(73 days)
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No
The summary describes a kit for maintaining a PEG tube, containing standard medical accessories. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a "PATIENT CARE KIT" for the maintenance of a P.E.G. (Percutaneous Endoscopic Gastrostomy), including items like a feeding adapter, cleaning brush, and antibiotic ointment. While PEG itself is a therapeutic procedure, this kit is for maintenance and does not directly treat a disease or condition itself, but rather supports a therapeutic intervention.
No
The device is described as a "PATIENT CARE KIT" for the maintenance of PEG tubes, including items like feeding adapters, cleaning brushes, and antibiotic ointment. Its purpose is for patient care and maintenance of an existing medical device, not for diagnosing a condition or disease.
No
The device description explicitly lists physical components such as a feeding adapter, cleaning brush, and antibiotic ointment, indicating it is a kit containing hardware, not a software-only device.
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.
- Device Function: The description clearly states the device is a "PATIENT CARE KIT" for the "maintenance of the Pull or Guidewire P.E.G." It includes items like a feeding adapter, cleaning brush, and antibiotic ointment. These are used for the care and maintenance of a medical device (the PEG tube) inserted into the body, not for testing samples taken from the body.
- Intended Use: The intended use is for providing nutrition to patients unable to eat normally via a functional gastrointestinal tract. This is a therapeutic and supportive function, not a diagnostic one.
Therefore, the U.S.E. PATIENT CARE KIT is a medical device used for patient care and maintenance of a PEG tube, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Percutaneous endoscopic gastrostomy (PEG) has become the method of choice for patients, both adults and children, unable to take nutrition through normal means, yet, have a functional gastrointestinal tract. Percutaneous endoscopic gastrostomy is a less invasive and less traumatic method of placement than a surgical procedure. A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)
Product codes
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Device Description
A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)
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
Gastrointestinal tract (stomach)
Indicated Patient Age Range
both adults and children
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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MAR 2 9 1996 - 1
SECTION II SUMMARY AND CERTIFICATION
SAFETY AND EFFECTIVENESS P.E.G. PATIENT CARE KIT
The Summary of Safety and Effectiveness on percutaneous endoscopic gastrostomy patient care kit used reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the 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 nutrition through normal means, yet, have a functional gastrointestinal tract. Percutaneous endoscopic gastrostomy is a less invasive and less traumatic method of placement than a surgical procedure.
The placement of PEGs, via endoscopy, has been clinical acceptable for more than 10 years. Several manufacturers provide PEG units to the market.
A U.S.E. PATIENT CARE KIT includes all necessary products for maintenance of the Pull or Guidewire P.E.G. (eg. feeding adapter, and accessory products - manual, cleaning brush, antibiotic ointment, etc...)
Contraindications For Utilizing a PEG
The following are contraindications for percutaneous endoscopic gastrostomy.
- Patients with massive ascites, sepsis, esophageal or (1) gastric obstructions, esophageal or gastric varices and morbid obesity.
- (2) If the patient's stomach can not be transluminated.
- If the patient is combative and can not be sedated. (3)
Manufacturing Overview
U.S.E. manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices.
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.
Image /page/0/Picture/17 description: The image shows a solid black circle against a white background. The circle is not perfectly round, with some slight irregularities in its shape. The contrast between the black circle and the white background is stark, making the circle stand out prominently. The circle is positioned towards the left side of the image.
1
Materials used in the manufacturing process are certified to standards appropriate for their use.
Bibliography
- Percutaneous Endoscopic Gastrostomy: A Review. Mamel, J.J .: American Society of Parenteral & Enteral Nutrition 87: 65, 1987.
- Endoscopic Mellinger, J.D. and Ponsky, J.L.: Percutaneous Gastrostomy. Endoscopy 24: 64-67, Jan-Feb 1992.
Ponsky, J.L. and Gauderer,M.: Percutaneous Endoscopic Gastrostomy: Feeding Gastrostomy. Nonoperative A Technique for Gastrointestinal Endoscopy 27: 9-11, 1981.
- Ponsky , J.L., Gauderer, M. and Stellato, T.A.: Percutaneous Endoscopic Gastrostomy in Children. Gastrointestinal Endoscopy 27: 128, May 1981.
- Ponsky , J.L., Gauderer, M. and Stellato, T.A.: Percutaneous Endoscopic Gastrostomy: Review of 150 Cases. Archives of 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.