K3900 Ultrasound Imaging System

{0}------------------------------------------------ October 25, 2023 Image /page/0/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 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. MAUI Imaging % Prabhu Raghavan Principal Consultant MDQR, LLC. 1790 Montemar Way SAN JOSE CA 95125 Re: K230511 Trade/Device Name: K3900 Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: September 27, 2023 Received: September 28, 2023 Dear Prabhu Raghavan: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Yanna S. Kang -S Yanna Kang Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230511 Device Name K3900 Ultrasound Imaging System #### Indications for Use (Describe) The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular). Modes of operation: B-Mode. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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. 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Below the graphic, the words "MAUI IMAGING" are written in red, with "MAUI" in a larger font size than "IMAGING". ## 510(k) Summary for K230511 Prepared in accordance with the requirements of 21 CFR 807.92 #### Submitter Information [807.92(a)(1)] | Submitter/Applicant | David Specht,<br>Chairman and CEO, MAUI Imaging<br>3600 136th PL SE, Ste 300,<br>Bellevue, WA 98006<br>Email: david.specht@mauiimaging.com<br>Phone: (408) 744-1127 | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Regulatory<br>Correspondent | Prabhu Raghavan<br>Regulatory Consultant for MAUI Imaging<br>Principal Consultant, MDQR Solutions, LLC<br>Phone: 408-316-5707<br>Email: prabhu@mdqr.solutions | | Secondary Regulatory<br>Correspondent | Roberta (Bobbi) Druyor-Sanchez<br>Regulatory Consultant for MAUI Imaging<br>Partner, NDA Partners, LLC.<br>Phone: 480-216-5377<br>Email: sanchezbobbi@ndapartners.com | Date Prepared October 25, 2023 #### Device Information [807.92(a)(2)] | Trade Name | K3900 Ultrasound Imaging System | |---------------------|---------------------------------------| | Product Codes | IYO, ITX | | Generic/Common Name | Ultrasonic Pulsed Echo Imaging System | | Regulation | § 892.1560 | | Device Class | II | #### Predicate Information [807.92(a)(3)] Predicate(s) K152309, GE LOGIQ E9, GE® Medical Systems Ultrasound and Primary Care Diagnostics ## Device Description [807.92(a)(4)] The K3900 Ultrasound Imaging System ("K3900") is a Track 3 general purpose ultrasound imaging system. The device generates and collects ultrasonic pulsed echo data via a transducer that is then digitized for further processing. The processing includes beamforming, image processing, and image optimization that then outputs an ultrasound image. This image may be displayed on a tablet or common displays through HDMI for general purpose radiological evaluation. The K3900 consists of an ultrasound transducer, a processing unit that manages the transducer and all data processing, and a tablet that provides the user interface to operate the device, view and analyze the ultrasound dataset, and manage patient study sessions. {4}------------------------------------------------ ## 510(k) Summary for K230511 MAUI Imaging, K3900 Ultrasound Imaging System The K3900 utilizes "ping" technology. In contrast to phased array transmission that transmit along predetermined scan lines using a large number of transducer elements with multiple focal regions, a ping is an unfocussed pulse transmitted by a limited set of transducer elements. Since the transmitted pulses are unfocussed, no beamforming or focusing is performed on the transmit side. Beamforming to create the ultrasound image is entirely done on the receive side. i.e., the process of combining the echo information is done by utilizing all of the receiver element data. In the predicate device, the beamforming process is split between the transmit side and the receive side, i.e., part of the beamforming is done by transmitting a focused pulse of ultrasound waves, and additional signal processing is conducted on the received echo data. This is a minor difference in signal processing and both the subject and predicate devices achieve the same imaging results. The differences in beamforming methods, which have been verified and validated through performance testing do not raise different questions of safety or effectiveness and demonstrate substantial equivalence to the predicate device. #### Indications for use [807.92(a)(5)] The K3900 Ultrasound Imaging System is intended for use by a qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular: Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular). Modes of operation: B-mode. #### Substantial Equivalence The K3900 Ultrasound Imaging System subject device has the same intended use, and substantially equivalent physical characteristics, technological characteristics and software as the K152309, GE LOGIQ E9 predicate device. A comparison of the two devices is provided in the table below. | Feature | K3900 Ultrasound Imaging System<br>(Subject Device) | LOGIQ E9 (K152309)<br>(Predicate Device) | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Ultrasound imaging and evaluation of<br>adults and pediatric patients | Ultrasound imaging and evaluation of<br>adults and pediatric patients | | Product Code | IYO, Ultrasonic Pulsed Echo Imaging<br>System<br>ITX, Diagnostic Ultrasonic Transducer | IYO, Ultrasonic Pulsed Echo Imaging<br>System<br>ITX, Diagnostic Ultrasonic Transducer<br>IYN, Ultrasonic Pulsed Doppler Imaging<br>System | | Regulation | 892.1560, Ultrasonic pulsed echo imaging<br>system | 892.1550, Ultrasonic pulsed doppler<br>imaging system<br>892.1560, Ultrasonic pulsed echo imaging<br>system | | Classification | Class II | Class II | | Feature | K3900 Ultrasound Imaging System<br>(Subject Device) | LOGIQ E9 (K152309)<br>(Predicate Device) | | Indications for<br>Use | The K3900 Ultrasound Imaging System is<br>intended for use by a qualified healthcare<br>personnel in environments where<br>healthcare is provided for ultrasound<br>evaluation of Fetal; Abdominal; Pediatric;<br>Small Organ (breast, testes, thyroid);<br>Neonatal Cephalic; Adult Cephalic;<br>Cardiac (adult and pediatric); Peripheral<br>Vascular; Musculo-skeletal Conventional<br>and Superficial; Urology (including<br>prostate); and Intraoperative (abdominal,<br>thoracic and vascular).<br>Modes of operation: B-mode. | The device is intended for use by a<br>qualified physician for ultrasound<br>evaluation of Fetal; Abdominal; Pediatric;<br>Small Organ (breast, testes, thyroid);<br>Neonatal Cephalic; Adult Cephalic;<br>Cardiac (adult and pediatric); Peripheral<br>Vascular; Musculo-skeletal Conventional<br>and Superficial; Urology (including<br>prostate); Transrectal; Transvaginal;<br>Transesophageal and Intraoperative<br>(abdominal, thoracic and vascular). | | Contact Type | Body surface, intraoperative | Body surface, Cavitary (TV, TR, TE) and<br>intraoperative | | Transducer<br>model.<br>type | MAUI3-Concave-192,<br>Curved Array Transducer | GE C1-6D.<br>Curved Array Transducer | | Number of<br>Elements | Approximately 192 | Approximately 192 | | Imaging<br>Modes | B-mode | B, M, Color M, Color & Power Doppler,<br>Pulsed & CW Doppler and various<br>combinations: B/M B/PW, Color/Pwr/PW.<br>Harmonic, Coded Pulse, Realtime 3D &<br>Multi-plane, Elastography Imaging, Shear<br>wave elastography (SWE) | | Beamforming | Beamforming is performed on the receive<br>side only. | Beamforming on both the transmit side,<br>i.e., when sending the ultrasound pulses<br>and on the receive side, i.e., when<br>processing the ultrasound echoes. | | Controls and<br>Display | Tablet-based touch screen controls with<br>display. HDMI output to secondary<br>external display | Adjustable height control panel with touch<br>screen and tilt/swivel LCD type image<br>monitor | | Feature | K3900 Ultrasound Imaging System<br>(Subject Device) | LOGIQ E9 (K152309)<br>(Predicate Device) | | Safety<br>Compliance | IEC60601-1, Medical Electrical equipment; General requirements for safety. IEC60601-1-2, Medical Electrical equipment; Electromagnetic Compatibility. ISO10993-1, Biological evaluation of medical devices. FDA Track 3 IEC 60601-2-37, Medical Electrical equipment; Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment. IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields | IEC60601-1, Medical Electrical equipment; General requirements for safety. IEC60601-1-2, Medical Electrical equipment; Electromagnetic Compatibility. ISO10993-1, Biological evaluation of medical devices. FDA Track 3 IEC 60601-2-37, Medical Electrical equipment; Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment. FDA Track 3, Compliance with Output Display Standard NEMA UD 3-2004 when connected to a GE Ultrasound system | ## Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)] {5}------------------------------------------------ # Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)] {6}------------------------------------------------ ## Comparison of Technological Characteristics with the Predicate Device [807.92(a)(6)] {7}------------------------------------------------ ### 510(k) Summary for K230511 MAUI Imaging, K3900 Ultrasound Imaging System ## Performance Data [807.92(b)] All necessary testing was conducted on K3900 Ultrasound Imaging System to support a determination of substantial equivalence to the predicate device. ## Nonclinical Testing Summarv [807.92(b)(1)] MAUI Imaging has conducted bench performance testing of the K3900 subject device to verify and validate that the device requirements and specifications and to demonstrate that any differences between the subject and predicate device do not raise different questions of safety or effectiveness. Additional testing to support the substantial equivalence between the subject and predicate device includes: - Evaluation of biocompatibility per ISO 10993-1, ● - Electrical safety testing per IEC 60601-1, ● - Electromagnetic compatibility per IEC 60601-1-2, ● - . Performance of the ultrasound safety, controls, and display in accordance with IEC60601-2-37:2015 and IEC 62359: 2017 to demonstrate that the device is within safety limits as well as requirements for a Track 3 ultrasound imaging device per FDA Guidance, "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated February 2023, and - . Human factors usability testing ## Clinical Testing Summary [807.92(b)(2)] Clinical performance testing was conducted to validate that a healthcare professional would get equivalent imaging from the K3900 subject device as compared to the GE LOGIO E9 predicate device. MAUI collected comparative ultrasound imaging data under an IRB approved study protocol at a radiology clinic where volunteers were recruited. After obtaining informed consent, a radiologist captured ultrasound images from both devices. Side-by-side comparisons of the still images of numerous anatomical structures showed that the imaging from the subject device was substantially equivalent to the predicate. #### Conclusions [807.92(b)(3)] The K3900 has the same intended use, indications for use and similar technological characteristics as the predicate. The minor differences in technological characteristics have been analyzed and addressed through software verification and validation testing. The testing results demonstrate that differences between the subject and predicate device do not raise different questions of safety or effectiveness. Therefore, the K3900 is substantially equivalent to the predicate device