Who is the manufacturer of Critical Care Suite with Endotracheal Tube Positing AI algorithm?

Ge Medical Systems, LLC filed the 510(k) submission for Critical Care Suite with Endotracheal Tube Positing AI algorithm (K211161).

What is the FDA product code for Critical Care Suite with Endotracheal Tube Positing AI algorithm?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Critical Care Suite with Endotracheal Tube Positing AI algorithm?

510(k) clearance (submission type: Traditional).

Does Critical Care Suite with Endotracheal Tube Positing AI algorithm use AI or machine learning?

Yes. Critical Care Suite with Endotracheal Tube Positing AI algorithm (K211161) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Critical Care Suite with Endotracheal Tube Positing AI algorithm?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Critical Care Suite with Endotracheal Tube Positing AI algorithm

Q: What are the predicate devices for Critical Care Suite with Endotracheal Tube Positing AI algorithm?

QLAB Advanced Quantification Software (K191647).

Q: Can an AI/ML device like Critical Care Suite with Endotracheal Tube Positing AI algorithm get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K211161 · Ge Medical Systems, LLC · QIH · Oct 29, 2021 · Radiology

Device Facts

Record ID	K211161
Device Name	Critical Care Suite with Endotracheal Tube Positing AI algorithm
Applicant	Ge Medical Systems, LLC
Product Code	QIH · Radiology
Decision Date	Oct 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Critical Care Suite with Endotracheal Tube Positioning Al Algorithm is intended to provide automated radiological image processing and analysis tools implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data.

Device Story

Critical Care Suite with Endotracheal Tube Positioning AI Algorithm is a software-based quantification tool for frontal chest X-rays. It processes digital X-ray images to detect and localize the endotracheal tube (ETT), identify the ETT tip and carina, and calculate the vertical distance between them. The device provides an on-screen overlay for immediate review by healthcare professionals at the point of care (e.g., mobile X-ray systems) and transmits findings to radiologists via PACS. It is designed to assist clinical teams in assessing proper ETT placement. The algorithm is a locked deep learning model. It does not account for geometric magnification, patient rotation, or tube rotation. The device is intended for adult patients and is deployable on various platforms including PACS, on-premise, cloud, and digital radiographic systems.

Clinical Evidence

Performance evaluated against a ground truth dataset. Results: ETT detection AUC 0.9999 (95% CI: 0.9998, 1.0000), sensitivity 0.9941 (95% CI: 0.9859, 1.0000), specificity 1.0000 (95% CI: 1.0000, 1.0000). ETT tip to Carina distance measurement success rate 0.9851 (95% CI: 0.9722, 0.9981). Carina localization success rate 0.9851 (95% CI: 0.9722, 0.9981). ETT tip localization success rate 0.9524 (95% CI: 0.9296, 0.9752). ETT localization (DICE) 0.9881 (95% CI: 0.9765, 0.9997).

Technological Characteristics

Deep learning locked AI algorithm. Deployable on PACS, on-premise, cloud, or imaging systems. Performs automated radiological image processing and analysis. Quantifies vertical distance between ETT tip and carina in the X-ray detector imaging plane.

Indications for Use

Indicated for adult-sized patients. Automated image analysis of frontal chest X-rays acquired on a digital x-ray system to detect/localize endotracheal tube (ETT), locate ETT tip and carina, and calculate vertical distance between ETT tip and carina. Intended for use by licensed qualified healthcare professionals and radiologists. Not for use in-lieu of full patient evaluation or as sole basis for diagnosis; not intended to replace professional review of X-ray image.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

QLAB Advanced Quantification Software (K191647)

Reference Devices

Critical Care Suite (K183182)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 29, 2021 GE Medical Systems, LLC Chris Paulik Regulatory Affairs Program Manager 3000 N. Grandview Blvd WAUKESHA, WI 53188 Re: K211161 Trade/Device Name: Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: QIH Dated: September 27, 2021 Received: September 28, 2021 Dear Chris Paulik: 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K21161 #### Device Name Critical Care Suite with Endotracheal Tube Positioning AI Algorithm #### Indications for Use (Describe) Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system. Critical Care Suite with the Endotracheal Tube Position produces an on-screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endoracheal tube tip and carina. This information is also transmitted to the radiologist for review. Intended users include licensed qualified healthcare professionals (HCPs) trained to independently place and/or assess endotracheal tube placement and radiologists. Critical Care Suite with the Endotracheal Tube Positioning AI Algorithm should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to review of the X-ray image by a qualified healthcare professional. Critical Care Suite with the Positioning AI Algorithm is indicated for adult-sized patients. 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | September 27, 2021 | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Healthcare, (GE Medical Systems, LLC) 3000 N. Grandview Blvd Waukesha, WI 53188 USA | | Primary Contact Person: | Chris Paulik Regulatory Affairs Program Manager GE Healthcare 262-894-5415 Christopher.A.Paulik@ge.com | | Secondary Contact Person: | Diane Uriell Regulatory Affairs Director GE Healthcare 262-290-8218 Diane.Uriell@ge.com | | Device Trade Name: | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm | | Common / Usual Name: | Automated Radiological Image Processing Software | | Classification Names and Product Code: | Regulation Name: Medical Image Management and Processing System Regulation: 21 CFR 892.2050 Classification: Class II Product Codes: QIH | | Predicate Device: | QLAB Advanced Quantification Software (K191647) Regulation Name: Picture archiving and communications system Regulation: 21 CFR 892.2050 Classification: Class II | | | Product Codes: QIH | | Reference Device: | Critical Care Suite (K183182) Regulation Name: Radiological computer aided triage and notification software Regulation: 21 CFR 892.2080 Classification: Class II Product Codes: QFM | | Device Description: | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm is an additional AI Algorithm incorporated into the Critical Care Suite software previously cleared under K183182. It introduces the Endotracheal Tube Positioning Al Algorithm which is a quantification tool that analyzes frontal chest x-ray images and based on the data in the image determines the location of the tip of an intubated patient's endotracheal tube, determines the location of the carina, and then calculates and displays the vertical distance between them. The distance provided is within the x-ray detector imaging plane and does not take into account the geometric magnification resultant from the geometry of the x-ray acquisition based on source to image distance (SID), patient size, or any impacts due to patient rotation or tube rotation. This information can aide clinical care teams and radiologists to determine the proper placement of the endotracheal tube in an intubated patient. All algorithms previously cleared under K183182 are still available with Critical Care Suite, including the Pneumothorax Detection Algorithm for triage and notification. The benefit of the proposed modification is not specific to the platform on which it is deployed. This benefit applies to all previously cleared computational platforms for Critical Care Suite, including PACS, On Premise, On Cloud and Digital Projection Radiographic Systems. The Optima XR240amx was chosen as the initial platform for deployment because endotracheal tube placement images are almost exclusively acquired on mobile X-ray systems due to the immobilization of the patients being intubated with an endotracheal tube. | | Intended Use: | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm is intended to provide automated radiological image processing and analysis tools implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. | | Indications for Use: | Critical Care Suite is a suite of Al algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system. Critical Care Suite with the Endotracheal Tube Positioning AI algorithm produces an on- screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review. | | | Intended users include licensed qualified healthcare professionals (HCPs) trained to independently place and/or assess endotracheal tube placement and radiologists. | | | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray image by a qualified healthcare professional. Critical Care Suite with the Endotracheal Tube Positioning Al Algorithm is indicated for adult-size patients. | | Technology: | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm employs the same fundamental scientific technology as its predicate device. It is a deep learning locked AI algorithm that can be deployed on several computing platforms such as PACS, On Premise, On Cloud or Imaging Systems. The patient and user populations are identical to what is provided with Critical Care Suite, adult-sized patients. The Endotracheal Tube Positioning Al Algorithm is an automated radiological image processing and analysis tool, which is equivalent to the image analysis and quantification algorithms provided in the QLAB Advanced Quantification Software. | | | The differences between Critical Care Suite with Endotracheal Tube Positioning AI Algorithm and QLAB Advanced Quantification Software are the acquisition systems that provide the images as well as the specific anatomies that are being analyzed. Critical Care Suite with Endotracheal Tube Positioning Al Algorithm analyzes chest radiographic images where QLAB Advanced Quantification Software analyzes ultrasound images of the heart. This difference does not impact the safety or efficacy of Critical Care Suite with Endotracheal Tube Positioning Al Algorithm since both devices analyze images using deep learning Al technology to identify/visualize anatomical structure and then provide quantification measurements based on that data to aide qualified healthcare professionals trained on endotracheal tube placement and radiologists. | {5}------------------------------------------------ {6}------------------------------------------------ | Product Device | Critical Care Suite with Endotracheal Tube | QLAB Advanced Quantification Software | |---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Comparison | Positioning Al Algorithm | (K191647) | | Device | Picture archiving and communications system | Picture archiving and communications system | | Classification | Class II, QIH | Class II, QIH | | Targeted clinical condition, anatomy, and imaging modality | Endotracheal Tube Positioning Visualization and Quantification Chest/Lung Frontal Chest X-Ray Imaging | Right Ventricle Visualization and Quantification Heart Ultrasound Heart Imaging | | Algorithm Inferencing Mechanism | Al deep learning algorithms designed to visualize and quantify endotracheal tube positioning in frontal chest X-ray images | Al deep learning algorithm designed to visualize and quantify the right ventricle within heart ultrasound images | {7}------------------------------------------------ | Product Device Comparison | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm | QLAB Advanced Quantification Software (K191647) | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Computational Platform | On-Device computation (integrated onto x-ray system) Critical Care Suite with Endotracheal Tube Positioning AI Algorithm is designed as a self- contained software module deployable on various computational and imaging system platforms. | Provided as stand-alone product that can function on a standard PC, a dedicated workstation, and on- board Philips' ultrasound systems. | | Notification / Visualization Recipient and Timing | qualified healthcare professionals trained on endotracheal tube placement – immediately on device upon image acquisition for Endotracheal Tube Positioning AI Algorithm Radiologist – immediately after images are sent to PACS via secondary capture image and DICOM tag | Clinical Care Team - immediately upon image acquisition on device Radiologist - immediately after images are sent to PACS | | Algorithm Outputs | Visualization ● Endotracheal tube ● Endotracheal Tube Tip ● Carina Quantification ● Vertical distance between endotracheal tube tip and carina | Visualization ● 3D surface modeling of anatomical landmarks of right ventricle Quantification ● Numerous distance and volumetric measurements concerning the right ventricle | | Clinical and Non-Clinical Tests: | Summary of Non-Clinical Tests: | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The following quality assurance measures were applied to the development of Critical Care Suite with Endotracheal Tube Positioning AI Algorithm and deployment onto the Optima XR240amx system: | | | 1. Risk Analysis | | | 2. Requirements Reviews | | | 3. Design Reviews | | | 4. Testing on unit level (Module verification) | | | 5. Integration testing (System verification) | | | 6. Performance testing (Verification) | | | 7. Safety testing (Verification) | | | 8. Simulated use testing (Validation) | {8}------------------------------------------------ | | Critical Care Suite with Endotracheal Tube Positioning Al Algorithm specific verification was conducted to demonstrate proper implementation of Critical Care Suite software design requirements. | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Regression testing on the Optima XR240amx feature functionality was conducted to verify proper integration of Critical Care Suite with Endotracheal Tube Positioning AI Algorithm into the Optima XR240amx software and device. Validation was performed on Optima XR240amx with integrated Critical Care Suite with Endotracheal Tube Positioning Al Algorithm. | | | Design verification and validation testing was performed to confirm that the safety and effectiveness of the device has not been affected. The test plans and results have been executed with acceptable results. | | | Summary of Clinical Tests: | | | The performance of the Endotracheal Tube Positioning Al Algorithm was tested against a ground truth dataset. The ground truth dataset contained a sufficient number of images to adequately analyze all the primary and secondary endpoints and the results met the defined passing criteria. | | | The Endotracheal Tube Positioning Al Algorithm achieved an AUC of 0.9999 (0.9998, 1.0000), a sensitivity of 0.9941 (0.9859, 1.0000) and a specificity of 1.0000 (1.0000, 1.0000) for ETT detection. Additionally, the Endotracheal Tube Positioning Al Algorithm achieved an ETT tip to Carina distance measurement success rate of 0.9851 (0.9722, 0.9981), a carina localization success rate 0.9851 (0.9722, 0.9981), an ETT tip localization success rate of 0.9524 (0.9296, 0.9752) and an ETT localization success rate (DICE) of 0.9881 (0.9765, 0.9997). | | Determination of Substantial Equivalence: | The introduction of Critical Care Suite with Endotracheal Tube Positioning Al Algorithm does not result in any new potential safety risks, and has the same technological characteristics, and performs as well as the predicate devices currently on the market. | | | After analyzing design verification and validation testing on the bench it is the conclusion of GE Healthcare that the Critical Care Suite with Endotracheal Tube Positioning AI Algorithm software to be as safe, as effective, and performance is substantially equivalent to the predicate device. |