devices [4D, IQ and
MAX] with Dolphin/XF Robot
accessory | Dolphin devices [4D, IQ and
MAX] / EMS9UA with
Roboprobe Headband
[Predicate devices] | Differences discussion |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Proposed Device | K191023 / K122710 | NA |
| Manufacturer | VIASONIX LTD. | VIASONIX LTD. / Shenzhen
Delicate
Electronics | NA |
| Product
regulation
and code | 21 CFR 892.1550
Code: IYN, ITX and OQQ | 21 CFR 892.1550 Code: IYN, ITX /
21 CFR 892.15 70 Code: IYN, ITX
and OQQ | IYN and ITX identical to
Dolphin predicate

OQQ is identical to
EMS9UA reference
device |
| Indications for
use | The Dolphin/IQ, Dolphin/4D and
Dolphin/MAX 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.

| Specification | Dolphin devices [4D, IQ and
MAX] with Dolphin/XF Robot
accessory | Dolphin devices [4D, IQ and
MAX] / EMS9UA with
Roboprobe Headband
[Predicate devices] | Differences discussion |
| Search Axis | 2 | NA / 2 | Identical to EMS9UA
reference device |
| Signal search | Probe position is incrementally
moved in 2 angular directions in
a generally square grid pattern | NA / Probe position is
incrementally moved in 2
angular directions in a generally
square grid pattern | Similar to EMS9UA
reference device |
| Grid matrix | 16 x 16 points | NA / 9 x 9 points | The grid is similar. The
Dolphin/XF has an
improved resolution and
further search points
which doesn't impact
product safety and
performance |
| Search for signal | At each grid position, assessing
for cerebral signal and signal
intensity | NA / At each grid position,
assessing for cerebral signal and
signal intensity | Identical to EMS9UA
reference device |
| Grid point
coloring | Coloring each grid position with
a color map of a range of red for
flow towards the probe, range
of blue for flow away from the
probe, or no color if no signal
detected | NA / Coloring each grid position
with black for no signal
detected, and then a range of
colors from blue to yellow to
green to orange to red based on
signal quality | Similar to EMS9UA, the
color codes used with
the Dolphin/XF are in
line with accepted m-
mode color standards
for towards and away
flows |
| Search duration | Under 2 minutes | NA / Under 2 minutes | Identical to EMS9UA |

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5.5 UTILIZATION OF STANDARDS AND GUIDANCE'S:

The Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory 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
1. IEC 62366-1: 2015 Medical devices Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
1. IEC 60601-1-6: 2013 |Edition 3.1] Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

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5.6 Summary of Non-Clinical Performance Testing

Summary of Non-Clinical Tests:

The Dolphin/IQ, Dolphin/4D and Dolphin/MAX devices with Dolphin/XF robot accessory have been thoroughly tested through verification of specifications and validation, including software validation.

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, Dolphin/4D and Dolphin/MAX with the Dolphin/XF robot accessory are substantially equivalent to the predicate devices.