(29 days)
No
The document describes a standard Doppler device and does not mention any AI or ML capabilities.
No.
The device is described as a medical Doppler device for noninvasive measurements of blood flow velocities, indicating a diagnostic rather than therapeutic function.
Yes
The 'Device Description' explicitly states: "Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of non-invasive peripheral vascular diagnostic systems." Also, the 'Intended Use / Indications for Use' section mentions "noninvasive measurements of blood flow velocities in arteries and veins," which are diagnostic measurements.
No
The device description explicitly states that the Dolphin systems include "identical Doppler hardware" and describes different configurations (module requiring external computer, integrated system with computer and display, system with battery). It also lists specific Doppler probes and accessories, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Dolphin Device Function: The Dolphin device uses Doppler technology to non-invasively measure blood flow velocities within the body. It does not analyze samples taken from the body.
The description clearly states that the Dolphin systems are "noninvasive measurements of blood flow velocities" and are based on "Doppler technology." This aligns with the definition of a medical device used for physiological measurements, not an IVD.
N/A
Intended Use / Indications for Use
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.
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
Device Description
Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of non-invasive peripheral vascular diagnostic 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. 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. 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/4D and 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 and monitoring head set.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler imaging system
Anatomical Site
Arteries and veins (intracranially, extracranially, and in peripheral circulation), Ophthalmic, Adult Cephalic, Peripheral vessel
Indicated Patient Age Range
Adults and Pediatric. Not intended for fetal or neonatal applications.
Intended User / Care Setting
Trained medical personnel. Can be used in 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)
No clinical study was conducted to support this application. The devices were thoroughly tested through verification of specifications and validation, including software validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
± 10% accuracy for measurement
Predicate Device(s)
Dolphin/IQ and Dolphin/4D, K170859
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. The FDA logo is a recognizable symbol of the agency responsible for regulating food and drugs in the United States.
May 16, 2019
Viasonix Ltd. % Shlomi Deler Regulatory Affairs 10 Hamelacha Street Raanana, 4366105 ISRAEL
Re: K191023
Trade/Device Name: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX Dated: April 10, 2019 Received: April 24, 2019
Dear Shlomi Deler:
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/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.
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
1
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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Dolphin/IQ, Dolphin/4D and Dolphin/MAX
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 vediatic. 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX 1.6 MHz Hand Held Transducer:
| 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) |
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX 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 | ||||||||
| 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 and Dolphin/MAX 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 | × | ||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | Pediatric | |||||||
| Imaging | ||||||||
| & Other | 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 | Peripheral vessel | × | ||||||
| Vessel | Other (Specify) |
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX 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 | ||||||||
| 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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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX 8 MHz Hand Held Transducer:
| 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) |
8
SECTION 5 - 510(K) SUMMARY
K191023
5.1 ADMINISTRATIVE INFORMATION
| Date: | 10-April-2019 |
|---|---|
| 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 |
| Classification Name: | |
| Classification Number: | Ultrasonic Pulsed Doppler Imaging System |
| 21 CFR 892.1550 | |
| Product Code: | |
| Device Class: | IYN, ITX |
| Class II | |
| Predicate Devices: | Dolphin/IQ and Dolphin/4D, K170859 |
5.2 DEVICE DESCRIPTION
Dolphin/IQ, Dolphin/4D and Dolphin/MAX systems are part of the Dolphin product family of non-invasive peripheral vascular diagnostic 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. 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. 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/4D and 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 and monitoring head set.
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.
9
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.
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.
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 device cited above [section 5.1] 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/4D and Dolphin/MAX devices is substantially equivalent to the predicate device cited above.
10
| 5.4.1 Summary table of Comparison | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------- |
| Specification | Dolphin/4Q,
Dolphin/IQ and
Dolphin/MAX | Dolphin/4D and
Dolphin/IQ | Differences discussion |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Proposed Device | K170859 | NA |
| Manufacturer | VIASONIX LTD. | VIASONIX LTD. | NA |
| Product regulation
and code | 21 CFR 892.1550
Code: IYN, ITX | 21 CFR 892.1550
Code: IYN, ITX | Identical to predicate |
| 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/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. | Identical
The Dolphin/MAX model was
added with this submission.
Intended use, use
environment and target
patient population is identical
to the predicate device. |
| Clinical Applications | Intracranial
Extracranial
Peripheral | Intracranial
Extracranial
Peripheral | Identical |
| Weight (kg) | Dolphin/4D: ~6 Kg
Dolphin/IQ: 2 Kg 6 Kg | Dolphin/4D: ~6 Kg
Dolphin/MAX:
Dolphin/IQ: ~2 Kg | Identical to Dolphin/4D |
| Dimensions (cm) | Dolphin/4D: 47x30x7
Dolphin/MAX:
47x30x7
Dolphin/IQ:
26.5x20.5x5.5 | Dolphin/4D: 47x30x7
Dolphin/IQ:
26.5x20.5x5.5 | -Dolphin/MAX is similar to
Dolphin/4D |
| Frequency modes /
Transducers
(MHz) | 1.6MHz PW
2MHz PW
4MHz PW/CW
8MHz PW/CW | 1.6MHz PW
2MHz PW
4MHz PW/CW
8MHz PW/CW | Identical |
| Patient surface
contact materials | Compatible | Compatible | Identical |
| 2 MHz Monitoring
Probe | available | available | Identical |
| Monitoring headset | available | available | Identical |
| Specification | Dolphin/4Q, Dolphin/IQ and Dolphin/MAX | Dolphin/4D and Dolphin/IQ | Differences discussion |
| User controls | Remote control, foot switch, touch screen, key board, mouse | Remote control, foot switch, touch screen, key board, mouse | Identical |
| Display modes | Unilateral, bilateral, monitoring, external channels, HITS | Unilateral, bilateral, monitoring, external channels, HITS | Identical |
| Sample Volume (2 MHz) | 1-20 mm | 1-20 mm | Identical |
| Scale (2 MHz) | Up to 32 KHz depth dependent | Up to 32 KHz depth dependent | Identical |
| Power control | 0-100 % of maximal derated Ispta within FDA guidelines | 0-100 % of maximal derated Ispta within FDA guidelines | Identical |
| Maximal Acoustic Ispta.3 (mW/cm²) | Below maximal FDA guideline limits | Below maximal FDA guideline limits | Identical |
| | 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. | Identical |
| M-mode display | available | available | Identical |
| Multi-gate windows | Up to 8 | Up to 8 | Identical |
| HITS detection | Available | Available | Identical |
| Velocity profile display | Available | Available | Identical |
| Cursors | Available | Available | Identical |
| Audio replay | Available | Available | Identical |
| Sweep time display | Up to 3 minutes | Up to 3 minutes | Identical |
| 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, rise time, heart rate | Identical |
| Measurement accuracy | ± 10% accuracy | ± 10% accuracy | Identical |
| accessories | Remote control, foot switch, monitoring head set, External Channels connection box, Wired remote control | Remote control, foot switch, monitoring head set | Equivalent. The added accessories don't impact product performance and effectiveness |
| Velocity units | Cm/sec or KHz | Cm/sec or KHz | Identical |
| Summary screens | available | available | Identical |
| Specification | Dolphin/4Q,
Dolphin/IQ and
Dolphin/MAX | Dolphin/4D and
Dolphin/IQ | Differences discussion |
| Patient search options | available | available | Identical |
| Spectrum color palette selection | available | available | Identical |
| Insonation angle | User defined | User defined | Identical |
| Database backup options | available | available | Identical |
| Database statistics | available | available | Identical |
| Export | Multiple formats | Multiple formats | Identical |
| Analog input channels | 8 | 8 | Identical |
| Analog output channels | 4 | 4 | Identical |
| Configurable protocols | available | available | Identical |
| Specialty tests | available | available | Identical |
| Connectivity to PACS systems | available | available | Identical |
| Printer support | available | available | Identical |
| Standards Compliance | IEC 60601-1, 3.1 Ed.
IEC 60601-1-2. 4 Ed.
IEC 60601-2-37. 2.1 Ed. | IEC 60601-1, 3.1 Ed.
IEC 60601-1-2. 4 Ed.
IEC 60601-2-37. 2.1 Ed. | Identical |
| Power Input | Dolphin/4D 100-240V, 50/60 Hz, 1.5A max. Dolphin/IQ 12VDC, 5A.
Dolphin/MAX External 15VDC, 9.6A or internal battery | Dolphin/4D 100-240V, 50/60 Hz, 1.5A max. Dolphin/IQ 12VDC, 5A. | Dolphin/MAX is similar to Dolphin/4D which provides additional internal rechargeable battery option. No impact to product performance and effectiveness |
| Battery Operating Time | At least 3 hours of routine examination [applicable only to Dolphin/MAX] | NA | The Dolphin/MAX is capable to operate with internal rechargeable battery with no impact to product performance and effectiveness |
11
12
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5.5 UTILIZATION OF STANDARDS AND GUIDANCE'S:
The Dolphin/IQ, Dolphin/4D and Dolphin/MAX meets the following standards and guidance's:
-
- IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- 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
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- 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
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- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
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- UD 3-2004 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. Revision 2.
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- Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: September 9, 2008
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- IEC 62366-1: 2015 Medical devices Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]
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- 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 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 are substantially equivalent to the predicate device.