ReShape Calibration Tubes

K230131 · Reshape Lifesciences · KNT · Feb 15, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230131
• Device Name: ReShape Calibration Tubes
• Applicant: Reshape Lifesciences
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 15, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ReShape Calibration Tubes™ are 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.

Device Story

ReShape Calibration Tubes are flexible, dual-lumen gastric tubes used during gastric and bariatric surgeries. The device is inserted by a surgeon to provide visible and tactile delineation of the gastroesophageal junction, esophageal hiatus, and stomach antrum. It functions as a sizing guide while simultaneously allowing for gastric decompression, fluid drainage, and irrigation via aspiration holes and a distal tip with eyelets. The device includes an inflation valve for an integrated balloon and an adapter for connection to room suction. It is a single-patient-use, non-sterile device. The output is physical sizing and fluid management, which assists the surgeon in performing the procedure accurately, potentially improving surgical outcomes.

Clinical Evidence

No clinical data. Bench testing was not conducted for this submission as the device is identical to the predicate device (K221898).

Technological Characteristics

Flexible dual-lumen silicone gastric tube. Features include a distal tip with 12 aspiration eyelets, a balloon with ≥ 100 cc inflation capacity, and an inflation valve. Includes suction adapter and depth markings at 30-60 cm. Non-sterile, single-patient use. No software or electronic components.

Indications for Use

Indicated for patients undergoing gastric and bariatric surgical procedures requiring gastric decompression, fluid drainage, irrigation, or stomach sizing.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• ReShape Lifesciences Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube (K221898)

Submission Summary (Full Text)

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February 15, 2023

ReShape Lifesciences Dov Gal VP of Regulatory, Quality, & Clinical 1001 Calle Amanecer San Clemente, CA 92673

Re: K230131

Trade/Device Name: ReShape Calibration Tubes Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: January 16, 2023 Received: January 17, 2023

Dear Dov Gal:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the text "Je An -S" in black font. The text is arranged horizontally, with "Je" on the left, "An" in the middle, and "-S" on the right. There is a faint, light blue watermark in the background that is difficult to discern.

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K230131

Device Name ReShape Calibration TubesTM

Indications for Use (Describe)

ReShape Calibration Tubes™ are indicated for use in gastric surgical procedures to decompress the stomach. drain and remove gastric fluid, irrigate, and act as a sizing guide.

Type of Use (Select one or both, as applicable)

|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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Confidential

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Image /page/3/Picture/0 description: The image contains the logo for ReShape Lifesciences. The logo features a stylized orange circle that is not fully complete. The text "ReShape" is written in a combination of orange and purple, with "Re" in orange and "Shape" in purple. Below "ReShape" is the word "Lifesciences" in purple.

# 510(k) Summary

#### I. Basic Information

| 510(k) Owner | ReShape Lifesciences<br>1001 Calle Amanecer<br>San Clemente CA 92673<br>Phone: [phone]<br>Establishment Registration No: 3013508647 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Dov Gal, VP of Regulatory, Quality, & Clinical |
| Date of summary | January 16, 2023 |
| Trade Name | The ReShape Calibration Tubes™ |
| Common Name | Introduction/Drainage Catheter |
| Classification | Class II, KNT |
| Classification Name | Gastrointestinal Tube and Accessories |
| Predicate Device | ReShape Lifesciences Gastrointestinal Boundary Identifier (GIBI HD ™)<br>Calibration Tube, K221898 |

#### II. DEVICE DESCRIPTION

The subject device is the same as the Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube, which is also manufactured by our company, ReShape Lifesciences Inc., and was cleared under 510(k) K221898. The reason for the submission is the addition of a contraindication to the Directions for Use (DFU). Other changes described in this submission are the device name and minor edits to the DFU.

The ReShape Calibration Tubes™ is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures and is available in three larger sizes. The trade name has been changed Gastrointestinal Boundary Identifier (GIBI HD ™) to ReShape Calibration Tubes ™ for these three (3) sizes.

The ReShape Calibration Tubes™ provide visible and tactile delineation of the gastroesophageal (GE) junction, and its location relative to the esophageal hiatus and antrum of the stomach. The device provides the ability to decompress the stomach, drain and remove gastric fluid and act as a sizing guide (Figure 1).

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Image /page/4/Picture/1 description: The image shows a clear, flexible tube, likely a medical device such as a feeding tube or catheter. The tube is coiled and has a blue clamp attached to it. One end of the tube has a bulbous tip with multiple holes, while the other end has a connector with a cap.

Figure 1: ReShape Calibration Tubes™ (Representative figure of all Models: B-2032, B-2040)

#### III. INDICATIONS FOR USE

ReShape Calibration Tubes™ are 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.

#### IV. BASIS FOR SUBSTANTIAL EQUIVALENCE

Substantial equivalence of the ReShape Calibration Tubes™ to the predicate device (ReShape Lifesciences Gastrointestinal Boundary Identifier (GIBI HD ™) Calibration Tube, K221898) was already 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.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. THE PREDICATE DEVICE

A comparison of the ReShape Calibration Tubes and the predicate device is provided in Table 1.

| Feature | Predicate Device<br>ReShape Lifesciences Gastrointestinal<br>Boundary Identifier (GIBI HD ™) Calibration<br>Tube, K221898 | Subject Device<br>ReShape Calibration Tubes | Effect on<br>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-Urology | Same | None |

| | | | | Table 1: Comparison of Subject Device and Predicate Device |
|--|--|--|--|------------------------------------------------------------|
|--|--|--|--|------------------------------------------------------------|

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| Feature | Predicate Device<br>ReShape Lifesciences Gastrointestinal<br>Boundary Identifier (GIBI HD ™) Calibration<br>Tube, K221898 | Subject Device<br>ReShape Calibration Tubes | Effect on<br>Substantial<br>Equivalence |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Indications for Use | The GIBI HD™ is indicated for use in<br>gastric and bariatric surgical<br>procedures to decompress the<br>stomach, drain and remove gastric<br>fluid, irrigate, and act as a sizing<br>guide. | ReShape Calibration Tubes™<br>are indicated for use in<br>gastric and bariatric surgical<br>procedures to decompress<br>the stomach, drain and<br>remove gastric fluid, irrigate,<br>and act as a sizing guide. | None |
| Outer Diameter /<br>French Size nominal | <b>B-2032</b> : 32F<br><b>B-2036</b> : 36FB-2040: 40F | Same | None |
| Outer Diameter /<br>French Size distal tip | <b>B-2032</b> : 38F<br><b>B-2036</b> : 42F<br><b>B-2040</b> : 42F | Same | None |
| Outer Diameter /<br>French Size deflated<br>balloon | <b>B-2032</b> : 50F<br><b>B-2036</b> : 52FB-2040: 56F | Same | None |
| Tubing | Dual lumen | Same | None |
| Distal Side Holes | 3 aspiration holes proximal to the<br>balloon to ensure a steady vacuum | Same | None |
| Distal Tip | Molded tip with twelve (12)<br>aspiration eyelets. | Same | No impact to<br>substantial<br>equivalence. |
| Connector for<br>Suction | The catheter includes an adapter<br>for room suction | Same | None |
| Balloon + Inflation<br>Valve | The balloon has an inflation<br>capacity ≥ 100 cc min. | Same | None |
| Tubing Material | Silicone | Same | None |
| Markings | Indication marks at 30, 35, 40, 45,<br>and 50, 55, and 60 centimeters. | Same | None |
| Sterility | Non-sterile, disposable, single<br>patient use | Same | None |
| Shelf Life | 2 years | Same | None. |

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#### VI. PERFORMANCE DATA

Bench testing was not conducted and remains same as the predicate device cleared under K221898.

#### VII. CONCLUSION

Data presented in this submission demonstrate that the updated DFU is similar and equivalent to of the ReShape Gastrointestinal Boundary Identifier (GIBI HD) Calibration tube (K221898).

The ReShape Calibration Tubes™ device, and the predicate device (Gastrointestinal Boundary Identifier

(GIBI HD) Calibration tube):

- have the same intended use,
- · use the same principle of operation,
- · incorporate the same design,
- have the same construction and material, and
- are both provided non-sterile.

In summary, the ReShape Calibration Tubes™ device described in this submission is substantially equivalent to the predicate device, the Gastrointestinal Boundary Identifier (GIBI HD) Calibration tube (K221898).