(87 days)
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No
The document describes a mechanical feeding tube system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a feeding system (gastrostomy tube and jejunal feeding tube) for nutritional support, not a therapeutic device that treats or cures a disease or condition.
No
The device is described as a "Jejunal Feeding System" which includes a gastrostomy tube and a jejunal feeding tube, designed for feeding, not for diagnosis. Its function is to allow access to the jejunum for feeding.
No
The device description explicitly details physical components (gastrostomy tube, jejunal feeding tube) made of materials like polyurethane, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for delivering feeding directly into the jejunum. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a gastrostomy tube and a jejunal feeding tube, which are physical devices used for delivering substances into the body. There is no mention of reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other bodily fluids to diagnose a condition, monitor treatment, or screen for diseases.
Therefore, the Kangaroo® EntriStar Jejunal Feeding System is a medical device used for feeding, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses and components of the of Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Kangaroo Jejunal Feeding System is comprised of a gastrostomy tube and a jejunal feeding tube. The gastrostomy tube is identical to the BioSearch gastrostomy tube, and is a Foley-type of catheter. It is a dual lumen catheter with a retention balloon and outlet port at the the distal end. The proximal end has a female luer balloon inflation valve and an outlet adapter. The Gastrostomy Tube allows access to the jejunum by the Kangaroo Jejunal Feeding Tube. It is ethylene oxide sterilized to an SAL of 106.
The Jejunal feeding tube is included with the system, and may also be packaged and sold separately. It consists of a polyetherbased polyurethane and will be available in lengths ranging from 18" to 36", and in a range of tube diameters from 6 to 12 French.
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
jejunum
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): 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.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
SECTION 6 - 510K SUMMARY
Sherwood Medical Co., 1915 Olive St., Submitted By: St. Louis, MO 63103, (314) 241-5700 C. Winters-Heard, RAC, Regulatory Affairs Manager Contact :
The Kangaroo® EntriStar Jejunal Feeding System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distributed by Sherwood Medical. Sherwood Medical Company will manufacture this product line.
The intended uses and components of the of Kangaroo Jejunal Feeding System are identical to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube and System.
The Kangaroo Jejunal Feeding System is comprised of a gastrostomy tube and a jejunal feeding tube. The gastrostomy tube is identical to the BioSearch gastrostomy tube, and is a Foley-type of catheter. It is a dual lumen catheter with a retention balloon and outlet port at the the distal end. The proximal end has a female luer balloon inflation valve and an outlet adapter. The Gastrostomy Tube allows access to the jejunum by the Kangaroo Jejunal Feeding Tube. It is ethylene oxide sterilized to an SAL of 106.
The Jejunal feeding tube is included with the system, and may also be packaged and sold separately. It consists of a polyetherbased polyurethane and will be available in lengths ranging from 18" to 36", and in a range of tube diameters from 6 to 12 French.
Technological and performance characteristics of the Kangaroo Jejunal Feeding System are the same as that of the Biosearch predicate device; only the manufacturing site has been changed.
Page 9 of 10 February 15, 1996