Venue Go (K183362)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard ultrasound functionalities and hardware.
No
The device is described as a "general purpose diagnostic ultrasound system" and its intended use is for "ultrasound imaging, measurement, display and analysis," which are diagnostic rather than therapeutic functions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Venue Go is a general purpose diagnostic ultrasound system".
No
The device description explicitly details hardware components such as a high-resolution color LCD monitor, internal battery, transducers, and the capability to connect to an electrical wall outlet. It is described as a compact, portable system, not solely software.
Based on the provided information, the Venue Go is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Venue Go's Function: The Venue Go is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures and analyze fluid flow within the living body. This is an in vivo diagnostic method.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes an imaging modality, not a test performed on a sample.
Therefore, the Venue Go falls under the category of diagnostic imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Venue Go 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 Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, 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 (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Go is a compact, portable system with a small footprint The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time.
The Venue Go 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 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 information is not intended for monitoring or diagnosis.
A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a built-in Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.
The Venue Go is a general purpose diagnostic ultrasound system Intended Use: for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go 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.
Mentions image processing
Not Found
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, 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).
Indicated Patient Age Range
neonatal and adult cephalic, pediatric, cardiac (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 Go, 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.
Venue Go (K183362)
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.
Venue (K180599), 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 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.
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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K202233
Trade/Device Name: Venue Go 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/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
November 18, 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
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Indications for Use
510(k) Number (if known)
Device Name Venue Go
Indications for Use (Describe)
The Venue Go 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 Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. 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 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: | August 6, 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 Go |
| 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 | |
| Primary Predicate Device: | Venue Go (K183362) |
| Reference Device(s): | Venue (K180599) |
| 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) | |
| Device Description: | Venue Go is a general-purpose diagnostic ultrasound system |
| intended for use by qualified and trained healthcare professionals | |
| to evaluate the body by ultrasound imaging and fluid flow | |
| analysis. The Venue Go is a compact, portable system with a | |
| small footprint The system can be hand carried using an |
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Image /page/4/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 or flourishes around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely associated with the multinational conglomerate.
integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time.
The Venue Go 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 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 information is not intended for monitoring or diagnosis.
A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.
The Venue Go is a general purpose diagnostic ultrasound system Intended Use: for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue Go is intended to be used in a hospital or medical clinic. Venue Go 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.
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Image /page/5/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 or flourishes 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.
| Technology: | The Venue Go employs the same fundamental scientific
technology as its predicate and reference devices. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of
Substantial Equivalence: | Comparison to Predicate Device
The Venue Go 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 Go and the predicate Venue Go.
• The proposed Venue Go and predicate Venue Go (K183362)
have similar clinical indications for use.
• Vascular has been added with peripheral vascular and for
intraoperative, 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. Non-vascular access (instead of nerve block) is
added as subcategory from the predicate IFU table. Fluid
drainage is added as it is 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.
• The IFU statement is updated to add "trained" to the operator
qualification for clarity however it was stated in 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:
• The proposed Venue Go and predicate Venue Go
(K183362) have identical imaging modes. |
- (INT85502) nave identical imaging inoucs.
The proposed Venue Go and predicate Venue Go . (K183362) systems transducers are similar, except for:
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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 a white border with wave-like designs.
GE Healthcare
510(k) Premarket Notification Submission
- Adding 12S-RS, which was first cleared on Vivid o q. K121062. The clinical indications of 12S-RS are the same on the proposed Venue as they are on the reference device Vivid iq, K121062.
- Adding L10-22-RS which was first cleared on O LOGIQ e, K133533. The clinical indications of L10-22-RS are similar on the proposed Venue as they are on the reference device LOGIO e. K133533.
- L4-20t-RS is a new transducer being added to the ● proposed Venue Go system. The L4-20t-RS has similar clinical indications for use as the predicate L4-12t-RS transducer which was first cleared on LOGIQ 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 predicate 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 Go (K183362) which is a similar transducer.
- L10-22-RS transducer: added Pediatric, cleared with o L8-18i-RS in predicate Venue Go (K183362) which is a similar transducer.
- L8-18i-RS transducer: added Ophthalmic, cleared o with 12L-RS in predicate Venue Go (K183362) which is a similar transducer.
- 8C-RS transducer: added Musculoskeletal O (Conventional and Superficial) and Adult cephalic, cleared with reference Venue (K180599).
- Removed Vascular Access application from 3Sc-RS, C1-5-RS and 6S-RS. No impact to safe or effective use.
- Adding Coded Pulse mode to Vascular/Peripheral Vascular, Vascular Access and Non-vascular on L10-22-RS.
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Features/Functionality:
- Simple Screen is a modification of Full Screen that is on predicate Venue Go (K183362).
- . 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 Go (K183362).
- cNeedle enhances the needle, and projects a trajectory line. Capabilities are similar to needle recognition that has been cleared on predicate Venue Go, K183362 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 Go, K183362.
- Added biopsy guidzones cleared on reference Versana Premier, K200138.
- Added additional off-the-shelf SW. ●
Accessories:
- Adding compatible OEM ECG triggering leads for . pediatrics, similarly to what is on predicate Vivid iq K181727.
- . Adding compatible OEM biopsy guide accessory compatibility for the C1-5-RS, and for 12L-RS and 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 a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the long-standing brand identity of General Electric.
Summary of Non-Clinical Tests:
The proposed Venue Go 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 Go complies with voluntary standards:
- o 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: ● 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 Devices-● 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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Summary of Clinical Tests: The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Venue Go to be as safe, as effective, and performance is substantially equivalent to the predicate device.