Venue Sprint 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.

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance.

Venue Sprint 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, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular access). Modes of operation include: B. M. PW Doppler, Color Doppler and Harmonic Imaging.

Device Description

Venue Sprint 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 Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.

AI/ML Overview

This document describes the Venue Sprint diagnostic ultrasound system (K240206). Based on the provided text, the device is an ultrasound system and does not appear to have AI/ML functionality that requires specific performance metrics beyond general safety and effectiveness. The document explicitly states that clinical studies were not required to support substantial equivalence.

Therefore, most of the requested information regarding acceptance criteria, specific performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this 510(k) summary for the Venue Sprint.

Here's an attempt to answer the questions based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain a specific table of acceptance criteria or performance metrics for an AI/ML component. The "acceptance criteria" for this device appear to be compliance with various safety and performance standards for diagnostic ultrasound systems.

Acceptance Criteria Category	Reported Device Performance Summary (from document)
Acoustic Output	Complies with applicable medical device safety standards.
Biocompatibility	Complies with applicable medical device safety standards; Transducer material is biocompatible.
Cleaning and Disinfection Effectiveness	Complies with applicable medical device safety standards.
Thermal, Electrical, Electromagnetic, and Mechanical Safety	Complies with applicable medical device safety standards.
Voluntary Standards Compliance	Complies with: - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance- AAMI/ANSI ES60601-1- IEC 60601-1-2- IEC 60601-2-37- IEC 62359- ISO 10993-1- ISO 14971- NEMA PS 3.1-3.20e (DICOM)- AAMI TIR69- IEC 60601-1-11- IEC 60601-1-12
Quality Assurance Measures	Risk Analysis, Requirements Reviews, Design Reviews, Testing (unit, integration, performance, safety)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "The subject of this premarket submission, Venue Sprint, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a test set, its sample size, or data provenance from clinical studies within this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document does not describe any AI-assisted features or MRMC studies. The device is described as a "general-purpose diagnostic ultrasound system." The phrase "expanding cleared Auto Inferior Vena Cava (IVC), Auto B-Lines, Real Time ejection fraction (RT-EF) and cNerve" refers to features already cleared on other predicate devices and their expansion to new probes on this system; it does not constitute a new AI feature with its own performance study described here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as no standalone algorithm performance study is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies requiring ground truth were conducted or described.

8. The sample size for the training set

Not applicable, as no machine learning model training is described in this submission.

9. How the ground truth for the training set was established

Not applicable, as no machine learning model training is described in this submission.

Summary

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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: K240206

Trade/Device Name: Venue Sprint Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 25, 2024 Received: May 9, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

K240206

Device Name

Venue Sprint

Indications for Use (Describe)

The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance.

Type of Use (Select one or both, as applicable)
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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 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 with swirling patterns inside. The text is in a sans-serif font and is colored in the same shade of purple as the emblem.

GE HealthCare 510(k) Premarket Notification Submission

510(k) Summary - K240206

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:Submitter:	January 25, 2024GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Karin ShimoniRegulatory Affairs ManagerGE HealthCareT: (+972) 546347710
Secondary Contact Person:	Lee BushRegulatory Affairs DirectorGE HealthCareT: (262) 3099429
Device Trade Name:Common/Usual Name:Classification Names:Product Code:	Venue SprintDiagnostic Ultrasound SystemClass IIUltrasonic 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:Classification Names:Product Code:	K220848 Venue Fit, Diagnostic Ultrasound SystemClass IIUltrasonic 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:	K231301 Vscan AirClass IIUltrasonic 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):	K170714 Venue
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):	K202035 Vscan Air
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):	K203137 Venue Fit
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):	K200851 Vivid T8, Vivid T9
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
Device Description:	Venue Sprint is a general-purpose diagnostic ultrasound systemintended for use by qualified and trained healthcare professionalsto evaluate the body by ultrasound imaging and fluid flowanalysis.The Venue Sprint is used together with the Vscan Air probes andprovides the user interface for control of the probes and theneeded software functionality for analysis of the ultrasoundimages and saving/storage of the related images and videos.
Intended Use:	Venue Sprint is a general-purpose diagnostic ultrasound systemfor use by qualified and trained healthcare professionals orpractitioners that are legally authorized or licensed by law in thecountry, state or other local municipality in which he or shepractices, for ultrasound imaging, measurement, display andanalysis of the human body and fluid. The users may or may not

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GE HealthCare 510(k) Premarket Notification Submission

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GE HealthCare 510(k) Premarket Notification Submission

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. The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance. Venue Sprint 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, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler and Harmonic Imaging.

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

Determination of Comparison to Predicate Device

Substantial Equivalence: The Venue Sprint system is substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. All probes used with the proposed Venue Sprint 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 Sprint and the predicate Venue Fit:

Indications for Use:

The proposed Venue Sprint and predicate Venue Fit ● (K220848) have similar clinical indications for use, however the IFU statement is updated to be consistent with the wording cleared for predicate Vscan Air K231301:
- Add details to the operator qualification/profile O
- Add "free hand", as the method for tissue biopsy O
- Add "40 kg and above" for cardiac (pediatric) O application
The proposed Venue Sprint and predicate Venue Fit (K220848) have similar use-environments, however Venue Sprint is to be used also in home environment and road/air ambulance. No impact to safe or effective use. This is consistent with the use-environments of the cleared predicate Vscan Air K231301

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Image /page/6/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram on the left. To the right of the emblem, the words "GE HealthCare" are written in a simple, sans-serif font, also in purple. The logo is clean and modern, reflecting the company's focus on healthcare technology and innovation.

GE HealthCare

510(k) Premarket Notification Submission

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

Transducers:

Vscan Air CL and SL probes on proposed Venue Sprint: The Vscan Air CL was first cleared in K202035 and the Vscan Air SL was first cleared in K231301. The clinical indications of the Vscan Air CL and SL are identical as on the reference device Vscan Air K231301.

Features/Functionality:

Vscan Air CL and Vscan Air SL probes: The proposed ● Venue Sprint system supports the Vscan Air CL and Vscan Air SL cleared in K231301.
. 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 Sprint, 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 Sprint system. From the Venue Coach tab, user can configure a diagram, a reference image or both.
Electronic delivery of SW: The proposed Venue Sprint . system 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 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:

The Venue Sprint software can be installed on a Windows-based off-the-shelf (OTS) consumer display device (tablet). Similar to predicate Venue Fit K220848, the tablet can be attached to a

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Image /page/7/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with the letters "GE" inside, followed by the text "GE HealthCare" in purple. The text is written in a clean, sans-serif font.

GE HealthCare

510(k) Premarket Notification Submission

mobile cart. The cart of proposed Venue Sprint provides power for the wireless charger of Vscan Air CL and SL probes.

Summary of Non-Clinical Tests:

The proposed Venue Sprint 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 Sprint 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
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
IEC 60601-1-11, Medical Electrical Equipment Part 1-● 11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment, 2020

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Image /page/8/Picture/1 description: The image contains the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside. To the right of the emblem, the words "GE HealthCare" are written in purple sans-serif font. The text is aligned horizontally with the emblem.

GE HealthCare

510(k) Premarket Notification Submission

IEC 60601-1-12, Medical Electrical Equipment Part 1-. 12: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Intended For Use In The Emergency Medical Services Environment, 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 are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Venue Sprint, 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 Sprint to be as safe, Effective, and performs in a substantially equivalent manner as the predicate Venue Fit (K220848).

Regulation Number and Section

§ 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.