(86 days)
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, GynecologyPelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
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. The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.
The provided FDA submission for the GE LOGIQ E10 does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML component or performance metrics for diagnostic accuracy beyond general equivalence claims.
The document primarily focuses on establishing substantial equivalence of the LOGIQ E10 ultrasound system to predicate devices based on:
- Intended Use: Similar clinical applications.
- Technology: Same fundamental scientific technology (ultrasound imaging).
- Components: Similar transducers and system capabilities (measurements, digital imaging, reporting).
- Safety Standards: Compliance with electrical, thermal, electromagnetic safety, and biocompatibility.
- Software Features: Identical software features with some migrations from other GE systems (Voluson E10, LOGIQ E9, LOGIQ S8) and a new feature (UGAP) similar to one on another predicate.
The document explicitly states: "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." This means no specific performance metrics comparing the LOGIQ E10 to a gold standard or human readers were presented for this submission.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any details about MRMC or standalone AI studies, as this information is not present in the provided text.
The information provided only demonstrates that the device is an ultrasound system with various imaging capabilities, and its submission for FDA clearance relies on substantial equivalence to existing predicate devices, rather than a de novo clinical performance study showcasing specific diagnostic accuracy metrics.
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GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K200158
Trade/Device Name: LOGIO E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, ITX, IYO, Dated: January 21, 2020 Received: January 22, 2020
Dear Tracey Ortiz:
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
April 17, 2020
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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,
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) K200158
P 100000
Device Name LOGIO E10
Indications for Use (Describe)
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, GynecologyPelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including Prostate); Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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GE Healthcare 510(k) Premarket Notification Submission
Image /page/3/Picture/1 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 is surrounded by a decorative border of swirling lines. The logo is simple and recognizable, and it is associated with a well-known and established company.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | January 21, 2020 |
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics,LLC9900 Innovation DrWauwatosa, WI 53226 |
| Manufacturer: | GE Medical Systems Ultrasound and Primary Care Diagnostics,LLC9900 Innovation DrWauwatosa, WI 53226 |
| Primary Contact Person: | Tracey OrtizRegulatory Affairs DirectorGE HealthcareT: (262)676-6120 |
| Alternate Contact Person: | Elizabeth WentworthRegulatory Affairs SpecialistGE Healthcare |
| Device: | |
| Trade Name: | LOGIQ E10 |
| Common/Usual Name: | LOGIQ E10 |
| 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: | K173555 LOGIQ E10 Diagnostic Ultrasound System |
| Reference Device(s): | K170445 LOGIQ S8 Diagnostic Ultrasound SystemK192159 Voluson E10 Diagnostic Ultrasound SystemK152309 LOGIQ E9 Diagnostic Ultrasound SystemK161843 Aplio i900/i800/i700 Diagnostic Ultrasound SystemV2.0 (ATI)K190442 Koios DS for Breast |
| Device Description: | The LOGIQ E10 is a full featured, track 3, general purposediagnostic ultrasound system which consists of a mobile consolethat provides digital acquisition, processing and displaycapability. The user interface includes a computer keyboard,specialized controls, LCD touch screen and color widescreen |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue, and the border has decorative white swirls around it.
GE Healthcare 510(k) Premarket Notification Submission
monitor. The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.
Intended Use:
LOGIO 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).
- Technology: The LOGIQ E10 employs the same fundamental scientific technology as its predicate device(s).
Determination of Substantial Equivalence:
Comparison to Predicates
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 (K173555). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- · The LOGIO E10 and predicate LOGIO E10 systems have the same clinical intended use, except Intraoperative (Abdominal) that is available on predicate LOGIQ E9 K152309).
- · 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 LOGIQ E10 and predicate LOGIQ E10 systems have been designed in compliance with approved electrical and physical safety standards.
- · The transducers supported in proposed LOGIO E10 and predicate LOGIQ E10 are identical except:
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GE Healthcare
510(k) Premarket Notification Submission
previously cleared L8-18i-D
- adding B-Flow (hybrid) as a new mode to: C1-6-D, C1-6VN-D, C2-9-D, C2-9VN-D, L2-9-D, L2-9VN-D, L3-12-D. ML6-15-D. L8-18i-D:
- · The software features supported in proposed LOGIQ E10 and predicate LOGIQ E10 are identical except: - the following software features have been migrated from Voluson E10 (K192195): SonoNT, SonoIT, SonoAVC for renal cyst, SonoRenderLive.
- · UGAP is a new feature similar to ATI on Aplio i900/i800/i700 Diagnostic Ultrasound System V2.0 (K161843) that measures the attenuation value in the liver.
- · Other minor software feature modifications are: improved the Vnav image based registration, enabled Device Management, add a type 2 to SRI-HD
Summary of Non-Clinical Tests:
been evaluated for acoustic output, The device has 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 LOGIO 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
- 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 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within A Risk Management Process, 2009
- ISO 14971, Application of risk management to medical ● devices, 2007
- NEMA PS 3.1 3.20, ● -Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology) 2016
FDA Guidance's used:
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GE Healthcare
510(k) Premarket Notification Submission
- o Off-The-Shelf Software Use in Medical Devices -Guidance for Industry and Food and Drug Administration Staff - Issued on September 27, 2019
- Marketing Clearance of Diagnostic Ultrasound Systems ● and Transducer- Guidance for Industry and Food and Drug Administration Staff Document - Issued on June 27, 2019
- o Guidance for Industry and Food and Drug Administration Staff. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Issues on October 2, 2014
- Guidance for the Content of Premarket Submissions for ● Software Contained in Medical Devices - Issued on May 11,2005
- Guidance for Industry - Cyber Security for Networked Medical Devices Containing Off-The-Shelf (OTS) Software issued January 14, 2005
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 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).
§ 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.