(205 days)
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No
The summary describes a simple medical device (gastrostomy tube) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
Explanation: A replacement gastrostomy tube is used for nutritional support and convenience, not for treating a disease or medical condition.
No
The device, a Gastrostomy tube, is for replacing an existing tube due to issues like blockage or for long-term nutritional support, not for diagnosing conditions.
No
The device description clearly states "Replacement Gastrostomy Tube," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description of this device clearly indicates it is a physical tube inserted into the body for feeding purposes. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for direct patient care and support. The indications for use relate to maintaining nutritional support and patient comfort, which are direct clinical interventions, not diagnostic procedures.
The device described is a medical device used for patient care, specifically for enteral feeding, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Gastrostomy tube is replaced with a Replacement Gastrostomy Tube for such things as indications of a blocked feeding tube, patient comfort and esthetics, and the need for long-term nutritional support.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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SECTION II 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS REPLACEMENT GASTROSTOMY TUBE
The Summary of Safety and Effectiveness on percutaneous endoscopic gastrostomy and the Replacement Gastrostomy Tube used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The future studies may require alterations of the results of conclusions or recommendations set forth.
Procedure/Product Overview
Percutaneous endoscopic gastrostomy (PEG) has become the method of choice for patients, both adults and children, unable to take through normal means, yet, have a functional nutrition gastrointestinal tract. Percutaneous endoscopic gastrostomy is a less invasive and traumatic method of placement than a surgical procedure.
of PEGs, via endoscopy, has been clinically The placement acceptable for more than 10 years. Several manufacturers provide PEG units to the market. The Gastrostomy tube is replaced with a Replacement Gastrostomy Tube for such things as indications of a blocked feeding tube, patient comfort and esthetics, and the need for long-term nutritional support.
Contraindications For Utilizing a Replacement Gastrostomy Tube and Percutaneous Endoscopic Gastrostomy
- Patients with massive ascites, sepsis, esophageal or (1) gastric obstructions, esophageal or gastric varices and morbid obesity.
- (2) Individuals who do not have a well established gastrostomy tract.
- If the patient is combative and can not be sedated. (3)
- ( 4 ) If the patient is bleeding.
- If the patient has signs of infection or irritation of stoma (5) tissue.
- (6) If the patient has evidence of granulation tissue at stoma site.
- (7) A patient who does not have a well established qastrostomy tract.
- ( 8 ) Evidence of granulation tissue, infection or irritation should be addressed medically prior to insertion of this device.
- ( Other contraindications as determined by physician.
Manufacturing Overview
U.S.E. manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices.
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U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.
Materials used in the manufacturing process are certified to standards appropriate for their use.
Sterility
The Replacement Gastrostomy Tube will be sterilized using ETO. Sterilization parameters are on file with U.S. Endoscopy Group, Inc.
Bibliography
- Marjorie (Editors), Beck, Manual of Hardick, Marcia and Gastrointestinal Procedures, (2nd Edition). New York: Society of Gastroenterology Nurses and Associates, Inc., 1989.
- Percutaneous Endoscopic Gastrostomy: Mamel, J.J .: A Review. American Society of Parenteral & Enteral Nutrition 87: 65, 1987.
- Mellinger, J.D. and Ponsky, J.L.: Percutaneous Endoscopic Gastrostomy. Endoscopy 24: 64-67, Jan-Feb 1992.
- Ponsky, J.L. and Gauderer,M.: Percutaneous Endoscopic Gastrostomy: A Nonoperative Technique for Feeding Gastrostomy. Gastrointestinal Endoscopy 27: 9-11, 1981.
- Gauderer, M. and Stellato, T.A.: Ponsky, J.L., Percutaneous Endoscopic Gastrostomy in Children. Gastrointestinal Endoscopy 27: 128, May 1981.
- Ponsky, Gauderer, M. and Stellato, T.A.: J.L., Percutaneous Review of 150 Cases. Archives of Endoscopic Gastrostomy: Surgery 118: 913-914, August 1983.
- Ponsky, J.L., Gauderer,M., Stellato, T.A. and Aszodi, A.: Percutaneous Approaches to Enteral Alimentation. The American Journal of Surgery 149: 102-105, January 1985.
- Ponsky, J.L.: Percutaneous Endoscopic Gastrostomy A Closer Look. Endoscopy Review 1: 24-29, December 1984.
- Starkey J.F., Jefferson P.A., Kirby, D.F.: Taking Care of Percutaneous Endoscopic Gastrostomy. American Journal of Nursing 88: 42, 1988.