(29 days)
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.
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.
The provided text is a 510(k) summary for the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX ultrasonic pulsed Doppler imaging systems. It asserts substantial equivalence to a previously cleared predicate device (Dolphin/IQ and Dolphin/4D, K170859).
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against which specific "device performance" metrics are reported in a granular way that would be typical for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, based on the Comparison Table (Section 5.4.1), we can infer performance characteristics that are expected to be "identical" or "equivalent" to the predicate. The key performance criterion explicitly mentioned is Measurement Accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Measurement accuracy (Blood flow velocity) | ± 10% accuracy (Identical to predicate) |
| Acoustic Output (Ispta.3) | Below maximal FDA guideline limits (≤ 720 mW/cm²) |
| Acoustic Output (MI) | ≤ 1.9 |
| Acoustic Output (ISPPA) | ≤ 190 W/cm² |
| Battery Operating Time (Dolphin/MAX only) | At least 3 hours of routine examination |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study was conducted to support this application." Therefore, there is no test set in the context of clinical data, no sample size, and no data provenance for such a test set. This submission relies on "non-clinical performance testing" and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical study was conducted, there are no "experts used to establish the ground truth for the test set."
4. Adjudication Method for the Test Set
Not applicable, as no clinical study or test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool for human readers in the way an AI/ML diagnostic software might be.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone medical Doppler device. The "performance" discussed relates to its physical and functional specifications. It is not an AI algorithm in the contemporary sense that would have separate standalone performance evaluated. The comparison is made against the performance of its predicate device, which is also a standalone medical device.
7. The Type of Ground Truth Used
For the key performance metric of "Measurement accuracy," the "ground truth" would implicitly be the established accuracy of the predicate device, which is stated as ± 10%. For the acoustic output criteria, the "ground truth" is compliance with FDA guidelines and standards (e.g., IEC 60601-2-37, NEMA UD 2 & 3). For the Dolphin/MAX battery, the stated 3-hour operating time would have been verified through internal testing.
8. The Sample Size for the Training Set
Not applicable, as no AI/ML algorithm was being developed or trained. This is a traditional medical device submission for an ultrasound system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" to prove the device meets acceptance criteria primarily consists of non-clinical performance testing and a comparison to a legally marketed predicate device.
-
Non-Clinical Performance Testing: The document states that the devices "have been thoroughly tested through verification of specifications and validation, including software validation." This would include engineering bench tests to verify parameters such as measurement accuracy, acoustic output, and electrical safety. The specific details of these non-clinical tests (e.g., the number of devices tested, the protocols, the exact results) are not provided in this 510(k) summary but would have been part of the full submission to the FDA. The compliance with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, and UD 3-2004 indicates that specific tests related to electrical safety, electromagnetic compatibility, acoustic output, and diagnostic ultrasound equipment performance were conducted and successfully met.
-
Predicate Device Comparison (Substantial Equivalence): The core of the submission is to demonstrate that the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX systems are "substantially equivalent" to predicate devices (Dolphin/IQ and Dolphin/4D, K170859). The comparison table (Section 5.4.1) highlights that the new devices share identical or equivalent technical characteristics, indications for use, clinical applications, frequency modes, transducers, patient contact materials, user controls, display modes, various measurement parameters, and measurement accuracy to the predicate. The few differences (e.g., the addition of Dolphin/MAX with an internal battery, new accessories) are discussed and deemed not to impact product performance or effectiveness. The predicate device's existing clearance implies its performance already met FDA requirements, and by demonstrating equivalence, the new devices are considered to do the same.
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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
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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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| 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 and Dolphin/MAX 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 | ||||||
| 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 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 | 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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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 | 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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SECTION 5 - 510(K) SUMMARY
K191023
5.1 ADMINISTRATIVE INFORMATION
| Date: | 10-April-2019 |
|---|---|
| Submitter: | Viasonix Ltd.10 Hamelacha StreetRaanana , ISRAEL 4366105Phone : 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 System21 CFR 892.1550 |
| Product Code:Device Class: | IYN, ITXClass 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.
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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.
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| 5.4.1 Summary table of Comparison | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------- |
| Specification | Dolphin/4Q,Dolphin/IQ andDolphin/MAX | Dolphin/4D andDolphin/IQ | Differences discussion |
|---|---|---|---|
| 510(k) number | Proposed Device | K170859 | NA |
| Manufacturer | VIASONIX LTD. | VIASONIX LTD. | NA |
| Product regulationand code | 21 CFR 892.1550Code: IYN, ITX | 21 CFR 892.1550Code: IYN, ITX | Identical to predicate |
| Indications for use | The Dolphin/IQ,Dolphin/4D andDolphin/MAX aremedical Dopplerdevices intended fornoninvasivemeasurements ofblood flow velocitiesin arteries and veinsin adults andPediatric. TheDolphin systems canbe used in hospitals,clinics and physicianoffices. | The Dolphin/IQ andDolphin/4D aremedical Dopplerdevices intended fornoninvasivemeasurements ofblood flow velocitiesin arteries and veinsin adults andPediatric. TheDolphin systems canbe used in hospitals,clinics and physicianoffices. | IdenticalThe Dolphin/MAX model wasadded with this submission.Intended use, useenvironment and targetpatient population is identicalto the predicate device. |
| Clinical Applications | IntracranialExtracranialPeripheral | IntracranialExtracranialPeripheral | Identical |
| Weight (kg) | Dolphin/4D: ~6 KgDolphin/IQ: | Dolphin/4D: ~6 KgDolphin/IQ: ~2 Kg | Identical to Dolphin/4D |
| Dimensions (cm) | Dolphin/4D: 47x30x7Dolphin/MAX:47x30x7Dolphin/IQ:26.5x20.5x5.5 | Dolphin/4D: 47x30x7Dolphin/IQ:26.5x20.5x5.5 | -Dolphin/MAX is similar toDolphin/4D |
| Frequency modes /Transducers(MHz) | 1.6MHz PW2MHz PW4MHz PW/CW8MHz PW/CW | 1.6MHz PW2MHz PW4MHz PW/CW8MHz PW/CW | Identical |
| Patient surfacecontact materials | Compatible | Compatible | Identical |
| 2 MHz MonitoringProbe | 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/cm²MI ≤ 1.9 or the global maximum deratedISPPA ≤ 190 W/cm². | Comply with FDA limits:Ispta.3 ≤ 720 mW/cm²MI ≤ 1.9 or the global maximum deratedISPPA ≤ 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 andDolphin/MAX | Dolphin/4D andDolphin/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 |
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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
-
- 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.
§ 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.