E-Brik Visualization Assistant

K221293 · Jdi Surgical, Inc. · OCT · Jul 7, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K221293
• Device Name: E-Brik Visualization Assistant
• Applicant: Jdi Surgical, Inc.
• Product Code: OCT · Gastroenterology, Urology
• Decision Date: Jul 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

E-Brik Visualization Assistant is a sterile, single-use, battery-powered accessory for endoscopes and laparoscopes (3mm-10mm diameter). Used in hospitals/healthcare facilities during minimally invasive surgery. Device activated by removing non-conductive slip sheet; internal circuitry warms two ports. User adds sterile water to ports; device warms solution and scope distal end to prevent lens fogging. LED indicates active status. Device acts as a horizontal scope stand. Benefits include improved visualization by preventing fogging during procedures. Operated by surgical staff.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1), sterilization (Gamma, SAL 10^-6), packaging (ISO 11607, ASTM D4169, ISTA IIIA), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2). All performance testing met pre-determined acceptance criteria.

Technological Characteristics

Battery-powered (alkaline) heating device; two ports for 3mm-10mm scopes. Materials biocompatible per ISO 10993-1. Sterilization via Gamma radiation. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Single-use, disposable.

Indications for Use

Indicated for use in endoscopic and laparoscopic procedures to prevent fogging of the scope lens in patients undergoing minimally invasive surgery requiring camera visualization.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• LaparoVue (K150569)

Submission Summary (Full Text)

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July 7, 2022

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## ીDI ડ

510(k) Summary

### 510(K) SUMMARY

(21 CFR 807.92)

### GENERAL INFORMATION

| Submitter: | JDI Surgical, Inc. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Srividya Pothana, MS – Regulatory Affairs Associate<br>University of Utah/ Center for Medical Innovation<br>10 North 1900 East, Rm. 22B<br>Salt Lake City, UT 84112<br>[phone]<br>[e-mail] |
| Date Prepared: | May 02, 2022 |
| Trade Name: | E- Brik Visualization Assistant, Model EBK100 |
| Common Name: | Endoscopes Anti-Fogging Device |
| Classification Name: | Endoscopes and Accessories<br>21 CFR §870.1500, Product Code GCJ & OCT |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K150569<br>Model: LaparoVue<br>Manufacture: Buffalo Filter, LLC<br>Classification: GCJ & OCT |

### 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

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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 -<br>E-Brik™ | Predicate - K150569<br>LaparoVue |
| Ind. for Use | The E-Brik™ is intended to be used prior<br>to and during endoscopic and<br>laparoscopic procedures to prevent<br>fogging of the scope lens. | The LaparoVue is intended to be used<br>prior to and during endoscopic and<br>laparoscopic procedures to prevent<br>fogging of the scope lens. |
| Endoscope size<br>accommodated | 3mm - 10mm | 3mm - 12mm |
| Solution | Sterile water added by the user | Surfactant solution |
| Sponge | No Sponge | Yes |
| Mechanism of<br>Action | Heating & dipping distal end of endoscope<br>into solution. | Heating & dipping distal end of endoscope<br>into solution. |
| Number of Ports | 2 | 2 |
| Classification<br>Name | Endoscopes and Accessories -<br>Endoscope Anti-fogging Device 21 CFR<br>§870.1500<br>Product Code: GCJ & OCT<br>Class II | Endoscopes and Accessories -<br>Endoscope Anti-fogging Device 21 CFR<br>§870.1500<br>Product Code: GCJ & OCT<br>Class II |
| Reuse/ Disposable | Single use disposable | Single use disposable |
| Accessories | None Provided | Microfiber cloth & Swab |
| Prescription<br>(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 |
| Biocompatibility<br>Classification | External device, indirect tissue<br>contact, limited duration (<24 hr) | External device, indirect tissue<br>contact, 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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# ીં રા

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.