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 40FR 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

This document is a 510(k) premarket notification for a medical device, the GastriSail™ Gastric Positioning System. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics for a novel AI algorithm.

Therefore, many of the requested categories relating to AI algorithm performance and clinical study design are not applicable or cannot be extracted from this document.

Here's an analysis of the provided text in relation to your request:

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

The document does not present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for a device's performance in the way an AI algorithm study would. Instead, it details non-clinical and in-vivo testing to demonstrate that the modified device's characteristics are comparable to the predicate device.

The "acceptance criteria" are implied by the types of tests conducted and their successful completion, indicating that the device performs as expected and is substantially equivalent to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (for new tip material)	Testing conducted in accordance with ISO 10993-1:2009. (Implies successful completion, as the conclusion states substantial equivalence).
Stability (for new tip material)	Testing conducted. (Implies successful completion, as the conclusion states substantial equivalence).
Performance (Nonclinical - Visual Inspection)	Testing conducted. (Implies satisfactory results).
Performance (Nonclinical - Dimensional Measurement)	Testing conducted. (Implies satisfactory results, ensuring dimensions are within acceptable tolerances, especially the 40 Fr/Ch size).
Performance (Nonclinical - Vacuum Pressure Evaluation)	Testing conducted. (Implies satisfactory results, demonstrating proper suction function).
Performance (Nonclinical - Tensile Test Evaluation)	Testing conducted. (Implies satisfactory results, ensuring material strength and integrity).
Performance (Nonclinical - Battery Test)	Testing conducted. (Implies satisfactory results for the LED guide lights).
Performance (In Vivo - Esophageal Insertion Test in Porcine)	Evaluation conducted. (Implies successful insertion and functionality in an in-vivo model, confirming safety and performance related to insertion and positioning).
Substantial Equivalence to predicate device (K143088)	"The results of testing demonstrate that the modified GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm) is substantially equivalent to the legally marketed GastriSail™ Gastric Positioning System (K143088)."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the "test set" in terms of number of patients or cases. The non-clinical and in-vivo tests likely used a predetermined number of devices/specimens for each test, but these are not explicitly stated.

Test Set Sample Size: Not specified.
Data Provenance: Not specified, but the in-vivo testing was conducted in "porcine," indicating animal model data, not human patient data. These studies are typically prospective laboratory/animal model studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable. This device is a physical surgical tool, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the performance tests would be objective measurements and observations determined by engineers and researchers during the testing.

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

Not applicable. This concept applies to human expert review and consensus, typically for establishing ground truth in diagnostic studies, which is not the nature of this submission.

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 is not an AI-powered diagnostic device, and no MRMC study was conducted. The device is a physical surgical instrument.

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

Not applicable. This device is a physical instrument, not an algorithm.

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

The ground truth for the non-clinical and in-vivo testing would be based on:

Objective Measurements: For dimensional measurements, vacuum pressure, tensile strength, battery performance.
Engineering Specifications: Whether the device meets predefined criteria for its physical and functional attributes.
Observation/Evaluation by Trained Personnel: For visual inspection and the esophageal insertion test in porcine models, assessing proper function and absence of adverse events.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

May 4, 2016

Covidien LLC Rebecca Magnanimo Regulatory Affairs Product Specialist 60 Middletown Ave. North Haven, CT 06473

Re: K160654

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: April 7, 2016 Received: April 13, 2016

Dear Rebecca Magnanimo:

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.

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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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)

K160654

Device Name GastriSail™ Gastric Positioning System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

SUBMITTER:	Covidien Ilc60 Middletown AvenueNorth Haven, CT 06473 USA
CONTACT PERSON:	Rebecca MagnanimoRegulatory Affairs Product SpecialistCovidien IlcPhone: (203) 492-6479Fax: (203) 492-5029e-mail: Rebecca.magnanimo@covidien.com
DATE PREPARED:	02/22/16
PRODUCT CODE:	KNT
REGULATION NUMBER:	21CFR 876.5980
TRADE/PROPRIETARY NAME:	GastriSail™ Gastric Positioning System
COMMON/USUAL NAME:	Gastric Positioning System
CLASSIFICATION NAME:	Tubes, Gastrointestinal (and Accessories)
PREDICATE DEVICES:	GastriSail™ Gastric Positioning System (K143088)
DEVICE DESCRIPTION:	The GastriSail™ Gastric Positioning System is a 40FR flexible,non-sterile, single-use, dual lumen gastric tube designed to beinserted into the esophagus by an anesthesiologist for use ingastric and bariatric surgical procedures, such as sleevegastrectomy.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 provides vacuumto the stomach for evacuation of stomach contents and suctionfixation along the lesser curvature of the stomach. This lumen isalso used to perform leak testing at the end of the procedure.
INDICATIONS FOR USE:	The GastriSail™ Gastric Positioning System is indicated for usein gastric and bariatric surgical procedures for the application ofsuction, decompression and to radially expand the stomach, todrain gastric fluids, to test for leaks, to provide visible and tactiledelineation of the lesser curvature of the stomach and to serveas a sizing guide for gastric and bariatric procedures, such assleeve gastrectomy.

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SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:

Modifications to design of the current GastriSail™ Gastric Positioning System (K143088) has created a new product to be launched as the proposed GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm).

The changes include a change in the size of diameter of the lumen flexible tubing from a 36 Fr/Ch (12.0mm) (predicate) to a 40 Fr/CH (13.3mm)(proposed) size. Increasing tube diameter by (1.3mm).

Additionally, there will also be a material change to the previously cleared 36 Fr/Ch GastriSail™ Gastric Positioning System (K143088). The tip material for the 36Fr/Ch and 40Fr/Ch will be changing from a polycarbonate to a Silastic Silicone material.

The proposed GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm) was evaluated for the following:

. Biocompatibility testing was conducted to evaluate proposed tip material change from polycarbonate to silastic silicone in accordance with ISO 10993-1:2009.
I Stability testing was conducted to evaluate proposed tip material change from polycarbonate to silastic silicone.
. Performance studies (nonclinical testing) was conducted to demonstrate that the proposed device, is substantially equivalent to the predicate device.

Non Clinical testing that supports the intended use of this device includes:

. Visual Inspection
. Dimensional Measurement
Vacuum Pressure Evaluation
I Tensile Test Evaluation
I Battery Test

In vivo testing that supports the intended use of this device includes:

. Evaluation of esophageal insertion test in porcine
GastriSail™ Gastric Positioning System is sold nonsterile therefore sterility is not required. Only Non Clinical Testing was performed for the proposed changes therefore, clinical testing was not performed or relied on for a determination of substantial equivalence.

NONCLINICAL TESTING

IN VIVO TESTING

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CHARACTERISTICS	ProposedGastriSail™ GastricPositioning Systm	K143088GastriSail™ GastricPositioning System
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 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.
Length of tube	132 cm (total)	132 cm (total)
Tubing	Multi lumen with rounded,closed distal end	Multi lumen with rounded,closed distal end
Size	40 FR	36 Fr
Sterility	Clean, Non Sterile, single-patient use	Clean, Non Sterile, single-patient use
Suction fixation	Yes	Yes
Decompressioncapability	Yes	Yes
Sail feature	Yes	Yes
LED Guide lights	Yes	Yes
Disposable	Yes	Yes
Tip Material	Silastic Silicone	Polycarbonate

CONCLUSION:

The results of testing demonstrate that the modified GastriSail™ Gastric Positioning System 40 Fr/Ch (13.3mm) is substantially equivalent to the legally marketed GastriSail™ Gastric Positioning System (K143088).

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.