(28 days)
The GIBI HD™ is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
The Gastrointestinal Boundary Identifier, or GIBI HD™, is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The dual lumen GIBI HD utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6inch tubing with a stopcock for filling the balloon.
The provided document is a 510(k) premarket notification for the Gastrointestinal Boundary Identifier (GIBI HD™). It describes the device, its indications for use, and a comparison to a predicate device, including performance data from bench tests.
Acceptance Criteria and Device Performance Study for the Gastrointestinal Boundary Identifier (GIBI HD™)
The document primarily focuses on bench testing to demonstrate substantial equivalence, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the typical questions regarding AI-driven medical devices (like MRMC studies, ground truth establishment for complex imaging, training set details, or expert adjudication) are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Balloon leakage test | The balloon component of the GIBI HD shall inflate to a minimum volume of 100 cc without exhibiting fluid leak or air egress. | Samples retained 100 cc of fluid at least 1 minute without leakage. | Pass |
| Fluid removal test | The GIBI HD shall remove a minimum of 500 cc of saline or clean water in under 1 minute. | Samples evacuated a minimum of 500 cc of fluid in under 1 minute. | Pass |
| Balloon bond joint strength test | The mated joint between the GIBI HD 's Balloon and Tubing shall withstand a minimum of 13 lbf prior to separation. | Samples did not exhibit balloon separation under 13 lbf. | Pass |
| Distal tip bond joint strength test | The mated joint between the GIBI HD 's distal tip and Tubing shall withstand a minimum of 19.5 lbf prior to separation. | Samples did not exhibit sensor tip separation under 19.5 lbf. | Pass |
| Stopcock separation test | The stopcock component of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the fill tube. | Samples did not exhibit stopcock separation under 1 lbf. | Pass |
| Fill tube separation test | The fill tube attached to the stopcock of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the y connector. | Samples did not exhibit fill tube separation under 1 lbf. | Pass |
| Adapter tubing separation test | The proximal tubing of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the y connector. | Samples did not exhibit adapter tube separation under 1 lbf. | Pass |
| Adapter separation test | The adapter of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the adapter tube. | Samples did not exhibit adapter separation under 1 lbf. | Pass |
| Visual Inspection and Measurement verification test (Length) | The dual lumen catheter component of the GIBI HD, from the distal edge of the Y connector to the end of the dual lumen catheter, shall have a minimum length of 75 cm. | Minimum length of measured sample is 75 cm. | Pass |
| Visual Inspection and Measurement verification test (Indicator Marks) | The dual lumen catheter component of the GIBI HD shall include indication marks on the surface of the tube at 30, 35, 40, 45, 50, 55 and 60 cm with respect to the distal portion of the component. | Indicator marks are located 30, 35, 40, 45, 50, 55, and 60 cm with respect to distal portion of the component. | Pass |
| Visual Inspection and Measurement verification test (Outer Diameter) | The dual lumen catheter component of the GIBI HD shall have three size configurations: 0.42" (32 Fr), 0.47" (36 Fr) and 0.53" (40 Fr). | Outer diameter of 32Fr, 36Fr and 40Fr samples are 0.42", 0.47" and 0.53", respectively. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Samples" for the performance tests, but does not specify the exact sample size (N) used for each test. The tests are bench tests, meaning they were performed in a lab setting, not on patient data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" study design in the context of clinical data does not apply here. The data provenance is from in-house bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is based on engineering specifications and measurable physical properties (e.g., fluid retention volume, force required for separation, length, diameter, and presence of markings) as evaluated during bench testing. This does not involve expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As the tests are physical measurements and functional evaluations, there is no need for expert adjudication in the classic sense. The "ground truth" is determined by the Pass/Fail criteria directly from the physical testing.
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. This device is a mechanical surgical instrument, not an AI-driven diagnostic or interpretative tool. No MRMC study was conducted or is relevant for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is defined by the engineering specifications and physical requirements for the device's components and functionality. This is a technical ground truth based on measurable physical properties rather than clinical outcomes, pathology, or expert consensus on medical images.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured physical good, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this device does not involve a training set for an AI model, this question is not relevant.
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July 28, 2022
ReShape Lifesciences Michelle Ravert Regulatory Affairs Manager 1001 Calle Amanecer San Clemente, CA 92673
Re: K221898
Trade/Device Name: Gastrointestinal Boundary Identifier (GIBI HDTM) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: June 28, 2022 Received: June 30, 2022
Dear Michelle Ravert:
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. You must comply with all the
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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-regulatory-information/postmarketing-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-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). 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-devices/device-advicecomprehensive-regulatory-assistance/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,
April Marrone, Ph.D., MBA Assistant Director (acting) 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
510(k) Number (if known) K221898
Device Name
Gastrointestinal Boundary Identifier (GIBI HDTM)
Indications for Use (Describe)
The GIBI HD™ is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Basic Information
| 510(k) Owner | ReShape Lifesciences1001 Calle AmanecerSan Clemente CA 92673Phone: (844) 937-7374Establishment Registration No: 3013508647 |
|---|---|
| Contact Person | Michelle Ravert, Regulatory Affairs Manager |
| Date summaryPrepared | July 26, 2022 |
| Trade Name | Gastrointestinal Boundary Identifier (GIBI HD™) |
| Common Name | Introduction/Drainage Catheter |
| Classification name | Gastrointestinal tube and accessories (21 CFR 876.5980) |
| Regulatory Class | Class II |
| Product Code | KNT |
| Predicate Device | Lap-Band® System Calibration Tube, K220455 |
| Reference Device | ViSiGi 3D®, K130483 |
DEVICE DESCRIPTION II.
The Gastrointestinal Boundary Identifier, or GIBI HD™, is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The dual lumen GIBI HD utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6inch tubing with a stopcock for filling the balloon.
III. INDICATIONS FOR USE
The GIBI HD is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH IV. THE PREDICATE DEVICE
| Technical Element | GIBI HDB-2032, B-2036, B-2040 | Predicate DeviceCalibration Tube, K220455 |
|---|---|---|
| Outer Diameter(OD), inches | B-2032 = 0.420" +0.000" / -0.012"B-2036 = 0.472" + 0.000" / -0.012"B-2040 = 0.525" + 0.000" / -0.012" | 0.380" +0.000" / -0.012" |
| OD, French Size | B-2032 = 32 FB-2036 = 36 FB-2040 = 40 F | 29F |
| Working length(distal end of Y -connector to distalend of distal tip) | 32.43 ± 0.52" | 24.73" ± 0.52" |
| Tubing Material | Silicone | Silicone |
V. PERFORMANCE DATA
| Test Performed | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Balloon leakagetest | The balloon component of the GIBI HD shallinflate to a minimum volume of 100 cc withoutexhibiting fluid leak or air egress. | Samples retained 100 cc of fluid atleast 1 minute without leakage. | Pass |
| Fluid removal test | The GIBI HD shall remove a minimum of 500cc of saline or clean water in under 1 minute. | Samples evacuated a minimum of500 cc of fluid in under 1 minute. | Pass |
| Balloon bond jointstrength test | The mated joint between the GIBI HD 's Balloonand Tubing shall withstand a minimum of 13 lbfprior to separation. | Samples did not exhibit balloonseparation under 13 lbf. | Pass |
| Distal tip bondjoint strength test | The mated joint between the GIBI HD 's distaltip and Tubing shall withstand a minimum of19.5 lbf prior to separation. | Samples did not exhibit sensor tipseparation under19.5 lbf. | Pass |
| Stopcockseparation test | The stopcock component of the GIBI HD shallwithstand a minimum of 1 lbf prior toseparation from the fill tube. | Samples did not exhibit stopcockseparation under 1 lbf. | Pass |
| Fill tubeseparation test | The fill tube attached to the stopcock of theGIBI HD shall withstand a minimum of 1 lbfprior to separation from the y connector. | Samples did not exhibit fill tubeseparation under 1 lbf. | Pass |
| Adaptertubingseparationtest | The proximal tubing of the GIBI HD shallwithstand a minimum of 1 lbf prior toseparation from the y connector. | Samples did not exhibit adaptertube separation under 1 lbf. | Pass |
| Adapterseparation test | The adapter of the GIBI HD shall withstand aminimum of 1 lbf prior to separation from theadapter tube. | Samples did not exhibit adapterseparation under 1 lbf. | Pass |
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| Test Performed | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Visual Inspectionand Measurementverification test | The dual lumen catheter component of theGIBI HD, from the distal edge of the Yconnector to the end of the dual lumencatheter, shall have a minimum length of 75cm. | Minimum length of measuredsample is 75 cm. | Pass |
| The dual lumen catheter component of the GIBIHD shall includeindication marks on the surface of the tube at 30,35, 40, 45, 50, 55 and 60 cm with respect to thedistal portion of the component. | Indicator marks are located 30, 35,40, 45, 50, 55,and 60 cm with respect to distalportion of the component. | Pass | |
| The dual lumen catheter component of theGIBI HD shall have three size configurations:0.42" (32 Fr), 0.47" (36 Fr) and 0.53" (40 Fr). | Outer diameter of 32Fr, 36Fr and40Fr samples are 0.42", 0.47" and0.53", respectively. | Pass |
BASIS FOR SUBSTANTIAL EQUIVALENCE VI.
Substantial equivalence of the GIBI HD to the predicate device (Lap-Band® System Calibration Tube, K220455) was established through an evaluation of the indications for use, principle of operation, device design, materials of construction, and an assessment of usability, safety, and effectiveness via bench studies.
The data presented in this summary demonstrates the technological similarity and equivalency of the GIBI HD to the predicate device (Lap-Band® System Calibration Tube, K220455).
The devices:
- · have the same intended use,
- · use the same principle of operation,
- · incorporate the same basic design,
- · use similar construction and material, and
- · are provided non-sterile.
In addition, the GIBI HD and the reference device (ViSiGi 3D, K130483) have the same outer
diameter sizes and are substantially equivalent with respect to working length.
In summary, the Gastrointestinal Boundary Identifier (GIBI HD™) device described in this submission is substantially equivalent to the predicate device, the LAP-BAND System Calibration tube (K220455).
§ 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.