The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

Device Description

The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide.

The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

AI/ML Overview

The provided text is a 510(k) summary for the Standard Bougie device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

The "Performance Data" section (VII) lists several types of verification and testing, such as "Drainage Flow Rate Verification," "Balloon Strength Verification," and "Device Usability." These tests are likely related to the physical and functional performance of the bougie itself, not to an AI system's diagnostic accuracy or a human-AI team's effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them from the provided text. The document describes a medical device (a bougie) used in bariatric surgery, not an AI or imaging diagnostic device.

To answer your request, I would need a different document that details the development, validation, and performance studies of an AI-powered medical device.

Summary

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April 8, 2020

Standard Bariatrics Alison Sathe Regulatory 4362 Glendale Milford Rd. Cincinnati, OH 45242

Re: K191885 Device Name: Standard Bougie Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 9, 2020 Received: March 11, 2020

Dear Alison Sathe:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Daniel G. Walter, Jr. 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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Indications for Use

510(k) Number (if known) K191885

Device Name Standard Bougie

Indications for Use (Describe)

The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectorny procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

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

I. SUBMITTER

Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA

Phone: 513-304-7971 Email: alison@standardbariatrics.com

Contact Person: Alison Sathe Date Prepared: July 12, 2019

DEVICE II.

Name of Device: Standard Bougie Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Tubes, Gastrointestinal (And Accessories) (21 CFR 876.5980) Regulatory Class: II Product Code: KNT

III. PREDICATE DEVICE

Predicate Device: Boehringer Laboratories Gastric Sizing Tube (Tradename: ViSiGi), K130483 Reference Device: Cook Incorporated Gastric Sizing Balloon Catheter, K173355

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Standard Bougie technological characteristics are provided in Table 1.

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Table 1: Technological Characteristics

Product	Standard Bougie(subject device)	ViSiGi(Boehringer LaboratoriesGastric Sizing Tube-K130483)	Equivalence
Typical Use	Gastric and bariatric surgicalprocedures	Gastric and bariatric surgicalprocedures	Same
Use Environment	Surgery centers, hospitals	Surgery centers, hospitals	Same
Patient Population	Patients undergoing bariatricand/or gastric procedures	Patients undergoing bariatricand/or gastric procedures	Same
Single Patient Use	Yes	Yes	Same
Sterility	Supplied non-sterile, singlepatient use only, disposable	Supplied non-sterile, singlepatient use only, disposable	Same
Functionality	Suction, drainage, irrigationand sizing	Suction, drainage, irrigationand sizing	Same
Method of Application	Insertion into the mouth andmanually advance the distalend into the desired locationwithin the stomach	Insertion into the mouth andmanually advance the distalend into the desired locationwithin the stomach	Same
Tubing Design	Double lumen with rounded,closed distal end	Single lumen with rounded,atraumatic distal end	Equivalent. The StandardBougie double lumen isprovided to allow forinflation of the balloon
Diameter	18 Fr	32 Fr, 36 Fr, or 40 Fr	Equivalent. The smallersize Standard Bougie isprovided for surgeonpreference as some prefera smaller size lumen. 18Fris a standard size forbougie devices and manyare available in 18Fr.¹
Length	95 cm	76 cm	Equivalent. The StandardBougie is slightly longerthan the ViSiGi. Bothdevices are long enough toperform their intended use.The Standard Bougie isslightly longer in order toensure adequate length forthe inflation lumen.
Materials	Thermoplastic elastomer	Styrene-Ethylene-Butylene-Styrene (SEBS Copolymer)	Equivalent. Both devicesutilize materials compliantwith ISO 10993 for theirintended use. Both havesimilar mechanicalproperties to allow fortheir intended use.
Connection for suction	Yes	Yes	Same
Method of Suction	Connection with hospital	Connection with hospital	Same
	apply suction within thestomach	apply suction within thestomach
Markings	Yes (numbers every 10 cmand gradations every 5 cm)	No	Equivalent. Markings areprovided on the StandardBougie to aid in deviceplacement but are notnecessary for the deviceuse.
Packaging	Tyvek pouch for single devicewith 6 pouched devices withina cardboard box	Plastic pouch for a singledevice with 5 pouched deviceswithin a cardboard box	Equivalent. Both devicesare packaged nonsterile ina pouch with a cardboardouter package

1 The Cook Gastric Sizing Balloon cleared pursuant to K173355 is 18Fr and is provided as an example of a currently marketed 18Fr diameter bougie.

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VII. PERFORMANCE DATA

Standard Bougie performance testing has been submitted in this 510(k) as follows:

Drainage Flow Rate Verification -
-Balloon Strength Verification
-Balloon Size Verification
-Tensile Strength Verification
-Reliability Testing
Device Usability -

VIII. CONCLUSIONS

The Standard Bougie has the same intended use, and principles of operation as its predicate device. The minor differences in technological characteristics do not raise new questions of safety or effectiveness and testing demonstrates substantial equivalence. The Standard Bougie is substantially equivalent to the predicate device.

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.