(237 days)
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.
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.
The provided text describes the Viasonix Ltd. Dolphin/IQ and Dolphin/4D medical devices, which are ultrasonic pulsed Doppler imaging systems. However, it explicitly states that no clinical study was conducted to support the application. Therefore, it is impossible to describe acceptance criteria and a study proving the device meets those criteria from the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to standards.
Here's a breakdown of what can be extracted and what cannot based on your request and the provided text:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no specific performance-based acceptance criteria related to clinical efficacy or accuracy that can be directly reported for the device’s performance in a clinical setting. The document only provides a "Measurement accuracy" specification of "± 10% accuracy" as a technical characteristic compared to predicate devices (page 10). This is a technical specification, not clinical acceptance criteria derived from a study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as no clinical study was conducted, and the device is a diagnostic ultrasound system, not explicitly an AI-driven tool for human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no clinical study defining standalone performance was conducted. The device itself is a diagnostic tool operated by trained medical personnel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical study was conducted. The "Measurement accuracy" of ± 10% mentioned on page 10 would typically be assessed against a known standard or reference value in a bench test, not against a clinical ground truth.
8. The sample size for the training set
Not applicable, as no clinical study was conducted.
9. How the ground truth for the training set was established
Not applicable, as no clinical study was conducted.
Information from the document related to "acceptance criteria" and "testing" (but not clinical trials):
- Non-Clinical Performance Testing (page 12):
- "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."
- Standards Compliance (page 11 & 12): The device meets several IEC and NEMA standards related to medical electrical equipment, electromagnetic disturbances, essential performance of ultrasonic diagnostic equipment, acoustic output measurement, and real-time display of thermal and mechanical acoustic output indices. These standards define the "acceptance criteria" for the safety and technical performance of the device, rather than its clinical diagnostic accuracy.
In summary, based solely on the provided document, it is not possible to answer most of your questions because the submission explicitly states: "No clinical study was conducted to support this application." The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with relevant safety and technical standards.
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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);
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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
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Indications for Use
510(k) Number (if known)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | x | ||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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) |
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| System: | Dolphin/IQ, Dolphin/4D |
|---|---|
| Transducer: | 2 MHz Hand Held |
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | x | ||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | X | X | |||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | x | x | |||||
| FetalImaging& 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) | ||||||||
| PeripheralVessel | 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 StreetRaanana , ISRAEL 4366105Phone : 972-9-7441692 |
| Official Correspondent: | Dan Manor, CEO |
| Trade Name: | Dolphin/IQ and Dolphin/4D |
| Classification Name:Classification Number: | Ultrasonic Pulsed Doppler Imaging System21 CFR 892.1550 |
| Product Code:Device Class: | IYN, ITXClass II |
| Predicate Devices: | Primary:Sonara and Sonara/TekVIASYS Healthcare, Inc,510(k) Number - K060421Secondary:Doppler-BoxCOMPUMEDICS GERMANY GMGH - DWL510(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
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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 andDolphin/IQ | Sonara and Sonara/tek | Doppler-Box | Differences discussion |
|---|---|---|---|---|
| 510(k) number | Proposed Device | K060421 | K051085 | NA |
| Manufacturer | VIASONIX LTD. | VIASYS HEALTHCARE, INC | COMPUMEDICS GERMANYGMGH - DWL | NA |
| Product regulationand code | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to predicates |
| Indications for use | Code: IYN, ITXThe Dolphin/IQ and | Code: IYN, ITXSonara and Sonara/Tek | Code: IYN, ITXThe Doppler-Box is a medical | Equivalent. |
| Dolphin/4D are medicalDoppler devices intendedfor noninvasivemeasurements of bloodflow velocities in arteriesand veins in adults andPediatric. The Dolphinsystems can be used inhospitals, clinics andphysician offices. | systems are medicalultrasound Dopplerdevices for measuring theblood flow velocities inarteries and veins non-invasively. | ultrasound device formeasuring the blood flowvelocities in arteries andveins mainly subcutaneously.The 16MHz probe can also beused intraoperative. | Intended use, use environment andtarget patient population issubstantially equivalent to thepredicate devices. The Dolphindevices don't include the 16MHzoption for intraoperative use. | |
| Clinical Applications | IntracranialExtracranialPeripheral | IntracranialExtracranialPeripheral | IntracranialExtracranialPeripheralIntraoperative | Identical to Sonara and Sonara/tek |
| Weight (kg) | Dolphin/4D: ~6 KgDolphin/IQ: ~2 Kg | Sonara: 10 KgSonara/tek: 2 Kg | 1.5 Kg | -Dolphin/4D and the predicate,Sonara have an integrated computerand display.-Dolphin/IQ and the predicate,Sonara/tek to be connectedexternally to PC and monitor. |
| Dimensions (cm) | Dolphin/4D: 47x30x7Dolphin/IQ: 26.5x20.5x5.5 | Sonara: 39x30x26Sonara/tek: 26.5x22x4 | 27x10.5x9 | -Dolphin/4D and the predicate,Sonara have an integrated computerand display.-Dolphin/IQ and the predicate,Sonara/tek to be connectedexternally to PC and monitor. |
| Frequency modes / | 1.6MHz PW | 2MHz PW | 1MHz PW | The Dolphin 1.6MHz PW doesn't |
| Transducers(MHz) | 2MHz PW4MHz PW/CW8MHz PW/CW | 4MHz PW/CW8MHz PW/CW | 2MHz PW4MHz PW/CW8MHz PW/CW16MHz PW | adversely impact the substantialequivalent to the predicate, theDoppler-Box. |
| Patient surfacecontact materials | Compatible | compatible | compatible | Patient surface contact probesmaterials are identical to allpredicate devices from the samematerial/assembly manufacturer |
| 2 MHz MonitoringProbe | available | available | available | Identical to the predicate Sonaradevice |
| Monitoring headset | available | available | available | Similar to the predicate devices. Allhave same look, function and probehandling. |
| User controls | Remote control, footswitch, touch screen, keyboard, mouse | Remote control, footswitch, touch screen, keyboard, mouse | Remote control, foot switch,touch screen, key board,mouse | Identical to the predicate devices |
| Display modes | Unilateral, bilateral,monitoring, externalchannels, HITS | Unilateral, bilateral,monitoring, externalHITS | Unilateral, bilateral,monitoring, externalchannels, HITS | Identical to Doppler-Box |
| Specification | Dolphin/4D andDolphin/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/cm²MI ≤ 1.9 or the global maximum derated ISPPA ≤ 190 W/cm². | Comply with FDA limits:Ispta.3 ≤ 720 mW/cm²MI ≤ 1.9 or the global maximum derated ISPPA ≤ 190 W/cm² | Comply with FDA limits:Ispta.3 ≤ 720 mW/cm²MI ≤ 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:
-
- 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
-
- 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
-
- NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment Revision 3
-
- UD 3-2004 (R2009) Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. Revision 2.
-
- 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.
§ 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.