Standard Bougie, 38 Fr. and Hand Pump
Device Facts
| Record ID | K212728 |
|---|---|
| Device Name | Standard Bougie, 38 Fr. and Hand Pump |
| Applicant | Standard Bariatrics |
| Product Code | KNT · Gastroenterology, Urology |
| Decision Date | Sep 23, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Standard Bougie (SB38) is an 80 cm, 38 Fr tube with a distal inflatable balloon and proximal luer connector. Used in surgery centers/hospitals by surgeons during vertical sleeve gastrectomy. Functions as a sizing guide, suction/drainage tool, and irrigation/insufflation conduit. The new Hand Pump accessory allows manual air insufflation via squeeze bulb for gastric fold rearrangement or leak testing. Device inputs include manual operation of the pump or syringe; outputs include gastric decompression, fluid drainage, and sizing guidance. Benefits include controlled gastric pouch creation and intraoperative leak testing. No changes to the core bougie design; hand pump adds an alternative method for insufflation.
Clinical Evidence
Bench testing only. No clinical data provided. Verification and validation activities included transit and 1-year accelerated aging, performance testing, pressure decay testing, insufflation testing, and reliability testing to confirm the hand pump accessory does not introduce new risks.
Technological Characteristics
80 cm, 38 Fr tube with distal inflatable balloon. Materials and design identical to predicate. Hand pump accessory is a manual squeeze bulb for air insufflation. Non-sterile, single-patient use. No software or electronic components.
Indications for Use
Indicated for patients undergoing bariatric and/or gastric procedures requiring vertical sleeve gastrectomy pouch creation.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- Standard Bougie (SB38) (K210437)
Submission Summary (Full Text)
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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)
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.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 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 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.
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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<br>(SB38 with Hand Pump<br>Accessory) | Predicate Device (SB38) | Determination |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Standard Bougie, 38 Fr<br>with Standard Bougie<br>Hand 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 876.5980<br>Gastrointestinal tube and<br>accessories | 21 CFR 876.5980<br>Gastrointestinal tube and<br>accessories | Same |
| Classification | II | II | Same |
| Intended Use | The Standard BougieTM<br>SB38 is indicated for use<br>in conjunction with the<br>Titan SGSTM Stapler in<br>vertical sleeve<br>gastrectomy pouch<br>creation for the<br>application of suction,<br>stomach decompression,<br>drainage of gastric fluids,<br>irrigation and | The Standard BougieTM<br>SB38 is indicated for use<br>in conjunction with the<br>Titan SGSTM Stapler in<br>vertical sleeve gastrectomy<br>pouch creation for the<br>application of suction,<br>stomach decompression,<br>drainage of gastric fluids,<br>irrigation and insufflation, | Same |
| | Subject Device<br>(SB38 with Hand Pump<br>Accessory) | Predicate Device (SB38) | Determination |
| | insufflation, and to serve<br>as a sizing guide. | and to serve as a sizing<br>guide. | |
| Indications for Use | The Standard Bougie™<br>SB38 is indicated for use<br>in conjunction with the<br>Titan SGST™ Stapler in<br>vertical sleeve<br>gastrectomy pouch<br>creation for the<br>application of suction,<br>stomach decompression,<br>drainage of gastric fluids,<br>irrigation and<br>insufflation, and to serve<br>as a sizing guide. | The Standard Bougie™<br>SB38 is indicated for use<br>in conjunction with the<br>Titan SGST™ Stapler in<br>vertical sleeve gastrectomy<br>pouch creation for the<br>application of suction,<br>stomach decompression,<br>drainage of gastric fluids,<br>irrigation and insufflation,<br>and to serve as a sizing<br>guide. | Same |
| How Supplied | Single patient use, non-<br>sterile device | Single patient use, non-<br>sterile device | Same |
| Design Information | | | |
| Typical Use | Gastric and bariatric<br>surgical procedures | Gastric and bariatric<br>surgical procedures | Same |
| Use Environment | Surgery centers,<br>hospitals | Surgery centers, hospitals | Same |
| Patient Population | Patients undergoing<br>bariatric and/or gastric<br>procedures requiring<br>vertical sleeve<br>gastrectomy | Patients undergoing<br>bariatric and/or gastric<br>procedures requiring<br>vertical sleeve gastrectomy | Same |
| Single Patient Use | Yes | Yes | Same |
| Sterility | Supplied non-sterile,<br>single patient use only,<br>disposable | Supplied non-sterile,<br>single patient use only,<br>disposable | Same |
| Functionality | Suction, drainage,<br>irrigation, insufflation,<br>and sizing | Suction, drainage,<br>irrigation, insufflation, and<br>sizing | Same |
| Method of<br>Insufflation | Syringe OR Standard<br>Bougie Hand Pump to<br>apply air | Syringe to apply air | Equivalent insufflation<br>pressure as compared with<br>predicate device, Standard<br>Bougie (SB38). Both devices<br>are capable of connection<br>with hospital air and suction.<br>The addition of the Standard<br>Bougie Hand Pump to the<br>Standard Bougie includes the<br>option for manual insufflation<br>using a squeeze bulb. |
| Catheter Diameter | 38Fr | 38Fr | Same |
| Connection for<br>suction | Yes | Yes | Same |
| | Subject Device<br>(SB38 with Hand Pump<br>Accessory) | Predicate Device (SB38) | Determination |
| Packaging | SB38: Tyvek Pouch<br>Hand Pump Accessory:<br>Polybag | SB38: Tyvek pouch | SB38 packaging remains<br>unchanged. Hand pump<br>accessory provided in Non-<br>sterile packaging, routinely<br>used 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.
