Venue Fit

K234106 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Jun 10, 2024 · Radiology

Device Facts

• Record ID: K234106
• Device Name: Venue Fit
• Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
• Product Code: IYN · Radiology
• Decision Date: Jun 10, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit 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 M Doppler, Color M 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.

Device Story

General purpose diagnostic ultrasound system; hospital/clinic use by authorized healthcare professionals. Inputs: ultrasound transducer signals; ECG trace (synchronized gating); barcode/RFID scanner. Operation: linear, convex, phased array transducers; B, M, Doppler, Harmonic, Coded Pulse modes. Output: real-time ultrasound images, measurements, and analysis displayed on system monitor. Features: Auto Volume Flow (AVF) for vessel inflow; Bladder Volume Tool; MSK diagrams; Venue Coach reference images. Connectivity: wired/wireless internet; DICOM-compliant for PACS/archiving. Benefits: facilitates interventional guidance (biopsy, drainage, access) and clinical assessment. System powered by wall outlet or internal battery; includes optional cart connectivity for wireless Vscan Air probes.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing per recognized standards (AAMI/ANSI ES60601-1, IEC 60601-2-37, ISO 10993-1).

Technological Characteristics

Diagnostic ultrasound system; linear, convex, phased array transducers. Materials: biocompatible patient-contact materials. Connectivity: wired/wireless, Bluetooth, DICOM. Power: AC or internal battery. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for ultrasound imaging, measurement, display, and analysis of human body and fluid in hospital/clinic settings. Patient populations include adult, pediatric, and neonatal patients across abdominal, thoracic, ophthalmic, OB/GYN, small organ, vascular, musculoskeletal, and cardiac applications.

Regulatory Classification

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.

Predicate Devices

• Venue Fit (K220848)

Reference Devices

• Vscan Air (K231301)
• LOGIQ P9 and LOGIQ P7 (K161047)
• LOGIQ E10s/LOGIQ Fortis (K231989)
• Voluson S8/ Voluson S10/ Voluson S10 Expert (K180374)
• Vscan Air (K202035)
• LOGIQ E10 (K211488)

Submission Summary (Full Text)

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June 10, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right, the FDA logo is displayed in blue, with the acronym "FDA" above the words "U.S. FOOD & DRUG" and "ADMINISTRATION" below.

GE Medical Systems Ultrasound and Primary Care Diagnostics % Karin Shimoni Regulatory Affairs manager 9900 Innovation Drive WAUWATOSA WI 53226

Re: K234106

Trade/Device Name: Venue Fit Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 8, 2024 Received: May 8, 2024

Dear Karin Shimoni:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Yanna S. Kang -S

Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team 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

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### Indications for Use

Submission Number (if known)

K234106

Device Name Venue Fit

Indications for Use (Describe)

The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.

Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit 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 M Doppler, Color M 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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510(k) Premarket Notification Submission

# 510(k) Summary - K234106

| Date: | December 26, 2023 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Karin Shimoni<br>Regulatory Affairs Manager<br>GE HealthCare<br>T: ([phone] |
| Secondary Contact Person: | Lee Bush<br>Regulatory Affairs Director<br>GE HealthCare<br>T: (262) 3099429 |
| Device Trade Name: | Venue Fit |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Primary Predicate Device: | K220848 Venue Fit, Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Reference Device(s): | K231301 Vscan Air |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Reference Device(s): | K161047 LOGIQ P9 and LOGIQ P7 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Reference Device(s): | K231989 LOGIQ E10s/LOGIQ Fortis |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Reference Device(s): | K180374 Voluson S8/ Voluson S10/ Voluson S10 Expert |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |
| Reference Device(s): | K202035 Vscan Air |
| Classification Names: | Class II |
| Product Code | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-<br>IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,<br>90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,<br>90-ITX |

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Image /page/4/Picture/0 description: The image contains the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, circular design in purple, while the text is also in purple.

510(k) Premarket Notification Submission

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510(k) Premarket Notification Submission

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 with full functionality and scanning.

The Venue Fit 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.

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.

Venue Fit is capable of wired or wireless internet connection. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as Q-Path) and allows for output to printing devices.

- Intended Use: The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit 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,

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Image /page/6/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare". The emblem and text are both in a purple color.

510(k) Premarket Notification Submission

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.

Re. Technology: The Venue Fit employs the same fundamental scientific technology as its predicate and reference devices.

Determination of Comparison to Predicate Device

The Venue Fit system is substantially equivalent to the predicate Substantial Equivalence: device with regards to imaging capabilities, technological characteristics and safety and effectiveness. All probes used with the proposed Venue Fit system are used unchanged from the cleared predicate. They are made of the same materials and their shape is unchanged.

> The following is an overview of the differences between the proposed Venue Fit and the predicate Venue Fit:

#### Indications for Use:

The proposed Venue Fit and predicate Venue Fit (K220848) have similar clinical indications for use, however the IFU statement is updated to add details to the operator qualification/profile for clarity. No change to the product and no impact to safe or effective use.

The proposed Venue Fit and predicate Venue Fit (K220848) have identical imaging modes.

Transducers:

The proposed Venue Fit and predicate Venue Fit (K220848) systems transducers are similar, except for

- . Addition of C2-9-RS which was first cleared on Voluson S8/ Voluson S10/ Voluson S10 Expert K180374. This probe is unchanged from the cleared reference device (K180374). It is made of the same materials and its shape is unchanged. The clinical indications of C2-9-RS are the same on the proposed Venue Fit as they are on the reference device LOGIQ E10 K211488 with C2-9-D probe. The C2-9-RS probe is the same as the C2-9-D except it uses an RS connector instead of a D connector. The transducer body is identical between the two.
- Addition of Vscan Air CL and SL probes. The Vscan Air CL was first cleared in K202035 and the Vscan Air SL was first cleared in K231301. The clinical indications of

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Image /page/7/Picture/0 description: The image contains the logo for GE HealthCare. The logo consists of a circular emblem with a stylized "GE" monogram in purple. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple.

510(k) Premarket Notification Submission

the Vscan Air CL and SL are identical as on the reference device Vscan Air K231301. The Vscan Air CL probe is cleared also on reference LOGIQ E10s/LOGIQ Fortis K231989.

- Addition of neonatal cephalic application on existing L10-● 22-RS probe. This application was already cleared with this probe on reference device LOGIQ P9 and LOGIQ P7 (K161047).
- Addition of PDI+ on existing ML6-15-RS probe (both ● imaging mode and probe are cleared on predicate Venue Fit (K220848).

#### Features/Functionality:

- Vscan Air CL and Vscan Air SL probes: The proposed Venue Fit system supports the Vscan Air CL and Vscan Air SL cleared in K231301. The Vscan Air CL probe is cleared also on reference LOGIQ E10s/LOGIQ Fortis K231989.
- Auto Volume Flow (AVF): The AVF tool is a semi-● automated tool intended to measure inflow in the vessel. It enables the user to perform a quick assessment, especially when measuring inflow in the artery of the fistula of a dialysis patient. The rate of volume flow is calculated using pulsed wave (PW) Doppler flow measurement.
- . Bladder Volume Tool: Bladder Volume Tool provides a simplified workflow for bladder volume measurement.
- MSK diagrams The MSK Diagram enables documenting ● and summarizing MSK exam in an anatomical view. On predicate Venue Fit K220848, the only diagram that was available for MSK preset was the shoulder diagram. On the proposed Venue Fit, diagrams are also added for the knee, wrist/hand, hip, elbow and ankle/foot.
- . Venue Coach: Venue Coach contains all the diagrams and reference images available in the proposed Venue Fit system. From the Venue Coach tab, user can configure a diagram, a reference image or both.
- Electronic delivery of SW: The proposed Venue Fit ● system now allows the user, in addition to service personnel, to update the SW by logging into a GEHC website to download SW available to them and install it on the system.
- . Expanding cleared Auto Inferior Vena Cava (IVC), Auto B-Lines, Real Time ejection fraction (RT-EF) and cNerve for Vscan Air CL and SL probes. These probes are

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Image /page/8/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is a stylized, intertwined "GE" in a circular frame. The text "GE HealthCare" is written in a simple, sans-serif font.

510(k) Premarket Notification Submission

already cleared on predicate Vscan Air K231301. The Vscan Air CL probe is cleared also on reference device LOGIQ E10s/LOGIQ Fortis K231989.

- AppAPI functionality: to facilitate future integration of ● multiple software components.
#### Hardware:

When Vscan Air CL and SL probes are to be used with the proposed Venue Fit system, then the cart on proposed Venue Fit is updated to include an optional connectivity solution that allows wireless and Bluetooth connectivity with the Vscan Air CL and SL probes and also provide power for the wireless charger.

#### Summary of Non-Clinical Tests:

The proposed Venue Fit 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 Fit complies with voluntary standards:

- . Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff, issued on February 21, 2023
- . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/ A2:2021
- 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 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, Fifth edition, 2018
- ISO 14971, Application of risk management to medical ● devices, 2019

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Image /page/9/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with the letters 'GE' inside. To the right of the emblem is the text 'GE HealthCare' in a matching purple color. The text is written in a clean, sans-serif font.

510(k) Premarket Notification Submission

- NEMA PS 3.1 3.20e, Digital Imaging and ● Communications in Medicine (DICOM) Set, 2021
- . AAMI TIR69, Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems, 2020

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.

#### Summary of Clinical Tests:

The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence.

- Conclusion: Based on the equipment design similarities, conformance to recognized performance standards, and performance testing, GE HealthCare considers the proposed Venue Fit to be as safe, Effective, and performs in a substantially equivalent manner as the predicate Venue Fit (K220848).