(137 days)
None
No
The device description and performance studies focus on mechanical properties and fluid handling, with no mention of AI/ML terms or functionalities.
No
The device primarily serves as a sizing guide and for procedural functions like suction, drainage, irrigation, and insufflation during a surgical procedure, rather than directly treating a medical condition or disease.
No
The device is primarily used for stomach decompression, fluid management, irrigation, insufflation, and as a sizing guide during surgical procedures, not for identifying a medical condition or disease.
No
The device description clearly outlines a physical, single-patient-use tube with a balloon, luer connector, and multiple holes. The performance studies listed are all related to the physical properties and function of this hardware device. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the STANDARD BOUGIE™ SB38 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- STANDARD BOUGIE™ SB38 Function: The description clearly states the device is used within the body during a surgical procedure (vertical sleeve gastrectomy). Its functions are related to:
- Mechanical actions: Suction, decompression, drainage, irrigation, insufflation.
- Physical guidance: Serving as a sizing guide.
- No Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens.
Therefore, the STANDARD BOUGIE™ SB38 is a surgical accessory used directly on or within the patient's body, not an IVD device used for testing specimens in a lab setting.
N/A
Intended Use / Indications for Use
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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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)
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.
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 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.
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 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 |
| Tubing Design | Double lumen with rounded,
closed distal end | Double lumen with rounded,
closed distal end | Same |
| Balloon Diameter Range | Minimum = $2.0$ cm
Nominal = $2.5$ cm
Maximum = $3.0$ cm | Minimum = $1.5$ cm
Nominal = $2.0$ cm
Maximum = $2.5$ cm | Equivalent. The SB18 is
designed for use with the
Standard Clamp, while the
SB38 is not designed for
use with the Standard
Clamp. The larger balloon
diameter ensures the same
sizing in procedures not
utilizing the Standard
Clamp. |
| | Length of balloon is
approximately $4$ cm long | Length of balloon is
approximately $4$ cm long | |
| Catheter Diameter | $38$ Fr | $18$ Fr | Equivalent. The SB18 is
designed for use with the
Standard Clamp, while the
SB38 is not designed for
use with the Standard
Clamp. The larger
diameter ensures the same
procedures not utilizing
the 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 hospital
suction, holes in distal end
apply suction within the
stomach | Connection with hospital
suction, holes in distal end
apply suction within the
stomach | Same |
| Markings | Yes (numbers every $10$ cm
and gradations every $5$ cm) | Yes (numbers every $10$ cm
and 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.