(24 days)
Not Found
Yes
The device description explicitly states that the software "uses artificial intelligence to emulate the expertise of sonographers."
No
The device is described as an accessory to diagnostic ultrasound systems intended to assist medical professionals in acquiring cardiac ultrasound images, not to treat a condition.
No
The device is an accessory to diagnostic ultrasound systems, intended to assist in image acquisition, not to perform diagnosis itself.
Yes
The device description explicitly states, "Caption Guidance is a software-only device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist medical professionals in the acquisition of cardiac ultrasound images." This is focused on the process of obtaining images, not on analyzing biological samples or providing diagnostic information from those samples.
- Device Description: The description emphasizes providing "real-time user guidance during acquisition of echocardiography" and assisting in "obtaining anatomically correct images." This reinforces its role in image acquisition, not in vitro analysis.
- Lack of In Vitro Activity: There is no mention of the device interacting with biological samples (blood, tissue, etc.) or performing any tests on them. IVDs are specifically designed to analyze these types of samples.
- Input Modality: The input is "two-dimensional transthoracic echocardiography (2D-TTE)," which is an imaging modality, not an in vitro test.
The device is clearly focused on improving the quality and consistency of ultrasound image acquisition, which is a crucial step in the diagnostic process, but it does not perform the diagnostic test itself.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible qeneral purpose diagnostic ultrasound systems.
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
Product codes
QJU
Device Description
The Caption Guidance software is a radiological computer assisted acquisition quidance system that provides real-time user guidance during acquisition of echocardiography to assist the user in obtaining anatomically correct images that represent standard 2D echocardiographic diagnostic views and orientations. Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.
Caption Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include:
- Quality Meter: The real-time feedback from the Quality Meter advises the user on the .expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below.
- Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view.
- Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it.
- Save Best Clip: This feature continually assesses clip quality while the user is scanning .and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The Caption Guidance software is a radiological computer assisted acquisition quidance system that provides real-time user guidance during acquisition of echocardiography to assist the user in obtaining anatomically correct images that represent standard 2D echocardiographic diagnostic views and orientations. Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.
Input Imaging Modality
cardiac ultrasound images, two-dimensional transthoracic echocardiography (2D-TTE)
Anatomical Site
cardiac, heart
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
Images and cases used for verification testing were carefully separated from training algorithms.
Description of the test set, sample size, data source, and annotation protocol
The Caption Guidance algorithm was tested for the performance of the modified Auto-Capture feature in recording clinically-acceptable images and clips. Furthermore, the subject device's algorithm was tested for the performance of providing Prescriptive Guidance (PG), using the following tasks:
-
- Frame-level PG prediction of the probe maneuver needed to acquire an image/frame of heart, for a specific view.
-
- Clip-level PG prediction of the probe maneuver needed to acquire a diagnostic quality clip for a specific view.
Additionally, the modified Caption Guidance underwent additional human factors testing. Caption Guidance has undergone preliminary formative evaluations, as well as final summative testing that assesses the critical tasks potentially impacted by the modification to the prescriptive guidance features. While risk assessment and formative testing concluded that no new critical tasks were introduced, two existing critical tasks were implicated by the changes, Summative testing has been completed with 16 users without prior scanning experience and 9 users with prior experience).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Overall, the non-clinical performance testing results provide evidence in support of the functionality of Caption Guidance fundamental algorithms.
The summative human factors testing concluded that there were no use errors associated with critical tasks likely to lead to patient injury. Additionally, although the testing was not comparative in nature, when viewed in context of the testing provided in the original De Novo, the enhanced product appears to provide optimization of usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Caption Guidance (DEN190040)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
892.2100 Radiological acquisition and/or optimization guidance system.
892.2100 Radiological acquisition and/or optimization guidance system.
(a)
Identification. A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed, technical device description, including a detailed description of the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, and the associated inputs and outputs.
(ii) A detailed, technical report on the non-clinical performance testing of the subject device in the intended use environments, using relevant consensus standards when applicable.
(iii) A detailed report on the clinical performance testing, obtained from either clinical testing, accepted virtual/physical systems designed to capture clinical variability, comparison to a closely-related device with established clinical performance, or other sources that are justified appropriately. The choice of the method must be justified given the risk of the device and the general acceptance of the test methods. The report must include the following:
(A) A thorough description of the testing protocol(s).
(B) A thorough, quantitative evaluation of the diagnostic utility and quality of images/data acquired, or optimized, using the device.
(C) A thorough, quantitative evaluation of the performance in a representative user population and patient population, under anticipated conditions and environments of use.
(D) A thorough discussion on the generalizability of the clinical performance testing results.
(E) A thorough discussion on use-related risk analysis/human factors data.
(iv) A detailed protocol that describes, in the event of a future change, the level of change in the device technical specifications or indications for use at which the change or changes could significantly affect the safety or effectiveness of the device and the risks posed by these changes. The assessment metrics, acceptance criteria, and analytical methods used for the performance testing of changes that are within the scope of the protocol must be included.
(v) Documentation of an appropriate training program, including instructions on how to acquire and process quality images and video clips, and a report on usability testing demonstrating the effectiveness of that training program on user performance, including acquiring and processing quality images.
(2) The labeling required under § 801.109(c) of this chapter must include:
(i) A detailed description of the device, including information on all required and/or compatible parts.
(ii) A detailed description of the patient population for which the device is indicated for use.
(iii) A detailed description of the intended user population, and the recommended user training.
(iv) Detailed instructions for use, including the information provided in the training program used to meet the requirements of paragraph (b)(1)(iv) of this section.
(v) A warning that the images and data acquired using the device are to be interpreted only by qualified medical professionals.
(vi) A detailed summary of the reports required under paragraphs (b)(1)(ii) and (iii) of this section.
(vii) A statement on upholding the As Low As Reasonably Achievable (ALARA) principle with a discussion on the associated device controls/options.
0
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April 16, 2020
Caption Health % Sam Surette Head of RA/QA 2000 Sierra Point Pkwy. BRISBANE CA 94005
Re: K200755
Trade/Device Name: Caption Guidance Regulation Number: 21 CFR 892.2100 Regulation Name: Radiological acquisition and/or optimization guidance system Regulatory Class: Class II Product Code: QJU Dated: April 14, 2020 Received: April 14, 2020
Dear Sam Surette:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
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
510(k) Number (if known)
K200755
Device Name
Caption Guidance
Indications for Use (Describe)
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems.
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
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510(k) SUMMARY
K200755
Caption Health, Inc.'s
Caption Guidance Software
Submitter
Caption Health, Inc.
2000 Sierra Point Parkway, 8th Floor Brisbane, CA 94005 Contact Person: Sam Surette, Head of RA/QA Phone: (415) 671-4711 Email: sam@captionhealth.com Date Prepared: April 14, 2020
Name of Device: Caption Guidance
Classification Name: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Regulatory Class: II
Product Code: QJU
Predicate Device: Caption Guidance (DEN190040)
Device Description:
The Caption Guidance software is a radiological computer assisted acquisition quidance system that provides real-time user guidance during acquisition of echocardiography to assist the user in obtaining anatomically correct images that represent standard 2D echocardiographic diagnostic views and orientations. Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.
Caption Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include:
- Quality Meter: The real-time feedback from the Quality Meter advises the user on the . expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below.
- . Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view.
4
- . Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it.
- Save Best Clip: This feature continually assesses clip quality while the user is scanning . and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.
Intended Use / Indications for Use:
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible qeneral purpose diagnostic ultrasound systems.
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
Summary of Technological Characteristics:
The Caption Guidance software is an updated version of the predicate device and features very similar technological characteristics. The modified version included device enhancements designed to increase usability and performance. This includes additional prescriptive guidance for the users, information for users via the UI, optimized quality meter and automated image capture, ability to set the scanning convention to that of the user's facility, ability to set custom protocols and skip certain portions of protocols at the user's discretion.
None of the differences raise different questions of safety or effectiveness and available data demonstrate that the current iteration of the Caption Guidance software performs in a substantially equivalent manner.
Performance Data
The Caption Guidance software was developed and tested in accordance with Caption Health's Design Control processes and has been subjected to extensive safety and performance testing.
Caption Guidance was identified as having a moderate level of concern as defined in the FDA quidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software documentation included:
-
- Software/Firmware Description
-
- Device Hazard Analysis
5
-
- Software Requirement Specifications
-
- Architecture Design Chart
-
- Software Design Specifications
-
- Traceability
-
- Software Development Environment Description
-
- Verification and Validation Documentation
-
- Revision Level History
-
- Unresolved Anomalies
-
- Cybersecurity
Risk analysis was provided for the software with detailed description of the hazards, their causes and severity as well as acceptable methods for control of the identified risks. Caption Health provided a description, with test protocols including pass/fail criteria and report of results, of acceptable verification and validation activities at the unit, integration and system level.
Extensive algorithm development and software verification testing assessed the performance of the software. Images and cases used for verification testing were carefully separated from training algorithms. The Caption Guidance algorithm was tested for the performance of the modified Auto-Capture feature in recording clinically-acceptable images and clips. Furthermore, the subject device's algorithm was tested for the performance of providing Prescriptive Guidance (PG), using the following tasks:
-
- Frame-level PG prediction of the probe maneuver needed to acquire an image/frame of heart, for a specific view.
-
- Clip-level PG prediction of the probe maneuver needed to acquire a diagnostic quality clip for a specific view.
Overall, the non-clinical performance testing results provide evidence in support of the functionality of Caption Guidance fundamental algorithms.
Additionally, the modified Caption Guidance underwent additional human factors testing. Caption Guidance has undergone preliminary formative evaluations, as well as final summative testing that assesses the critical tasks potentially impacted by the modification to the prescriptive guidance features. While risk assessment and formative testing concluded that no new critical tasks were introduced, two existing critical tasks were implicated by the changes, Summative testing has been completed with 16 users without prior scanning experience and 9 users with prior experience). The summative human factors testing concluded that there were no use errors associated with critical tasks likely to lead to patient injury. Additionally, although the testing was not comparative in nature, when viewed in context of the testing provided in the original De Novo, the enhanced product appears to provide optimization of usability.
Taken together, the performance testing demonstrates that the Caption Guidance software performs as expected and in a manner that is substantially equivalent to the predicate device.
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Conclusions
The current iteration of the Caption Guidance software is as safe and effective as the previous iteration of such software. The Caption Guidance software has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between the current iteration of the Caption Guidance software and the previous iteration of the Caption Guidance software raise no new issues of safety or effectiveness. Performance data demonstrate that the current iteration of the Caption Guidance software is as safe and effective as the previous iteration of the Caption Guidance software. Thus, the Caption Guidance software is substantially equivalent.