The TEECAD System is intended to provide visualization during the placement of a Transesophageal Echocardiogram (TEE) probe in adults. Do not use this system for any purpose other than the intended use.

Device Description

The Visura TEE Camera Assist Device (TEECAD) is an accessory that provides visualization for the physician during TEE probe placement. It consists of a very simple design that has two main components:

Disposable Carrier a single-use carrier with an integrated camera .
Viewing System a physician interface display unit .
The TEECAD System is not a diagnostic or therapeutic device. The TEECAD Disposable Carrier acts as an accessory that attaches to the commercially available Philips X7-2t TEE transducer probe and is removed once the probe reaches its target location in the patient's esophagus to allow for normal ultrasound imaging of the heart.
The TEECAD Disposable Carrier is a single use device, and is designed to be manufactured with commonly used medical device materials that are considered safe for body contact.
The Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement. The software is installed by the manufacturer and cannot be accessed, modified or installed by the user.

AI/ML Overview

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It is an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to a predicate device based on non-clinical testing.

Here's what can be extracted based on the provided text, and what information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics in detail. It mentions that "the collective results of the non-clinical tests demonstrate that the TEECAD System meets the established specifications necessary for consistent performance for its intended use" and that "the TEECAD System is a safe and effective device." However, the 'established specifications' are not detailed, nor are the specific performance results in a quantifiable manner.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers to "non-clinical tests" including "TEECAD Design Verification and Validation Studies," "Packaging Testing," "Biocompatibility Testing," "Cleaning Validation," "Software Verification and Validation," "Electrical safety, electromagnetic compatibility, and laser safety testing," and "TEECAD System GLP Animal Safety and Performance Report."

Sample Size for Test Set: Not specified for any of the tests.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
- The "GLP Animal Safety and Performance Report" implies animal testing, but specifics of the animal model, location, and study design are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The testing described is "non-clinical" and appears to involve engineering, material science, and animal studies rather than human clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable or not provided. The described tests are non-clinical and do not involve adjudication by experts for diagnostic or similar outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not described. The device, TEECAD System, is an accessory for visualization during TEE probe placement, not an AI diagnostic tool requiring human reader improvement comparison.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The TEECAD System's "Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement." The software is not described as an AI algorithm providing diagnostic or analytical output; rather, it facilitates live image viewing. Therefore, a standalone algorithm performance in the context of AI is not relevant or described. The non-clinical tests assess the device's functional and safety performance, which would include the performance of the imaging system itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the non-clinical nature of the studies (design verification, biocompatibility, animal safety), the concept of "ground truth" as typically applied in diagnostic imaging (e.g., pathology, expert consensus) is not directly applicable. The "ground truth" for these tests would be defined by the specified engineering standards, material properties, safety parameters, and physiological responses observed in animal models.

8. The sample size for the training set

Not applicable. The TEECAD System is described as a "very simple design" with hardware components (disposable carrier with integrated camera, viewing system) and software for image viewing. There is no mention of machine learning or an AI algorithm that would require a "training set."

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI algorithm appears to be involved.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters 'FDA' in white, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue. To the left of the FDA logo is the Department of Health & Human Services seal, which includes an emblem with a caduceus-like symbol and the text 'DEPARTMENT OF HEALTH & HUMAN SERVICES-USA' arranged around it.

Visura Technologies, LLC % Gina Correa Valleygrey Enterprise 396 N. Whisman Rd. Mountain View, California 94043 July 10, 2018

Re: K180911

Trade/Device Name: Visura Technologies TEECAD System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, ITX Dated: June 8, 2018 Received: June 11, 2018

Dear Gina Correa:

This letter corrects our substantially equivalent letter of June 20, 2018.

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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara and the For

Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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3.0 INDICATION FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Transesophageal Echocardiogram Camera Assist Device (TEECAD) System

Indications for Use (Describe)

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
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Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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4.0 510(K) SUMMARY

510(k) Notification K_

4.1 GENERAL INFORMATION

Applicant:

Visura Technologies, LLC 9337 Harding Avenue Evanston, IL, 60203 U.S.A. Phone: 630-487-0140

Contact Person:

Ms. Gina Correa, RAC Visura Technologies, LLC - Regulatory Consultant Phone: 414-975-0022 Email: Gina.correa@gmail.com

Date Prepared: June 1st 2018

4.2 DEVICE INFORMATION

Trade Name:

Transesophageal Echocardiogram Camera Assist Device (TEECAD) System

Generic/Common Name: Transesophageal Echocardiogram Visualization System

Classification:

21 CFR 876.1500, Endoscope and accessories, Class II

Product Codes:

FDS and ITX

PREDICATE DEVICE

Third Eye Panoramic Auxiliary Endoscopy System (K140595)

REFERENCE DEVICE

Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System. Affiniti 70 Diagnostic Ultrasound System (K172607)

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DEVICE DESCRIPTION

Disposable Carrier a single-use carrier with an integrated camera .
Viewing System a physician interface display unit .

The TEECAD System is not a diagnostic or therapeutic device. The TEECAD Disposable Carrier acts as an accessory that attaches to the commercially available Philips X7-2t TEE transducer probe and is removed once the probe reaches its target location in the patient's esophagus to allow for normal ultrasound imaging of the heart.

The TEECAD Disposable Carrier is a single use device, and is designed to be manufactured with commonly used medical device materials that are considered safe for body contact.

The Viewing System includes software that allows the operator to view the endoscopic images during TEE probe placement. The software is installed by the manufacturer and cannot be accessed, modified or installed by the user.

Image /page/4/Figure/7 description: This image shows a diagram of the TEECAD system. The diagram shows a viewing system that allows physicians to view live images from the TEECAD camera. The diagram also shows a disposable carrier that attaches to the TEE probe at the distal tip. The TEECAD system provides visualization during the TEE probe placement.

A diagram of the Visura TEECAD System is provided in Figure 4-1.

Figure 4-1: A diagram of the Visura TEECAD System

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4.3 INDICATIONS FOR USE

The Visura Technologies TEECAD System is intended to provide visualization during the placement of a transesophageal echocardiogram probe in adults.

4.4 SUBSTANTIAL EQUIVALENCE

The Third Eye Panoramic Auxiliary Endoscopy System is listed as the predicate device for the TEECAD System.

The Third Eye Panoramic Device is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon, while the Visura TEECAD System is intended to provide visualization during the placement of a transesophageal echocardiogram probe in adults. Both the Visura TEECAD System and the Third Eve Panoramic System have the same overall functionality of providing improved visualization capability to an existing device (i.e. TEE probe, colonoscope). Both devices are very low risk accessories.

The main questions regarding safety and effectiveness with either accessory is its interaction with the parent device and its impact on the functionality of the parent device. These issues have been addressed via the verification and validation testing performed using the Visura TEECAD System.

Any differences between the TEECAD System and the predicate device do not alter the intended use of the TEECAD System. The safety and effectiveness of the TEECAD System has been demonstrated via the bench and animal testing described in Section 9.4 and Section 9.5.

The TEECAD System is only intended for us with the commercially available Philips X7-2t TEE transducer probe, where the TEECAD Carrier acts as an accessory that attaches to the transducer probe. The Philips ultrasound imaging system that supports the TEE probe (X7-2t) is listed as the reference device in this 510(k) submission.

4.5 NON-CLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the TEECAD System to support a determination of substantial equivalence to the predicate device. The following non-clinical tests were conducted on the TEECAD System

TEECAD Design Verification and Validation Studies .
Packaging Testing .
Biocompatibility Testing .
Cleaning Validation ●
Software Verification and Validation .

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Electrical safety, electromagnetic compatibility, and laser safety testing .
. TEECAD System GLP Animal Safety and Performance Report

The collective results of the non-clinical tests demonstrate that the TEECAD System meets the established specifications necessary for consistent performance for its intended use.

4.6 CONCLUSION

The results of the nonclinical testing demonstrate that the TEECAD System is a safe and effective device. The risk assessment supported by the non-clinical testing demonstrates that the technological characteristics employed by the TEECAD System do not raise any new issues of safety or effectiveness. Therefore, the TEECAD System is substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.