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.

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. The Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Standard Bougie, 38 Fr. and Hand Pump" (K212728). The purpose of the submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of quantitative benchmarks for a novel diagnostic or treatment device. Instead, the submission for this Class II surgical accessory focuses on demonstrating substantial equivalence to a predicate device by comparing their technological characteristics and performing verification and validation activities.

The "acceptance criteria" are implicitly met if the device demonstrates equivalent performance and safety to the predicate device and introduces no new safety concerns. The "reported device performance" is demonstrated through nonclinical testing to ensure the added hand pump accessory does not negatively impact the device's original functions (suction, drainage, irrigation, insufflation, sizing) and maintains its safety profile.

Here's a summary derived from the "Overview of Substantial Equivalence" table and the "Performance Data" section:

Acceptance Criterion (Implicitly for Substantial Equivalence)	Reported Device Performance (via Nonclinical Testing)
Intended Use (Same as predicate)	The Standard Bougie Hand Pump (SBHP) with Standard Bougie (SB38) shares the same intended use as the predicate device (SB38). Indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy pouch creation for application of suction, stomach decompression, drainage of gastric fluids, irrigation, insufflation, and as a sizing guide.
Technological Characteristics (Similar to predicate)	Method of Insufflation: Equivalent insufflation pressure as compared to the predicate device (Standard Bougie (SB38)). Both devices are capable of connection with hospital air and suction. The addition of the SBHP provides an option for manual insufflation using a squeeze bulb, not present in the predicate, but deemed equivalent in function and safety. Packaging: SB38 packaging remains unchanged. Hand pump accessory provided in Non-sterile packaging, routinely used for non-sterile products. All other characteristics (Product Code, Regulation, Classification, How Supplied, Design Information, Typical Use, Use Environment, Patient Population, Single Patient Use, Sterility, Functionality, Catheter Diameter, Connection for suction) are identical to the predicate.
No new harms introduced (through addition of hand pump)	Verification and validation activities were conducted for the SBHP to confirm that no additional harms were introduced and the risk benefit analysis remains acceptable. This was assessed through: - Transit and 1 year Accelerated Aging - Performance Testing post Transit and 1 year Accelerated Aging - Pressure Decay Testing - Insufflation Testing - Reliability Testing
Safety and Effectiveness (As safe and effective as predicate)	The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device. The addition of the Standard Bougie Hand Pump does not raise any new types of questions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes nonclinical performance data (bench testing) for the accessory component (Standard Bougie Hand Pump) and confirms the existing data for the main device (Standard Bougie SB38) remains applicable.

Sample Size for Test Set: Not explicitly stated in terms of patient numbers, as this is a nonclinical study. The "test set" refers to the devices or accessories subjected to the specified engineering tests (Transit and 1 yr Accelerated Aging, Performance Testing, Pressure Decay, Insufflation, Reliability Testing). The number of units tested per test is not detailed.
Data Provenance: This is a submission for a medical device by Standard Bariatrics, Inc. located in Cincinnati, OH. The data would originate from internal company testing and validation activities. The document does not specify if any of the testing was conducted outside the U.S.
Retrospective or Prospective: Not applicable as this is nonclinical (bench) testing of a medical device accessory, not a clinical study involving patients or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes nonclinical (bench) testing of a surgical accessory, not a diagnostic device that requires expert interpretation for establishing ground truth (e.g., radiologist for imaging, pathologist for tissue samples). The "ground truth" here is defined by engineering specifications, risk assessments, and established testing methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human readers interpreting data where consensus is needed to establish ground truth. The tests described are objective engineering tests.

5. 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 vs without AI assistance

This is not applicable. A multi-reader multi-case (MRMC) comparative effectiveness study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) assistance for human interpretation. The Standard Bougie and Hand Pump is a surgical accessory, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This question refers to the performance of an AI algorithm independent of human input. The device is a physical surgical tool with a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device, in the context of its nonclinical performance evaluation, is based on:

Engineering specifications and design requirements: The device's ability to meet its functional requirements (e.g., insufflation pressure, reliability, transit resistance, aging effects) as defined by its design.
Risk assessment: The demonstration that the device (especially the new accessory) does not introduce unacceptable risks.
Comparison to predicate device: The fundamental "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it performs as safely and effectively.

8. The sample size for the training set

This is not applicable. A "training set" refers to data used to train machine learning models. This document describes the regulatory submission for a physical medical device, not an AI/ML product.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above (not an AI/ML product).

Summary

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September 23, 2021

Standard Bariatrics Michelle Schnell Director, Regulatory and Quality 4362 Glendale Milford Rd. Cincinnati, OH 45242

K212728 Re:

Trade/Device Name: Standard Bougie, 38 Fr. and Hand Pump Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: August 25, 2021 Received: August 27, 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. 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

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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-safety-reportingcombination-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,

for

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) K212728

Device Name Standard Bougie, 38 Fr. and Hand Pump

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/1 description: The image is a logo for Standard Bariatrics. The logo consists of a stylized letter "S" in red on the left, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The "S" is made up of three curved lines that overlap each other, creating a three-dimensional effect. The words "STANDARD" and "BARIATRICS" are in a bold, sans-serif font.

510(k) Summary

Submitter's Information I.

Company Name:	Standard Bariatrics, Inc.
Address:	4362 Glendale Milford Road
	Cincinnati, OH 45242
Phone Number:	513-658-0328
Fax Number:	513-436-0201
Contact Person:	Michelle Schnell
Phone Number:	513-702-6083
Email Address:	michelle@standardbariatrics.com

Date Prepared: August 25, 2021

II. Device Information

Device Name: Standard Bougie (SB38) with Standard Bougie Hand Pump Common Name: Bougie with Hand Pump Accessory Regulation Description: Gastrointestinal tube and accessories Regulatory Class: Class II Regulation: 21 CFR 876.5980 Product Code: KNT

III. Predicate Device:

Standard Bougie (SB38), K210437, 21CFR 876.5980, Class II, Product Code KNT Standard Bariatrics

Device Description IV.

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.

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The Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.

V. Indications for Use

The Standard Bougie™ SB38 is indicated for use in conjunction with the Titan SGSTM 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. Intended Use

Intended for use in vertical sleeve gastrectomy pouch creation during gastric and bariatric surgeries.

VII. Technological Characteristics

The technological specifications of Standard Bougie Hand Pump and its predicate have been evaluated to determine equivalence. As detailed in Section 010 of this Special 510(k) submission, upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Standard Bougie Hand Pump is determined by Standard Bariatrics to be substantially equivalent to existing legally marketed devices (Table 1).

	Subject Device(SB38 with Hand PumpAccessory)	Predicate Device (SB38)	Determination
Product Name	Standard Bougie, 38 Frwith Standard BougieHand Pump	Standard Bougie, 38 Fr	N/A
510(k) Holder	Standard Bariatrics	Standard Bariatrics	N/A
510(k) Number	TBD	K210437	N/A
Product Code	KNT	KNT	Same
Regulation	21 CFR 876.5980Gastrointestinal tube andaccessories	21 CFR 876.5980Gastrointestinal tube andaccessories	Same
Classification	II	II	Same
Intended Use	The Standard BougieTMSB38 is indicated for usein conjunction with theTitan SGSTM Stapler invertical sleevegastrectomy pouchcreation for theapplication of suction,stomach decompression,drainage of gastric fluids,irrigation and	The Standard BougieTMSB38 is indicated for usein conjunction with theTitan SGSTM Stapler invertical sleeve gastrectomypouch creation for theapplication of suction,stomach decompression,drainage of gastric fluids,irrigation and insufflation,	Same
	Subject Device(SB38 with Hand PumpAccessory)	Predicate Device (SB38)	Determination
	insufflation, and to serveas a sizing guide.	and to serve as a sizingguide.
Indications for Use	The Standard Bougie™SB38 is indicated for usein conjunction with theTitan SGST™ Stapler invertical sleevegastrectomy pouchcreation for theapplication of suction,stomach decompression,drainage of gastric fluids,irrigation andinsufflation, and to serveas a sizing guide.	The Standard Bougie™SB38 is indicated for usein conjunction with theTitan SGST™ Stapler invertical sleeve gastrectomypouch creation for theapplication of suction,stomach decompression,drainage of gastric fluids,irrigation and insufflation,and to serve as a sizingguide.	Same
How Supplied	Single patient use, non-sterile device	Single patient use, non-sterile device	Same
Design Information
Typical Use	Gastric and bariatricsurgical procedures	Gastric and bariatricsurgical procedures	Same
Use Environment	Surgery centers,hospitals	Surgery centers, hospitals	Same
Patient Population	Patients undergoingbariatric and/or gastricprocedures requiringvertical sleevegastrectomy	Patients undergoingbariatric and/or gastricprocedures requiringvertical 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, andsizing	Same
Method ofInsufflation	Syringe OR StandardBougie Hand Pump toapply air	Syringe to apply air	Equivalent insufflationpressure as compared withpredicate device, StandardBougie (SB38). Both devicesare capable of connectionwith hospital air and suction.The addition of the StandardBougie Hand Pump to theStandard Bougie includes theoption for manual insufflationusing a squeeze bulb.
Catheter Diameter	38Fr	38Fr	Same
Connection forsuction	Yes	Yes	Same
	Subject Device(SB38 with Hand PumpAccessory)	Predicate Device (SB38)	Determination
Packaging	SB38: Tyvek PouchHand Pump Accessory:Polybag	SB38: Tyvek pouch	SB38 packaging remainsunchanged. Hand pumpaccessory provided in Non-sterile packaging, routinelyused for non-sterile products.

Table 1: Overview of Substantial Equivalence

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VIII. Performance Data

The data collected during the preparation of this submission was based upon the findings of the Risk Assessment for the addition of the Standard Bougie Hand Pump (SBHP) to the Standard Bougie (SB38). No changes other than the addition of the hand pump were made to the Standard Bougie (SB38) therefore, testing was provided in the original 510(k), K210437, remains applicable to the SB38 device.

In accordance with Standard Bariatrics' risk management procedures, design inputs were identified, risks evaluated, risk control measures implemented, and residual risk assessed. The risk analysis identified verification and validation activities as follows, which were conducted for the SBHP to confirm that no additional harms were introduced and the risk benefit analysis remains acceptable:

Transit and 1 yr Accelerated Aging O
Performance Testing post Transit and 1 yr Accelerated Aging O
Pressure Decay Testing O
Insufflation Testing O
Reliability Testing O

IX. Conclusion

The Standard Bougie (SB38) with Standard Bougie Hand Pump 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 addition of the Standard Bougie Hand Pump to the Standard Bougie SB38 in the 38 Fr size does not raise any new types of questions and the performance data provide 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.