Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

K222880 · Endolumik, Inc. · KNT · Mar 3, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K222880
• Device Name: Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
• Applicant: Endolumik, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Mar 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

Device Story

Flexible gastric calibration tube used in gastric/bariatric surgery; provides suction, decompression, drainage, irrigation, and sizing. Features integrated LED guide lights (697-766nm) for visualization of tube position within the stomach. Operated by surgeons in hospitals/surgery centers. Device includes handle with suction regulator; optional squeeze bulb with pressure gauge. LED visualization assists surgeon in confirming tube placement and assessing gastric anatomy/integrity. Benefits include improved visualization of tube position and potential for enhanced leak testing during procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2, 60601-2-18), light safety (IEC 62471), packaging integrity (ASTM D4169), and mechanical performance (torsion, buckling, kink, leak, drainage, irrigation, suction testing).

Technological Characteristics

Flexible PVC multi-lumen tube (80cm length, 36F/40F diameters). Features rounded distal tip with side holes. Includes integrated LED guide lights (697-766nm) for visualization. Proximal handle with suction regulator. Non-sterile, single-patient use. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2/60601-2-18; light safety per IEC 62471.

Indications for Use

Indicated for individuals undergoing gastric and bariatric surgical procedures requiring suction, stomach decompression, drainage, irrigation, leak testing, tube visualization, and 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

• Visigi 3D (K130483)

Submission Summary (Full Text)

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March 3. 2023

Endolumik, Inc. % Michael Nilo President Nilo Medical Consulting Group 3491 Denny Street Pisstburgh, PA 15201

Re: K222880

> Trade/Device Name: Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: February 1, 2023 Received: February 1, 2023

Dear Michael Nilo:

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,

Image /page/1/Picture/5 description: The image contains the text "Je An -S". The text is written in a simple, sans-serif font. The letters are black, and the background is white. The letters are arranged horizontally, with a space between each letter.

Je Hi An, Ph.D. 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

Enclosure

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# Indications for Use

510(k) Number (if known) K222880

## Device Name

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)

Indications for Use (Describe)

The Endolumik Fluorescence Guided Gastric Callbration Tube (FG Bougie) is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="text-decoration: none;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> </span> </span> </span> |
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span style="letter-spacing: normal;"> <span style="text-decoration: none;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> </span> </span> </span> |

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

### Date Prepared 1.

1 March 2023

## Submitter 2.

| Applicant: | Endolumik, Inc |
|-------------------------------|-------------------------------------------------------------------|
| | 364 Patteson Dr. #293 |
| | Morgantown, WV 26505 |
| | United States |
| Official Contact: | Mara McFadden |
| | CEO |
| | Phone: [phone] |
| | Email: [e-mail] |
| Application<br>Correspondent: | Michael Nilo |
| | President and Principal Consultant, Nilo Medical Consulting Group |
| | Phone: [phone] |
| | Email: [e-mail] |

#### 3. Device Information

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

#### 4. Predicate Device Information

| Trade Name: | Visigi 3D |
|------------------------------------------------------------------|--------------------------------------------------------------------------|
| 510(k) Number: | K130483 |
| Common Name: | Gastrointestinal tube and accessories |
| Device Classification:<br>Regulation:<br>Product Code:<br>Class: | Tube, Gastrointestinal (and Accessories)<br>21 CFR 876.5980<br>KNT<br>II |

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## Device Description ട്.

The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in gastric and bariatric surgery. It may be used for the following: the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

The Endolumik Gastric Calibration Tube is a non-sterile, single patient use device. The tube is 80 cm long and is available in 2 different diameters: 36 and 40 French. It has a rounded tip and small side holes at the distal end. The proximal end includes a handle with an integral suction regulator. An additional squeeze bulb with pressure gauge may be attached to the end of the regulator.

### 6. Indications for Use

The Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

### 7. Technological Comparison

The Endolumik Gastric Calibration Tube is similar to the predicate with minor differences in length and material of the tube.

The minor differences in design do not raise new questions of safety or effectiveness. Endolumik has evaluated these characteristics using bench test methods.

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## 8. Comparison of Technical Characteristics with the Predicate Device

| | Endolumik | Predicate<br>Visigi 3d<br>(K130483) | Comparison |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Class | II | II | Same |
| Product Code | KNT | KNT | Same |
| Regulation | 876.5980 | 876.5980 | Same |
| Indication for Use Statement | The Endolumik Gastric Calibration<br>Tube is indicated for use in gastric<br>and bariatric surgical procedures for<br>the application of suction, stomach<br>decompression, drainage of gastric<br>fluids, irrigation, to test for leaks, to<br>provide visualization of the tube<br>position, and to serve as a sizing<br>guide. | The Boehringer Laboratories Gastric<br>Sizing Tube is indicated for use in<br>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. | Similar |
| 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, sizing, irrigation. | Suction, drainage, sizing, irrigation. | Same |
| Outer Diameter/ French Size | 36F, 40F | 32F, 36F, 40F | Same |
| Length | 92cm | 76cm | Similar |

# Table 1: Comparison of the Endolumik to the predicate device

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| Tubing | Multi lumen with rounded, closed<br>distal end | Single lumen with rounded, closed<br>distal end | Different design<br>Established equivalence via testing |
|------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|
| Distal Side Holes/<br>Decompression Capability | Yes | Yes | Same |
| Connector for Suction | Yes | Yes | Same |
| Slide Valve | No | Yes | Different design<br>Established equivalence via testing |
| Tubing material | PVC | Styrene-Ethylene-Butylene-Styrene<br>(SEBS co-polymer) | Different design<br>Established equivalence via testing |
| Markings | Markings every 5mm on distal end;<br>Markings every 10cm on proximal<br>end | No markings | Different<br>Established equivalence<br>via justification |
| Sterility | Supplied non-sterile, disposable,<br>single patient use. | Supplied non-sterile, disposable,<br>single patient use. | Same |
| LED Guide Lights | Yes | No | Different design<br>Established equivalence via testing |
| LED wavelength | 697-766nm | n/a | Different<br>Established equivalence via testing |

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### Non-clinical and/or Clinical Test Summary and Conclusions 9.

## Test Summary

The following testing was conducted to support substantial equivalence:

- Cytotoxicity Test, MEM/Agar Overlay/Direct Contact per ISO 10993-5
- Skin Sensitization Study, Magnusson-Kligman Polar and Non-polar Extraction ● per ISO 10993-10
- Acute Irritation/Intracutaneous Reactivity, Polar and Non-polar Extraction per ● ISO 10993-10
- EMC Evaluation per IEC 60601-1-2 and 60601-2-18 ●
- Electrical Safety Evaluation per IEC 60601-1 ●
- Light Safety Evaluation per IEC 62471 ●
- Packaging Integrity per ASTM D4169 ●
- Dimensional Analysis ●
- Tip Connection to Tube Joint Strength Test ●
- Fixed Deflection Testing ●
- Torsion Testing ●
- Buckling Testing ●
- Kink Testing ●
- Drainage Testing
- Irrigation Testing ●
- Suction Testing ●
- Leak Testing ●
- Bulb Compatibility

The biocompatibility, EMC, electrical safety, and performance testing demonstrate substantial equivalence to the predicate device.

#### 10. Conclusion

In conclusion, the proposed FG Bougie has the same classification information, the same intended use, and similar technologies as the predicate device. According to performance tests conducted, the device is as safe, as effective, and performs as well as the predicate device.