(116 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML technologies.
No
A therapeutic device is used to treat, cure, mitigate, or prevent disease. This device is used for sizing the gastric pouch and removing gastric fluid during surgical procedures, not for therapeutic purposes.
No
The device is used for sizing, draining, and removing gastric fluid during surgical procedures, not for diagnosing a condition.
No
The device description clearly describes a physical catheter made of silicone with specific dimensions and features, indicating it is a hardware device, not software-only.
Based on the provided information, the Cook Gastric Sizing Balloon Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid." This describes a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a flexible gastric tube designed for use in vivo to delineate the stomach, decompress it, drain fluid, and size a gastric pouch.
- 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. The description of the Cook Gastric Sizing Balloon Catheter does not involve the analysis of such samples.
Therefore, the Cook Gastric Sizing Balloon Catheter is a surgical device used directly on the patient during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Cook 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.
Product codes
KNT, 78
Device Description
The Cook Gastric Sizing Balloon Catheter is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the cardia of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch. The silicone catheter is 18 French and 55cm long with centimeter markings every centimeter from 10cm to 50cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Cook Gastric Sizing Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Analysis of Cuff Burst Volume .
- Analysis of Cuff Diameter Over Time ●
- Analysis of Cuff Pressure and Diameter at Various Inflation Volumes .
- . Biocompatibility
The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for it use as a gastric sizing balloon.
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.
0
510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED
K030841 Page 1 of 2
Safety and Effectiveness Information
Carol Zwissler Submitted By: Requlatory Affairs Coordinator COOK INCORPORATED 750 Daniels Way PO Box 489 Bloomington, IN 47402 (812) 339-2235 March 11, 2003 Trade Name: Cook Gastric Sizing Balloon Catheter Device: (KNT)
Proposed Classification Name: Gastrointestinal Tube and Accessories
Predicate
The Cook Gastric Sizing Balloon Catheter is similar in terms Device: of intended use, materials of construction and technological characteristics to the Gastric Balloon Suction Catheter marketed by BioEnterics.
Device Description:
The Cook Gastric Sizing Balloon Catheter is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the cardia of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch. The silicone catheter is 18 French and 55cm long with centimeter markings every centimeter from 10cm to 50cm.
Indications for Use:
The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove qastric fluid.
1
KOSATI
510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED
K030841 Page 2 of 2
Substantial Equivalence
The Cook Gastric Sizing Balloon Catheter is similar to another gastric balloon: the Gastric Balloon Suction Catheter, marketed by BioEnterics, which was found substantially equivalent under DC# K002838.
The similar indications for use, materials of construction and the technological characteristics of the Cook Gastric Sizing Balloon Catheter as compared to the predicate device support a determination of substantial equivalency.
Test Data
The Cook Gastric Sizing Balloon Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Analysis of Cuff Burst Volume .
- Analysis of Cuff Diameter Over Time ●
- Analysis of Cuff Pressure and Diameter at Various Inflation Volumes .
- . Biocompatibility
The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for it use as a gastric sizing balloon.
2
Image /page/2/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a symbol that resembles an abstract representation of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Ms. Carol Zwissler Regulatory Affairs Coordinator Cook Incorporated P.O. Box 489 BLOOMINGTON IN 47402-0489
Re: K030841
Trade/Device Name: Gastric Sizing Balloon Catheter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: June 17, 2003 Received: June 18, 2003
Dear Ms. Zwissler:
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. 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.
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 fairther 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification Cook Gastric Sizing Balloon Catheter COOK INCORPORATED
Device Name: Gastric Sizing Balloon Catheter
Indications for Use:
The Cook 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
Over-the-Counter-Use
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030841