The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

Device Description

The Cook Gastric Sizing Balloon Catheter is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the cardia of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch. The silicone catheter is 18 French and 55cm long with centimeter markings every centimeter from 10cm to 50cm.

AI/ML Overview

The Cook Gastric Sizing Balloon Catheter is a medical device and thus does not involve AI or algorithms, human readers, or image-based diagnostics. The provided context is a 510(k) premarket notification for a medical device, which outlines its substantial equivalence to an existing predicate device rather than presenting a study to prove its performance against specific acceptance criteria in the way an AI/algorithm would.

Therefore, many of the requested points are not applicable. Below is an interpretation of the available information in the context of a medical device submission, focusing on the available "Test Data" rather than an "acceptance criteria and reported device performance" as might be found for an AI model.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Tests Conducted)
Mechanical Performance	- Analysis of Cuff Burst Volume - Analysis of Cuff Diameter Over Time - Analysis of Cuff Pressure and Diameter at Various Inflation Volumes
Biocompatibility	- Biocompatibility
Overall Assurance	The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for its use as a gastric sizing balloon.

Study Information (Based on Available Data)

Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "tests" were conducted, but does not specify sample sizes for these tests or the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device, "ground truth" is typically established through direct physical measurements and standardized test procedures rather than expert consensus on interpretive data.
Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting data (e.g., medical images) where there might be inter-reader variability. This is not relevant for the type of physical performance tests described for this device.
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 versus without AI assistance: Not applicable. This device is a physical catheter, not an AI or algorithm, and does not involve human readers for interpretation in the context of its primary function.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical instrument, not an algorithm.
The type of ground truth used: For the mechanical performance tests, the ground truth would be the objective measurements obtained from the physical testing (e.g., actual burst volume, measured diameter and pressure at various inflation volumes). For biocompatibility, the ground truth would be established by standard biological assays and tests confirming the material's safety for contact with human tissue.
The sample size for the training set: Not applicable. This is not an AI/algorithm and therefore does not have a "training set." Device development involves iterative design and testing, but not in the machine learning sense of a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device Evaluation:

The Cook Gastric Sizing Balloon Catheter's substantial equivalence was established by comparing it to a predicate device (Gastric Balloon Suction Catheter by BioEnterics, K002838) based on similar indications for use, materials of construction, and technological characteristics. The provided "Test Data" primarily focuses on physical performance characteristics and biocompatibility, as expected for a physical medical device. These tests were conducted to "assure reliable design and performance under the specified testing parameters" and to provide "reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for its use as a gastric sizing balloon."

Summary

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510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED

K030841 Page 1 of 2

Safety and Effectiveness Information

Carol Zwissler Submitted By: Requlatory Affairs Coordinator COOK INCORPORATED 750 Daniels Way PO Box 489 Bloomington, IN 47402 (812) 339-2235 March 11, 2003 Trade Name: Cook Gastric Sizing Balloon Catheter Device: (KNT)

Proposed Classification Name: Gastrointestinal Tube and Accessories

Predicate

The Cook Gastric Sizing Balloon Catheter is similar in terms Device: of intended use, materials of construction and technological characteristics to the Gastric Balloon Suction Catheter marketed by BioEnterics.

Device Description:

Indications for Use:

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove qastric fluid.

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KOSATI

510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED

K030841 Page 2 of 2

Substantial Equivalence

The Cook Gastric Sizing Balloon Catheter is similar to another gastric balloon: the Gastric Balloon Suction Catheter, marketed by BioEnterics, which was found substantially equivalent under DC# K002838.

The similar indications for use, materials of construction and the technological characteristics of the Cook Gastric Sizing Balloon Catheter as compared to the predicate device support a determination of substantial equivalency.

Test Data

The Cook Gastric Sizing Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:

Analysis of Cuff Burst Volume .
Analysis of Cuff Diameter Over Time ●
Analysis of Cuff Pressure and Diameter at Various Inflation Volumes .
. Biocompatibility

The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for it use as a gastric sizing balloon.

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Image /page/2/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a symbol that resembles an abstract representation of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2003

Ms. Carol Zwissler Regulatory Affairs Coordinator Cook Incorporated P.O. Box 489 BLOOMINGTON IN 47402-0489

Re: K030841

Trade/Device Name: Gastric Sizing Balloon Catheter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: June 17, 2003 Received: June 18, 2003

Dear Ms. Zwissler:

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.

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 fairther 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); good manufacturing practice requirements as set forth in 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED

Device Name: Gastric Sizing Balloon Catheter

Indications for Use:

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

Over-the-Counter-Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030841

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.