(268 days)
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is described as a surgical tool used for suction, decompression, drainage, irrigation, and as a sizing guide during a vertical sleeve gastrectomy. Its primary functions are mechanical assistance during a surgical procedure, not directly treating a disease or condition for therapeutic benefit.
No
The device's intended uses are for suction, stomach decompression, drainage, irrigation, and as a sizing guide during a surgical procedure, not for diagnosing a 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 also focus on physical characteristics like flow rate, strength, and size, indicating a hardware device.
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 purposes like suction, decompression, drainage, irrigation, and sizing. These are all direct interventions on the patient's body.
- Device Description: The description details a physical tube with a balloon, designed for insertion into the stomach. It facilitates physical actions within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a tool used in vivo (within the living body).
The device's function is entirely focused on assisting with a surgical procedure and manipulating the stomach directly, not on analyzing biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.
Product codes
KNT
Device Description
The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French 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 contents, and allow for irrigation 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 performance testing has been submitted in this 510(k) as follows:
- Drainage Flow Rate Verification -
- -Balloon Strength Verification
- -Balloon Size Verification
- -Tensile Strength Verification
- -Reliability Testing
- Device Usability -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 side of the logo 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.
April 8, 2020
Standard Bariatrics Alison Sathe Regulatory 4362 Glendale Milford Rd. Cincinnati, OH 45242
Re: K191885 Device Name: Standard Bougie Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 9, 2020 Received: March 11, 2020
Dear Alison Sathe:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 (OS) 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 medical devices and radiation-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.
Daniel G. Walter, Jr. 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) K191885
Device Name Standard Bougie
Indications for Use (Describe)
The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectorny procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation 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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510(K) Summary
I. SUBMITTER
Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA
Phone: 513-304-7971 Email: alison@standardbariatrics.com
Contact Person: Alison Sathe Date Prepared: July 12, 2019
DEVICE II.
Name of Device: Standard Bougie Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Tubes, Gastrointestinal (And Accessories) (21 CFR 876.5980) Regulatory Class: II Product Code: KNT
III. PREDICATE DEVICE
Predicate Device: Boehringer Laboratories Gastric Sizing Tube (Tradename: ViSiGi), K130483 Reference Device: Cook Incorporated Gastric Sizing Balloon Catheter, K173355
IV. DEVICE DESCRIPTION
The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French 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 contents, and allow for irrigation 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® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Standard Bougie technological characteristics are provided in Table 1.
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Table 1: Technological Characteristics
| Product | Standard Bougie
(subject device) | ViSiGi
(Boehringer Laboratories
Gastric Sizing Tube-
K130483) | 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 | Patients undergoing bariatric
and/or gastric procedures | 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
and sizing | Suction, drainage, irrigation
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 | Single lumen with rounded,
atraumatic distal end | Equivalent. The Standard
Bougie double lumen is
provided to allow for
inflation of the balloon |
| Diameter | 18 Fr | 32 Fr, 36 Fr, or 40 Fr | Equivalent. The smaller
size Standard Bougie is
provided for surgeon
preference as some prefer
a smaller size lumen. 18Fr
is a standard size for
bougie devices and many
are available in 18Fr.¹ |
| Length | 95 cm | 76 cm | Equivalent. The Standard
Bougie is slightly longer
than the ViSiGi. Both
devices are long enough to
perform their intended use.
The Standard Bougie is
slightly longer in order to
ensure adequate length for
the inflation lumen. |
| Materials | Thermoplastic elastomer | Styrene-Ethylene-Butylene-
Styrene (SEBS Copolymer) | Equivalent. Both devices
utilize materials compliant
with ISO 10993 for their
intended use. Both have
similar mechanical
properties to allow for
their intended use. |
| Connection for suction | Yes | Yes | Same |
| Method of Suction | Connection with hospital | Connection with hospital | Same |
| | apply suction within the
stomach | apply suction within the
stomach | |
| Markings | Yes (numbers every 10 cm
and gradations every 5 cm) | No | Equivalent. Markings are
provided on the Standard
Bougie to aid in device
placement but are not
necessary for the device
use. |
| Packaging | Tyvek pouch for single device
with 6 pouched devices within
a cardboard box | Plastic pouch for a single
device with 5 pouched devices
within a cardboard box | Equivalent. Both devices
are packaged nonsterile in
a pouch with a cardboard
outer package |
1 The Cook Gastric Sizing Balloon cleared pursuant to K173355 is 18Fr and is provided as an example of a currently marketed 18Fr diameter bougie.
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VII. PERFORMANCE DATA
Standard Bougie performance testing has been submitted in this 510(k) as follows:
- Drainage Flow Rate Verification -
- -Balloon Strength Verification
- -Balloon Size Verification
- -Tensile Strength Verification
- -Reliability Testing
- Device Usability -
VIII. CONCLUSIONS
The Standard Bougie has the same intended use, and principles of operation as its predicate device. The minor differences in technological characteristics do not raise new questions of safety or effectiveness and testing demonstrates substantial equivalence. The Standard Bougie is substantially equivalent to the predicate device.