Standard Tapered Bougie, 38 Fr.

{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). 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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) 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. Type of Use (Select one or both, as applicable) | <span style="text-decoration: overline;">☑</span> 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. 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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 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. #### 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<br>(STB38, subject device) | Standard Bougie®, 38Fr<br>(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)<br><br>Diameter at angularis incisura:<br>Minimum: 2.1 cm<br>Nominal: 2.45 cm<br>Maximum: 2.8 cm<br><br>Length of balloon is approximately 16.6 cm long | Minimum = 2.0 cm<br>Nominal = 2.5 cm<br>Maximum = 3.0 cm<br><br>Length 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 along<br>length. | | 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 hospital<br>suction, hole in distal end<br>apply suction within the<br>stomach | Connection with hospital<br>suction, holes in distal end<br>and along catheter apply<br>suction within the stomach | Equivalent-Both devices<br>have drainage ports that<br>meet drainage flow rate<br>requirements | | Markings | Yes (numbers every 10 cm<br>and graduations every 5 cm) | Yes (numbers every 10 cm<br>and graduations every 5 cm) | Same | | Packaging | HIPS Tray with PETG lid | Tyvek pouch | Equivalent. Both devices<br>are provided non-sterile in<br>packaging to protect<br>during transport and<br>storage. A tray was<br>selected for the subject<br>device to accommodate<br>product configuration and<br>to include a 60mL/CC<br>syringe. | | Accessories (SBHP) | Compatible with optional<br>SBHP | Compatible with optional<br>SBHP | 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.