The Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® Stapler in vertical sleeve gastrectomy pouch creation for the application, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

Device Description

The Standard Tapered Bougie, 38Fr (STB38) is a non-sterile, single patient use device. The device comprises a tube with a rounded tip featuring drainage holes, and a tapered balloon at the distal end. The proximal end of the Standard Tapered Bougie, 38Fr (STB38) includes a standard Luer lock valve for balloon inflation/deflation using the 60mL/CC syringe (provided) and a 7.5mm inner diameter straight tube for connection to operating room suction, Standard Bougie Hand Pump (SBHP) or tapered tip syringe.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter and summary for a medical device called the "Standard Tapered Bougie, 38Fr (STB38)". It outlines the device's characteristics, intended use, and comparison to a predicate device.

However, this document does NOT contain information about acceptance criteria for an AI/ML-based device, nor does it describe a study involving human readers, ground truth establishment by experts, or any MRMC (Multi-Reader Multi-Case) studies.

The "Performance Data" section (VII) lists various engineering and bench tests performed on the physical device (e.g., Dimensional Verification, Drainage Flow Rate Verification, Tensile Strength Verification, Biocompatibility Testing). These are typical performance tests for physical medical devices and do not relate to the performance of an AI/ML algorithm or its impact on human reader performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI/ML device based on the provided text, as the text describes a physical device, not an AI/ML system.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 31, 2022

Standard Bariatrics, Inc. Michelle Schnell Director of QA/RA 4362 Glendale Milford Road Cincinnati, OH 45242

Re: K222085

Trade/Device Name: Standard Tapered Bougie, 38 Fr (STB38) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: October 4, 2022 Received: October 5, 2022

Dear Michelle Schnell:

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

{1}------------------------------------------------

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,

April Marrone, Ph.D., MBA Acting Assistant Director 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K222085

Device Name Standard Tapered Bougie, 38Fr (STB38)

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)
------------------------------------------------------------------------------------------------	-----------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" on the left and the words "STANDARD BARIATRICS" in black on the right. The letter "S" is made up of three parallel lines that curve around to form the shape of the letter. The words "STANDARD BARIATRICS" are in a bold, sans-serif font.

510(K) Summary

I. SUBMITTER

Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA

Phone: 513-702-6083 Email: michelle@standardbariatrics.com

Contact Person: Michelle Schnell Date Prepared: July 14, 2022

II. DEVICE

Name of Device: Standard Tapered Bougie, 38Fr (STB38) Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Gastrointestinal tube and accessories Regulation Number: 21 CFR 876.5980 Regulatory Class: II Product Code: KNT

III. PREDICATE DEVICE

Name of Device: Standard Bariatrics, Standard Bougie, SB38 510(k) Number: K210437 Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Gastrointestinal tube and accessories Regulation Number: 21 CFR 876.5980 Regulatory Class: II Product Code: KNT

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® stabler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The "TM" symbol is present to the right of the word "BARIATRICS".

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Standard Tapered Bougie, 38Fr (STB38) technological characteristics are provided in Table 1.

Table 1: Technological Characteristics

Product	Standard Tapered Bougie, 38Fr(STB38, subject device)	Standard Bougie®, 38Fr(SB38, predicate device, K210437)	Equivalence
Typical Use	Gastric and bariatric surgical procedures	Gastric and bariatric surgical procedures	Same
Use Environment	Surgery centers, hospitals	Surgery centers, hospitals	Same
Patient Population	Patients undergoing bariatric and/or gastric procedures requiring vertical sleeve gastrectomy	Patients undergoing bariatric and/or gastric procedures requiring vertical sleeve gastrectomy	Same
Single Patient Use	Yes	Yes	Same
Sterility	Supplied non-sterile, single patient use only, disposable	Supplied non-sterile, single patient use only, disposable	Same
Functionality	Suction, drainage, irrigation, insufflation, and sizing	Suction, drainage, irrigation, insufflation, and sizing	Same
Method of Application	Insertion into the mouth and manually advance the distal end into the desired location within the stomach	Insertion into the mouth and manually advance the distal end into the desired location within the stomach	Same
Method of Balloon Inflation	Connect a 60 ml syringe filled with air and inject into the balloon	Connect a 20 ml syringe filled with fluid and inject the desired amount of fluid into the balloon	Equivalent. Method of inflation is similar (air vs. liquid) and uses same type of connection via syringe.
Tubing Design	Double lumen with rounded, distal end	Double lumen with rounded, closed distal end	Equivalent. Both the subject and predicate device have the same double lumen tubing design. Both have a rounded, atraumatic tip with the same diameter and similar curvature. The subject device features drainage holes at the distal end, where the predicate device features drainage holes along the tubing.
Balloon Diameter Range	Maximum = 3.0 cm tapered to 38Fr (12.7mm)Diameter at angularis incisura:Minimum: 2.1 cmNominal: 2.45 cmMaximum: 2.8 cmLength of balloon is approximately 16.6 cm long	Minimum = 2.0 cmNominal = 2.5 cmMaximum = 3.0 cmLength of balloon is approximately 4 cm long	Equivalent. Both subject and predicate device are designed to ensure a minimum diameter at the angularis incisura. The additional length of the subject device aids in positioning down to the antrum to allow for stapler
			to be placed adjacent alonglength.
Catheter Diameter	38Fr	38Fr	Same
Overall Length	95 cm	95 cm	Same
Materials	Thermoplastic elastomer	Thermoplastic elastomer	Same
Connection for suction	Yes	Yes	Same
Method of Suction	Connection with hospitalsuction, hole in distal endapply suction within thestomach	Connection with hospitalsuction, holes in distal endand along catheter applysuction within the stomach	Equivalent-Both deviceshave drainage ports thatmeet drainage flow raterequirements
Markings	Yes (numbers every 10 cmand graduations every 5 cm)	Yes (numbers every 10 cmand graduations every 5 cm)	Same
Packaging	HIPS Tray with PETG lid	Tyvek pouch	Equivalent. Both devicesare provided non-sterile inpackaging to protectduring transport andstorage. A tray wasselected for the subjectdevice to accommodateproduct configuration andto include a 60mL/CCsyringe.
Accessories (SBHP)	Compatible with optionalSBHP	Compatible with optionalSBHP	Same

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" on the left and the words "STANDARD BARIATRICS" in black on the right. The "S" is made up of several parallel lines, and the word "BARIATRICS" has a small trademark symbol next to it.

VII. PERFORMANCE DATA

Standard Tapered Bougie, 38Fr (STB38) performance testing was completed and provided in support of substantial equivalence within this 510(k) submission, as follows:

-Dimensional Verification: Balloon Length, Balloon Size, Shape and Firmness Verification
-Drainage Flow Rate Verification
-Tensile Strength Verification;
-Reliability Testing: demonstrating product meets functional requirements under simulated use conditions
Aging and Transit Testing -
Balloon Strength -
Pressure Decay Testing: demonstrating device inflation using the Standard Bougie Hand Pump -
Biocompatibility Testing: Cytotoxicity, Sensitization, and Irritation -

VIII. CONCLUSIONS

The Standard Tapered Bougie, 38Fr (STB38) has the same intended use, and principles of operation as its predicate device. The provision of the Standard Tapered Bougie, 38Fr (STB38) does not raise any new types of questions and the performance data provides reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.

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.