(27 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
Yes.
The device is used for applications such as stomach decompression, drainage of gastric fluids, irrigation, and insufflation, which are therapeutic actions to manage or treat a condition (e.g., fluid buildup, gas). It also serves as a sizing guide during a surgical procedure, which is part of a therapeutic intervention.
No
The device is primarily used for surgical and procedural assistance (sizing guide, decompression, drainage, irrigation, insufflation), not for diagnosing a condition or disease. While it serves as a "sizing guide," this is a functional role within the surgery, not a diagnostic one.
No
The device description clearly outlines a physical device (tube, balloon, luer connector) and an accessory (hand pump), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (vertical sleeve gastrectomy) for mechanical functions like suction, drainage, irrigation, insufflation, and sizing. These are all actions performed directly on the patient's body or within the surgical field.
- Device Description: The description details a physical tube with a balloon and luer connector, designed for insertion into the stomach. This aligns with a surgical instrument, not a device that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely procedural and mechanical within the surgical context.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach/Gastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgery centers, hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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
1
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
2
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) | |
|---|---|
| ☑ 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 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.
4
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 Pump
Accessory) | Predicate Device (SB38) | Determination |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Standard Bougie, 38 Fr
with Standard Bougie
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
Gastrointestinal tube and
accessories | 21 CFR 876.5980
Gastrointestinal tube and
accessories | Same |
| Classification | II | II | Same |
| Intended Use | The Standard BougieTM
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 | The Standard BougieTM
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, | Same |
| | Subject Device
(SB38 with Hand Pump
Accessory) | Predicate Device (SB38) | Determination |
| | insufflation, and to serve
as a sizing guide. | and to serve as a sizing
guide. | |
| Indications for Use | The Standard Bougie™
SB38 is indicated for use
in conjunction with the
Titan SGST™ 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. | The Standard Bougie™
SB38 is indicated for use
in conjunction with the
Titan SGST™ 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. | Same |
| How Supplied | Single patient use, non-
sterile device | Single patient use, non-
sterile device | Same |
| Design Information | | | |
| 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
Insufflation | Syringe OR Standard
Bougie Hand Pump to
apply air | Syringe to apply air | Equivalent insufflation
pressure as compared with
predicate device, Standard
Bougie (SB38). Both devices
are capable of connection
with hospital air and suction.
The addition of the Standard
Bougie Hand Pump to the
Standard Bougie includes the
option for manual insufflation
using a squeeze bulb. |
| Catheter Diameter | 38Fr | 38Fr | Same |
| Connection for
suction | Yes | Yes | Same |
| | Subject Device
(SB38 with Hand Pump
Accessory) | Predicate Device (SB38) | Determination |
| Packaging | SB38: Tyvek Pouch
Hand Pump Accessory:
Polybag | SB38: Tyvek pouch | SB38 packaging remains
unchanged. Hand pump
accessory provided in Non-
sterile packaging, routinely
used for non-sterile products. |
Table 1: Overview of Substantial Equivalence
5
6
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.