Dolphin Medical Imaging USB Ultrasound System

{0}------------------------------------------------ November 19, 2019 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Dolphin Medical Imaging, LLC % Mr. Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 #### Re: K192573 Trade/Device Name: Dolphin Medical Imaging USB Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: November 8, 2019 Received: November 12, 2019 Dear Ms. Bom: 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 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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, 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192573 Device Name Dolphin Medical Imaging USB Ultrasound System Indications for Use (Describe) The Dolphin Medical Imaging USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. It is indicated for diagnostic ultrasound imaging in the following applications: - · Fetal/Obstetric - Abdominal Pediatric - · Small Organ - · Musculo-skeletal (conventional) - · Musculo-skeletal (superficial) - · Urology - · Gynecology - · Pelvic Floor - · Neuro-muscular - · Peripheral Vessel The system is intended for use by trained registered nurses and other trained healthcare professional healthcare environment. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Dolphin Medical Imaging. The logo features a stylized dolphin graphic on the left, with blue sound waves emanating from it. To the right of the graphic is the word "Dolphin" in a blue, sans-serif font, with the words "Medical Imaging" in a smaller font below. There is a registered trademark symbol to the right of the "n" in Dolphin. # 510(k) Summary Provided in accordance with 21CFR 807.92 (c). #### Submitter Information – 21 CFR 807.92 (a)(1) | Date of submission: | November 18, 2019 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter information: | Dolphin Medical Imaging, LLC<br>161 Dawn River<br>Folsom, CA 95630 | | Contact Person: | Brian Heaney<br>Chief Executive Officer<br>Dolphin Medical Imaging<br>161 Dawn River Way<br>Folsom, CA 95630<br>919.450.7668<br>brian.heaney@dolphinmedicalimaging.com | #### Name of Device and Classification – 21 CFR 807.92 (a)(2) | Device trade name: | Dolphin Medical Imaging USB Ultrasound System | |--------------------|-----------------------------------------------| | Model number: | DMI-USB-001 | | Common name: | Diagnostic ultrasound system and transducers | | Classification: | Class II | | 21 CFR Section | Classification Name | Product Code | |----------------|------------------------------------------|--------------| | 892.1560 | System, Imaging, Pulsed Echo, Ultrasonic | IYO | | 892.1570 | Transducer, Ultrasonic, Diagnostic | ITX | #### Acoustic Output Limits Track Track 3 {4}------------------------------------------------ # Predicate Device - 21 CFR 807.92 (a)(2) Interson USB Ultrasound System K163443 4/13/2017 ## Device Description - 21 CFR 807.92 (a)(4) The Dolphin Medical Imaging Ultrasound System ("DMI US") is a self-contained, solid-state portable ultrasound imaging system, physically comprised of the FDA-cleared Interson SP-L01 USB ultrasound probe (K163443), which is used in connection with the DMI US application software. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface, B-mode imaging and application software providing the user interface. The DMI US application software provides a task-oriented graphical user interface that runs on a personal computer with a USB 2.0 (or greater) port and the Windows 10 operating system. The user-selectable tasks supported are peripheral intravenous access and central venous access. The software application displays the ultrasound B-mode image at a depth appropriate for the selected task. The initial operational settings of the probe and/or application are preprogrammed in the system. User-customized parameter settings for each probe and/or application may be set by the operator and stored for recall as needed via the software user interface. Customization includes changing image brightness (gain), changing depth and freezing/unfreezing the ultrasound image. The system uses a probe with solid-state ultrasound array transducers which provide high resolution, high penetration performance #### Intended Use/Indications for Use - 21 CFR 807.92 (a)(5) The Dolphin Medical Imaging USB Ultrasound System is intended for diagnostic ultrasound imaging in B mode. It is indicated for diagnostic ultrasound imaging in the following applications: - Fetal/Obstetric - Abdominal Pediatric - Small Organ - Musculo-skeletal (conventional) - Musculo-skeletal (superficial) - Urology - Gynecology - Pelvic Floor - Neuro-muscular - Peripheral Vessel The system is intended for use by trained registered nurses and other trained healthcare professionals in a professional healthcare environment. {5}------------------------------------------------ ## Summary of technological characteristics of the device compared to the predicate device -21 CFR 807.92 (a)(6) | Device | Subject Device: | Predicate Device: | |-------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Features | DMI USB Ultrasound System | Interson Ultrasound System K164443 | | Intended Use | Diagnostic ultrasound imaging in B<br>mode. | Diagnostic ultrasound imaging in B, color<br>Doppler and Combined (B+Color) mode. | | Indications for Use | Indicated for diagnostic ultrasound<br>imaging in specified applications. | Indicated for diagnostic ultrasound imaging in<br>specified applications. | | Product Code | IYO, ITX | IYN, IYO, ITX | | Array Geometry | Linear | Curved and linear | | Mechanics | Solid State | Solid State | | Software platform | Commercial off-the-shelf operating<br>system (Windows) | Commercial off-the-shelf operating system<br>(Windows) | | Measurement<br>function | Not supported | 2D measurement and area measurement | | Wireless networking | Not supported | Not supported | | Connector | USB | USB | # Determination of Substantial Equivalence The Dolphin Medical Imaging USB Ultrasound System hardware is identical to the predicate device. The Dolphin Medical Imaging USB Ultrasound System application software provides a subset of the predicate device application software. #### Non-clinical Performance Data Non-clinical testing relied on in this premarket notification submission for a determination of substantial equivalence include tests which show compliance with the following standards. - NOTE: Testing per ES60601-1:2005; and IEC 60601-1-2:2014 was performed for use of the transducer with a specific computer model (Dell T15G) while internally powered and not connected to mains. Use of alternate USB 2.0 compatible computer hardware requires verification by the end user. Further information is provided in the Instructions for Use. - 1. Recognition Number 12-105: NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3. (Radiology) - 2. Recognition Number 19-4: AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) - 3. Recognition Number 12-293: IEC 60601-2-37 (2015), Amendment 2, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology) - 4. Recognition Number 19-8: IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests {6}------------------------------------------------ - 5. Recognition Number 5-89: IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability - 6. Recognition Number 5-40: ISO 14971 Second edition 2007-03-01, Medical devices -Application of risk management to medical devices - 7. Recognition Number 2-173: AAMI ANSI ISO 10993-10:2010/(R)2014, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - 8. Recognition Number 2-153: AAMI ANSI ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity # Summary of Clinical Tests The Dolphin Medical Imaging USB Ultrasound System introduces no new modes, features, or technologies relative to the predicate device (Interson K163443) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices. # 514 Performance Standards There are no Sec. 514 performance standards for this device. # Prescription Status This is a prescription device. The prescription device statement appears in the labeling. #### Sterilization Site(s) Not applicable. No components are supplied sterile. #### Conclusions Dolphin Medical Imaging concludes that the subject device, the Dolphin Medical Imaging USB Ultrasound System, has been shown to be substantially equivalent to the predicate device identified above.