(34 days)
The LOGIQ V5/LOGIQ V3 is general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Urological and Cardiac.
LOGIQ V5/LOGIQ V3 is a general-purpose ultrasound system used for acquiring and storing ultrasound images for applications such as: Obstetrics; Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Urological and Cardiac. The system used for performing measurements, annotating, printing/reporting on the acquired/stored images.
The LOGIQ V5/LOGIQ V3 is a general-purpose entry level ultrasound scanner from LOGIQ family for private clinics focusing on OB/GYN. The device is a general-purpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The provided document is a 510(k) premarket notification for the GE Healthcare LOGIQ V5/LOGIQ V3 Diagnostic Ultrasound System. It details the device's indications for use and compares it to predicate devices to establish substantial equivalence.
Based on the provided text, the following information can be extracted regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, the "acceptance criteria" are implied through the comparison with predicate devices and compliance with relevant standards to demonstrate substantial equivalence. The reported "performance" is based on functional capabilities and adherence to safety and regulatory benchmarks rather than specific diagnostic accuracy metrics.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Intended Use | Substantially equivalent to predicate devices for diagnostic ultrasound imaging and fluid flow analysis. The LOGIQ V5/LOGIQ V3 has a subset of clinical indications available on the predicate LOGIQ F series (e.g., Fetal/Obstetrics, Abdominal/GYN and Urological, Small Organ, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Transcranial, Transvaginal, Contact Type: Surface, Cavitary, TEE). |
| Imaging Capabilities/Modes | Substantially equivalent to predicate devices, having a subset of imaging modes (B; M; Color, Power, PW& CW Doppler modes, Color M-mode, Harmonic imaging, Combined modes) available on the predicate LOGIQ F series. |
| Transducers | Substantially equivalent to predicate devices, having a subset of transducers (3Sc-RS, 4C-RS, E8C-RS, L6-12-RS, 8C-RS, RAB2-6-RS) available on the predicate LOGIQ F series. New indications (N) and previously cleared (P) indications are specified for each transducer model and clinical application (e.g., for 4C-RS: Fetal/OB-P, Abdominal-P, Small Organ-N, Peripheral Vascular-N). |
| Processing & Display Features | Substantially equivalent to predicate devices, including features like Image freeze, Multiple images, Pan/Zoom, Image maps (color & gray), Cine loop, Spatial & temporal filters, L-R / T-B image rev., Digital harmonics, TGC, Raw data access, LOGIQ View, CrossXBeam, SRI-HD, B-Flow, TVI, Anatomical-M mode (AMM), Auto Optimization. |
| Safety and Effectiveness | The systems are manufactured with materials evaluated and found to be safe; acoustic power levels are below applicable FDA limits ("Track 3 (within FDA limits)"); designed in compliance with approved electrical and physical safety standards. Evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety. Conforms with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, and NEMA DICOM Set. |
| Fundamental Scientific Technology | Employs the same fundamental scientific technology as its predicate devices. |
| Measurement, Annotation, Reporting | Similar capability to predicate LOGIQ F series systems in terms of performing measurements, capturing digital images, reviewing and reporting studies. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The subject of this premarket submission, LOGIQ V5/LOGIQ V5, did not require clinical studies to support substantial equivalence."
Therefore, there is no clinical test set, no sample size, and no data provenance information for a clinical study to report. The evaluation relies on non-clinical tests and comparison to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical studies were required to support substantial equivalence, there was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 describes an ultrasound system, not an AI or computer-assisted diagnostic device, and no clinical comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device; it is a general-purpose ultrasound imaging system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set requiring ground truth was used. The substantial equivalence relies on comparison of technical specifications, safety standards compliance, and functional capabilities with predicate devices, rather than diagnostic accuracy against a definitive ground truth.
8. The sample size for the training set
Not applicable. The device is an ultrasound imaging system. The document does not describe the use of machine learning or AI models with training sets. Its development involved standard quality assurance measures such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).
9. How the ground truth for the training set was established
Not applicable, as there is no training set described.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2014
GE HEALTHCARE BRYAN BEHN REGULATORY AFFAIRS MANAGER 9900 INNOVATION DRIVE RP-2138 WAUWATOSA WI 53226
Re: K141768 Trade/Device Name: Logiq V5 / Logiq V3 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 30, 2014 Received: July 1, 2014
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. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Logiq V5 and Logiq V3, as described in your premarket notification:
| Transducer Model Number |
|---|
| 4C-RS |
| E8C-RS |
| 3Sc-RS |
| L6-12-RS |
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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
LOGIQ V5/LOGIQ V3 Diagnostic Ultrasound System
Indications for Use (Describe)
The LOGIQ V5/LOGIQ V3 is general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Abdominal, Obstetrical, Gynecological, Small parts, Vascular/Peripheral Vascular, Adult Cephalic, Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic, Transvaginal, Urological and Cardiac.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 PRAStaff(@fda.hhs.gov
"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."
FORM FDA 3881(1/14)
Page 1 of 7
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Indications for Use Forms
The following Indications for Use forms are appended.
System: LOGIQ V5/LOGIQ V3 Transducer: 4C-RS Transducer: 3Sc-RS Transducer: L6-12-RS Transducer: E8C-RS
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ V5 and LOGIQ V3. Combinations identified "P" for the transducers represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The logo is rendered in a light blue color, and the design has a vintage or classic feel. The circular frame around the letters has a decorative, swirling pattern.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V5 Ultrasound System
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Doppler Modes | CombinedModes * | HarmonicImaging | CodedPulse | Other | ||||||||
| Anatomy/Region of Interest | B | M | PW | CW | Color | ColorM | Power | |||||
| Ophthalmic | ||||||||||||
| Fetal/OB | N | N | N | N | N | N | N | N | N | N | N | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N | |
| Small Organ (specify)[2] | N | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Cardiac [3] | N | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | N | |
| Thoracic/Pleural (specify) | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | N | N | N | N | N | N | N | N | N | N | N | |
| Transorbital | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | N | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular/Intraluminal | ||||||||||||
| Intracardiac | ||||||||||||
| Laparoscopic |
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are color/power Doppler with B-mode
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 2 of 7
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The logo is rendered in a light blue color, providing a clean and recognizable design. The intertwined letters are stylized with elegant curves, giving the logo a classic and timeless appearance. The circular frame adds a sense of unity and completeness to the overall design.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V3 Ultrasound System
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Doppler Modes | CombinedModes * | HarmonicImaging | CodedPulse | Other | ||||||||
| Anatomy/Region of Interest | B | M | PW | CW | Color | ColorM | Power | |||||
| Ophthalmic | ||||||||||||
| Fetal/OB | N | N | N | N | N | N | N | N | N | N | N | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N | |
| Small Organ (specify)[2] | N | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | N | |
| Thoracic/Pleural (specify) | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | N | N | N | N | N | N | N | N | N | N | N | |
| Transorbital | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | N | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular/Intraluminal | ||||||||||||
| Intracardiac | ||||||||||||
| Laparoscopic |
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are color/power Doppler with B-mode
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 3 of 7
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a double-line border, with the inner line being slightly thicker than the outer line.
GE Healthcare 510(k) Premarket Notification Submission
Diagnostic Ultrasound Indications for Use Form LOGIQ V5/LOGIQ V3 with 4C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Doppler Modes | CombinedModes* | HarmonicImaging | CodedPulse | |||||||||
| Anatomy/Region of Interest | B | M | PW | CW | Color | ColorM | Power | Other | ||||
| Ophthalmic | ||||||||||||
| Fetal/OB | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal [1] | P | N | P | P | P | N | P | P | P | P | P | |
| Pediatric | ||||||||||||
| Small Organ (specify) [2] | N | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [3] | ||||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Thoracic/Pleural (specify) | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | ||||||||||||
| Transorbital | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular/Intraluminal | ||||||||||||
| Intracardiac | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K133034)
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PDI
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 4 of 7
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
Diagnostic Ultrasound Indications for Use Form LOGIQ V5/LOGIQ V3 with E8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW | CW | Doppler Modes | CombinedModes* | HarmonicImaging | CodedPulse | Other | |
| Ophthalmic | ||||||||||
| Fetal/OB | P | P | P | P | P | P | P | N | ||
| Abdominal [1] | N | N | N | N | N | N | N | N | ||
| Pediatric | ||||||||||
| Small Organ (specify)[2] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac [3] | ||||||||||
| Peripheral Vascular | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Thoracic/Pleural (specify) | ||||||||||
| Other (specify) | ||||||||||
| Exam Type, Means of Access | ||||||||||
| Transcranial | ||||||||||
| Transorbital | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | P | P | P | P | P | P | P | N | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Intravascular/Intraluminal | ||||||||||
| Intracardiac | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K133034)
[1] Abdominal includes GYN and Urological; Notes:
[2] Small Organ includes breast, testes, and thyroid
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PDI
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 5 of 7
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.
GE Healthcare 510(k) Premarket Notification Submission
Diagnostic Ultrasound Indications for Use Form LOGIQ V5/LOGIQ V3 with 3Sc-RS Transducer
| Clinical ApplicationAnatomy/Region of Interest | B | M | Doppler Modes | CombinedModes* | HarmonicImaging | CodedPulse | Other | |||
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal/OB | ||||||||||
| Abdominal[1] | P | P | P | N | P | P | P | P | P | N |
| Pediatric | P | P | P | N | P | P | P | P | P | N |
| Small Organ (specify)[2] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N |
| Cardiac[3] | P | P | P | N | P | P | P | P | P | N |
| Peripheral Vascular | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Thoracic/Pleural (specify) | ||||||||||
| Other (specify) | ||||||||||
| Exam Type, Means of Access | ||||||||||
| Transcranial | P | P | P | N | P | P | P | P | P | N |
| Transorbital | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Intravascular/Intraluminal | ||||||||||
| Intracardiac | ||||||||||
| Laparoscopic |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P = previously cleared by FDA (K133034)
[1] Abdominal includes GYN and Urological Notes:
[2] Small Organ includes breast, testes, and thyroid
[3] Cardiac is Adult and Pediatric
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PDI
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
Page 6 of 7
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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the background is white.
GE Healthcare 510(k) Premarket Notification Submission
Diagnostic Ultrasound Indications for Use Form LOGIQ V5/LOGIQ V3 with L6-12-RS Transducer
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW | CW | Color | Color M | Power | CombinedModes* | HarmonicImaging | CodedPulse | Other |
| Ophthalmic | |||||||||||
| Fetal/OB | |||||||||||
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N |
| Pediatric | P | N | P | P | N | P | P | P | P | N | |
| Small Organ (specify)[2] | P | N | P | P | N | P | P | P | P | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | N | P | P | N | P | P | P | P | N | |
| Musculo-skeletal Conventional | P | N | P | P | N | P | P | P | P | N | |
| Musculo-skeletal Superficial | P | N | P | P | N | P | P | P | P | N | |
| Thoracic/Pleural (specify) | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transorbital | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular/Intraluminal | |||||||||||
| Intracardiac | |||||||||||
| Laparoscopic |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P = previously cleared by FDA (K133034)
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, and thyroid;
[3] Cardiac is Adult and Pediatric;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PDI
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
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510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | June 30, 2014 |
| Submitter: | GE Healthcare9900 Innovation DrWauwatosa, WI 53226 |
| Primary Contact Person: | Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275 |
| Secondary Contact Person: | Jiawei ZHANGRegulatory AffairsGE HealthcareT: +86 510 8527 8259F: +86 510 8522 7347 |
| Device: Trade Name: | LOGIQ V5, LOGIQ V3 |
| Common/Usual Name: | LOGIQ V5, LOGIQ V3 |
| Classification Names: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 | |
| Product Code: | IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570,90-ITX |
| Predicate Device(s): | K133034 GE LOGIQ F SeriesK131267 Voluson E series |
| Device Description: | The LOGIQ V5/LOGIQ V3 is a general-purpose entry levelultrasound scanner from LOGIQ family for private clinicsfocusing on OB/GYN. The device is a general-purpose imagingand analysis system providing real-time digital acquisition,processing and display capability intended for general radiologyimaging and evaluation with some cardiology and vascularapplications. |
| Intended Use: | LOGIQ V5/LOGIQ V3 is a general-purpose ultrasound systemused for acquiring and storing ultrasound images for applicationssuch as: Obstetrics; Abdominal, Obstetrical, Gynecological,Small parts, Vascular/Peripheral Vascular, Adult Cephalic,Pediatric, Musculoskeletal, Transcranial, Neonatal Cephalic,Urological and Cardiac. The system used for performingmeasurements, annotating, printing/reporting on the |
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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
acquired/stored images.
LOGIO V5 and LOGIO V3 employ the same fundamental Technology: scientific technology as its predicate devices.
Comparison to Predicate Devices Determination of Substantial Equivalence: The LOGIQ V5 and LOGIQ V3 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- o The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The LOGIQ V5/LOGIQ V3 has a subset of clinical indications for use available on the predicate LOGIQ F series.
- o The LOGIQ V5/LOGIQ V3 has a subset of imaging modes on the predicate LOGIQ F series.
- The LOGIQ V5/LOGIQ V3 has a subset of transducers on ● the predicate LOGIQ F series.
- 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 LOGIO V5/LOGIO V3 and the predicate LOGIO F series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The LOGIQ V5/LOGIQ V3 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
| Proposed DeviceLOGIQ V5/LOGIQV3 | Predicate DeviceLOGIQ F Series(K133034) | |
|---|---|---|
| Indications and Clinical Applications: | ||
| • Fetal/Obstetrics; | ✓ | ✓ |
| • Abdominal/GYN and Urological | ✓ | ✓ |
| • Small Organ (breast, testes,thyroid); | ✓ | ✓ |
| • Pediatric | ✓ | ✓ |
| • Neonatal Cephalic; | ✓ | ✓ |
| • Adult Cephalic; | ✓ | ✓ |
| • Cardiac (adult and pediatric); | ✓ | ✓ |
| • Peripheral Vascular; | ✓ | ✓ |
| • Musculo-skeletal Conventional and Superficial; | ✓ | ✓ |
| • Transcranial | ✓ | ✓ |
| • Transvaginal; | ✓ | ✓ |
| Contact Type• Surface, Cavitary , TEE | ✓ | ✓ |
| Image modes:• B; M; Color, Power, PW& CW Doppler modes, Color M-mode, Harmonic imaging, Combined modes | ✓ | ✓ |
| Transducers | ||
| • 3Sc-RS | ✓ | ✓ |
| • 4C-RS | ✓ | ✓ |
| • E8C-RS | ✓ | ✓ |
| • L6-12-RS | ✓ | ✓ |
| • 8C-RS | ✓ | ✓ |
| • RAB2-6-RS | ✓ | ✓ |
| Processing &Display features:Image freeze, Multiple images, Pan /Zoom, Image maps (color & gray), Cine loop, Spatial & temporal filters, L-R / T-B image rev., Digital harmonics, TGC, Raw data access, LOGIQ View, CrossXBeam, SRI-HD, B-Flow, TVI, Anatomical-M mode (AMM), Auto Optimization. | ✓ | ✓ |
| Tested to meet Electrical Safety, EMC and Biocompatibility Standards | ✓ | ✓ |
| Track 3 (within FDA limits) | ✓ | ✓ |
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Image /page/12/Picture/0 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 decorative swirls around the outer edge of the circle, giving it a classic and recognizable appearance.
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Summary of Non-Clinical Tests:
LOGIQ V5/LOGIQ V3 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 LOGIO V5/LOGIQ V3 complies with voluntary standards:
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- AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety
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- IEC60601-1-2, Medical Electrical Equipment -Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37, Medical Electrical Equipment -3. Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
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- NEMA UD 3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
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- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
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- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
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- ISO14971, Application of risk management to medical devices
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- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
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)
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Image /page/14/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 some white swirls around the letters. The logo is simple and recognizable.
GE Healthcare
510(k) Premarket Notification Submission
- Simulated use testing (Validation) ●
Transducer material and other patient contact materials such as needle guidance kits are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ V5/LOGIQ V5, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the LOGIQ V5/LOGIQ V3 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.