(120 days)
No
The document does not mention AI, ML, or any related terms in the device description or intended use. While it mentions "processing capability," this is a standard feature of digital ultrasound systems and does not inherently indicate AI/ML.
No
The device is described as a "diagnostic ultrasound system" intended for "ultrasound evaluation," indicating its purpose is for diagnosis, not therapy.
Yes
The "Device Description" explicitly states, "The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system." Additionally, its "Intended Use / Indications for Use" describes its use for "ultrasound evaluation" of various anatomical sites, which is a diagnostic purpose.
No
The device description explicitly states it is a "full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console" and utilizes "a variety of linear, curved, phased, dual, and matrix array transducers," indicating it includes significant hardware components beyond just software.
Based on the provided information, the LOGIQ E10 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LOGIQ E10's Function: The LOGIQ E10 is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "ultrasound evaluation" of various anatomical sites. This involves imaging the body directly, not analyzing samples.
Therefore, the LOGIQ E10 falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color 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 E10 is intended to be used in a hospital or medical clinic.
Product codes
IYN, IYO, ITX
Device Description
The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor (OLED and HDU monitors). The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.
Mentions image processing
digital acquisition, processing and display capability.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Indicated Patient Age Range
Pediatric, Neonatal Cephalic, Adult Cephalic
Intended User / Care Setting
qualified physician / hospital or medical clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K200158 LOGIQ E10 Diagnostic Ultrasound System
Reference Device(s)
K202658 Vivid E95 Diagnostic Ultrasound System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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GE Healthcare GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
September 10, 2021
Re: K211488
Trade/Device Name: LOGIQ E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 11, 2021 Received: August 13, 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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number ( if known ) | K211488 |
---|---|
Device Name | LOGIQ E10 |
Indications for Use (Describe)
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal
(including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult
Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology
(including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color 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 E10 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) |
---|---|
-------------------------------------------------------------------------------------------------------- | --------------------------------------------- |
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GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: May 10, 2021 Date: GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: LLC 9900 Innovation Dr Wauwatosa, WI 53226 GE Medical Systems Ultrasound and Primary Care Diagnostics, Manufacturer: LLC 9900 Innovation Dr Wauwatosa, WI 53226 Primary Contact Person: Bryan Behn Regulatory Affairs Director GE Healthcare E: bryan.behn@ge.com T: (262) 247-5502 Alternate Contact Person: Elizabeth Wentworth Regulatory Affairs Specialist GE Healthcare LOGIO E10 Device: Trade Name: Common/Usual Name: LOGIO E10 Classification Names: Class II Product Code: IYN (primary), IYO, ITX (secondary) Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550. 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Primary Predicate Device: K200158 LOGIQ E10 Diagnostic Ultrasound System Reference Device(s): Vivid E95 K202658 Diagnostic Ultrasound System Device Description: The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, LCD touch screen and color widescreen monitor (OLED and HDU monitors). The system utilizes a variety of linear, curved, phased, dual, and matrix array
transducers to support the broad imaging capabilities.
Image /page/3/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three water droplet-like shapes surrounding the circle, positioned at the top, left, and right sides.
K211488
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Indications for Use:
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color 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 LOGIO E10 is intended to be used in a hospital or medical clinic.
- Technology: The LOGIQ E10 employs the same fundamental scientific technology as its predicate device(s).
Determination of Comparison to Predicates
Substantial Equivalence:
- The proposed LOGIO E10 is substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIQ E10 and the predicate LOGIQ E10 (K200158). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- · The LOGIQ E10 and predicate LOGIQ E10 systems have the same imaging modes.
- · 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 E10 and predicate LOGIQ E10 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- · The LOGIO E10 and predicate LOGIO E10 systems have been designed in compliance with approved electrical and physical safety standards.
- · The transducers supported in proposed LOGIQ E10 and predicate LOGIQ E10 are identical except:
- adding a new transducer, ML4-20-D, ML4-20VN-D which is similar to the previously cleared ML6-15-D
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GE Healthcare
510(k) Premarket Notification Submission
- · The software features supported in proposed LOGIQ E10 and predicate LOGIQ E10 are identical except:
- UGAP has been added to the C2-9(VN)-D probes
- SWE has been added to the L3-12D probe
- Contrast and B-Flow have been added to the L6-24-D
- Respirometer support
- · Other minor software feature modifications are: improved measurement updates and CTO improvements
- · EZ Imaging, Hepatic Assistant and SRI have minor enhancements and workflow improvements to existing features.
- · Device Management 2.0 and Remote Expert Training have been added
Summary of Non-Clinical Tests:
for acoustic output, device has been evaluated The biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E10 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
- o IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, 2014
- IEC 60601-2-37, Medical Electrical Equipment Part 2o 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- o ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within A Risk Management Process, 2018
- ISO 14971, Application of risk management to medical devices, 2012
- NEMA PS 3.1 - 3.20, Digital ● Imaging and Communications in Medicine (DICOM) Set. (Radiology) 2016
The following quality assurance measures are applied to the development of the system:
- . Risk Analysis
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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are four white water droplets around the circle. The logo is simple and recognizable.
GE Healthcare
510(k) Premarket Notification Submission
- Requirements Reviews ●
- Design Reviews ●
- Testing on unit level (Module verification) ●
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification) o
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the LOGIQ E10 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).