No
The document does not mention AI, ML, or any related terms, and the description focuses on standard ultrasound system components and capabilities.
No
The device is described as a "general purpose diagnostic ultrasound system" and its intended uses are all for "ultrasound evaluation," indicating diagnostic rather than therapeutic purposes.
Yes
The "Device Description" explicitly states, "The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system."
No
The device description clearly states it is a "full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console" and utilizes various "transducers," indicating it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, the LOGIQ E10 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound evaluation" of various anatomical sites and patient populations. This involves imaging the internal structures of the body.
- Device Description: The description details a "diagnostic ultrasound system" that performs "digital acquisition, processing and display capability." This is consistent with an imaging device.
- Input Imaging Modality: The input modality is "Ultrasound," which is an imaging technique, not a method for testing samples outside the body.
- Anatomical Site: The device is used to image various anatomical sites within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions. The LOGIQ E10 does not perform such tests.
The LOGIQ E10 is a diagnostic imaging device, specifically an ultrasound system, used for visualizing internal structures of the body.
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, 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).
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, IYO
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. The system utilizes a variety of linear, curved, phased, dual, and matrix array transducers to support the broad imaging capabilities.
Mentions image processing
Yes
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
Fetal, Neonatal, Pediatric, Adult
Intended User / Care Setting
qualified physician
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K173555 LOGIQ E10 Diagnostic Ultrasound System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K170445 LOGIQ S8 Diagnostic Ultrasound System, K192159 Voluson E10 Diagnostic Ultrasound System, K152309 LOGIQ E9 Diagnostic Ultrasound System, K161843 Aplio i900/i800/i700 Diagnostic Ultrasound System, K190442 Koios DS for Breast
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
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
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,
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
2
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. | |
| 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 |
"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
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, |
| LLC | |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Manufacturer: | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| LLC | |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T: (262)676-6120 | |
| Alternate Contact Person: | Elizabeth Wentworth |
| Regulatory Affairs Specialist | |
| GE 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-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90- | |
| IYO | |
| Diagnostic 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 System |
| K192159 Voluson E10 Diagnostic Ultrasound System | |
| K152309 LOGIQ E9 Diagnostic Ultrasound System | |
| K161843 Aplio i900/i800/i700 Diagnostic Ultrasound System | |
| V2.0 (ATI) | |
| K190442 Koios DS for Breast | |
| 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 |
4
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:
5
Image /page/5/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. The circle is surrounded by decorative swirls or flourishes, giving it a classic and recognizable appearance.
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:
6
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 a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets or waves. The logo is simple and recognizable, and it is often used to represent the company's brand.
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).