(89 days)
The LOGIQ P&P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ(Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(adult and pediatric); Peripheral Vascular; Musculo-skeletal Converticial; Urology(including Prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative(Abdominal, Vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P8/P9/P10 is intended to be used in a hospital or medical clinic.
The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display with HDMI audio function. All probes on the subject device have been previously cleared on the predicate K203114 with the exception of the E7C8L-RS which was previously cleared on predicate K210438. All probes available as accessories for the subject systems LOGIQ P Series uses are unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged.
The provided FDA 510(k) premarket notification for the GE LOGIQ P10, LOGIQ P9, and LOGIQ P8 ultrasound systems does not contain information about acceptance criteria or a study proving the device meets specific performance criteria for an AI/CAD product.
This document is primarily concerned with demonstrating substantial equivalence to previously cleared predicate devices (K203114 LOGIQ P10/P9/P8 Diagnostic Ultrasound System and K210438 Versana Premier). The focus is on the general diagnostic ultrasound system and its various imaging modes, not a specific AI or computer-aided detection (CAD) application with distinct performance metrics.
The "modifications" mentioned, such as the addition of the E7C8L-RS transducer, Stepper Volume Measurement support, "EZ DICOM Viewer," "Probe Health Test," and the KOIOS SW (KOIOS Breast) connectivity, are described as either hardware additions, software features for workflow/data management, or connectivity to a separate cleared CAD system (KOIOS DS for Breast, K190442).
Therefore, it is explicitly stated in the "Summary of Clinical Tests" section:
"The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence."
Without a specific clinical study detailed in this document to demonstrate the performance of an AI/CAD component against acceptance criteria, I cannot provide the requested information. The document focuses on demonstrating safety and effectiveness through compliance with standards and comparing the new device's features to those of cleared predicate devices.
If this were a submission for a new AI/CAD specific algorithm, the information you requested would typically be required and detailed within the 510(k) submission, often in sections dedicated to performance testing, clinical validation, or human factors studies.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Medical Systems Ultrasound and Primary Care Diagnostics GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K214039
March 22, 2022
Trade/Device Name: LOGIQ P10, LOGIQ P9, LOGIQ P8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 22, 2021 Received: December 23, 2021
Dear Mr. Behn:
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 (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
{1}------------------------------------------------
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,
Jessica Lamb, Ph.D. Assistant 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) K214039
Device Name LOGIQ P10, LOGIQ P9, LOGIQ P8
Indications for Use (Describe)
The LOGIQ P&P9/P10 is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ(Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(adult and pediatric); Peripheral Vascular; Musculo-skeletal Converticial; Urology(including Prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative(Abdominal, Vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P8/P9/P10 is intended to be used in a hospital or medical clinic.
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 shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has small, white droplet-like shapes around its perimeter, giving it a dynamic and fluid appearance.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary K214039
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | December 22, 2021 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC9900 Innovation DrWauwatosa, WI 53226 |
| Manufacturer: | GE Ultrasound Korea, Ltd.9, Sunhwan-ro 214 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea |
| Primary Contact Person: | Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(262)-247-5502 |
| Alternate Contact Person: | Chae-Rin, SongRegulatory Affairs SpecialistGE HealthcareGE Ultrasound Korea, Ltd.T: +82-31-740-6310 |
| Device:Trade Name: | LOGIQ P10, LOGIQ P9 and LOGIQ P8 |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN(primary), IYO, ITX(secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Primary Predicate Device: | K203114 LOGIQ P10/P9/P8 Diagnostic Ultrasound System |
| Classification Names: | Class II; IYN(primary), IYO, ITX(secondary) |
| Product Codes: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Reference PredicateDevice(s): | K210438 Versana Premier |
| Classification Names: | Class II |
| Product Code: | IYN(primary), IYO, ITX(secondary)Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Device Description: | The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3device, primarily intended for general purpose diagnostic ultrasoundsystem which consists of a mobile console approximately 55 cmwide, 74 cm deep and 160 cm high that provides digital acquisition,processing and display capability. The user interface includes acomputer keyboard, specialized controls, 10.4-inch LCD touch screenand color 23.8-inch LCD image display with HDMI audio function.All probes on the subject device have been previously cleared on thepredicate K203114 with the exception of the E7C8L-RS which waspreviously cleared on predicate K210438. All probes available asaccessories for the subject systems LOGIQ P Series uses areunchanged from the cleared predicates. They are made of the samematerials and their shape is unchanged |
| Intended Use: | The primary differences between the difference models are the theLOGIQ P10 is the highest configuration offering all the features andprobes available on the P Series and the other models offer a subset ofthem.The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purposediagnostic ultrasound system intended for use by a qualified andtrained healthcare professional physician for ultrasound imaging,measurement, display and analysis of the human body and fluid. TheLOGIQ P10, LOGIQ P9 and LOGIQ P8 clinical applications include:evaluation of Fetal/Obsteterics; Abdominal; Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(adult and pediatric); Peripheral Vascular; Musculo-skeletalConventional and Superficial; Urology (including prostate);Transrectal; Transvaginal; Transesophageal and Intraoperative(abdominal, vascular).Modes of operation include: B, M, PW, Doppler, CW Doppler, ColorDoppler, Color M Doppler, Power Doppler, Harmonic Imaging,Coded Pulse, 3D/4D Imaging mode, Elastography, Shear WaveElastography, Attenuation Imaging and Combined Modes: B/M,B/Color, B/PWD, B/Color/PWD, B/Power/PWD.The LOGIQ P8/P9/P10 is intended to be used in a hospital or medicalclinic. |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. There are also three curved lines emanating from the top of the circle, resembling water droplets or stylized arcs. The logo is simple, clean, and easily recognizable.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with small, white, teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the company's brand.
| Technology: | The LOGIQ P10, LOGIQ P9 and LOGIQ P8 employs the same fundamental scientific technology as its predicate devices. |
|---|---|
| Determination of Substantial Equivalence: | Comparison to Predicates The proposed LOGIQ P10, LOGIQ P9 and LOGIQ P8 systems are substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIQ P10, LOGIQ P9 and LOGIQ P8(Software version R4.5) and the predicate LOGIQ P10, LOGIQ P9 and LOGIQ P8(Software version R4)(K203114). |
| The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.The LOGIQ P10/P9/P8 and predicate LOGIQ P10/P9/P8 systems have the same clinical intended uses.The LOGIQ P10/P9/P8 and predicate LOGIQ P10/P9/P8 systems transducers are identical except for the addition of 1 new transducer, E7C8L-RS. E7C8L-RS has been migrated from Versana Premier(K210438).The LOGIQ P10/P9/P8 and predicate LOGIQ P10/P9/P8 systems have the same indications for use.The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.The systems have acoustic power levels which are below the applicable FDA limits.The LOGIQ P10/P9/P8 and predicate LOGIQ P10/P9/P8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.The LOGIQ P10/P9/P8 and predicate LOGIQ P10/P9/P8 systems have been designed in compliance with approved electrical and physical safety standards.The LOGIQ P10/P9/P8 and predicate LOGIQ P10/P9/P8 systems are identical except: E7C8L-RS(ERB) probe is migrated from Versana Premier K210438 and it can be attached to a stepper to be used for urological procedures including transperineal needle guidance, transperineal grid biopsy and prostate brachytherapy. |
- blopsy and prostate brachytherapy.
Stepper Volume Measurement(STVOL) is migrated from Versana Premier(K210438). This is the method used to calculate the volume of an organ using urology
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are also some white swirls around the circle, giving the impression of movement or energy.
software, a transaxial probe and a mechanical stepping device that moves the probe in fixed increments.
- "EZ DICOM Viewer" is Class I MD, which enables export DICOM(Digital Imaging and Communications in Medicine) to external medias along with standalone software.
- "Probe Health Test" which is to check for element integrity and function for all compatible probes when a transducer is connected to the main system or is activated is added according to the FDA guidance.
- KOIOS SW(KOIOS Breast), which is cleared on KOIOS DS for Breast(K190442), enables LOGIQ P8, P9 and P10 system connects via DICOM to PACs running KOIOS DS and is configured similar to a DICOM service.
- HDU monitor(LCD) for LOGIQ P10 only. LOGIQ P10 has two configurations. One is with 23.8inch bezel-less LCD monitor and the other one is with 23.8inch HDU monitor has much more high contrast image. Both of monitor has HDMI audio functions.
The following minor improvements have been made: Hepatic Assistant, week/day OB for SR, Hide date and time, Quick Patient Change, UPS support, HDMI Audio signal for external monitor, DICOM Viewer SR storage and Digital Expert.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC60601-1-2, Medical Electrical Equipment Part 1-. 2:General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edtion 4.0, 2014
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The circle has small, droplet-like shapes around its perimeter, giving it a dynamic and fluid appearance. The color of the logo is a medium blue.
- IEC60601-2-37, Medical Electrical Equipment Part 2-. 37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1.2015
- ISO10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009
- ISO14971, Application of risk management to medical . devices: 2019
- NEMA PS 3.1 3.20 (2016), Digital Imaging and ● Communications in Medicine (DICOM) Set. (Radiology)
- IEC 62359, Ultrasonics Field characterization Test ● methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1. 2017
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews ●
- Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification)
- Performance testing (Verification) ●
- Safety testing (Verification) ●
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the LOGIQ P10, LOGIQ P9 and LOGIQ P8 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
§ 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.