Gastrointestinal Boundary Identifier (GIBI HD)

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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. 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You must comply with all the {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Basic Information | 510(k) Owner | ReShape Lifesciences<br>1001 Calle Amanecer<br>San Clemente CA 92673<br>Phone: (844) 937-7374<br>Establishment Registration No: 3013508647 | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Michelle Ravert, Regulatory Affairs Manager | | Date summary<br>Prepared | 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. {4}------------------------------------------------ ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH IV. THE PREDICATE DEVICE | Technical Element | GIBI HD<br>B-2032, B-2036, B-2040 | Predicate Device<br>Calibration Tube, K220455 | |-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Outer Diameter<br>(OD), inches | B-2032 = 0.420" +0.000" / -0.012"<br>B-2036 = 0.472" + 0.000" / -0.012"<br>B-2040 = 0.525" + 0.000" / -0.012" | 0.380" +0.000" / -0.012" | | OD, French Size | B-2032 = 32 F<br>B-2036 = 36 F<br>B-2040 = 40 F | 29F | | Working length<br>(distal end of Y -<br>connector to distal<br>end 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 leakage<br>test | The balloon component of the GIBI HD shall<br>inflate to a minimum volume of 100 cc without<br>exhibiting fluid leak or air egress. | Samples retained 100 cc of fluid at<br>least 1 minute without leakage. | Pass | | Fluid removal test | The GIBI HD shall remove a minimum of 500<br>cc of saline or clean water in under 1 minute. | Samples evacuated a minimum of<br>500 cc of fluid in under 1 minute. | Pass | | Balloon bond joint<br>strength test | The mated joint between the GIBI HD 's Balloon<br>and Tubing shall withstand a minimum of 13 lbf<br>prior to separation. | Samples did not exhibit balloon<br>separation under 13 lbf. | Pass | | Distal tip bond<br>joint strength test | The mated joint between the GIBI HD 's distal<br>tip and Tubing shall withstand a minimum of<br>19.5 lbf prior to separation. | Samples did not exhibit sensor tip<br>separation under<br>19.5 lbf. | Pass | | Stopcock<br>separation test | The stopcock component of the GIBI HD shall<br>withstand a minimum of 1 lbf prior to<br>separation from the fill tube. | Samples did not exhibit stopcock<br>separation under 1 lbf. | Pass | | Fill tube<br>separation test | The fill tube attached to the stopcock of the<br>GIBI HD shall withstand a minimum of 1 lbf<br>prior to separation from the y connector. | Samples did not exhibit fill tube<br>separation under 1 lbf. | Pass | | Adapter<br>tubing<br>separation<br>test | The proximal tubing of the GIBI HD shall<br>withstand a minimum of 1 lbf prior to<br>separation from the y connector. | Samples did not exhibit adapter<br>tube separation under 1 lbf. | Pass | | Adapter<br>separation test | The adapter of the GIBI HD shall withstand a<br>minimum of 1 lbf prior to separation from the<br>adapter tube. | Samples did not exhibit adapter<br>separation under 1 lbf. | Pass | {5}------------------------------------------------ | Test Performed | Purpose | Acceptance Criteria | Results | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------| | Visual Inspection<br>and Measurement<br>verification test | The dual lumen catheter component of the<br>GIBI HD, from the distal edge of the Y<br>connector to the end of the dual lumen<br>catheter, shall have a minimum length of 75<br>cm. | Minimum length of measured<br>sample is 75 cm. | Pass | | | The dual lumen catheter component of the GIBI<br>HD shall include<br>indication marks on the surface of the tube at 30,<br>35, 40, 45, 50, 55 and 60 cm with respect to the<br>distal portion of the component. | Indicator marks are located 30, 35,<br>40, 45, 50, 55,<br>and 60 cm with respect to distal<br>portion of the component. | Pass | | | The dual lumen catheter component of the<br>GIBI HD shall have three size configurations:<br>0.42" (32 Fr), 0.47" (36 Fr) and 0.53" (40 Fr). | Outer diameter of 32Fr, 36Fr and<br>40Fr samples are 0.42", 0.47" and<br>0.53", 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).