No
The document does not mention AI, ML, or any related terms in the device description or intended use. While it mentions "automated tools designed to simplify and shorten the workflow time," this does not necessarily indicate AI/ML and could refer to more traditional automation techniques.
No.
The device is explicitly described as a "general purpose diagnostic ultrasound system" and a "diagnostic ultrasound device," with its clinical applications focused on imaging, measurement, display, and analysis for diagnostic purposes, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Venue is a general purpose diagnostic ultrasound system." The "Device Description" also refers to it as a "diagnostic ultrasound device."
No
The device description clearly outlines hardware components such as a high resolution color LCD monitor, articulated monitor arm, battery, wireless communication capability, barcode reader, and various linear, convex, and phased array transducers. These are physical components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Venue is a "general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid." It uses ultrasound waves to create images of internal structures.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the body to generate images.
Therefore, the Venue is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), VascularPeripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.
Product codes
IYN, IYO, ITX
Device Description
The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.
The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.
The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.
The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance
Indicated Patient Age Range
neonatal and adult cephalic, pediatric, adults and pediatric
Intended User / Care Setting
qualified and trained healthcare professionals / hospital or medical clinic
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, Venue, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Venue (K180599)
Reference Device(s)
Venue Go (K183362), Versana Premier (K200138), Vivid iq (K181727), LOGIQ e (K133533), LOGIQ e (K151028), Voluson S8 (K120741), Vivid q (K121062), Venue 50 (K152758), Vscan Extend (K180995), Vivid S70N (K182450)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
November 13, 2020
GE Medical Systems Ultrasound and Primary Care Diagnostics % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K202132
Trade/Device Name: Venue Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 8, 2020 Received: October 13, 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/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.
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
1
801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 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 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 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,
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
Indications for Use
510(k) Number (if known)
Device Name Venue
Indications for Use (Describe)
The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), VascularPeripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/6 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized script inside. The circle is surrounded by a decorative swirl pattern, also in blue. The logo is simple and recognizable, representing the multinational conglomerate corporation.
K202132
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| Date: | July 30, 2020 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)470-1003 | |
| Secondary Contact Person: | Karin Shimoni |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Device Trade Name: | Venue |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90 | |
| Product Code: | IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560- |
| 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, | |
| 90-ITX | |
| Predicate Device: | Venue (K180599) |
| Reference Devices: | Venue Go (K183362) |
| Versana Premier (K200138) | |
| Vivid iq (K181727) | |
| LOGIQ e (K133533) | |
| LOGIQ e (K151028) | |
| Voluson S8 (K120741) | |
| Vivid q (K121062) | |
| Venue 50 (K152758) | |
| Vscan Extend (K180995) | |
| Vivid S70N (K182450) |
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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The logo is colored in a light blue hue, and the background is white.
Device Description: The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions.
The proposed Venue has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient leads or as an output from an ECG monitoring device. ECG is not intended for monitoring or diagnosis.
The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication and a barcode reader is available to be used as an input device. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The user documentation is available via electronic media.
The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some transducers are compatible with OEM biopsy kits to support needle-guidance procedures. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.
5
Image /page/5/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 blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.
Intended Use: The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B. M. PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD. Technology: The Venue employs the same fundamental scientific technology as its predicate and reference devices. Determination of Comparison to Predicate Device Substantial Equivalence: The Venue system is substantially equivalent to the predicate device with regards to imaging capabilities, technological characteristics and safety and effectiveness. The following is an overview of the differences between the proposed Venue and the predicate Venue. · The proposed Venue and predicate Venue (K180599) have similar clinical indications for use, however the proposed Venue is adding the Intraoperative (vascular) application which has been cleared on reference device, Venue Go (K183362). · Vascular has been added with peripheral vascular, this clarifies vessels and does not change imaging or the product. No impact to safe or effectiveness use. · Imaging guidance of interventional procedures is changed to interventional guidance as it was in the IFU tables in the predicate. Biopsy and non-vascular access (instead of nerve block) are added as sub categories from the predicate IFU table. Fluid drainage is added as it part of intended use. There is no change to the intended use from the predicate, no change to the product and no impact to safe or effective use.
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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' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, 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.
GE Healthcare
510(k) Premarket Notification Submission
- · The IFU statement is updated to add "trained" to the operator qualification for clarity however it is in the proposed and the predicate product documentation. No change to the product and no impact to safe or effective use.
- · Device use settings and modes of operation are added as required in the 2019 ultrasound guidance. There was no change in the system modes or the use environment from the predicate.
Transducers and Modes:
- 0 The proposed Venue and predicate Venue (K180599) have identical imaging modes.
- . The proposed Venue and predicate Venue (K180599) systems transducers are similar, except for:
- o Addition of ML6-15-RS which was first cleared on Voluson S8, K120741. The clinical indications of ML6-15-RS are similar on the proposed Venue as they are on the reference device Vivid iq, K181727.
- o Addition of 12S-RS, which was first cleared on Vivid q, K121062. The clinical indications of 12S-RS are the same on the proposed Venue as they are on the reference device Vivid q, K121062.
- o Addition of L10-22-RS which was first cleared on LOGIQ e, K133533. The clinical indications of L10-22-RS are similar on the proposed Venue as they are on the reference devices LOGIQ e, K133533.
- L4-20t-RS is a new transducer being added to the proposed ● Venue system. The L4-20t-RS has similar clinical indications for use as the predicate L4-12t-RS transducer which was first cleared on LOGIO e K133533. L4-20t-RS is a surface, linear array transducer which operates in a wider range of frequencies compared to the predicate L4-12t-RS. The clinical indications of L4-20t-RS are the same as the L4-12t-RS transducer cleared with reference device Venue Go. K183362.
- New applications are added to transducers: ●
- ML6-15-RS transducer: added Ophthalmic, Cardiac o (Pediatric and Adult), Thoracic/Pleural, Vascular and Non-vascular access, cleared with 12L-RS in predicate Venue (K180599) which is a similar transducer.
- L10-22-RS transducer: added Pediatric, cleared with o L8-18i-RS in predicate Venue (K180599) which is a similar transducer.
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Image /page/7/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 a white border and a few white accents that give the impression of movement or energy around the letters.
GE Healthcare
510(k) Premarket Notification Submission
- L8-18i-RS transducer: added Ophthalmic, cleared with o 12L-RS in predicate Venue (K180599) which is a similar transducer.
- L8-18i-RS transducer: added intraoperative, cleared o with this probe on reference Venue Go (K183362).
- Removed Vascular Access application from 3Sc-RS, C1-5-● RS and 6S-RS. No impact to safe or effective use.
- Added Coded Pulse mode to Vascular/Peripheral Vascular, ● Vascular Access and Non-vascular on L10-22-RS.
Features/Functionality:
- Simple Screen is a modification of Full Screen that is on ● predicate Venue, K180599.
- Follow-up feature is being added with minor modifications ● to what has been cleared on Versana Premier, K200138.
- Venue View is being added and is a different name for LOGIQ View that has been cleared on Versana Premier, K200138.
- Lung Sweep allows multiple lung scans to play . simultaneously during review. Lung scanning was available also on predicate Venue, K180599.
- cNeedle enhances the needle, and projects a trajectory line. ● Capabilities are similar to needle recognition that has been cleared on predicate Venue, K180599 and Pinpoint GT feature on reference Venue 50, K152758, respectively.
- Real-Time Ejection Fraction (EF) is being added and is similar to the Auto EF feature on reference Vivid S70N, K182450.
- Renal Diagram is similar to the eFAST Navigation Tool cleared on predicate Venue, K180599.
- Added biopsy guidzones cleared on reference Versana ● Premier, K200138.
- Added additional off-the-shelf SW.
Accessories:
- Added compatible OEM ECG triggering leads for ● pediatrics, similarly to what is on predicate Vivid iq, K181727.
- Added compatible OEM biopsy guide accessory . compatibility for the C1-5-RS, and for 12L-RS, L12n-RS, & L4-12t-RS transducers.
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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' in a stylized, cursive font, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.
Summary of Non-Clinical Tests:
The proposed Venue 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 comply with applicable medical device safety standards. The Venue complies with voluntary standards:
- . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/ A2:2012
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: o General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility 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 Deviceso Part 1: Evaluation and Testing- Third Edition, 2009
- IEC 62359. Ultrasonics Field characterization Test ● methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017
- ISO 14971, Application of risk management to medical devices, 2019
- NEMA PS 3.1 3.20, Digital Imaging and Communications ● in Medicine (DICOM) Set, 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 & Validation)
- Safety testing (Verification) .
Transducer material and other patient contact materials are biocompatible.
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Image /page/9/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 blue circle. The circle has a decorative border that resembles swirling water or a stylized floral pattern. The logo is simple, recognizable, and associated with the multinational conglomerate GE.
Summary of Clinical Tests:
The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Venue to be as safe, as effective, and performance is substantially equivalent to the predicate device.