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 Description

The GastriSail™ Gastric Positioning System is a 36FR flexible, non-sterile, single-use, dual lumen gastric tube designed to be inserted into the esophagus by an anesthesiologist for use in gastric and bariatric surgical procedures, such as sleeve gastrectomy.

The GastriSail™ Gastric Positioning System consists of a dual lumen flexible tube. One lumen houses the Sail feature and integrated LED guidelights, and the other lumen has rows of distal holes which, when connected to suction provides vacuum to the stomach for evacuation of stomach contents and suction fixation along the lesser curvature of the stomach. This lumen is also used to perform leak testing at the end of the procedure.

AI/ML Overview

The provided text describes a medical device, the GastriSail™ Gastric Positioning System, and its clearance through the FDA's 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device. The document focuses on regulatory approval rather than a detailed study proving the device meets specific quantitative acceptance criteria in a clinical setting.

Therefore, much of the requested information (like effect size of MRMC studies, details of expert adjudication, ground truth for training sets, etc.) is not present in this regulatory document, as it is generally not required for a 510(k) submission unless clinical studies are specifically called for to demonstrate substantial equivalence.

However, I can extract the available information related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for a study in the sense of predefined thresholds for clinical performance metrics. Instead, it lists various non-clinical and comparative tests conducted to demonstrate the device's functionality and substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests.

Acceptance Criteria (Implied by Test Type)	Reported Device Performance (Summary)
Dimensional analysis	Passed (Dimensions are acceptable)
Tensile testing of adhered bonds	Passed (Bonds are sufficiently strong)
Battery functional testing	Passed (Battery operates as intended)
Vacuum relief testing	Passed (Vacuum relief functions correctly)
Suction tubing adapter test	Passed (Adapter performs as expected)
Decompression of the stomach (Comparative)	Comparable to Realize™ Gastric Calibration Tube
Suction fixation and evacuation of stomach contents (Comparative)	Comparable to Realize™ Gastric Calibration Tube
Sizing of a Gastric Sleeve (Comparative)	Comparable to Realize™ Gastric Calibration Tube
Esophageal insertion test in porcine (In-vivo)	Passed (Safe and effective insertion)
Biocompatibility (ISO 10993-1:2009)	Materials tested and passed
Electrical Safety Testing (IEC 60601-1: Ed3, IEC 60601-1-2: Ed 4)	Passed (Meets electrical safety standards)

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified for any of the non-clinical or comparative tests. For the in-vivo evaluation, it was performed "in porcine," meaning animal subjects, but the number of animals or procedures is not given.
Data Provenance: The studies are non-clinical (bench testing) and in-vivo animal testing. It's not human clinical data, so country of origin isn't relevant in the typical sense. The regulatory submission is from the USA (Covidien LLC, North Haven, CT).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided. For non-clinical and comparative performance tests, "ground truth" and "experts" as in a clinical study are not typically applicable in the same way. Performance is measured against engineering specifications or direct comparison with a predicate device. For the in-vivo test, veterinary or surgical expertise would be involved, but specific numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable/Not specified for the non-clinical and animal performance testing.

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

No MRMC or human-in-the-loop study was conducted. This device is a physical medical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

For non-clinical safety and performance tests: Engineering specifications, direct measurements, and comparison to the predicate device's established performance.
For biocompatibility: Adherence to ISO 10993-1:2009 standards.
For electrical safety: Adherence to IEC 60601-1 and 60601-1-2 standards.
For the in-vivo test: Observed physiological response and device function in a porcine model.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context.

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no training set.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 llc60 Middletown AvenueNorth Haven, CT 06473 USA
CONTACT PERSON:	Debra PeacockRegulatory Affairs Product ManagerCovidien llcPhone: (203) 492-6935Fax: (203) 492-5029e-mail: debra.peacock@covidien.com
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 byEthicon2). ViSiGi3D™ Sleeve Gastrectomy Calibration System withBulb (K130483). Mfg by Boehringer Laboratories
DEVICE DESCRIPTION:	The GastriSail™ Gastric Positioning System is a 36FRflexible, non-sterile, single-use, dual lumen gastric tubedesigned to be inserted into the esophagus by ananesthesiologist for use in gastric and bariatric surgicalprocedures, such as sleeve gastrectomy.The GastriSail™ Gastric Positioning System consists of a duallumen flexible tube. One lumen houses the Sail feature andintegrated LED guidelights, and the other lumen has rows ofdistal holes which, when connected to suction providesvacuum to the stomach for evacuation of stomach contents andsuction fixation along the lesser curvature of the stomach.This lumen is also used to perform leak testing at the end ofthe procedure.

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INTENDED USE

CHARACTERISTICS	ProposedGastriSail™ GastricPositioning System	PredicateViSiGi 3D(K130483)	PredicateRealizeTMGastricCalibration Tube(K071764)
IFU	The GastriSail™ GastricPositioning System is indicatedfor use in gastric and bariatricsurgical procedures for theapplication of suction,decompression and to radiallyexpand the stomach, to draingastric fluids, to test for leaks,to provide visible and tactiledelineation of the lessercurvature of the stomach and toserve as a sizing guide forgastric and bariatricprocedures, such as sleevegastrectomy.	The ViSiGi 3D™ isindicated for use in gastricand bariatric surgicalprocedures for theapplication of suction,stomach decompression,drainage of gastric fluids,irrigation and to serve as asizing guide.	The Ethicon Endo-SurgeryGastric Calibration Tube isindicated for use in gastricand bariatric surgicalprocedures to provide visibleand tactile delineation of theantrum of the stomach alongwith the ability todecompress the stomach,drain and remove gastricfluid, and size a gastricpouch.
Length of tube	132 cm (total)	107 cm	74.5 cm
Tubing	Multi lumen with rounded,closed distal end	Single lumen with rounded,closed distal end	Single lumen with rounded,closed distal end
Size	36 Fr	36 and 40 Fr	38 Fr
Sterility	Clean, Non Sterile, single-patient use	Same	Same
Suction fixation	Yes	Yes	Yes
Decompressioncapability	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 accordancewith ISO 10993-1:2009
PERFORMANCE DATA:	Design verification studies and Performance studies wereconducted as summarized below:
	GastriSail™Non-clinical Testing:● Dimensional analysis● Tensile testing of adhered bonds● Battery functional testing● Vacuum relief testing● Suction tubing adapter test
	Comparative testing to the predicate device, Realize™ GastricCalibration Tube● Decompression of the stomach:● Suction fixation and evacuation of stomach contents● Sizing of a Gastric Sleeve
	In-vivo Evaluation of esophageal insertion test in porcineElectrical Safety Testing:● IEC 60601-1: Ed3● IEC 60601-1-2: Ed 4
CONCLUSION:	It has been demonstrated that the proposed GastriSail™Gastric Positioning System is substantially equivalent to thelegally-marketed Ethicon Realize™ Gastric Calibration Tube(K071764), and to the Boehringer ViSiGi3D™ Sleeve

Gastrectomy Calibration System with Bulb (K130483).

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.