(64 days)
Not Found
No
The device description focuses on warming and applying a surfactant to prevent fogging, using basic circuitry and batteries. There is no mention of image processing, AI, ML, or any data processing that would suggest the use of such technologies. The performance studies are focused on biocompatibility, electrical safety, and basic performance, not algorithmic validation.
No
The device is an accessory to prevent fogging of a scope lens during procedures, not directly treating a disease or condition.
No
The device is described as an accessory to prevent fogging of scope lenses during endoscopic and laparoscopic procedures. Its function is to warm the scope and apply a warmed surfactant, which are preventative measures, not diagnostic actions.
No
The device description explicitly details hardware components such as batteries, internal circuitry, LED indicators, and physical ports designed to warm and apply surfactant to endoscopes/laparoscopes. It also mentions verification activities related to biocompatibility, electrical safety, and packaging, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent fogging of scope lenses during endoscopic and laparoscopic procedures. This is a function related to the surgical instrument itself, not to the analysis of biological samples or the diagnosis of a condition.
- Device Description: The device warms the scope and applies a warmed surfactant. This is a physical process applied to the scope, not a test performed on a patient sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or calibrators
The E-Brik™ Visualization Assistant is an accessory designed to improve the functionality of surgical scopes, not to perform diagnostic testing.
N/A
Intended Use / 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.
Product codes
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 ISTA IIIA requirements.
- Electrical Safety and Essential Performance Requirements Testing was 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™ 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 risk-based requirements. All testing passed.
- Performance Testing Animal No animal testing was conducted for this submission
- Performance Testing Clinical No clinical testing was conducted for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
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 Associate |
| University of Utah/ Center for Medical Innovation | |
| 10 North 1900 East, Rm. 22B | |
| Salt Lake City, UT 84112 | |
| (801) 587-1456 | |
| sri.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 Accessories |
| 21 CFR §870.1500, Product Code GCJ & OCT | |
| Device Class: | Class II |
| Predicate Device: | 510(k) No.: K150569 |
| Model: LaparoVue | |
| Manufacture: Buffalo Filter, LLC | |
| 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
4
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 - K150569 | |
| LaparoVue | ||
| Ind. for Use | The E-Brik™ is intended to be used prior | |
| to and during endoscopic and | ||
| laparoscopic procedures to prevent | ||
| fogging of the scope lens. | The LaparoVue is intended to be used | |
| prior to and during endoscopic and | ||
| laparoscopic procedures to prevent | ||
| fogging of the scope lens. | ||
| Endoscope size | ||
| accommodated | 3mm - 10mm | 3mm - 12mm |
| Solution | Sterile water added by the user | Surfactant solution |
| Sponge | No Sponge | Yes |
| Mechanism of | ||
| Action | Heating & dipping distal end of endoscope | |
| into solution. | Heating & dipping distal end of endoscope | |
| into solution. | ||
| Number of Ports | 2 | 2 |
| Classification | ||
| Name | Endoscopes and Accessories - | |
| Endoscope Anti-fogging Device 21 CFR | ||
| §870.1500 | ||
| Product Code: GCJ & OCT | ||
| Class II | Endoscopes and Accessories - | |
| Endoscope Anti-fogging Device 21 CFR | ||
| §870.1500 | ||
| Product Code: GCJ & OCT | ||
| Class 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 |
| Biocompatibility | ||
| Classification | External device, indirect tissue | |
| contact, limited duration ( |