(162 days)
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No
The summary describes a physical medical device (feeding tube) and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a feeding tube used to administer nutrition, not to cure, treat, or prevent a disease or condition. While it provides nourishment, which is essential for health, its primary function is supportive, not therapeutic in the medical device context.
No
The device is a feeding tube used to administer nutrition, not to diagnose a condition.
No
The device description clearly details physical components like tubing, internal bolster, and materials (silicone, barium sulfate), indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The description clearly states that this device is a "percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach." It is a device inserted into the body to deliver substances.
Therefore, based on its intended use and function, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach.
Product codes
78 KGC
Device Description
The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach. The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required. The device is sold sterile for single use with all the supplies required to perform the procedure.
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
stomach
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.
0
K 961345
EXHIBIT IX
510(k) SUMMARY
Kathy Feltrin Regulatory Affairs
April 5, 1996
| Common Name: | Percutaneous Endoscopic Gastrostomy (P.E.G.
Feeding Tube |
|----------------------|-------------------------------------------------------------|
| Classification name: | Gastroenterology Tube (78 KGC) |
| Trade Name: | None Established |
The Domed Percutaneous Endoscopic Gastrostomy (P.E.G.) Feeding Tube is a percutaneously placed gastrostomy feeding device used to administer nutrition directly into the stomach. This device has been designed to be substantially equivalent to the U.S. Endoscopy P.E.G. Systems and the AMT P.R.G. Feeding Tubes.
The device is available in either the guidewire or pullwire method. The domed shaped internal bolster is injection molded onto clear medical grade silicone tubing. The tubing has graduated markings which allows for verification of tube positioning. The internal bolster is also composed of medical grade silicone but which has been pigmented with barium sulfate which provides radiopacity. The internal bolsters' shape allows for ease of passage during placement and is advantages because it permits passage of a jeujenostomy tube if jeujenal feeding is required.
The Domed P.E.G. Feeding Tube has been developed incorporating all of the safety and effectiveness features of the U.S. Endoscopy P.E.G. Systems and the AMT P.R.G. Feeding Tubes. The device is sold sterile for single use with all the supplies required to perform the procedure.