(129 days)
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
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.
The provided FDA 510(k) summary (K202742) for the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX with Dolphin/XF Robot Accessory does not contain acceptance criteria or study data demonstrating device performance in a clinical context.
Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device (Dolphin/IQ, Dolphin/4D and Dolphin/MAX, K191023) and a reference device (EMS9UA, K122710) for the Dolphin/XF robot accessory, primarily through characteristic comparison and adherence to standards.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states:
- "No clinical study was conducted to support this application." (Page 17)
- The comparison table (Pages 11-12) lists "Measurement accuracy: ± 10%" as a specification for the Dolphin devices, shared with the predicate device. However, this is a specification rather than acceptance criteria for a study demonstrating performance against a ground truth.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document explicitly states: "No clinical study was conducted to support this application." (Page 17) Therefore, there is no test set or data provenance from a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical study was conducted, there was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. As no clinical study was conducted, there was no test set or need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical study was conducted to support this application." (Page 17) Therefore, no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. The document explicitly states: "No clinical study was conducted to support this application." (Page 17) The Dolphin/XF robot accessory "assists the user in the acquisition of cerebral blood flow velocity," implying a human-in-the-loop system, but no standalone performance data for the robotic assistance component is provided.
7. Type of Ground Truth Used
Not applicable regarding clinical performance. For demonstrating substantial equivalence, the "ground truth" implicitly used is the established performance and characteristics of the legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable, as this is related to clinical performance data which was not conducted. The submission focuses on device characteristics and adherence to standards rather than a machine learning model's training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no clinical study with a training set for a machine learning model was conducted or reported.
Summary of Device Acceptance:
The device's acceptance (510(k) clearance) is based on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new clinical performance study. The core of the submission relies on:
- Identical Indications for Use (for the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX systems).
- Similar Indications for Use for the Dolphin/XF robot accessory, comparing it to an extended indication of the existing Dolphin predicate (K191023) and a similar indication of a reference device (NeuralBot, K180455 under product code OQQ). The added accessory's function to "assists the user in the acquisition of cerebral blood flow velocity" is considered similar to a reference device with the same product code.
- Comparison of Technical Characteristics: A detailed table (Pages 11-12) outlines the specifications of the proposed device against the predicate and reference devices, highlighting similarities and discussing minor differences that do not impact safety or clinical performance (e.g., slight weight/dimensions of the robot, higher grid resolution).
- Compliance with Recognized Standards: The device meets several IEC and NEMA standards related to medical electrical equipment, electromagnetic disturbances, ultrasonic diagnostic equipment, acoustic output, and usability (Page 17).
- Non-Clinical Performance Testing: "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" (Page 17). These are bench tests and verification activities rather than clinical studies with performance metrics against a defined ground truth.
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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
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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
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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
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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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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 | ColorDoppler | Combined(Specify) | Other*(Specify) |
| FetalImaging& 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) | ||||||||
| PeripheralVessel | Peripheral vessel | X | ||||||
| Other (Specify) | ||||||||
| 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) | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | 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) | ||||||||
| 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) | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| (Track 1 Only) | (Tracks 1 & 3) | |||||||
| Ophthalmic | Ophthalmic | × | × | |||||
| 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 | × | × | |||||
| Other (Specify) |
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 2 MHz Hand Held
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 2 MHz Monitoring
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 4 MHz Hand Held
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System: Dolphin/IQ, Dolphin/4D and Dolphin/MAX Transducer: 8 MHz Hand Held
{9}------------------------------------------------
SECTION 5 - 510(K) SUMMARY
| 5.1 ADMINISTRATIVE INFORMATION | K202742 |
|---|---|
| Date: | 22-January-2021 |
| 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 withDolphin/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.
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5.4.1 Summary table of Comparison
| Specification | Dolphin devices [4D, IQ andMAX] with Dolphin/XF Robotaccessory | Dolphin devices [4D, IQ andMAX] / EMS9UA withRoboprobe Headband[Predicate devices] | Differences discussion |
|---|---|---|---|
| 510(k) number | Proposed Device | K191023 / K122710 | NA |
| Manufacturer | VIASONIX LTD. | VIASONIX LTD. / ShenzhenDelicateElectronics | NA |
| Productregulationand code | 21 CFR 892.1550Code: IYN, ITX and OQQ | 21 CFR 892.1550 Code: IYN, ITX /21 CFR 892.15 70 Code: IYN, ITXand OQQ | IYN and ITX identical toDolphin predicateOQQ is identical toEMS9UA referencedevice |
| Indications foruse | The Dolphin/IQ, Dolphin/4D andDolphin/MAX are medicalDoppler devices intended fornoninvasive measurements ofblood flow velocities in arteriesand veins in adults andPediatric. The Dolphin systemscan be used in hospitals, clinicsand physician offices.The Dolphin/XF robot accessory,when used with the Dolphinsystem, is a device which assiststhe user in the acquisition ofcerebral blood flow velocity. | The Dolphin/IQ, Dolphin/4D andDolphin/MAX are medicalDoppler devices intended fornoninvasive measurements ofblood flow velocities in arteriesand veins in adults andPediatric. The Dolphin systemscan be used in hospitals, clinicsand physician offices. /Transcranial Doppler UltrasoundSystem is intended for use as adiagnostic ultrasound fluid flowanalysis system.The Roboprobe Headbandfacilitates monitoring use by itsability to track the Dopplersignal | Identical to the Dolphinpredicate with theextended indication toassists the user in theacquisition of cerebralblood flow velocity. Thisindication is similar to areference device, theNeuralBot , K180455under the same productcode: OQQ .The NeuralBot whenused with Lucid M1System is a medicalultrasound device whichassists the user in thesetup and acquisition ofcerebral blood flowvelocity via the patient'stemporal windows |
| ClinicalApplications | IntracranialExtracranialPeripheral | IntracranialExtracranialPeripheral | Identical to Dolphinpredicate device |
| Weight (kg) | Dolphin/4D: ~6 KgDolphin/IQ: | Dolphin/4D: ~6 KgDolphin/IQ: | Identical to Dolphinpredicate device |
| Dimensions (cm) | Dolphin/4D: 47x30x7Dolphin/MAX: 47x30x7Dolphin/IQ: 26.5x20.5x5.5 | Dolphin/4D: 47x30x7Dolphin/MAX: 47x30x7Dolphin/IQ: 26.5x20.5x5.5 | Identical to Dolphinpredicate device |
| Frequency modes/ Transducers | 1.6MHz PW2MHz PW | 1.6MHz PW2MHz PW | Identical to Dolphinpredicate device |
| Specification | Dolphin devices [4D, IQ andMAX] with Dolphin/XF Robotaccessory | Dolphin devices [4D, IQ andMAX] / EMS9UA withRoboprobe Headband[Predicate devices] | Differences discussion |
| (MHz) | 4MHz PW/CW8MHz PW/CW | 4MHz PW/CW8MHz PW/CW | |
| Patient surfacecontact materials | Compatible | Compatible | Identical to Dolphinpredicate device |
| 2 MHz MonitoringProbe | available | available | Identical to Dolphinpredicate device |
| Monitoringheadset | available | available | Identical to Dolphinpredicate device |
| User controls | Remote control, foot switch,touch screen, key board, mouse | Remote control, foot switch,touch screen, key board, mouse | Identical to Dolphinpredicate device |
| Display modes | Unilateral, bilateral, monitoring,external channels, HITS | Unilateral, bilateral, monitoring,external channels, HITS | Identical to Dolphinpredicate device |
| Sample Volume (2MHz) | 1-20 mm | 1-20 mm | Identical to Dolphinpredicate device |
| Scale (2 MHz) | Up to 32 KHz depth dependent | Up to 32 KHz depth dependent | Identical to Dolphinpredicate device |
| Power control | 0-100 % of maximal derated Isptawithin FDA guidelines | 0-100 % of maximal derated Isptawithin FDA guidelines | Identical to Dolphinpredicate device |
| Maximal AcousticIspta.3 (mW/cm²) | Below maximal FDA guidelinelimits | Below maximal FDA guidelinelimits | Identical to Dolphinpredicate device |
| Comply with FDA limits:Ispta.3 ≤ 720 mW/cm²MI ≤ 1.9 or the global maximumderated ISPPA ≤ 190 W/cm². | Comply with FDA limits:Ispta.3 ≤ 720 mW/cm²MI ≤ 1.9 or the global maximumderated ISPPA ≤ 190 W/cm². | ||
| M-mode display | available | available | Identical to Dolphinpredicate device |
| Multi-gatewindows | Up to 8 | Up to 8 | Identical to Dolphinpredicate device |
| HITS detection | Available | Available | Identical to Dolphinpredicate device |
| Velocity profiledisplay | Available | Available | Identical to Dolphinpredicate device |
| Cursors | Available | Available | Identical to Dolphinpredicate device |
| Audio replay | Available | Available | Identical to Dolphinpredicate device |
| Sweep timedisplay | Up to 3 minutes | Up to 3 minutes | Identical to Dolphinpredicate device |
| Parameters | Peak velocity, mean velocity,end diastolic velocity, pulsatilityIndex, resistance index, systolicto diastolic ratio, rise time, heartrate | Peak velocity, mean velocity,end diastolic velocity, pulsatilityIndex, resistance index, systolicto diastolic ratio, rise time, heartrate | Identical to Dolphinpredicate device |
| Measurementaccuracy | ± 10% accuracy | ± 10% accuracy | Identical to Dolphinpredicate device |
| Specification | Dolphin devices [4D, IQ andMAX] with Dolphin/XF Robotaccessory | Dolphin devices [4D, IQ andMAX] / EMS9UA withRoboprobe Headband[Predicate devices] | Differences discussion |
| accessories | Remote control, foot switch,monitoring head set, ExternalChannels connection box, Wiredremote control , Dolphin/XFRobot | Remote control, foot switch,monitoring head set, ExternalChannels connection box, Wiredremote control | Equivalent.The added accessorysimilar to EMS9UApredicate device |
| Velocity units | Cm/sec or KHz | Cm/sec or KHz | Identical to Dolphinpredicate device |
| Summary screens | available | available | Identical to Dolphinpredicate device |
| Patient database | available | available | Identical to Dolphinpredicate device |
| Patient searchoptions | available | available | Identical to Dolphinpredicate device |
| Spectrum colorpalette selection | available | available | Identical to Dolphinpredicate device |
| Insonation angle | User defined | User defined | Identical to Dolphinpredicate device |
| Database backupoptions | available | available | Identical to Dolphinpredicate device |
| Databasestatistics | available | available | Identical to Dolphinpredicate device |
| Export | Multiple formats | Multiple formats | Identical to Dolphinpredicate device |
| Analog inputchannels | 8 | 8 | Identical to Dolphinpredicate device |
| Analog outputchannels | 4 | 4 | Identical to Dolphinpredicate device |
| Configurableprotocols | available | available | Identical to Dolphinpredicate device |
| Specialty tests | available | available | Identical to Dolphinpredicate device |
| Connectivity toPACS systems | available | available | Identical to Dolphinpredicate device |
| Printer support | available | available | Identical to Dolphinpredicate device |
| StandardsCompliance | 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 to Dolphinpredicate device |
| Power Input | Dolphin/4D 100-240V, 50/60 Hz,1.5A max. Dolphin/IQ 12VDC,5A. Dolphin/MAX External15VDC, 9.6A or internal battery | Dolphin/4D 100-240V, 50/60 Hz,1.5A max. Dolphin/IQ 12VDC,5A. Dolphin/MAX External15VDC, 9.6A or internal battery | Identical to Dolphinpredicate device |
| Battery OperatingTime | At least 3 hours of routineexamination [applicable only toDolphin/MAX] | At least 3 hours of routineexamination [applicable only toDolphin/MAX] | Identical to Dolphinpredicate device |
| XF/Dolphin Robot Specifications: | |||
| ClinicalApplication | Intracranial measurements | NA / Intracranial measurements | Identical to EMS9UA |
| Specification | Dolphin devices [4D, IQ andMAX] with Dolphin/XF Robotaccessory | Dolphin devices [4D, IQ andMAX] / EMS9UA withRoboprobe Headband[Predicate devices] | Differences discussion |
| Weight (kg) | 126 gr. | NA / 55 gr. | Both are very light,Dolphin/XF is slightlyheavier which doesn'timpact safety andclinical performance |
| Dimensions (cm) | 8.5x7.5x3.5 cm | NA / 10.5x6x2 cm | Both have similarsurface area. TheDolphin/XF slightlythicker which doesn'timpact safety andclinical performance |
| Bilateralmeasurements | Yes | NA / Yes | Identical to EMS9UA |
| Option forUnilateralmeasurements | Yes | NA / Yes | Identical to EMS9UA |
| Probe Frequencyused with therobot | 2 MHz - same Doppler probemanufacturer | NA / 2MHz and 1 MHz - sameDoppler probe manufacturer | The 2MHz monitoringprobe is included withthe EMS9UA referencedevice |
| Bilateral robotcontrol | Separate control for each robot | NA / Separate control for eachrobot | Identical to EMS9UAreference device |
| Headset for robot | Dedicated bilateral headset.Allows to move the robotenclosure up/down andright/left and lock in place | NA / Robot headset. Allows tomove the robot enclosureup/down and right/left and lockin place | Similar to EMS9UADolphin/XF headset isprimarily made withflexible Velcro strapsthat allow tighteningand loosening of theheadset around thecircumference of thehead. The EMS9UAreference roboprobeheadset is made from acombination of plasticparts and Velcro straps,whereas the tighteningaround the head is witha knob located in theregion of the forehead.Both shares the samepurpose. |
| Probe cover | A disposable biocompatible Cupin direct skin contact | Surrounding rubber ring aroundthe probe | Similar to EMS9UAreference device. TheDolphin/XF Cup isbiocompatible materialcomplies with ISO10993-1. |
| Specification | Dolphin devices [4D, IQ andMAX] with Dolphin/XF Robotaccessory | Dolphin devices [4D, IQ andMAX] / EMS9UA withRoboprobe Headband[Predicate devices] | Differences discussion |
| Search Axis | 2 | NA / 2 | Identical to EMS9UAreference device |
| Signal search | Probe position is incrementallymoved in 2 angular directions ina generally square grid pattern | NA / Probe position isincrementally moved in 2angular directions in a generallysquare grid pattern | Similar to EMS9UAreference device |
| Grid matrix | 16 x 16 points | NA / 9 x 9 points | The grid is similar. TheDolphin/XF has animproved resolution andfurther search pointswhich doesn't impactproduct safety andperformance |
| Search for signal | At each grid position, assessingfor cerebral signal and signalintensity | NA / At each grid position,assessing for cerebral signal andsignal intensity | Identical to EMS9UAreference device |
| Grid pointcoloring | Coloring each grid position witha color map of a range of red forflow towards the probe, rangeof blue for flow away from theprobe, or no color if no signaldetected | NA / Coloring each grid positionwith black for no signaldetected, and then a range ofcolors from blue to yellow togreen to orange to red based onsignal quality | Similar to EMS9UA, thecolor codes used withthe Dolphin/XF are inline with accepted m-mode color standardsfor towards and awayflows |
| 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:
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- IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
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- 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 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.
§ 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.