The Endolumik Gastric Calibration Tube is indicated for use in gastric 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 guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.

Device Description

The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in esophageal, 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 tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.
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 suctionregulator. An additional squeeze bulb with pressure gauge may be attached to the end of the

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Endolumik Gastric Calibration Tube M Series." It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria and a study proving those criteria are met for the device's primary function of gastric calibration.

However, the document does list several non-clinical tests that were performed to evaluate the substantial equivalence of the new device (M Series) to the predicate device. These tests primarily relate to electrical safety and electromagnetic compatibility standards, suggesting that the acceptance criteria for these aspects were met by passing the listed standards.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

Information Present or Inferable:

Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Inferred): The device (Endolumik Gastric Calibration Tube M Series) must pass the requirements of the following international standards:
  - IEC 60601-2
  - IEC 60601-2 Section 5 (Likely refers to a specific section or part of IEC 60601-2)
  - IEC 60601-1
  - IEC 60601-2-18
  - IEC 62471
- Reported Device Performance: "All tests passed." This indicates that the device met the requirements of the listed standards.
Type of Ground Truth Used: Not applicable for the electrical safety and electromagnetic compatibility tests listed. These are objective engineering standard tests.

Missing Information:

The document does not provide information for most of the requested categories because it's a 510(k) summary focused on substantial equivalence to a predicate device, rather than a detailed clinical or performance study of the device's functional efficacy in gastric calibration. Specifically, the following are not mentioned:

Sample size used for the test set and the data provenance: Not applicable for the engineering tests listed. There's no "test set" of clinical cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical gastric calibration tube, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary Table of Available Information:

Information Category	Details from Text
1. Acceptance Criteria and Reported Device Performance	Acceptance Criteria (Inferred from tests performed): Compliance with the following standards: - IEC 60601-2 - IEC 60601-2 Section 5 - IEC 60601-1 - IEC 60601-2-18 - IEC 62471 Reported Device Performance: "All tests passed."
2. Sample size for test set and data provenance	Not applicable (engineering standard testing, no clinical test set described).
3. Number of experts and qualifications for ground truth	Not applicable.
4. Adjudication method for test set	Not applicable.
5. MRMC comparative effectiveness study and effect size (AI assistance)	Not applicable (device is a physical gastric calibration tube, not AI software).
6. Standalone (algorithm only without human-in-the-loop performance) study	Not applicable.
7. Type of ground truth used	Objective engineering standards (for electrical safety, electromagnetic compatibility, etc.).
8. Sample size for the training set	Not applicable.
9. How the ground truth for the training set was established	Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 8, 2024

Endolumik % Michael Nilo President Nilo Medical Consulting Group 3706 Butler Street, #313 Pittsburgh, Pennsylvania 15201

Re: K240069

Trade/Device Name: Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT. FAT Dated: January 8, 2024 Received: January 9, 2024

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 (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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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).

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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Anthony Lee -S

Anthony C. Lee, 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) K240069

Device Name

Endolumik Gastric Callbration Tube M Series (EGCT36M): Endolumik Gastric Calibration Tube M Series (EGCT40M)

Indications for Use (Describe)

The EndolumikGastric Calibration Tube is indicated for use in gastric 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 guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.

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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K240069 Page 1 of 2

Contact Details

510(k) Summary

21 CFR 807.92(a)(1)

Prepared on: 2024-01-08

Applicant Name	ENDOLUMIK
Applicant Address	364 Patteson Dr. #293 Morgantown WV 26505 United States
Applicant Contact Telephone	510.468.4426
Applicant Contact	Mrs. Mara McFadden
Applicant Contact Email	mcfadden@endolumik.com
Correspondent Name	Nilo Medical Consulting Group
Correspondent Address	3706 Butler Street, #313 Pittsburgh PA 15201 United States
Correspondent Contact Telephone	717.421.4396
Correspondent Contact	Mr. Michael Nilo
Correspondent Contact Email	michael.nilo@nilomedicalconsulting.com

Device Name 21 CFR 807.92(a)(2)

Device Trade Name	Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
Common Name	Gastrointestinal tube and accessories
Classification Name	Tubes, Gastrointestinal (And Accessories)
Regulation Number	876.5980
Product Code(s)	KNT, FAT

Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K222880	Endolumik Gastric Calibration Tube	KNT

Device Description Summary 21 CFR 807.92(a)(4)
The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in esophageal, 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 tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.
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 suctionregulator. An additional squeeze bulb with pressure gauge may be attached to the end of the

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Intended Use/Indications for Use

The EndolumikGastric Calibration Tube is 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 guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.

Indications for Use Comparison

The Indications for Use between the currently marketed predicate device and the subject device are identical.

The predicate device Indications for Use were updated after clearance to include identification as an esophageal bougie as this is a Class I indication which did not require a new 510(k).

Technological Comparison

The proposed Endolumik M Series Gastric Calibration Tube is identical to the predicate device with the previously cleared EGCT36 models utilized LEDs of wavelengths between 697 - 766nm, which is in the visible range of the Near Infrared (NIR) spectrum. The M models utilize LEDs between wavelengths 766 and 920nm. These wavelengths are also in the NIR spectrum, and are designed for use with NIR cameras that can only visualize NIR light between 800-900nm. However, these proposed wavelengths are not visible to the human eye, so one additional 520nm (green visible light) LED was added to give users a positive indication that the product had been powered on.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following tests were performed to evaluate the substantial equivalence. All tests passed. IEC 60601-2 IEC 60601-2 Section 5 IEC 60601-1 IEC 60601-2-18 IEC 6247 1

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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.