(96 days)
K202132 Venue, Diagnostic Ultrasound System
Yes
The summary explicitly mentions "algorithm performance" and describes a "training process" and "verification dataset" with "ground truth annotations" used to assess the accuracy of "cNerve detections" of "nerve bundles". This strongly indicates the use of an algorithm trained on data, which is characteristic of machine learning.
No
Explanation: The device is described as a "general purpose diagnostic ultrasound system" and its intended use is for "ultrasound imaging, measurement, display and analysis." It does not mention treating or curing any conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The Venue is a general purpose diagnostic ultrasound system". The "Device Description" also mentions "The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device".
No
The device description clearly states it is a "general-purpose, Track 3, diagnostic ultrasound device" and describes physical components like a monitor, user interface, articulated monitor arm, barcode reader, RFID scanner, battery, and transducers. This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided text, the Venue device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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." This describes a device used on the human body for imaging, not a device used to test samples from the human body in a laboratory setting.
- Device Description: The description details a mobile ultrasound system with probes, a monitor, and features for image acquisition and display. This aligns with an in-vivo imaging device, not an in-vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVD devices are designed for such purposes.
The device is a diagnostic imaging system used directly on patients.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device; PCCP is listed as "Not Found" in the document.
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), 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.
Product codes (comma separated list FDA assigned to the subject device)
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 system is capable of 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 which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.
A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system.
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.
System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.
The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.
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)
Indicated Patient Age Range
neonatal, pediatric, adult
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
Dataset: Test dataset representative of the Nerve block scouting procedures which cNerve supports was assessed for accuracy. Test dataset included 124 sequences, and 3776 frames.
The number of individuals images were collected from: A total of 44 individuals contributed to the verification dataset.
The number of samples, if different from above, and the relationship between the two: Each individual contributed up to 2 sequences per view location. Often both laterals (left and right) were scanned. Test dataset included 124 sequences, and 3776 frames.
Demographic distribution including: Gender: Male and Female, Age: 18-82 years, Ethnicity/Country: USA, Japan, Israel
Information about clinical subgroups and confounders present in the dataset: The algorithm performance was verified via frame accuracy on all demographic subgroups: Gender (M/F), Age (=60), BMI (25). Similarly, it was tested for all supported nerve block locations and all supported probe types.
Information about equipment and protocols used to collect images: Mix of data from across five different probes in the appropriate nerve mode, and three different Console variants.
Information about how the reference standard was derived from the dataset (i.e. the "truthing" process): Ground truth annotations of the verification dataset were obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame.
Description of how independence of test data from training data was ensured: The data used for verification is completely distinct from that used during training process and there is no overlap between the two.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
AI Summary of Testing: cNerve:
Appropriateness of the characterized performance:
- Success criteria were based on conformance of the cNerve detections to ground truth annotations of nerve bundles in individual frames. Since the intended use is nerve tracking during scouting rather than nerve segmentation accuracy, success criteria were derived via a preliminary survey. The target of the survey was to identify thresholds for pixel accuracy in frames and for frame accuracy in sequences that are appropriate for the intended use.
- cNerve performance requirements.
- Sequence accuracy requirement for testing overall cNerve performance: At least 70% of the sequences are meaningfully detected, and at least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria).
Summary of Clinical Tests: 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): 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.
K202132 Venue, 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.
K210438 Versana Premier, Diagnostic Ultrasound System, K161706 Vivid iq, Diagnostic Ultrasound System, K203114 LOGIQ P10, Diagnostic Ultrasound System, K210426 HS40, Diagnostic Ultrasound System, K202658 Vivid E95, Diagnostic Ultrasound System, K182234 Optima XR240amx, Mobile X-ray system
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
June 27, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
GE Medical Systems % Lee Bush Regulatory Affairs Director Ultrasound and Primary Care Diagnostics, LLC 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K220851
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: May 24, 2022 Received: May 25, 2022
Dear Lee Bush:
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); 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 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,
For
Michael D. O'Hara, Ph.D. Deputy Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/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. There are four white flourishes around the circle, one in each quadrant. The logo is simple and recognizable.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K220851
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), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), 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, Harnonic 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)
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 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 (7/17)
Page 1 of 1
PSC Publishing Services (101) 443-6740 12
3
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 white inside. The letters are stylized and connected, and there are water droplets around the letters. The logo is simple and recognizable, and it is associated with a large and well-known company.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | June 17, 2022 |
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Lee Bush |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T: (262) 3099429 | |
| Secondary Contact Person: | Karin Shimoni |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Device Trade Name: | Venue |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | 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: | K202132 Venue, Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | 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 | |
| Reference Device(s): | |
| Classification Names: | |
| Product Code: | K210438 Versana Premier, Diagnostic Ultrasound System |
| Class II | |
| 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 | |
| Reference Device(s): | |
| Classification Names: | |
| Product Code: | K161706 Vivid iq, Diagnostic Ultrasound System |
| Class II | |
| 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 | |
| Reference Device(s): | |
| Classification Names: | |
| Product Code: | K203114 LOGIQ P10, Diagnostic Ultrasound System |
| Class II | |
| 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 | |
| Reference Device(s): | |
| Classification Names: | |
| Product Code: | K210426 HS40, Diagnostic Ultrasound System |
| Class II | |
| 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 | |
| Reference Device(s): | |
| Classification Names: | |
| Product Code: | K202658 Vivid E95, Diagnostic Ultrasound System |
| Class II | |
| 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; Diagnostic intravascular catheter, 21 CFR 870.1200, 90- | |
| OBJ | |
| Reference Device(s): | |
| Classification Names: | |
| Product Code: | K182234 Optima XR240amx, Mobile X-ray system |
| Class II | |
| Mobile x-ray system 21 CFR 892.1720 IZL, Solid state x-ray | |
| imager 892.1680 MOB |
4
Image /page/4/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. Three curved lines, resembling water droplets or stylized flames, surround the circle, adding a dynamic element to the design. The logo is simple, recognizable, and associated with the multinational conglomerate.
GE Healthcare
510(k) Premarket Notification Submission
5
Image /page/5/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 also four curved lines emanating from the circle, resembling water droplets or stylized flourishes. The logo is simple, clean, and recognizable.
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 system is capable of 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 which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.
A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system.
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.
System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices.
The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.
6
Image /page/6/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 three water droplet-like shapes surrounding the circle. The logo is simple and recognizable, representing the company's brand identity.
The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments.
The user documentation is available electronically.
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. The Venue employs the same fundamental scientific technology 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. All probes used with the proposed Venue system are used unchanged from the cleared predicate. They are made of the same materials and their shape is unchanged. The proposed Venue and predicate Venue (K202132) have identical clinical indications for use. The proposed Venue and predicate Venue (K202132) have identical imaging modes. The following is an overview of the differences between the
7
Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white, stylized script in the center. There are three white swirls around the letters, positioned at the top, left, and right of the circle. The logo is simple and recognizable, representing the company's brand.
GE Healthcare
510(k) Premarket Notification Submission
proposed Venue and the predicate Venue:
The proposed Venue and predicate Venue (K202132) systems transducers are similar, except for:
- Additions of M5Sc-RS which was first cleared on Vivid . iq K 161706. This probe is used unchanged from the cleared reference device (K161706). It is made of the same materials and its shape is unchanged. The clinical indications of M5Sc-RS are the same on the proposed Venue as they are on the reference device Vivid E95 K202658 with M5Sc-D probe. The M5Sc-RS probe is the same as the M5Sc-D except it uses an RS connector instead of a D connector. The transducer body is identical between the two.
- New applications are added to the following transducers: ●
- o M5Sc-RS transducer: added Ophthalmic application. This application was already cleared with 3Sc-RS in predicate Venue (K202132) which is a similar transducer.
- 3Sc-RS, E8C-RS, 6S-RS, 12S-RS: added o Nonvascular access to the Interventional guidance application which was already cleared with these probes on reference device Versana Premier (K210438).
Features/Functionality:
- . Scribble: assists the user during system training and teaching by providing a touch-operated pointer and free drawing capabilities.
- Power Doppler Imaging+ (PDI+): is intended for slow blood flows like those found in wrists, ankles, hands, and feet.
- . Catheter Vessel Ratio: a measurement that supports clinicians in selecting the appropriate sized catheter based on vessel diameter.
- . Probe Check: provides an automated probe element check and notifies user of potential probe issue.
- . Shoulder Diagram: simplifies documentation and assists the clinician in the follow up for patients with suspected shoulder disorders. Is similar to the Renal Diagram feature previously available on the cleared predicate Venue (K202132), except it does not contain an anatomical organ
8
Image /page/8/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 circle. There are three water droplet shapes evenly spaced around the outside of the circle. The logo is blue and the background is white.
drawing and the question/request that appears to the user is tailored to the shoulder region.
- . cNerve: may help the user to detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material. Is similar to the NerveTrack tool on cleared reference HS40 system by Samsung (K210426). The cNerve tool on proposed Venue system is available for adults only.
- Expanding B-lines tool for pediatrics (excluding neonates). This allows Lung sweep and Lung Diagram to pediatrics (excluding neonates) as well. B-lines tool is available on the cleared predicate Venue (K202132) for adults only.
- Expanding Real-Time Ejection Fraction (EF) to pediatrics ● (excluding neonates). Real-Time EF tool is available on the cleared predicate Venue (K202132) for adults only.
- Updates to software related to workflow improvements. .
Hardware:
New Back-End (BE) accelerated processing unit (APU), with similar functionality as computation hardware on the cleared predicate Venue K202132. The processor selected is also used on other cleared systems from the Venue family.
Accessories:
- Adding compatible OEM biopsy guides (for 3Sc-RS, . E8C-RS and M5Sc-RS transducers).
- Adding RFID scanner that enables easy login/logout using . a badge. This capability is similar to RFID option on reference device Optima XR240amx, K182234.
9
Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white, stylized script in the center. There are three white swirls around the letters, positioned at the top, left, and right of the circle. The logo is simple and recognizable, representing the company's brand.
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: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2020
- . IEC 60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- 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.
10
Image /page/10/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. There are also three curved lines that surround the circle, giving the impression of motion or energy. The logo is simple, recognizable, and has been used by GE for many years.
AI Summary of Testing
cNerve:
Summary test statistics and other results including acceptance criteria and information supporting the appropriateness of the characterized performance
Dataset:
- . Test dataset representative of the Nerve block scouting procedures which cNerve supports was assessed for accuracy.
- . Test dataset included 124 sequences, and 3776 frames.
Appropriateness of the characterized performance:
- Success criteria were based on conformance of the cNerve ● detections to ground truth annotations of nerve bundles in individual frames. Since the intended use is nerve tracking during scouting rather than nerve segmentation accuracy, success criteria were derived via a preliminary survey. The target of the survey was to identify thresholds for pixel accuracy in frames and for frame accuracy in sequences that are appropriate for the intended use.
- cNerve performance requirements. ●
- Sequence accuracy requirement for testing overall ● cNerve performance: At least 70% of the sequences are meaningfully detected, and at least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria).
The number of individuals images were collected from:
-
A total of 44 individuals contributed to the verification ● dataset.
The number of samples, if different from above, and the relationship between the two: -
Each individual contributed up to 2 sequences per view location. Often both laterals (left and right) were scanned.
-
. Test dataset included 124 sequences, and 3776 frames.
Demographic distribution including:
- Gender: Male and Female
- Age: 18-82 years ●
- Ethnicity/Country: USA, Japan, Israel ●
11
Image /page/11/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 also some white swirls around the letters. The logo is simple and recognizable.
Information about clinical subgroups and confounders present in the dataset:
- The algorithm performance was verified via frame ● accuracy on all demographic subgroups: Gender (M/F), Age (=60), BMI (25).
- Similarly, it was tested for all supported nerve block locations and all supported probe types.
Information about equipment and protocols used to collect images:
-
Mix of data from across five different probes in the appropriate nerve mode, and three different Console variants.
Information about how the reference standard was derived from the dataset (i.e. the "truthing" process): -
Ground truth annotations of the verification dataset were . obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame.
Description of how independence of test data from training data was ensured: -
The data used for verification is completely distinct from . that used during training process and there is no overlap between the two.
Summary of Clinical Tests:
The subject of this premarket submission, Venue, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Venue to be as safe, as effective, and Conclusion: performance is substantially equivalent to the predicate device.