(162 days)
Not Found
No
The document describes a mechanical device (a tube) and its physical properties and functions. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No.
The device description and intended uses focus on procedural assistance (suction, drainage, sizing, visualization) during surgery rather than directly treating a medical condition or disease.
No
The device is described for uses such as suction, decompression, drainage, irrigation, testing for leaks, visualization, and as a sizing guide, which are all interventional or procedural functions rather than diagnostic ones. While it can "test for leaks," this is a procedural check during surgery, not a diagnostic assessment of a condition.
No
The device description clearly outlines a physical, flexible gastric tube with a handle, suction regulator, and optional squeeze bulb. The performance studies also include physical testing like dimensional analysis, joint strength, deflection, torsion, buckling, kink, drainage, irrigation, suction, and leak testing, all indicative of a hardware device.
Based on the provided information, the Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Endolumik FG Bougie's Intended Use: The intended use of this device is for direct use within the body during surgical procedures. It is used for mechanical functions like suction, drainage, irrigation, sizing, and visualization of its position within the gastric system.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. Its function is entirely related to manipulating and interacting with the internal anatomy during surgery.
Therefore, the Endolumik Fluorescence Guided Gastric Calibration Tube falls under the category of a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgery centers, hospitals
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
§ 876.5980 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
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)
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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 | |
| Application | |
| Correspondent: | 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 876.5980 | |
| KNT | |
| 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
Visigi 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 Calibration
Tube 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
guide. | The Boehringer Laboratories Gastric
Sizing Tube 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. | 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
and/or gastric procedures | Individuals undergoing bariatric
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
distal end | Single lumen with rounded, closed
distal end | Different design
Established equivalence via testing |
|------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|
| Distal Side Holes/
Decompression Capability | Yes | Yes | Same |
| Connector for Suction | Yes | Yes | Same |
| Slide Valve | No | Yes | Different design
Established equivalence via testing |
| Tubing material | PVC | Styrene-Ethylene-Butylene-Styrene
(SEBS co-polymer) | Different design
Established equivalence via testing |
| Markings | Markings every 5mm on distal end;
Markings every 10cm on proximal
end | No markings | Different
Established equivalence
via justification |
| Sterility | Supplied non-sterile, disposable,
single patient use. | Supplied non-sterile, disposable,
single patient use. | Same |
| LED Guide Lights | Yes | No | Different design
Established equivalence via testing |
| LED wavelength | 697-766nm | n/a | Different
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.