(102 days)
The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M 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 E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.
The LOGIQ E10s is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch high- resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or an optional 22-inch color OLED widescreen monitor).
The LOGIQ Fortis is a full featured, Track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 575 mm wide (keyboard), 925 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a digital keyboard (physical keyboard as an option), specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCD monitor (or 23.8-inch High Resolution LED LCD monitor as an option).
The provided text is a 510(k) Premarket Notification from the FDA for GE Healthcare's LOGIQ E10s and LOGIQ Fortis diagnostic ultrasound systems. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific clinical studies with acceptance criteria, sample sizes, or ground truth establishment in the way typically found for AI/ML-driven medical devices that require such studies for de novo or PMA applications.
Therefore, most of the requested information cannot be extracted from this document as it explicitly states: "The subject of this premarket submission, LOGIQ E10s, LOGIQ Fortis, did not require clinical studies to support substantial equivalence."
However, I can provide available information:
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for clinical applications. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing intended use, technology, imaging modes, safety, and functionality.
2. Sample size used for the test set and the data provenance:
Not applicable. The document states that clinical studies were not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document states that clinical studies were not required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The document states that clinical studies were not required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The document states that clinical studies were not required, and this device is primarily a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool as described in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The document states that clinical studies were not required. This device is a diagnostic ultrasound system operated by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The document states that clinical studies were not required.
8. The sample size for the training set:
Not applicable. The document states that clinical studies were not required. This is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific training set with ground truth in the context described.
9. How the ground truth for the training set was established:
Not applicable. The document states that clinical studies were not required.
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August 27, 2021
Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare % Mr. Bryan Behn RA Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K211524
Trade/Device Name: LOGIO E10s, LOGIO Fortis Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 30, 2021 Received: August 2, 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/cfpmp/bmn.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
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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,
Michael D. O'Hara
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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Indications for Use
510(k) Number (if known) K211524
Device Name LOGIQ E10s and LOGIQ Fortis
Indications for Use (Describe)
The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo- skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M 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 E10s and LOGIQ Fortis are intended to be used in a hospital or medical clinic.
| 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) |
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| K211524 | 510(k) Summary |
|---|---|
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
| Date:Submitter: | May 14, 2021GE 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:(414)721-4214E: bryan.behn@ge.com |
| Alternate Contact Person: | Qingmeng ChenRegulatory Affairs Program ManagerGE HealthcareT: +86-18180590723 |
| Device Trade Name: | LOGIQ E10s, LOGIQ Fortis |
| 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-IYN;Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Primary Predicate Device: | K200119 LOGIQ E10s Diagnostic Ultrasound System |
| Reference Device(s): | K200158 LOGIQ E10 Diagnostic Ultrasound SystemK202658 Vivid E95 Diagnostic Ultrasound System |
| Device Description: | The LOGIQ E10s is a full featured, Track 3, general purpose diagnosticultrasound system which consists of a mobile console approximately 585mm wide (keyboard), 991 mm deep and 1300 mm high that providesdigital acquisition, processing and display capability. The user interfaceincludes a computer keyboard, specialized controls, 12-inch high-resolution color touch screen and 23.8-inch High Contrast LED LCDmonitor (or an optional 22-inch color OLED widescreen monitor). |
| The LOGIQ Fortis is a full featured, Track 3, general purpose diagnosticultrasound system which consists of a mobile console approximately 575mm wide (keyboard), 925 mm deep and 1300 mm high that providesdigital acquisition, processing and display capability. The user interfaceincludes a digital keyboard (physical keyboard as an option), specializedcontrols, 12-inch high-resolution color touch screen and 23.8-inch HighContrast LED LCD monitor (or 23.8-inch High Resolution LED LCDmonitor as an option). | |
| Indications for Use: | The LOGIQ E10s and LOGIQ Fortis are general-purpose diagnosticultrasound systems intended for use by qualified and trained healthcareprofessionals for ultrasound imaging, measurement, display and analysisof the human body and fluid. LOGIQ E10s and LOGIQ Fortis clinicalapplications include: 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; Transesophagealand Intraoperative (Vascular). Modes of operation include: B, M, PWDoppler, 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 E10sand LOGIQ Fortis are intended to be used in a hospital or medical clinic. |
| Technology: | The LOGIQ E10s and LOGIQ Fortis employ the same fundamentalscientific technology as its predicate device(s). |
| Determination ofSubstantial Equivalence: | Comparison to PredicatesThe proposed LOGIQ E10s and LOGIQ Fortis are substantiallyequivalent to the predicate devices. The following is an overview of thedifferences between the proposed LOGIQ E10s, LOGIQ Fortis and thepredicate LOGIQ E10s (K200119). The systems are all intended fordiagnostic ultrasound imaging and fluid flow analysis.The proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQE10s have the same clinical intended use. The proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQE10s have the same imaging modes. The systems are manufactured with materials which have beenevaluated and found to be safe for the intended use of the device. The systems have acoustic power levels which are below theapplicable FDA limits. The proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQE10s have similar capability in terms of performing measurements, |
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capturing digital images, reviewing and reporting studies.
- . The proposed LOGIQ E10s, LOGIQ Fortis and the predicate LOGIQ E10s have been designed in compliance with approved electrical and physical safety standards.
- The probes supported in proposed LOGIQ E10s and the predicate LOGIO E10s are identical except: - the following probe migrated from LOGIQ E10 (K200158): L6-24-
D:
-
adding new probes ML4-20-D and ML4-20VN-D, which are equivalent to the previously cleared ML6-15-D;
-
adding Contrast and B-Flow as new modes to: L6-24-D;
-
adding UGAP as a new mode to: C2-9-D, C2-9VN-D;
-
adding Shear Wave Elastography as a new mode to: L3-12-D;
-
adding Pleural under Abdominal application use
-
The probes supported in proposed LOGIO Fortis and the predicate ● LOGIQ E10s are identical except:
-
the following probe migrated from LOGIQ E10 (K200158): L6-24-D:
-
adding Contrast and B-Flow as new modes to: L6-24-D:
-
adding UGAP as a new mode to: C2-9-D, C2-9VN-D;
-
adding Shear Wave Elastography as a new mode to: L3-12-D;
-
adding Pleural under Abdominal application
-
The software features supported in proposed LOGIQ E10s, LOGIQ ● Fortis and predicate LOGIQ E10s are identical except:
- software features added: EZ Imaging, Hepatic Assistant, Software Download, Digital Expert Remote Training, Respirometer Support;
- other minor software improvement: Device Management 2.0, Advanced SRI-HD.
-
Other minor hardware modification: adding hardware A/N keyboard . as an option to the proposed LOGIQ Fortis.
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 with applicable medical device safety standards. The LOGIQ E10s, LOGIQ Fortis complies 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
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and Tests, Edition 4.0, 2014
- IEC 60601-2-37, Medical Electrical Equipment Part 2-37: ● Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- o ISO 10993-1. Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within A Risk Management Process, Fourth edition, 2018
- 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
- 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, LOGIO E10s, LOGIO Fortis, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the LOGIQ E10s, LOGIQ Fortis 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.