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.

Device Description

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.

AI/ML Overview

The Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is a flexible gastric tube for use in gastric and bariatric surgery. The device is intended for 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.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Visigi 3D) through various non-clinical tests. The "acceptance criteria" implicitly are that the device performs comparably to the predicate or meets established safety standards.

Acceptance Criteria (Implied by equivalence testing)	Reported Device Performance (Summary from Non-clinical Test Summary)
Biocompatibility: No cytoxicity, sensitization, or irritation.	Passed Cytotoxicity Test (ISO 10993-5), Skin Sensitization Study (ISO 10993-10), Acute Irritation/Intracutaneous Reactivity (ISO 10993-10).
Electromagnetic Compatibility (EMC): Adherence to relevant standards.	Passed EMC Evaluation (IEC 60601-1-2 and 60601-2-18).
Electrical Safety: Adherence to relevant standards.	Passed Electrical Safety Evaluation (IEC 60601-1).
Light Safety: Adherence to relevant standards.	Passed Light Safety Evaluation (IEC 62471).
Packaging Integrity: Maintains sterility and integrity.	Passed Packaging Integrity (ASTM D4169).
Physical/Mechanical Characteristics:
- Dimensional Accuracy	Passed Dimensional Analysis.
- Tip Connection Strength	Passed Tip Connection to Tube Joint Strength Test.
- Deflection Resistance	Passed Fixed Deflection Testing.
- Torsion Resistance	Passed Torsion Testing.
- Buckling Resistance	Passed Buckling Testing.
- Kink Resistance	Passed Kink Testing.
Functional Performance:
- Drainage Capability	Passed Drainage Testing.
- Irrigation Capability	Passed Irrigation Testing.
- Suction Capability	Passed Suction Testing.
- Leak Testing Capability	Passed Leak Testing.
- Bulb Compatibility	Passed Bulb Compatibility.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical bench testing, not a clinical study on human subjects with a "test set" as typically understood in AI/ML performance evaluation. Therefore, there is no information about sample size for a test set of data or its provenance (country of origin, retrospective/prospective). The "samples" would refer to the number of devices or components tested in the various non-clinical evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device underwent non-clinical testing rather than expert-adjudicated performance evaluation based on clinical cases. The "ground truth" for these tests would be the established scientific and engineering principles and the performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no clinical test set requiring adjudication of findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is a physical medical instrument (gastric calibration tube), not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests was established by:

Compliance with recognized international and national standards: e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and EMC safety, IEC 62471 for light safety, ASTM D4169 for packaging.
Bench test results demonstrating functional equivalence to the predicate device for aspects like suction, drainage, irrigation, leak testing, and mechanical integrity.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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: (304) 250-9238
	Email: mcfadden@endolumik.com
ApplicationCorrespondent:	Michael Nilo
	President and Principal Consultant, Nilo Medical Consulting Group
	Phone: (717) 421-4396
	Email: michael.nilo@nilomedicalconsulting.com

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:Regulation:Product Code:Class:	Tube, Gastrointestinal (and Accessories)21 CFR 876.5980KNTII

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Device Description ട്.

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	PredicateVisigi 3d(K130483)	Comparison
Class	II	II	Same
Product Code	KNT	KNT	Same
Regulation	876.5980	876.5980	Same
Indication for Use Statement	The Endolumik Gastric CalibrationTube is indicated for use in gastricand bariatric surgical procedures forthe application of suction, stomachdecompression, drainage of gastricfluids, irrigation, to test for leaks, toprovide visualization of the tubeposition, and to serve as a sizingguide.	The Boehringer Laboratories GastricSizing Tube is indicated for use ingastric and bariatric surgicalprocedures for the application ofsuction, stomach decompression,drainage of gastric fluids, irrigation,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 bariatricand/or gastric procedures	Individuals undergoing bariatricand/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, closeddistal end	Single lumen with rounded, closeddistal end	Different designEstablished equivalence via testing
Distal Side Holes/Decompression Capability	Yes	Yes	Same
Connector for Suction	Yes	Yes	Same
Slide Valve	No	Yes	Different designEstablished equivalence via testing
Tubing material	PVC	Styrene-Ethylene-Butylene-Styrene(SEBS co-polymer)	Different designEstablished equivalence via testing
Markings	Markings every 5mm on distal end;Markings every 10cm on proximalend	No markings	DifferentEstablished equivalencevia justification
Sterility	Supplied non-sterile, disposable,single patient use.	Supplied non-sterile, disposable,single patient use.	Same
LED Guide Lights	Yes	No	Different designEstablished equivalence via testing
LED wavelength	697-766nm	n/a	DifferentEstablished 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.

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.