ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)

K234033 · Boehringer Laboratories, LLC · KNT · May 6, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K234033
• Device Name: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
• Applicant: Boehringer Laboratories, LLC
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: May 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ViSiGi® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Device Story

ViSiGi LUX is a non-sterile, single-patient-use gastrointestinal tube used during gastric and bariatric surgery. It functions as a sizing guide and provides suction, stomach decompression, drainage, and irrigation. The device consists of a tube with a closed, rounded distal tip with side holes, a proximal slide valve, an integral suction regulator, and a battery case. It incorporates an array of battery-powered LEDs at the distal end to aid visualization via tissue transillumination during laparoscopic surgery. The device is inserted by an anesthesiologist under surgeon supervision. The LEDs provide visual guidance to the surgeon, potentially improving procedural efficiency; they do not alter the fundamental intended use or safety profile of the gastric tube.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, irritation), electrical safety (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2, AIM 7351731), photobiological safety (IEC 62471), and mechanical/functional performance (suction, drainage, irrigation, dimensional analysis, cyclic flex, kink, and component integrity testing).

Technological Characteristics

Materials: Styrene-Ethylene-Butylene-Styrene (SEBS) block copolymer. Dimensions: 32F, 36F, 40F; 1067 mm length. Energy: Battery-powered LED array. Connectivity: None. Sterilization: Non-sterile. Standards: ISO 10993-5/10/23, IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, AIM 7351731, IEC 62471, ASTM 4169.

Indications for Use

Indicated for individuals undergoing gastric and bariatric surgical procedures requiring suction, stomach decompression, drainage of gastric fluids, irrigation, or gastric sizing.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Boehringer Laboratories ViSiGi® 3D (K130483)

Reference Devices

• Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (K222880)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.

May 6, 2024

Boehringer Laboratories, LLC Ondrej Nikel, Ph.D. New Product Development Engineer 300 Thoms Drive Phoenixville, PA 19460

Re: K234033

Trade/Device Name: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: March 28, 2024 Received: March 28, 2024

Dear Ondrej Nikel:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Anthony Lee -S

Anthony C. Lee, PhD, MBA Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

### Indications for Use

Submission Number (if known)

#### K234033

Device Name

ViSiGi LUX (5332); ViSiGi LUX (5336);

ViSiGi LUX (5340)

Indications for Use (Describe)

ViSiGi® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing quide.

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)

### 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the Boehringer Ingelheim logo. The logo consists of the word "BOEHRINGER" in red, with a registered trademark symbol in the upper right corner. The text is enclosed in a blue rectangular border.

Caring for Lives through Innovation, Quality and Service

This 510(k) summary was prepared in accordance with 21 CFR 807.92.

# 1. Date

27th March, 2024

## 2. Submitter

| Applicant: | Boehringer Laboratories, LLC |
|-------------------|----------------------------------|
| | 300 Thoms Dr |
| | Phoenixville, PA 19460 |
| | United States |
| | |
| Official Contact: | Ondrej Nikel |
| | New Product Development Engineer |
| | Phone: [phone] |
| | Email: [e-mail] |

## 3. Device Information

| Trade Name: | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) |
|------------------------|---------------------------------------------------------|
| 510(k) Submission: | K234033 |
| Common Name: | Gastrointestinal tube |
| Device Classification: | Tubes, Gastrointestinal (and Accessories) |
| Regulation: | 21 CFR 876.5980 |
| Product Code: | KNT |
| Class: | II |

### 4. Predicate Device Information

| Trade Name: | Boehringer Laboratories ViSiGi® 3D |
|------------------------|-------------------------------------------|
| 510(k) Submission: | K130483 |
| Common Name: | Gastrointestinal tube and accessories |
| Device Classification: | Tubes, Gastrointestinal (and Accessories) |
| Regulation: | 21 CFR 876.5980 |
| Product Code: | KNT |
| Class: | II |

### Boehringer Laboratories, LLC

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Boehringer Ingelheim logo. The logo consists of the word "BOEHRINGER" in red, all capital letters, inside a blue rectangular box. To the right of the box is a circled "R", indicating a registered trademark.

### 5. Reference Device Information

| Trade Name: | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) |
|------------------------|--------------------------------------------------------------------|
| 510(k) Submission: | K222880 |
| Common Name: | Gastrointestinal tube and accessories |
| Device Classification: | Tubes, Gastrointestinal (and Accessories) |
| Regulation: | 21 CFR 876.5980 |
| Product Code: | KNT |
| Class: | II |

## 6. Device Description

VISIGi® LUX is a non-sterile, single patient use device for use in gastric and bariatric surgery. It is used to apply suction, decompress the stomach, drain gastric fluids, irrigate and to serve as a sizing guide.

The design is derived from the predicate by addition of battery-powered LED lights. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end includes a slide valve, integral suction regulator and a battery case. The non-rechargeable batteries power up an array of LEDs enclosed within the distal end of the tube. The purpose of the LED lights is to aid visualization of the tube by tissue transillumination during insertion and surgery under laparoscopic vision. The device is inserted by an anesthesiologist under supervision of the surgeon. The added lights do not change the intended use and are not required for the surgery to proceed safely.

## 7. Indications for Use

VISIGI® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

## 8. Technological Comparison

Technological characteristics of ViSiGi® LUX are similar to its predicate. ViSiGi® LUX design uses the components of the predicate device and adds to them the battery-powered LED lights subassembly. The addition of the LED light subassembly does not change intended use or indications for use.

The technological characteristics of ViSiGi® LUX do not raise new questions of safety and effectiveness. Bench tests were conducted to establish that the function, safety, and effectiveness of ViSiGi® LUX is equivalent to the predicate device.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the Boehringer Ingelheim logo. The logo consists of the word "BOEHRINGER" in red, all capital letters, inside a blue rectangular box. A circled "R" trademark symbol is located in the upper right corner of the box.

Caring for Lives through Innovation, Quality and Service

# 9. Comparison of Technical Characteristics with the Predicate Device

| Device | ViSiGi® LUX<br>Subject Device | ViSiGi® 3D<br>Predicate (K130483) | Comparison |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Class | II | II | Same |
| Product code<br>and Regulation | KNT,<br>876.5980 | KNT,<br>876.5980 | Same |
| Indications for use | The Boehringer laboratories<br>ViSiGi® LUX is indicated for<br>use in gastric and bariatric surgical<br>procedures for the application of<br>suction, stomach decompression,<br>drainage of gastric fluids, irrigation,<br>and to serve as a sizing guide. | The Boehringer Laboratories<br>Gastric Sizing Tube is indicated for<br>use in gastric and bariatric surgical<br>procedures for the application of<br>suction, stomach decompression,<br>drainage of gastric fluids, irrigation,<br>and to serve as a sizing guide. | Same |
| Typical Use | Gastric and bariatric procedures. | Gastric and bariatric procedures. | Same |
| Environments of Use | Surgery centers, hospitals | Surgery centers, hospitals | Same |
| Patient Population | Individuals undergoing bariatric<br>and/or gastric procedures | Individuals undergoing bariatric<br>and/or gastric procedures | Same |
| Intraoperative Use | Yes | Yes | Same |
| Functions | Suction, drainage, irrigation, sizing | Suction, drainage, irrigation, sizing | Same |
| Technical/Performance Characteristics | | | |
| Outer Diameter<br>/French size | 32F, 36F, 40F | 32F, 36F, 40F | Same |
| Length | 1067 mm | 1067 mm | Same |
| Tubing | Single lumen with rounded, closed<br>distal end | Single lumen with rounded, closed<br>distal end | Same |
| Distal Side Holes | Yes | Yes | Same |
| Connector for Suction | Yes | Yes | Same |
| Slide Valve | Yes | Yes | Same |
| Tubing Material | Styrene-Ethylene-Butylene-Styrene<br>(SEBS block copolymer) | Styrene-Ethylene-Butylene-Styrene<br>(SEBS block copolymer) | Same |
| Markings | Yes | Yes | Same |
| Sterility | Supplied non-sterile, disposable,<br>single patient use | Supplied non-sterile, disposable,<br>single patient use | Same |
| LED lights | No | Yes | Different,<br>equivalence<br>established<br>via testing |

#### Boehringer Laboratories, LLC

300 Thoms Drive, Phoenixville, PA 19460 • 800-642- 4945 • 610-278-0900 • Fax: [phone] • www.boehringerlabs.com

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Boehringer Ingelheim logo. The logo consists of the word "BOEHRINGER" in red, enclosed in a blue rectangle. A registered trademark symbol is located in the upper right corner of the rectangle. The logo is simple and clean, with a focus on the company name.

Caring for Lives through Innovation, Quality and Service

#### 10. Non-clinical and/or Clinical Test Summary

The tests listed below were conducted to support Substantial equivalence of ViSiGi® LUX:

- · Cytotoxicity Test, ISO Elution Method per ISO 10993-5
- · Guinea Pig Maximization Sensitization Test, Polar and Non-polar Extraction per ISO 10993-10
- Intracutaneous Irritation Test, Polar and Non-polar Extraction per ISO 10993-23
- Basic Safety and Essential Performance Evaluation per IEC 60601-1
- Basic Safety and Essential Performance of Endoscopic Equipment per IEC 60601-2-18
- Electromagnetic compatibility (EMC) Evaluation per IEC 60601-1-2
- EMC Evaluation (RFID and common EM emitters) per AIM 7351731
- Photobiological Safety Evaluation per IEC 62471
- Packaging Integrity Test per ASTM 4169
- Visual Inspection
- · Suction Testing
- Drainage Testing
- · Irrigation Testing
- Dimensional Analysis
- Gastric Fluid Resistance
- · Cyclic Flex Testing
- Kink Testing
- · Component Integrity Testing
- Circuit Characteristics
- Thermal Characteristics

Passing these tests demonstrates substantial equivalence to the predicate device.

## 11. Conclusion

In summary, ViSiGi® LUX has the same classification and intended use as the predicate device. The technological characteristics are similar and do not raise new questions of safety and effectiveness. Passing the tests demonstrated that ViSiGi® LUX functions as well as the predicate with equivalent safety and effectiveness. In conclusion, the results support that ViSiGi® LUX is substantially equivalent to the predicate device.