The E-Brik™ Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

Device Description

The E-Brik™ Visualization Assistant is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile and is intended for single use only in a healthcare facility/ hospital.

The E-Brik™ is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by an LED which is illuminated below both ports. The E-Brik™ has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 10mm in diameter. Both ports can be used prior to the surgical case to warm the scope(s) before the insertion into a body cavity. The E-Brik™ can act as a scope stand as it is designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. A sterile surfactant solution is added to the ports prior to use, which is warmed when the device is active. The ports allow for the user to apply the warmed surfactant prior to and during the case.

The E-Brik™ is powered by alkaline batteries and has a single-use surgical life of a minimum of 4 hours.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the E-Brik Visualization Assistant, based on the provided FDA 510(k) summary:

Device Name: E-Brik Visualization Assistant
Intended Use: To be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for functional aspects. However, it states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence."

The following performance characteristics were tested and "passed," implying they met their respective acceptance criteria:

Acceptance Criteria Category	Reported Device Performance
Functional/Safety Testing
Biocompatibility	Verified according to ISO 10993-1 and FDA guidance for an external communicating device with indirect tissue contact for limited duration (<24hrs). Specific tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity) passed.
Sterilization	Demonstrated sterility via Gamma radiation to a SAL level of 10-6.
Packaging Sterile Barrier	Met or exceeded ISO 11607, ASTM D4169, and ISTA IIIA requirements.
Electrical Safety	Complied with IEC 60601-1 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance).
Electromagnetic Compatibility (EMC)	Complied with IEC 60601-1-2/EN 60601-1-2 (Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests).
Performance Testing (Bench)	"All testing passed" based on design and risk-based requirements.
Duration of Operation	Operated for a minimum of 4 hours (surgical life).
Scope Accommodation	Accommodates endoscopes/laparoscopes from 3mm to 10mm in diameter.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in terms of cases or patients. The studies conducted were primarily bench testing and laboratory evaluations (e.g., sterilization, packaging, electrical safety, biocompatibility).

Sample Size for Bench/Laboratory Tests: Not explicitly stated as a number of "samples" in a clinical sense. For each functional test (e.g., electrical safety, EMC, sterilization verification), an appropriate number of device units would have been tested according to relevant standards, but these specific numbers are not provided.
Data Provenance: The studies were conducted as part of the device's design verification and validation. This is retrospective in the sense that it's part of the development process rather than prospective clinical data. The country of origin of the data is not specified, but it's implied to be from the manufacturer's testing facilities or accredited testing laboratories.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the studies described are bench tests and laboratory evaluations, not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for these tests are the standards themselves (e.g., ISO 10993, IEC 60601-1).

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench tests and laboratory evaluations, not clinical studies requiring human adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The submission explicitly states:

"Performance Testing Clinical No clinical testing was conducted for this O submission"

Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as this device itself is not an AI-assisted diagnostic or interpretative tool for medical images. It's a physical accessory.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the E-Brik Visualization Assistant is a physical device, not an algorithm or AI software, and its primary function is to physically prevent fogging, not to provide an interpretation or analysis.

7. Type of Ground Truth Used

The ground truth used for verifying the device's performance against its intended use and safety standards was:

Engineering and Performance Standards: Such as ISO 10993-1, ISO 11607, ASTM D4169, ISTA IIIA, IEC 60601-1, and IEC 60601-1-2.
Manufacturer's Design and Risk-Based Requirements: Internal specifications against which the "performance testing bench" was conducted and "all testing passed."

8. Sample Size for the Training Set

This information is not applicable. The E-Brik Visualization Assistant is a physical medical device, not a machine learning or AI model, thus it does not have a "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

Summary

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July 7, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of a human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

JDI Surgical, Inc. % Srividya Pothana Regulatory Affairs Associate University of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, Utah 84112

Re: K221293

Trade/Device Name: E-Brik Visualization Assistant Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, OCT Dated: Mav 2, 2022 Received: May 4, 2022

Dear Srividya Pothana:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name E-Brik Visualization Assistant

Indications for Use (Describe)

The E-Brik Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

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)

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510(k) Summary

510(K) SUMMARY

(21 CFR 807.92)

GENERAL INFORMATION

Submitter:	JDI Surgical, Inc.
Contact Person:	Srividya Pothana, MS – Regulatory Affairs AssociateUniversity of Utah/ Center for Medical Innovation10 North 1900 East, Rm. 22BSalt Lake City, UT 84112(801) 587-1456sri.pothana@utah.edu
Date Prepared:	May 02, 2022
Trade Name:	E- Brik Visualization Assistant, Model EBK100
Common Name:	Endoscopes Anti-Fogging Device
Classification Name:	Endoscopes and Accessories21 CFR §870.1500, Product Code GCJ & OCT
Device Class:	Class II
Predicate Device:	510(k) No.: K150569Model: LaparoVueManufacture: Buffalo Filter, LLCClassification: GCJ & OCT

Device Description:

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JDI

510(k) Summary

scope(s) before the insertion into a body cavity. The E-Brik™ can act as a scope stand as it is designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. A sterile surfactant solution is added to the ports prior to use, which is warmed when the device is active. The ports allow for the user to apply the warmed surfactant prior to and during the case.

The E-Brik™ is powered by alkaline batteries and has a single-use surgical life of a minimum of 4 hours.

Intended Use:

The E-Brik™ is designed for general minimally invasive surgery that utilizes a camera system for visualization into a body cavity. The E-Brik™ enables the operator to warm the camera prior to and throughout the surgical case, along with applying a warmed solution (i.e., sterile water) to lens prior to insertion into the surgical field.

Indications for Use:

The E-Brik™ Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

Comparative Analysis:

It has been demonstrated that the E-Brik™ is comparable to the predicate device in fundamental scientific technology, design, materials, principles of operation and functional performance evaluations and is substantial equivalent as summarized in Table 1. Furthermore, the E-Brik™ system has been fully assessed within the JDI Surgical Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence. The differences raise no additional or different questions of safety or effectiveness from that already identified for the predicate device.

It has been demonstrated that the E-Brik™ system is comparable to the predicate device in the following manner:

· Same intended use
· Same indications for use
· Same fundamental scientific technology
· Same or similar material properties
· Same operating principle
· Same or similar performance specifications
· Same or similar patient-user interface

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JDI Su

510(k) Summary

Table 1: Substantial Equivalence Comparison Chart
	Subject Device -E-Brik™	Predicate - K150569LaparoVue
Ind. for Use	The E-Brik™ is intended to be used priorto and during endoscopic andlaparoscopic procedures to preventfogging of the scope lens.	The LaparoVue is intended to be usedprior to and during endoscopic andlaparoscopic procedures to preventfogging of the scope lens.
Endoscope sizeaccommodated	3mm - 10mm	3mm - 12mm
Solution	Sterile water added by the user	Surfactant solution
Sponge	No Sponge	Yes
Mechanism ofAction	Heating & dipping distal end of endoscopeinto solution.	Heating & dipping distal end of endoscopeinto solution.
Number of Ports	2	2
ClassificationName	Endoscopes and Accessories -Endoscope Anti-fogging Device 21 CFR§870.1500Product Code: GCJ & OCTClass II	Endoscopes and Accessories -Endoscope Anti-fogging Device 21 CFR§870.1500Product Code: GCJ & OCTClass II
Reuse/ Disposable	Single use disposable	Single use disposable
Accessories	None Provided	Microfiber cloth & Swab
Prescription(Rx Only)	Yes	Yes
Contains Batteries	Yes	Yes
Battery Activation	Remove non-conductive slip sheet	Remove non-conductive slip sheet
LED Light	Notify the user the device is active	Notify the user the device is active
Sterility	Sterile-Gamma	Sterile - Gamma
BiocompatibilityClassification	External device, indirect tissuecontact, limited duration (<24 hr)	External device, indirect tissuecontact, limited duration (<24 hr)
Biocompatibility	ISO 10993	ISO 10993

Functional/Safety Testing:

Verification activities were performed on the subject E-Brik™ to demonstrate substantial equivalence to the predicate device:

Biocompatibility Biocompatibility of the complete and finished E-Brik™ system has ● been verified according to the requirements and testing prescribed in ISO 10993-1 and

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510(k) Summary

in accordance with FDA guidance document "Use of International Standard ISO 10993-1" for an external communicating device with indirect tissue contact for a limited duration (<24hrs). Per ISO 10993-1, testing included the following:

Cytotoxicity O
Sensitization O
Intracutaneous Reactivity O
Acute Systemic Toxicity o
Material Mediated Pyrogenicity o
Design Verification Performance bench testing was conducted to ensure that the E-● Brik ™ system met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate device. The following performance testing was performed or fulfilled with the E-Brik™ system.
- Sterilization Testing was conducted to demonstrate that the E-Brik™ system O could be sterilized via Gamma radiation to a SAL level of 10-6.
- Packaging Sterile barrier meet or exceeded the ISO 11607, ASTM D4169, and o ISTA IIIA requirements.
- Electrical Safety and Essential Performance Requirements Testing was o conducted on the E-Brik™ system for compliance with IEC 60601-1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
- Electromagnetic Compatibility (EMC) Testing was conducted on the E-Brik™ O system for compliance with IEC 60601-1-2/ EN 60601-1-2 – Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- Performance Testing Bench The testing was completed based design and o risk-based requirements. All testing passed.
- Performance Testing Animal No animal testing was conducted for this O submission
- Performance Testing Clinical No clinical testing was conducted for this O submission

Conclusion:

The subject E-Brik™ Visualization Assistant system is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device. The minor differences between the subject E-Brik™ and the predicated device has no effect on safety or effectiveness, as established through various performance tests.

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.