U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 1 2
Silver Spring, MD 20993
www.fda.gov
February 7, 2020
Caption Health, Inc.
Sam Surette
RA/QA Manager
2000 Sierra Point Parkway
8th Floor
Brisbane, CA 94005
Re: DEN190040
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: August 27, 2019
Received: August 27, 2019
Dear Sam Surette:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has
completed its review of your De Novo request for classification of the Caption Guidance, a prescription
device under 21 CFR Part 801.109 with the following indications for use:
The Caption Guidance software is intended to assist medical professionals in the acquisition of
cardiac ultrasound images. 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).
Although this letter refers to your product as a device, please be aware that some granted products may
instead be combination products. If you have questions on whether your product is a combination product,
contact [email protected]. FDA concludes that this device should be classified into
Class II. This order, therefore, classifies the Caption Guidance, and substantially equivalent devices of this
DEN190040 - Sam Surette Page
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generic type, into Class II under the generic name radiological acquisition and/or optimization guidance
system.
FDA identifies this generic type of device as:
Radiological acquisition and/or optimization guidance system – 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.
Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two
options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE)
determination in response to a 510(k) for a device that has not been previously classified under the Act may
request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On
December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted
within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no
legally marketed device upon which to base a determination of substantial equivalence may request FDA to
make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a
510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall
be the initial classification of the device. Within 30 days after the issuance of an order classifying the device,
FDA must publish a notice in the Federal Register announcing the classification.
On August 27, 2019, FDA received your De Novo requesting classification of the Caption Guidance. The
request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the Caption Guidance
into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the
information submitted in the De Novo request FDA has determined that, for the previously stated indications
for use, the Caption Guidance can be classified in class II with the establishment of special controls for class
II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness
of the device type. The identified risks and mitigation measures associated with the device type are
summarized in the following table:
Identified Risks to Health
Mitigation Measures
Device Error – Failure to provide guidance on
acquiring diagnostic-quality images or signals,
leading to delay, prolonged examination, or
additional unnecessary procedures, due to:
• Algorithm failure
• Hardware or software failure
• Design verification and validation
• Labeling
User Error – Operator failure to follow the
guidance provided by the device to acquire
diagnostic-quality images or signals, leading to
• Design verification and validation
• Labeling
DEN190040 - Sam Surette Page
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delay, prolonged examination, or additional
unnecessary procedures, due to human error
In combination with the general controls of the FD&C Act, the radiological acquisition and/or optimization
guidance system is subject to the following special controls:
1. Design verification and validation must include:
a. 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.
b. 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.
c. 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:
i. A thorough description of the testing protocol(s).
ii. A thorough, quantitative evaluation of the diagnostic utility and quality of images/data
acquired, or optimized, using the device.
iii. A thorough, quantitative evaluation of the performance in a representative user population
and patient population, under anticipated conditions and environments of use.
iv. A thorough discussion on the generalizability of the clinical performance testing results.
v. A thorough discussion on use-related risk analysis/human factors data.
d. 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.
e. 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 21 CFR 801.109(c) must include:
a. A detailed description of the device, including information on all required and/or compatible parts.
b. A detailed description of the patient population for which the device is indicated for use.
c. A detailed description of the intended user population, and the recommended user training.
d. Detailed instructions for use, including the information provided in the training program used to
meet the requirements of paragraph (1)(e).
e. A warning that the images and data acquired using the device are to be interpreted only by qualified
medical professionals.
f. A detailed summary of the reports required under paragraphs 1(b) and 1(c).
g. A statement on upholding the As Low As Reasonably Achievable (ALARA) principle with a
discussion on the associated device controls/options.
DEN190040 - Sam Surette Page
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In addition, this is a prescription device and must comply with 21 CFR 801.109.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket
notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket
notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device
type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification
requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a
premarket notification containing information on the radiological acquisition and/or optimization guidance
system they intend to market prior to marketing the device.
Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a
determination that your device complies with other requirements of the FD&C Act or any Federal statutes
and regulations administered by other Federal agencies. You must comply with all the FD&C Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (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-reporting-
combination-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 FD&C Act); 21 CFR 1000-1050.
A notice announcing this classification order will be published in the Federal Register. A copy of this order
and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection
between 9 a.m. and 4 p.m., Monday through Friday.
As a result of this order, you may immediately market your device as described in the De Novo request,
subject to the general control provisions of the FD&C Act and the special controls identified in this order.
For comprehensive regulatory information about medical devices and radiation-emitting products, please see
Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-
regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or
contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).
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If you have any questions concerning the contents of the letter, please contact Shahram Vaezy at 301-796-
6242.
Sincerely,
Robert Ochs, Ph.D.
Deputy Director for Radiological Health
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
