(185 days)
BoneView (K212365)
Yes
The document explicitly and repeatedly states that the device is a "suite of AI algorithms" and uses "deep learning locked AI algorithms" for image analysis.
No
The device aids in diagnosis and workflow prioritization but does not directly treat or provide therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax." It also serves as a "concurrent reading aide during interpretation of radiographs" and assists in the "detection / diagnosis of pneumothoraxes."
Yes
The device is explicitly described as a "software module" and a "suite of Al algorithms" that can be deployed on various computing platforms, without mentioning any accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The Critical Care Suite with Pneumothorax Detection AI Algorithm analyzes frontal chest X-ray images. This is image analysis, not the analysis of biological samples.
The device falls under the category of medical imaging software or a computer-aided detection/triage device, which is distinct from an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Critical Care Suite with Pneumothorax Detection AI Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax. Critical Care Suite identifies and highlights images with a pneumothorax to enable case prioritization or triage and assist as a concurrent reading aide during interpretation of radiographs.
Intended users include qualified independently licensed healthcare professionals (HCPs) trained to independently assess the presence of pneumothoraxes in radiographic images and radiologists.
Critical Care Suite 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 physician. Critical Care Suite is indicated for adults and Transitional Adolescents (18 to
§ 892.2090 Radiological computer-assisted detection and diagnosis software.
(a)
Identification. A radiological computer-assisted detection and diagnostic software is an image processing device intended to aid in the detection, localization, and characterization of fracture, lesions, or other disease-specific findings on acquired medical images (e.g., radiography, magnetic resonance, computed tomography). The device detects, identifies, and characterizes findings based on features or information extracted from images, and provides information about the presence, location, and characteristics of the findings to the user. The analysis is intended to inform the primary diagnostic and patient management decisions that are made by the clinical user. The device is not intended as a replacement for a complete clinician's review or their clinical judgment that takes into account other relevant information from the image or patient history.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithm, including a description of the algorithm inputs and outputs, each major component or block, how the algorithm and output affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide improved assisted-read detection and diagnostic performance as intended in the indicated user population(s), and to characterize the standalone device performance for labeling. Performance testing includes standalone test(s), side-by-side comparison(s), and/or a reader study, as applicable.
(iii) Results from standalone performance testing used to characterize the independent performance of the device separate from aided user performance. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, positive and negative predictive values, and diagnostic likelihood ratio). Devices with localization output must include localization accuracy testing as a component of standalone testing. The test dataset must be representative of the typical patient population with enrichment made only to ensure that the test dataset contains a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant disease, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Results from performance testing that demonstrate that the device provides improved assisted-read detection and/or diagnostic performance as intended in the indicated user population(s) when used in accordance with the instructions for use. The reader population must be comprised of the intended user population in terms of clinical training, certification, and years of experience. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, positive and negative predictive values, and diagnostic likelihood ratio). Test datasets must meet the requirements described in paragraph (b)(1)(iii) of this section.(v) Appropriate software documentation, including device hazard analysis, software requirements specification document, software design specification document, traceability analysis, system level test protocol, pass/fail criteria, testing results, and cybersecurity measures.
(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the device instructions for use, including the intended reading protocol and how the user should interpret the device output.
(iii) A detailed description of the intended user, and any user training materials or programs that address appropriate reading protocols for the device, to ensure that the end user is fully aware of how to interpret and apply the device output.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) A detailed summary of the performance testing, including test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as anatomical characteristics, patient demographics and medical history, user experience, and imaging equipment.
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GE Medical Systems, LLC % Chris Paulik Regulatory Affairs Manager 3000 N. Grandview Blvd. WAUKESHA WI 53188
May 25, 2023
Re: K223491
Trade/Device Name: Critical Care Suite with Pneumothorax Detection AI Algorithm Regulation Number: 21 CFR 892.2090 Regulation Name: Radiological computer assisted detection and diagnosis software Regulatory Class: Class II Product Code: QBS Dated: April 26, 2023 Received: April 27, 2023
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
223491
Device Name
Critical Care Suite with Pneumothorax Detection AI Algorithm
Indications for Use (Describe)
Critical Care Suite with Pneumothorax Detection AI Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax. Critical Care Suite identifies and highlights images with a pneumothorax to enable case prioritization or triage and assist as a concurrent reading aide during interpretation of radiographs.
Intended users include qualified independently licensed healthcare professionals (HCPs) trained to independently assess the presence of pneumothoraxes in radiographic images and radiologists.
Critical Care Suite 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 physician. Critical Care Suite is indicated for adults and Transitional Adolescents (18 to ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 25, 2023 | |
|---|---|---|
| Submitter: | GE HealthCare, (GE Medical Systems, LLC) | |
| 3000 N. Grandview Blvd | ||
| Waukesha, WI 53188 USA | ||
| Primary | ||
| Contact | ||
| Person: | Chris Paulik | |
| Senior Regulatory Affairs Manager | ||
| GE HealthCare | ||
| 262-894-5415 | ||
| Christopher.A.Paulik@ge.com | ||
| Secondary | ||
| Contact | ||
| Person: | Gregory Pessato | |
| Regulatory Affairs Director | ||
| GE HealthCare | ||
| +33 (6) 34423240 | ||
| GregoryPessato@ge.com | ||
| Device Trade | ||
| Name: | Critical Care Suite with Pneumothorax Detection Al Algorithm | |
| Common / | ||
| Usual Name: | Radiological computer assisted detection and diagnosis software | |
| Classification | ||
| Names and | ||
| Product Code: | Regulation Name: Radiological computer assisted detection and diagnosis software | |
| Regulation: 21 CFR 892.2090 | ||
| Classification: Class II | ||
| Product Codes: QBS | ||
| Predicate | ||
| Device: | BoneView (K212365) | |
| Regulation Name: Radiological computer assisted detection and diagnosis software | ||
| Regulation: 21 CFR 892.2090 | ||
| Classification: Class II | ||
| Product Codes: QBS | ||
| 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 is a suite of Al algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system for the presence of critical findings. Critical Care Suite with Pneumothorax Detection Al Algorithm is indicated for adults and transitional adolescents (18 to |