Gastric Sizing Balloon Catheter
Device Facts
| Record ID | K173355 |
|---|---|
| Device Name | Gastric Sizing Balloon Catheter |
| Applicant | Cook Incorporated |
| Product Code | KNT · Gastroenterology, Urology |
| Decision Date | Nov 17, 2017 |
| Decision | SESK |
| Submission Type | Special |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Gastric Sizing Balloon Catheter is indicated for use in gastric surgical procedures to size the gastric pouch and drain and remove gastric fluid.
Device Story
Invasive 55 cm flexible gastric tube; 18 Fr diameter; used in healthcare facilities by clinicians during gastric and bariatric surgeries. Device inserted through mouth, down esophagus, into stomach. Used to size gastric pouch and drain/remove gastric fluid. Supplied with 20 cc syringe; single-use; sterile. Clinician manually operates device; provides physical sizing and drainage. Benefits patient by facilitating accurate pouch sizing and fluid management during bariatric procedures.
Clinical Evidence
Bench testing only. No clinical data. Testing included biocompatibility (BS EN ISO 10993-1:2003), dimensional/compatibility analysis, inflated balloon tensile testing (BS EN 1618), balloon burst testing, and sideport tensile testing (BS EN 1618). All tests met acceptance criteria.
Technological Characteristics
18 Fr, 55 cm flexible catheter. Materials: Silicone (MED-4720 balloon, E951 adhesive, GE615 markings). Mechanical sensing/actuation. Sterilized via Ethylene Oxide (SAL 10^-6). Packaging: Polyester-polyethylene/Tyvek. Shelf life: 2 years. No software or electronic components.
Indications for Use
Indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid in patients undergoing such procedures.
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
- Cook Gastric Sizing Balloon Catheter (K030841)
Submission Summary (Full Text)
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November 17, 2017
Cook Incorporated Colin Jacob Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K173355
> Trade/Device Name: Gastric Sizing Balloon Catheter Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: October 24, 2017 Received: October 25, 2017
Dear Colin Jacob:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K173355
Device Name Gastric Sizing Balloon Catheter
Indications for Use (Describe)
The Gastric Sizing Balloon Catheter is indicated for use in gastric surgical procedures to size the gastric pouch and drain and remove gastric fluid.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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#### K173355 Page 1 of 3
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Image /page/3/Picture/2 description: The image shows the Cook Medical logo and the text "510(K) SUMMARY". The Cook Medical logo is a red square with the word "COOK" in white letters on the top line and the word "MEDICAL" in white letters on the bottom line. The text "510(K) SUMMARY" is in black letters and is located below the Cook Medical logo.
#### Submitted By:
Applicant: Contact: Applicant Address:
Contact Phone Number: Contact Fax Number:
#### Device Information:
Trade Name: Classification Name: Panel: Regulation: Product Code:
Gastric Sizing Balloon Catheter Gastrointestinal tube and accessories Gastroenterology/Urology 21 CFR § 876.5980 KNT
Cook Incorporated
Cook Incorporated P.O. Box 489 750 Daniels Way
(812) 332-0281
Bloomington, IN 47402
(812) 335-3575 x 104965
Colin Jacob
## Predicate Devices:
- 트 Cook Gastric Sizing Balloon Catheter (K030841)
#### Device Description:
The Gastric Sizing Balloon Catheter is an invasive device that consists of a 55 cm flexible gastric tube designed to be used during gastric and bariatric surgical procedures in a healthcare facility/hospital environment by a clinician. The 18 Fr catheter is inserted into the mouth, down the esophageal passage and advanced into the stomach temporarily. The Gastric Sizing Balloon Catheter is supplied with a 20 cc syringe, provided sterile in peel-open packaging, and intended for single-use only.
## Indications for Use:
The Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.
## Comparison to Predicates:
The Gastric Sizing Balloon Catheter and the predicate device, Gastric Sizing Balloon Catheter (K030841), are substantially equivalent in that these devices have the same intended use and
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Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font on a darker red background.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
principles of operation, basic design, and functional characteristics. The only differences between the subject and predicate device are the materials as stated in the comparison table below.
| | Predicate Device | Subject Device |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| | Gastric Sizing Balloon Catheter | Gastric Sizing Balloon Catheter |
| | (K030841) | (subject of submission) |
| Regulation | 21 CFR § 876.5980 | IDENTICAL TO PREDICATE |
| Product Code | KNT | IDENTICAL TO PREDICATE |
| Classification | Class II | IDENTICAL TO PREDICATE |
| Indications for Use | Indicated for use in gastric and<br>bariatric surgical procedures to size<br>the gastric pouch and drain and<br>remove gastric fluid. | IDENTICAL TO PREDICATE |
| Intraoperative Use? | Yes | IDENTICAL TO PREDICATE |
| Clinical Applications | Gastric and bariatric surgical<br>procedures | IDENTICAL TO PREDICATE |
| Principle of Operation | Inserted into the esophageal passage<br>and advanced into the stomach<br>temporarily. | IDENTICAL TO PREDICATE |
| Catheter Outer Diameter | 18 Fr | IDENTICAL TO PREDICATE |
| Catheter Length | 55 cm | IDENTICAL TO PREDICATE |
| Markings Available? | Yes (every 5 cm from 10 cm to 50<br>cm) | IDENTICAL TO PREDICATE |
| Balloon Cuff Silicone<br>Material | MED-4020 | MED-4720 |
| Backfilled Tip Silicone<br>Adhesive Material | MED-2000 | E951 |
| Black Markings Material | MED-4213 | GE615 |
| | Ferro Black Powder | IDENTICAL TO PREDICATE |
| Additional Accessories | Monoject luer-lock syringe | IDENTICAL TO PREDICATE |
| Device for One-time Use? | Yes | IDENTICAL TO PREDICATE |
| Provided Sterile? | Yes | IDENTICAL TO PREDICATE |
| Sterilization Process | Ethylene Oxide | IDENTICAL TO PREDICATE |
| Sterility Assurance Level | 10-6 | IDENTICAL TO PREDICATE |
| Packaging | Polyester-polyethylene/Tyvek | IDENTICAL TO PREDICATE |
| Shelf life | Two (2) years | IDENTICAL TO PREDICATE |
## Technological Characteristics:
The subject device, Gastric Sizing Balloon Catheter, was subjected to applicable non-clinical testing to assure reliable design and performance under the testing parameters. The following non-clinical tests have been conducted to ensure reliable design and performance under the specified testing parameters.
- Biocompatibility Testing - Testing was performed in accordance with BS EN ISO 10993-1:2003, the material and methods used to manufacture the subject device are nontoxic and met the acceptance criteria for their intended use.
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Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in smaller, white letters, set against a darker red background.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
- Dimensional and Compatibility Analysis (Zero-time & Accelerated Aged) Dimensional . testing on the outer diameter and length of the balloon catheter was performed in accordance with the sponsor's acceptance criteria. The acceptance criteria were met.
- Inflated Balloon Tensile (Zero-time & Accelerated Aged) Peak load of the balloon ■ portion was conducted in accordance with Annex B of BS EN 1618. The acceptance criteria were met.
- Balloon Burst (Zero-time & Accelerated Aged) Balloon burst testing on the catheter . balloon was conducted in accordance with sponsor's acceptance criteria. The acceptance criteria were met.
- Sideport Tensile (Zero-time & Accelerated Aged) – Uniaxial testing was conducted in accordance with Annex B of BS EN 1618. The acceptance criteria were met.
In conclusion, the results of these non-clinical tests support a determination of substantial equivalence to the predicate device.
