(121 days)
The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ Totus clinical applications 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.
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, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.
The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide(monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.
The provided document contains information on two AI features: "Auto preset selection" and "Auto Abdominal Color Assistant". The acceptance criteria and study details for each are presented below.
Auto Preset Selection
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance (Summary Test Statistics) |
|---|---|
| The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid (Mixed) view suggestion is expected to be 80% or higher. | The document states, "The overall model success rate of the Abdomen, Air, Breast, Carotid, Leg, MSK, Scrotal, Thyroid and Carotid/Thyroid(Mixed) view suggestion is expected to be 80% or higher." This indicates the device met this criterion. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Number of individual patients' images collected from: 50+ patients
- Number of samples (images): 330+ images
- Data Provenance:
- Country of Origin: USA (57%) and Australia (43%)
- Retrospective/Prospective: Not explicitly stated, but the mention of "data collection protocol was standardized" suggests it might be retrospective collection of pre-existing data, or a controlled prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
- Qualifications of Experts: "Certified sonographer/clinician." No years of experience or specific board certifications are mentioned.
4. Adjudication method for the test set:
- Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified as Pass or Fail by a certified sonographer/clinician." This implies a single expert verification without explicit multi-reader adjudication (e.g., 2+1 or 3+1).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was explicitly mentioned for this AI feature. The testing method described focuses on the AI's success rate verified by experts, not on comparing human performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "overall model success rate" refers to the algorithm's performance in suggesting views. The "verified as Pass or Fail by a certified sonographer/clinician" is likely a post-hoc verification of the algorithm's output, rather than an interactive human-in-the-loop study.
7. The type of ground truth used:
- Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail". This can be considered a form of "expert consensus" or "expert truth" (albeit with a single expert verification as mentioned in point 4).
8. The sample size for the training set:
- Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (330+ images from 50+ patients) is specified for the test set.
9. How the ground truth for the training set was established:
- Not explicitly stated. The document mentions that the test data was independent of the training data but doesn't detail the ground truth establishment for the training set. It's generally assumed that ground truth for training data in such AI applications would also be established by experts.
Auto Abdominal Color Assistant
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance (Summary Test Statistics) |
|---|---|
| The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher. | The document states, "The overall model success rate of the Aorta, Kidney, Liver, GB and Pancreas view suggestion is expected to be 80% or higher." This indicates the device met this criterion. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Number of individual patients' images collected from: 40 patients
- Number of samples (images): 280+ images
- Data Provenance:
- Country of Origin: USA (35%) and Australia (65%)
- Retrospective/Prospective: Similar to "Auto preset selection", not explicitly stated, but a "standardized data collection protocol" is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual sonographers/clinicians were involved.
- Qualifications of Experts: "Certified sonographer / clinician." No years of experience or specific board certifications are mentioned.
4. Adjudication method for the test set:
- Adjudication Method: "For the testing process, the results are generated by the AI software and the same are verified a Pass or Fail by a certified sonographer / clinician." This implies a single expert verification without explicit multi-reader adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study was explicitly mentioned for this AI feature.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "overall model success rate" refers to the algorithm's performance. The "verified as Pass or Fail by a certified sonographer / clinician" is likely a post-hoc verification of the algorithm's output.
7. The type of ground truth used:
- Type of Ground Truth: Expert verification by certified sonographer/clinician, determining if the AI's view suggestion was a "Pass or Fail".
8. The sample size for the training set:
- Not explicitly stated. The document only mentions that "The exams used for test/training validation purpose are separated from the ones used during training process and there is no overlap between the two." The sample size (280+ images from 40 patients) is specified for the test set.
9. How the ground truth for the training set was established:
- Not explicitly stated. Similar to the "Auto preset selection" feature, it's assumed expert input would have been used for training data ground truth, but no details are provided.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue box, and the full name is in blue text.
December 7, 2023
GE Medical Systems Ultrasound and Primary Care Diagnostics % Bryan Behn Regulatory Affairs Director GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226
Re: K232381
Trade/Device Name: LOGIO Totus Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: November 16, 2023 Received: November 16, 2023
Dear Bryan 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 (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).
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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, Ph.D. 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
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Indications for Use
510(k) Number (if known) K232381
Device Name LOGIQ Totus
Indications for Use (Describe)
The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIO Totus clinical applications 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); Transvaginal.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppier, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging, Contrast, Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office(Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.
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
K232381
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | Dec 5, 2023 |
| Submitter: | GE Medical Systems Ultrasound and Primary CareDiagnostics, LLC.9900 Innovation DrWauwatosa, WI 53226 |
| Manufacturer: | GE Ultrasound Korea, Ltd.9, Sunhwan-ro 214 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13204, Republic of Korea |
| Primary Contact Person: | Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(262)-247-5502 |
| Alternate Contact Person: | Chae-Rin, SongRegulatory Affairs LeaderGE HealthcareGE Ultrasound Korea, Ltd.T: +82-31-740-6310 |
| Device: | LOGIQ Totus |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN(primary), IYO, ITX, QIH (secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System,21CFR 892.1560, 90-IYO Diagnostic UltrasoundTransducer, 21 CFR 892.1570, 90-ITX, 21CFR 892.2050 | |
| Primary Predicate Device: | K211524 LOGIQ E10s, LOGIQ Fortis DiagnosticUltrasound System |
| Reference PredicateDevice(s): | K202035 Vscan AirK200743 Vivid E80/Vivid E90/Vivid E95 R4 |
| Device Description: | The LOGIQ Totus is full featured, Track 3 device,primarily intended for general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 490mm wide(monitor width: 545mm),835mm deep and 1415~1815mm high that providesdigital acquisition, processing and display capability. |
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Indications for Use:
specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display. The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ Totus clinical applications 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. 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, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.
The user interface includes a computer keyboard,
| Technology: | The LOGIQ Totus employs the same fundamentalscientific technology as its predicate devices. |
|---|---|
| Determination ofSubstantial Equivalence: | The proposed LOGIQ Totus systems is substantiallyequivalent to the predicate LOGIQ E10s and LOGIQFortis(K211524) with regards to intended use, imagingcapabilities, technological characteristics, imagingmodes, hardware, and safety effectiveness.The system is all intended for diagnostic ultrasoundimaging and fluid flow analysis.The Proposed LOGIQ Totus and the predicate LOGIQE10s and LOGIQ Fortis(K211524) have the same |
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clinical intended use except Transesophageal and Intraoperative(Abdominal, Vascular). LOGIQ Totus doesn't include both clinical applications.
The proposed LOGIQ Totus and the predicate LOGIQ E10s and LOGIQ Fortis(K211524) have the same imaging modes.
The proposed LOGIQ Totus are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
The proposed LOGIQ Totus have acoustic power levels which are below the applicable FDA limits.
The proposed LOGIQ Totus and the predicate LOGIQ E10s and LOGIQ Fortis(K211524) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
The proposed LOGIQ Totus have been designed in compliance with approved electrical and physical safety standards.
The following is an overview of the differences between the proposed LOGIO Totus and the predicate LOGIQ E10s, LOGIQ Fortis(K211524).
Probes:
The probes supported in prosed LOGIQ Totus and the predicate LOGIQ E10s, LOGIQ Fortis(K211524) are identical except;
- Addition
- -9S-D (migrated from Vivid E80/E90/E95 R4 K200743)
- -12S-D (migrated from Vivid E80/E90/E95 R4 K200743)
Software:
The software features supported in proposed LOGIQ Totus and the predicate LOGIQ E10s, LOGIQ Fortis(K211524) are similar except:
- Auto Preset Selection
- Auto Abdominal Color Assistant ●
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- Vscan Air CL Support .
- VITA on demand ●
- Auto EF/AFI Enhancement
Compatible device:
Addition of Vscan Air CL, WiFi SUB for Vscan Air CL and Wireless Charger
AI Testing Summary:
- Auto preset selection:
| Summary test staticsor other test resultsincluding acceptancecriteria or otherinformationsupporting theappropriateness of thecharacterizedperformance | • The overall model successrate of the Abdomen, Air,Breast, Carotid, Leg, MSK,Scrotal, Thyroid andCarotid/Thyroid(Mixed)view suggestion is expectedto be 80% or higher.• The number of individualpatient's images werecollected from: 50+ patients• The number of samples, ifdifferent from above, andthe relationship between thetwo: 330+ images |
|---|---|
| Information aboutclinical subgroups andconfounders presentin the dataset | • Gender: Male & Female• Age: Reproductive age,specific age not collected.• Ethnicity/Country;USA(57%) andAustralia(43%) |
| Information aboutequipment andprotocols used tocollect images | Mix of data from across 4different probe models withLOGIQ Totus console. Thedata collection protocol wasstandardized across all data |
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| collection sites. | |
|---|---|
| Information abouthow the referencestandard was derivedfrom the dataset(i.e.the "truthing"process) | For the testing process, theresults are generated by theAI software and the sameare verified as Pass or Failby a certifiedsonographer/clinician. Theresults are then aggregatedto yield an accuracy metricfor the AI algorithm. |
| Description of howindependence of testdata from trainingdata was ensured | The exams used fortest/training validationpurpose are separated fromthe ones used duringtraining process and there isno overlap between the two. |
- Auto Abdominal Color Assistant:
| Summary teststatistics or other testresults includingacceptance criteria orother informationsupporting theappropriateness of thecharacterizedperformance | • The overall model successrate of the Aorta, Kidney,Liver, GB and Pancreasview suggestion is expectedto be 80% or higher.• The number of individualpatients' images werecollected from: 40 patients.• The number of samples, ifdifferent from above, andthe relationship between thetwo: 280+ images |
|---|---|
| Information aboutclinical subgroups andconfounders presentin the dataset | • Gender: Male & Female• Age: Reproductive age,specific age not collected.• Ethnicity/country:USA(35%) andAustralia(65%) |
| Information aboutequipment andprotocols used to | Mix of data from across 4different probe models withLOGIQ Totus console. The |
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GE Healthcare 510(k) Premarket Notification Submission
| collect images | data collection protocol wasstandardized across all datacollection sites. |
|---|---|
| Information abouthow the referencestandard was derivedfrom the dataset(i.e.the "truthing"process) | For the testing process, theresults are generated by theAI software and the sameare verified a Pass or Fail bya certified sonographer /clinician. The results arethen aggregated to yield anaccuracy metric for the AIalgorithm. |
| Description of howindependence of testdata from trainingdata was ensured | The exams used fortest/training validationpurpose are separated fromthe ones used duringtraining process and there isno overlap between the two. |
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 Totus and its applications comply with voluntary standards:
- . ANSI AAMI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012, C1:2009/(R)2012 & A2:2010/(R)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, Edition 4.1, 2020
- IEC 60601-2-37, Medical Electrical Equipment ● – Part 2-37: Particular Requirements for the
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Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical . Devices-Part 1: Evaluation and Testing Within A Risk Management Process, Fifth edition, 2018
- . ISO 14971, Medical devices - Application of risk management to medical device, 2019
- 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
- . 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
- 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 Totus, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the LOGIQ Totus to be as Conclusion: 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.