(214 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a gastric lavage tube and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a gastric lavage tube used to remove substances from the stomach, which is a process of clearing an issue rather than treating a condition or disease.
No
The device description indicates its use for gastric lavage, a procedure for emptying the stomach, primarily in cases of overdose. This is a treatment procedure rather than one used for diagnosing a condition.
No
The device description clearly describes a physical tube made of flexible PVC, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The described device is a tube used for gastric lavage. This is a procedure performed in vivo (within the body) to remove substances from the stomach. It is a physical intervention, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for gastric lavage, acting as a conduit for fluid to and from the stomach.
- Device Description: The description focuses on the physical characteristics and function of the tube for fluid exchange within the stomach.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Disposable, non-sterile tube for gastric lavage.
Product codes
Not Found
Device Description
The lavage tube is used as a two way conduit from a lavage bag set to the stomach. The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage.
The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action. It is a standard accepted feature used in the market . It will not change the function or the lavage procedure in any other way.
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
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)
Not Found
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.
Not Found
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
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
K962850
510 (k) SUMMARY
FEB 2 1 1997
251 Seneca St. Buffalo NY 14204 716-842-400 716-842-4040 Fax John A Young - Vice President/Operations Dr. J. George Haar - Vice President/Proprietary Sales
DUAL LUMEN GASTRIC LAVAGE TUBE
Comparable to single tube Gastric lavage and stomach evacuator tubes.
Disposable, non-sterile tube for gastric lavage. Includes plastic tubing and connectors.
The lavage tube is used as a two way conduit from a lavage bag set to the stomach. The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage.
The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action. It is a standard accepted feature used in the market . It will not change the function or the lavage procedure in any other way.
Image /page/0/Picture/9 description: The image shows the logo for Ethox Corp. The logo is black and white and features a stylized "E" followed by the word "thox" in a bold, sans-serif font. Below the word "thox" is the word "CORP." in a smaller font. There is a registered trademark symbol to the right of the "x" in "thox".
Ethox Corp.
251 Seneca Street
Buffalo, New York
14204-2088
716-842-4000
FAX 716-842-4040
Image /page/0/Picture/12 description: The image shows a sign that commemorates an anniversary. The sign reads "1966-1996 Celebrating Our 30th Anniversary". The sign is rectangular and has a decorative border. The text is in a simple, bold font.