Lap-Band System Calibration Tube

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June 7, 2022 ReShape Lifesciences Michelle Ravert Sr. Regulatory Specialist 1001 Calle Amanecer San Clemente, CA 92673 Re: K220455 Trade/Device Name: Lap-Band System Calibration Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: March 8, 2022 Received: March 10, 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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-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 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, 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K220455 Device Name LAP-BAND® System Calibration Tube ### Indications for Use (Describe) The LAP-BAND® System Calibration Tube is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch. | Type of Use ( <i>Select one or both, as applicable</i> ) | |----------------------------------------------------------| |----------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| |----------------------------------------------------------------------------------|----------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the logo for ReShape Lifesciences. The logo consists of an orange partial circle on the top left, followed by the word "ReShape" in purple. Below "ReShape" is the word "Lifesciences" in gray, with a trademark symbol next to it. # 510(k) Summary #### I. 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 | June 06, 2022 | | Prepared | | | Trade Name | Lap-Band® System Calibration Tube | | Common Name | Introduction/Drainage Catheter | | Classification | Class II, KNT | | Predicate Device | ReShape Lifesciences Gastric Balloon Suction Catheter, K002838 | #### II. DEVICE DESCRIPTION The Lap-Band® System Calibration Tube 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 Calibration Tube 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 6-inch tubing with a stopcock for filling the balloon. #### III. INDICATIONS FOR USE The Lap-Band® System Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch. #### IV. BASIS FOR SUBSTANTIAL EQUIVALENCE Substantial equivalence of the Lap-Band® System Calibration Tube to the predicate device (Gastric Balloon Suction Catheter, K002838) 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 and animal studies. The data presented in this summary demonstrates the technological similarity and equivalency of the Lap-Band® System Calibration Tube to the predicate device (Gastric Balloon Suction Catheter K002838). {4}------------------------------------------------ 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 and packaged using the same processes. In summary, the Lap-Band® System Calibration Tube described in this submission is substantially equivalent to the predicate device (Gastric Balloon Suction Catheter K002838). ### V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE A comparison of the Lap-Band® System Calibration Tube and the predicate device (Gastric Balloon Suction Catheter K002838) is provided in Table 1. | Feature | Predicate Device<br>Gastric Balloon<br>Suction Catheter<br>K002838 | Subject Device<br>Calibration Tube | Effect on Substantial<br>Equivalence | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KNT | Same | None | | Regulatory Class | Class II | Same | None | | Regulation Number | 21 C.F.R. 876.5980 | Same | None | | Regulation Name | Gastroenterology-<br>Urology | Same | None | | Feature | Predicate Device<br>Gastric Balloon<br>Suction Catheter<br>K002838 | Subject Device<br>Calibration Tube | Effect on Substantial<br>Equivalence | | Indications for Use | The Gastric Balloon<br>Suction Catheter is<br>indicated for use in<br>gastric and bariatric<br>surgical procedures to<br> | The LAP-BAND®<br>System Calibration<br>Tube is indicated for<br>use in gastric and bariatric<br>surgical procedures to<br>decompress the<br>stomach, drain and<br>remove gastric fluid<br>and size the gastric<br>pouch. | None | | Outer Diameter | OD = 0.38" + 0.00" /<br>- 0.12" | Same | None | | Working Length | 23.29" +/- 0.50" | 24.73" +/- 0.52" | No impact to<br>substantial<br>equivalence.<br>The additional 1.23" is<br>due to the presence of<br>the distal tip (see<br>Distal Tip feature<br>below). The addition<br>of the distal tip does<br>not affect risk. | | Tubing | Dual lumen | Same | None | | Distal Side Holes | 3 aspiration holes<br>proximal to the<br>balloon to ensure a<br>steady vacuum | Same | None | | Feature | Predicate Device<br>Gastric Balloon<br>Suction Catheter<br>K002838 | Subject Device<br>Calibration Tube | Effect on Substantial<br>Equivalence | | Distal Tip | None | Includes a tip distal to<br>the balloon with 12<br>aspiration holes. | No impact to<br>substantial<br>equivalence.<br>Tip aids in tracking<br>through the anatomy<br>and the holes<br>minimize the potential<br>for blockage. The<br>addition of the distal<br>tip does not affect<br>risk. | | Connector for Suction | The catheter includes<br>an adapter for room<br>suction | Same | None | | Balloon + Inflation<br>Valve | The balloon has an<br>inflation capacity $≥$<br>100 cc min.<br><br>The catheter is<br>attached to a 6-inch<br>tubing with a<br>stopcock for filling<br>the balloon. | Same | None | | Tubing Material | Silicone | Same | None | | Markings | Indication marks at<br>30, 35, 40, 45, and<br>50 centimeters. | Same | None | | Sterility | non-sterile,<br>disposable, single<br>patient use | Same | None | | Shelf Life | None. | 7 years | None. | Table 1: Comparison of Subject Device and Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### VI. PERFORMANCE DATA Comparative performance testing was conducted to demonstrate that the technological differences between the Lap-Band® System Calibration Tube and the predicate device (Gastric Balloon Suction Catheter, K002838) do not raise concerns of substantial equivalence. ## Performance Testing - Bench Refer to Table 2 below for a summary of the performance testing performed on the Lap-Band® System Calibration Tube. | Test Performed | Acceptance Criteria | Results | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Burst Test of<br>Calibration Tube<br>Balloon | The balloon must remain intact while inflated to four (4) times its recommend fill volume (25cc x 4 = 100cc). | Pass | | Sensor Tip Force to<br>Pull | The sensor tip (distal tip) must be 1.5 times greater than the acceptance criteria of the calibration balloon pull (1.5 x 13 = 19.5lbf). | Pass | | Force to Remove<br>StopCock | The stopcock must withstand a force of 1 lbf. | Pass | | Pull Force of Bushing | The bushing must withstand a force of 1 lbf. | Pass | | Pull force of Fill Tube | The fill tube adhesive joint must withstand a force of 1 lbf. | Pass | | Adhesive Strength<br>Balloon Pull | The balloon must withstand 13 lbf. | Pass | | End Connector Pull<br>Force | The end connector must withstand 6 lbf. | Pass | | Hybrid Calibration<br>Tube Suction<br>Functional Testing | Hybrid calibration tube must remove all of the saline in glass beaker within 1 minute. | Pass | | Pull Force Fill Tube /<br>Over-Mold Testing | The fill tube or over-mold joint must withstand a force of 1 lb. This component's only function is to provide a path for inflation of the balloon. | Pass | | Pull Force of Proximal<br>Tubing / Over-Mold<br>Testing | The proximal tubing or over-mold joint must withstand a force of 1 lb. | Pass | ### Table 2: Summary of Non-Clinical Bench Testing for the Subject Device {8}------------------------------------------------ # Biocompatibility Testing Refer to Table 3 below for a summary of the biocompatibility testing performed on Lap-Band® System Calibration Tube. | Biocompatibility Test | Acceptance Criteria | Results | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Cytotoxicity Study<br>Using the ISO Elution<br>Method | Observations for test and negative control<br>at 24, 48 and 72 hours. Presence or<br>absence of a confluent monolayer,<br>vacuolization, cellular swelling and<br>crenation and the percentage of cellular<br>lysis are recorded. Scoring was nontoxic,<br>intermediate, or toxic. | The CTE Score was N<br>(non-toxic at 24, 48 and<br>72 hours). | | ISO Sensitization<br>Study in the Guinea<br>Pig | The response, pattern, character, and<br>duration of any test animal reactions are<br>compared to any reactions in the controls.<br>Any dermal inflammatory response at the<br>test sites greater than that seen in any<br>control condition is considered evidence<br>of a potential allergic response. | No evidence of delayed<br>dermal contact<br>sensitization was<br>observed. | | ISO Vaginal<br>Irritation Study in the<br>Rabbit | Each animal was observed daily for<br>general health and external signs of<br>irritation around the opening of the<br>vaginal vestibule. After euthanization,<br>tissue sections were evaluated.<br>Macroscopic reactions were compared<br>between test and control animals.<br>Microscopic evaluation scores for all SC<br>test animals were added together and<br>divided by the number of test animals to<br>obtain the SC average. The CSO averages<br>were similarly calculated. The Irritation<br>Index was scored from zero to 16, with<br>zero as nonirritant and 16 severe irritant. | The microscopic SC<br>and CSO extracts were<br>a nonirritant. | | Table 3: Biocompatibility Testing Summary - Subject Device | | |------------------------------------------------------------|--| | | | {9}------------------------------------------------ #### VII. CONCLUSION ReShape Lifesciences concludes, through a review of the non-clinical assessments, the comparison of the device classifications for use, operating principle, technological characteristics, and biocompatibility that the subject device, the Lap-Band® System Calibration Tube, is substantially equivalent to the predicate device, the Gastric Balloon Suction Catheter (K002838). Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.