GastriSail Gastric Positioning System

K143088 · Covidien · KNT · Feb 25, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143088
• Device Name: GastriSail Gastric Positioning System
• Applicant: Covidien
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.

Device Story

GastriSail is a 36FR dual-lumen flexible gastric tube; inserted into esophagus by anesthesiologist during bariatric/gastric surgery. One lumen provides suction for stomach decompression, fluid drainage, and suction fixation along the lesser curvature; second lumen houses a 'Sail' feature and integrated LED guidelights. LED lights provide visible delineation of the stomach's lesser curvature; Sail feature provides tactile delineation and radial expansion. Device serves as a sizing guide for gastric sleeves and facilitates leak testing. Healthcare providers use visual and tactile feedback to guide surgical procedures. Benefits include improved visualization and positioning during sleeve gastrectomy.

Clinical Evidence

No clinical data. Evidence consists of bench testing (dimensional analysis, tensile testing, battery functional testing, vacuum relief, suction adapter testing) and comparative performance testing against the Realize™ Gastric Calibration Tube (decompression, suction fixation, sizing). In-vivo evaluation was performed via porcine esophageal insertion test.

Technological Characteristics

36FR dual-lumen flexible tube; non-sterile, single-patient use. Features integrated LED guidelights and a 'Sail' mechanism for radial expansion. Materials tested for biocompatibility per ISO 10993-1:2009. Electrical safety compliant with IEC 60601-1 (Ed 3) and IEC 60601-1-2 (Ed 4).

Indications for Use

Indicated for patients undergoing gastric and bariatric surgical procedures, such as sleeve gastrectomy, requiring gastric suction, decompression, fluid drainage, leak testing, and 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

• Realize™ Gastric Calibration Tube (K071764)
• ViSiGi3D™ Sleeve Gastrectomy Calibration System with Bulb (K130483)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2015

Covidien Debbie Peacock Regulatory Product Manager 60 Middletown Ave. North Haven. CT 06473

Re: K143088

> Trade/Device Name: Gastrisail Gastric Positioning System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 9, 2015 Received: January 12, 2015

Dear Debbie Peacock,

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation 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)

#### K143088

Device Name

GastriSail™ Gastric Positioning System

#### Indications for Use (Describe)

The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.

| 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)

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## Traditional 510(k) Summary

| SUBMITTER: | Covidien llc<br>60 Middletown Avenue<br>North Haven, CT 06473 USA |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Debra Peacock<br>Regulatory Affairs Product Manager<br>Covidien llc<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| DATE PREPARED: | 10/27/2014 |
| PRODUCT CODE: | KNT |
| REGULATION NUMBER: | 21CRF 876.5980 |
| REVIEW PANEL: | Gastroenterology/Urology |
| TRADE/PROPRIETARY NAME: | GastriSail™ Gastric Positioning System |
| COMMON/USUAL NAME: | Gastric Positioning System |
| CLASSIFICATION NAME: | Tubes, Gastrointestinal (and Accessories) |
| PREDICATE DEVICES: | 1). Realize™ Gastric Calibration Tube (K071764). Mfg by<br>Ethicon<br>2). ViSiGi3D™ Sleeve Gastrectomy Calibration System with<br>Bulb (K130483). Mfg by Boehringer Laboratories |
| DEVICE DESCRIPTION: | The GastriSail™ Gastric Positioning System is a 36FR<br>flexible, non-sterile, single-use, dual lumen gastric tube<br>designed to be inserted into the esophagus by an<br>anesthesiologist for use in gastric and bariatric surgical<br>procedures, such as sleeve gastrectomy.<br><br>The GastriSail™ Gastric Positioning System consists of a dual<br>lumen flexible tube. One lumen houses the Sail feature and<br>integrated LED guidelights, and the other lumen has rows of<br>distal holes which, when connected to suction provides<br>vacuum to the stomach for evacuation of stomach contents and<br>suction fixation along the lesser curvature of the stomach.<br>This lumen is also used to perform leak testing at the end of<br>the procedure. |

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#### INTENDED USE

The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.

| CHARACTERISTICS | Proposed<br>GastriSail™ Gastric<br>Positioning System | Predicate<br>ViSiGi 3D<br>(K130483) | Predicate<br>RealizeTMGastric<br>Calibration Tube<br>(K071764) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IFU | The GastriSail™ Gastric<br>Positioning System is indicated<br>for use in gastric and bariatric<br>surgical procedures for the<br>application of suction,<br>decompression and to radially<br>expand the stomach, to drain<br>gastric fluids, to test for leaks,<br>to provide visible and tactile<br>delineation of the lesser<br>curvature of the stomach and to<br>serve as a sizing guide for<br>gastric and bariatric<br>procedures, such as sleeve<br>gastrectomy. | The ViSiGi 3D™ is<br>indicated for use in gastric<br>and bariatric surgical<br>procedures for the<br>application of suction,<br>stomach decompression,<br>drainage of gastric fluids,<br>irrigation and to serve as a<br>sizing guide. | The Ethicon Endo-Surgery<br>Gastric Calibration Tube is<br>indicated for use in gastric<br>and bariatric surgical<br>procedures to provide visible<br>and tactile delineation of the<br>antrum of the stomach along<br>with the ability to<br>decompress the stomach,<br>drain and remove gastric<br>fluid, and size a gastric<br>pouch. |
| Length of tube | 132 cm (total) | 107 cm | 74.5 cm |
| Tubing | Multi lumen with rounded,<br>closed distal end | Single lumen with rounded,<br>closed distal end | Single lumen with rounded,<br>closed distal end |
| Size | 36 Fr | 36 and 40 Fr | 38 Fr |
| Sterility | Clean, Non Sterile, single-<br>patient use | Same | Same |
| Suction fixation | Yes | Yes | Yes |
| Decompression<br>capability | Yes | Yes | Yes |
| Sail feature | Yes | No | No |
| LED Guide lights | Yes | No | No |
| Disposable | Yes | Yes partly | Yes |

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| MATERIALS: | Materials have been tested for Biocompatibility in accordance<br>with ISO 10993-1:2009 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE DATA: | Design verification studies and Performance studies were<br>conducted as summarized below: |
| | GastriSail™Non-clinical Testing:<br>● Dimensional analysis<br>● Tensile testing of adhered bonds<br>● Battery functional testing<br>● Vacuum relief testing<br>● Suction tubing adapter test |
| | Comparative testing to the predicate device, Realize™ Gastric<br>Calibration Tube<br>● Decompression of the stomach:<br>● Suction fixation and evacuation of stomach contents<br>● Sizing of a Gastric Sleeve |
| | In-vivo Evaluation of esophageal insertion test in porcine<br>Electrical Safety Testing:<br>● IEC 60601-1: Ed3<br>● IEC 60601-1-2: Ed 4 |
| CONCLUSION: | It has been demonstrated that the proposed GastriSail™<br>Gastric Positioning System is substantially equivalent to the<br>legally-marketed Ethicon Realize™ Gastric Calibration Tube<br>(K071764), and to the Boehringer ViSiGi3D™ Sleeve |

Gastrectomy Calibration System with Bulb (K130483).