(138 days)
No
The device description and performance studies focus on mechanical and electrical safety and function, with no mention of AI or ML algorithms for data processing or decision making.
No.
A therapeutic device is one that treats a disease or condition. This device is used as a surgical tool for suction, drainage, irrigation, and as a sizing guide during bariatric and gastric procedures, which are supportive functions during surgery, not therapeutic in themselves.
No
The device description and intended use clearly state its functions are for surgical procedures such as suction, stomach decompression, drainage, irrigation, and as a sizing guide, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical tube with a closed tip, holes, a slide valve, suction regulator, battery case, and LED lights. It is a hardware device with added electrical components.
Based on the provided information, the ViSiGi® LUX device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ViSiGi® LUX Function: The description clearly states the device's intended use is for surgical procedures (gastric and bariatric) for purposes like suction, drainage, irrigation, and serving as a sizing guide. It is a surgical tool used during a procedure, not a test performed on a sample outside the body.
- Lack of Diagnostic Testing: There is no mention of the device analyzing biological samples or providing diagnostic information about a patient's health status.
Therefore, the ViSiGi® LUX is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 quide.
Product codes (comma separated list FDA assigned to the subject device)
KNT
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.
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 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.
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.
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 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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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: (484) 383 5870 | |
| Email: onikel@boehringelabs.com |
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
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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.
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Caring for Lives through Innovation, Quality and Service
9. Comparison of Technical Characteristics with the Predicate Device
| Device | ViSiGi® LUX
Subject Device | ViSiGi® 3D
Predicate (K130483) | Comparison |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Class | II | II | Same |
| Product code
and Regulation | KNT,
876.5980 | KNT,
876.5980 | Same |
| Indications for use | The Boehringer laboratories
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. | 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. | 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
and/or gastric procedures | Individuals undergoing bariatric
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
/French size | 32F, 36F, 40F | 32F, 36F, 40F | Same |
| Length | 1067 mm | 1067 mm | Same |
| Tubing | Single lumen with rounded, closed
distal end | Single lumen with rounded, closed
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
(SEBS block copolymer) | Styrene-Ethylene-Butylene-Styrene
(SEBS block copolymer) | Same |
| Markings | Yes | Yes | Same |
| Sterility | Supplied non-sterile, disposable,
single patient use | Supplied non-sterile, disposable,
single patient use | Same |
| LED lights | No | Yes | Different,
equivalence
established
via testing |
Boehringer Laboratories, LLC
300 Thoms Drive, Phoenixville, PA 19460 • 800-642- 4945 • 610-278-0900 • Fax: 610-278-0907 • www.boehringerlabs.com
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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.