Caption Guidance

K201992 · Caption Health · QJU · Sep 18, 2020 · Radiology

Device Facts

• Record ID: K201992
• Device Name: Caption Guidance
• Applicant: Caption Health
• Product Code: QJU · Radiology
• Decision Date: Sep 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2100
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, PCCP

Intended 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 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).

Device Story

Caption Guidance is a software-only radiological computer-assisted acquisition guidance system; assists medical professionals in obtaining standard 2D transthoracic echocardiographic (2D-TTE) views. Device integrates with compatible general-purpose ultrasound systems; uses AI to emulate sonographer expertise. Features include: Quality Meter (real-time feedback on diagnostic quality); Prescriptive Guidance (directions for transducer manipulation); Auto-Capture (automatic recording when diagnostic quality is reached); Save Best Clip (retrospective recording of highest quality clip). Software provides real-time guidance during scanning; helps users achieve anatomically correct images. Benefits include improved image acquisition consistency and diagnostic quality for clinicians.

Clinical Evidence

No clinical data presented; substantial equivalence is based on identical technological characteristics and principles of operation to the predicate device.

Technological Characteristics

Software-only device; AI-based radiological acquisition guidance system. Operates as an accessory to general-purpose ultrasound systems. Features include real-time quality assessment, prescriptive guidance, and automated image capture. Algorithms are trained, tuned, and locked prior to release; no adaptive/continuous learning in the field.

Indications for Use

Indicated for adult patients undergoing 2D-TTE for acquisition of standard cardiac views (PLAX, PSAX-AV/MV/PM, AP4/5/2/3, SubC4, SC-IVC).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Caption Guidance (K200755)

Submission Summary (Full Text)

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September 18, 2020

Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Caption Health % Sam Surette Head of RA/QA 2000 Sierra Point Pkwy., 8th Floor BRISBANE CA 94005

Re: K201992

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: July 17, 2020 Received: July 17, 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/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K201992

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)

| <span style="font-family: 'Wingdings';">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart G) |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------|
|-----------------------------------------------------------------------------------------------|-----------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## K201992

# 510(k) SUMMARY 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: [phone]

Email: [e-mail]

Date Prepared: July 17, 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 (K200755)

#### Device Description:

The Caption Guidance software is a radiological computer assisted acquisition guidance system that provides real-time user quidance 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 quidance 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.

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- 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:

No differences exist between the subject device and the predicate device with respect to intended use or indications for use. The following summary of intended use / indications for use is reproduced here for reference:

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).

## Summary of Technological Characteristics:

The Caption Guidance software is identical to the predicate device, and as such, the technological characteristics are incorporated by reference.

# 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 use, indications for use, technological characteristics, and principles of operation as its predicate device. Thus, the Caption Guidance software is substantially equivalent.

The purpose of the 510(k) submission is to address the modification of a predetermined change control plan (PCCP) to outline anticipated modifications to the Caption Guidance software and the methods that will be utilized to implement those modifications in a controlled manner while maintaining safety and efficacy. In accordance with the PCCP, all algorithm modifications will be trained, tuned, and locked prior to release of the software to the field. The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field.