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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the ReShape Lifesciences Lap-Band System Calibration Tube. It describes the device, its indications for use, and the basis for substantial equivalence to a predicate device. The information required to answer your request, specifically regarding detailed acceptance criteria and the study that proves the device meets them, is primarily found in the "Performance Data" section.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Test Performed	Acceptance Criteria	Reported Device Performance
Burst Test of Calibration Tube 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 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 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 Balloon Pull	The balloon must withstand 13 lbf.	Pass
End Connector Pull Force	The end connector must withstand 6 lbf.	Pass
Hybrid Calibration Tube Suction Functional Testing	Hybrid calibration tube must remove all of the saline in glass beaker within 1 minute.	Pass
Pull Force Fill Tube / 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 Tubing / Over-Mold Testing	The proximal tubing or over-mold joint must withstand a force of 1 lb.	Pass

Biocompatibility Testing:

Biocompatibility Test	Acceptance Criteria	Reported Device Performance
Cytotoxicity Study Using the ISO Elution Method	Observations for test and negative control at 24, 48 and 72 hours. Presence or absence of a confluent monolayer, vacuolization, cellular swelling and crenation and the percentage of cellular lysis are recorded. Scoring was nontoxic, intermediate, or toxic.	The CTE Score was N (non-toxic at 24, 48 and 72 hours).
ISO Sensitization Study in the Guinea Pig	The response, pattern, character, and duration of any test animal reactions are compared to any reactions in the controls. Any dermal inflammatory response at the test sites greater than that seen in any control condition is considered evidence of a potential allergic response.	No evidence of delayed dermal contact sensitization was observed.
ISO Vaginal Irritation Study in the Rabbit	Each animal was observed daily for general health and external signs of irritation around the opening of the vaginal vestibule. After euthanization, tissue sections were evaluated. Macroscopic reactions were compared between test and control animals. Microscopic evaluation scores for all SC test animals were added together and divided by the number of test animals to obtain the SC average. The CSO averages were similarly calculated. The Irritation Index was scored from zero to 16, with zero as nonirritant and 16 severe irritant.	The microscopic SC and CSO extracts were a nonirritant.

2. Sample sizes used for the test set and the data provenance:

Sample Size: The document does not explicitly state the sample sizes (number of units tested) for each specific bench test. It only provides the "Pass" result, indicating that the tested units met the criteria.
Data Provenance: The studies were described as "bench" and "animal studies." There is no information regarding the country of origin of the data, nor whether the studies were retrospective or prospective experiments on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This document describes bench testing and biocompatibility testing for a medical device (calibration tube), not a diagnostic AI system or a study requiring human expert assessment for ground truth. Therefore, there were no "experts" in the sense of clinicians establishing ground truth for a diagnostic test set. The acceptance criteria are based on engineering and material science standards (e.g., force, volume, material properties).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As noted above, this is not a study assessing human or AI diagnostic performance requiring adjudication of interpretations. The tests described are objective, quantitative measurements or qualitative observations (e.g., presence/absence of allergic response) against predefined criteria.

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 document pertains to the clearance of a physical medical device (a calibration tube) and its performance in bench and animal studies to demonstrate substantial equivalence, not a diagnostic AI system. Therefore, no MRMC study with human readers assisting AI was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance data in this context is defined by the pre-defined acceptance criteria based on established engineering principles, material science, and ISO standards for biocompatibility. For example, for the Burst Test, the ground truth is simply whether the balloon remained intact at the specified pressure. For biocompatibility, it's the observed biological reactions (or lack thereof) compared to ISO standards.

8. The sample size for the training set:

Not applicable. This device is not an AI system that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. As this is not an AI system, there is no "ground truth for a training set."

Summary

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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. 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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

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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 ( Select one or both, as applicable )
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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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 Lifesciences1001 Calle AmanecerSan Clemente CA 92673Phone: (844) 937-7374Establishment 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

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).

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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 DeviceGastric BalloonSuction CatheterK002838	Subject DeviceCalibration Tube	Effect on SubstantialEquivalence
Product Code	KNT	Same	None
Regulatory Class	Class II	Same	None
Regulation Number	21 C.F.R. 876.5980	Same	None
Regulation Name	Gastroenterology-Urology	Same	None
Feature	Predicate DeviceGastric BalloonSuction CatheterK002838	Subject DeviceCalibration Tube	Effect on SubstantialEquivalence
Indications for Use	The Gastric BalloonSuction Catheter isindicated for use ingastric and bariatricsurgical procedures to	The LAP-BAND®System CalibrationTube is indicated foruse in gastric and bariatricsurgical procedures todecompress thestomach, drain andremove gastric fluidand size the gastricpouch.	None
Outer Diameter	OD = 0.38" + 0.00" /- 0.12"	Same	None
Working Length	23.29" +/- 0.50"	24.73" +/- 0.52"	No impact tosubstantialequivalence.The additional 1.23" isdue to the presence ofthe distal tip (seeDistal Tip featurebelow). The additionof the distal tip doesnot affect risk.
Tubing	Dual lumen	Same	None
Distal Side Holes	3 aspiration holesproximal to theballoon to ensure asteady vacuum	Same	None
Feature	Predicate DeviceGastric BalloonSuction CatheterK002838	Subject DeviceCalibration Tube	Effect on SubstantialEquivalence
Distal Tip	None	Includes a tip distal tothe balloon with 12aspiration holes.	No impact tosubstantialequivalence.Tip aids in trackingthrough the anatomyand the holesminimize the potentialfor blockage. Theaddition of the distaltip does not affectrisk.
Connector for Suction	The catheter includesan adapter for roomsuction	Same	None
Balloon + InflationValve	The balloon has aninflation capacity $≥$100 cc min.The catheter isattached to a 6-inchtubing with astopcock for fillingthe balloon.	Same	None
Tubing Material	Silicone	Same	None
Markings	Indication marks at30, 35, 40, 45, and50 centimeters.	Same	None
Sterility	non-sterile,disposable, singlepatient use	Same	None
Shelf Life	None.	7 years	None.

Table 1: Comparison of Subject Device and Predicate Device

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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 ofCalibration TubeBalloon	The balloon must remain intact while inflated to four (4) times its recommend fill volume (25cc x 4 = 100cc).	Pass
Sensor Tip Force toPull	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 RemoveStopCock	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 StrengthBalloon Pull	The balloon must withstand 13 lbf.	Pass
End Connector PullForce	The end connector must withstand 6 lbf.	Pass
Hybrid CalibrationTube SuctionFunctional Testing	Hybrid calibration tube must remove all of the saline in glass beaker within 1 minute.	Pass
Pull Force Fill Tube /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 ProximalTubing / Over-MoldTesting	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

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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 StudyUsing the ISO ElutionMethod	Observations for test and negative controlat 24, 48 and 72 hours. Presence orabsence of a confluent monolayer,vacuolization, cellular swelling andcrenation and the percentage of cellularlysis are recorded. Scoring was nontoxic,intermediate, or toxic.	The CTE Score was N(non-toxic at 24, 48 and72 hours).
ISO SensitizationStudy in the GuineaPig	The response, pattern, character, andduration of any test animal reactions arecompared to any reactions in the controls.Any dermal inflammatory response at thetest sites greater than that seen in anycontrol condition is considered evidenceof a potential allergic response.	No evidence of delayeddermal contactsensitization wasobserved.
ISO VaginalIrritation Study in theRabbit	Each animal was observed daily forgeneral health and external signs ofirritation around the opening of thevaginal vestibule. After euthanization,tissue sections were evaluated.Macroscopic reactions were comparedbetween test and control animals.Microscopic evaluation scores for all SCtest animals were added together anddivided by the number of test animals toobtain the SC average. The CSO averageswere similarly calculated. The IrritationIndex was scored from zero to 16, withzero as nonirritant and 16 severe irritant.	The microscopic SCand CSO extracts werea nonirritant.

Table 3: Biocompatibility Testing Summary - Subject Device

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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.

Regulation Number and Section

§ 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.