The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS ™ stapler in vertical sleve gastrectorny pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

Device Description

The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) 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, remove stomach contents, and allow for irrigation and insufflation 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 describes the regulatory clearance of the "Standard Bougie, SB38" device and outlines its characteristics and comparison to a predicate device, along with a list of performance tests conducted. However, it does not provide detailed acceptance criteria or the specific results of those performance tests. The document states that "Standard Bougie SB38 performance testing has been submitted in this 510(k)", and then lists the types of tests. It concludes that "The conclusion drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device." but does not present the data itself.

Therefore, for aspects requiring specific numerical data, sample sizes, expert qualifications, or details of a study (like an MRMC study or standalone performance), the information is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document only lists the types of performance tests conducted. It doesn't specify the acceptance criteria for each test or the quantitative results achieved by the device against those criteria.

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document lists performance tests but does not specify the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/available. The performance tests mentioned (Drainage Flow Rate Verification, Balloon Strength Verification, Balloon Size Verification, Balloon Firmness Verification, Tensile Strength Verification, Reliability Testing) appear to be engineering/mechanical tests rather than studies involving expert assessment of medical outcomes or images. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic device studies does not apply here.

4. Adjudication Method for the Test Set

Not applicable/available. As the tests are engineering/mechanical in nature, an adjudication method (like 2+1, 3+1) is not typically used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC comparative effectiveness study. The device is a "bougie," which is a physical medical instrument used as a sizing guide and for other functions during surgery, not a diagnostic imaging or AI device that would typically undergo an MRMC study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used

Not explicitly stated, but implied as engineering/physical measurements. For the listed performance tests (e.g., strength, size, flow rate), the ground truth would be based on precise physical measurements and engineering specifications, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary

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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.

June 29, 2021

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

Re: K210437

Trade/Device Name: Standard Bougie, SB38 Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: May 28, 2021 Received: June 1, 2021

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.

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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 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-regulatoryinformation/postmarketing-safety-reporting-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Je Hi An, Ph.D. Acting 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) K210437

Device Name Standard Bougie, SB38

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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Image /page/3/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized "S" inside, followed by the words "STANDARD BARIATRICS" in black, bold letters. The "TM" symbol is located to the right of the word "BARIATRICS".

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: June 24, 2021

II. DEVICE

Name of Device: Standard Bougie, SB38 Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Tube, Gastrointestinal (And Accessories) (21 CFR 876.5980) Regulatory Class: II Product Code: KNT

III. PREDICATE DEVICE

Standard Bariatrics, Standard Bougie (SB18), K191885

IV. DEVICE DESCRIPTION

The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation 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.

V. INDICATIONS FOR USE

The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS™ stapler 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Standard Bougie SB38 technological characteristics are provided in Table 1.

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Image /page/4/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized "S" inside, followed by the words "STANDARD BARIATRICS" in black, sans-serif font. The "TM" symbol is present after the word "BARIATRICS".

Table 1: Technological Characteristics

Product	Standard Bougie, 38Fr(subject device)	Standard Bougie, 18Fr(predicate device, K191885)	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 proceduresrequiring vertical sleevegastrectomy	Patients undergoing bariatricand/or gastric proceduresrequiring vertical sleevegastrectomy	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, irrigation,insufflation, and sizing	Suction, drainage, irrigation,insufflation, and 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	Double lumen with rounded,closed distal end	Same
Balloon Diameter Range	Minimum = $2.0$ cmNominal = $2.5$ cmMaximum = $3.0$ cm	Minimum = $1.5$ cmNominal = $2.0$ cmMaximum = $2.5$ cm	Equivalent. The SB18 isdesigned for use with theStandard Clamp, while theSB38 is not designed foruse with the StandardClamp. The larger balloondiameter ensures the samesizing in procedures notutilizing the StandardClamp.
	Length of balloon isapproximately $4$ cm long	Length of balloon isapproximately $4$ cm long
Catheter Diameter	$38$ Fr	$18$ Fr	Equivalent. The SB18 isdesigned for use with theStandard Clamp, while theSB38 is not designed foruse with the StandardClamp. The largerdiameter ensures the sameprocedures not utilizingthe Standard Clamp.
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, holes in distal endapply suction within thestomach	Connection with hospitalsuction, holes in distal endapply suction within thestomach	Same
Markings	Yes (numbers every $10$ cmand gradations every $5$ cm)	Yes (numbers every $10$ cmand gradations every $5$ cm)	Same
Packaging	Tyvek pouch	Tyvek pouch	Same

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K210437 Page 3 of 3

Image /page/5/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized "S" inside it on the left. To the right of the square are the words "STANDARD" and "BARIATRICS" stacked on top of each other in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "BARIATRICS".

VII. PERFORMANCE DATA

Standard Bougie SB38 performance testing has been submitted in this 510(k) as follows:

Drainage Flow Rate Verification -
Balloon Strength Verification -
-Balloon Size Verification
-Balloon Firmness Verification
-Tensile Strength Verification
-Reliability Testing

VIII. CONCLUSIONS

The Standard Bougie SB38 has the same intended use, and principles of operation as its predicate device. The conclusion drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device. The provision of the Standard Bougie in the 38 Fr size do not raise any new types of questions and the performance data provided 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.