(90 days)
No
The device description and performance studies focus on the physical characteristics and functional performance of a feeding tube, with no mention of AI or ML capabilities.
No
The device is described as a feeding tube used to "provide nutrition via nasal or oral gastric placement" rather than to treat a specific disease or condition. While providing nutrition is supportive care, it is not described as a direct therapeutic intervention in this context.
No
This device is a feeding tube used to deliver nutrition, not to diagnose a condition. The mention of X-ray is for verifying placement of the tube, not for diagnostic imaging of the patient's condition.
No
The device description clearly outlines a physical medical device (PVC single lumen catheter) with hardware components (tubing, connector hub, radiopaque stripe, side holes). It does not mention any software as a component or function of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide nutrition via nasal or oral gastric placement." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a catheter used for delivering liquid nutritional media. This aligns with a medical device for treatment or support, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition.
Therefore, this device falls under the category of a medical device used for patient care, specifically for providing nutrition, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeoMed Gastrointestinal Tube and Accessories is intended for short-term use
§ 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
K120/82
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APR 1 9 2012
NeoMe
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
DATE:
April 11, 2012
APPLICANT:
NeoMed, Inc. 100 Londonderry Ct Suite 112 Woodstock, GA 30188 Tony Lair, President Tel: 770-516-2225 email: lair1@concentric.net
Official Correspondent: Penny Northcutt, RAC, CQA Regulatory Consultant for NeoMed, Inc. REGSolutions, LLC Tel: 678-428-6978 Fax: 678-513-0937 email: pennynorthcutt@theregsolutions.com
Trade Name:
NeoMed Gastrointestinal Tube and Accessories
Classification Tubes, Gastrointestinal (and accessories) Name:
| DEVICE | Class II per 21 CFR §876.5980 |
|---|---|
| CLASSIFICATION AND | Gastroenterology/Urology |
| PRODUCT CODE: | Product Code: KNT |
| PREDICATE DEVICE | Vygon Nutrisafe 2, KO60944 |
|---|---|
| NAME: | Kendall Argyle PVC Feeding Tube, K820441 (Sherwood) |
1
K12 0182
Page 2 of 3
SUBSTANTIAL EQUIVALENCE:
The NeoMed Gastrointestinal Tube and Accessories is substantially equivalent to the legally marketed Vygon Nutrisafe 2 (K060944) and Kendall Argyle PVC Feeding Tube (K820441). In addition, the NeoMed PVC feeding tube device design is the same as previously cleared NeoMed Silicone (K072881) and Polyurethane (K082238) Feeding Tubes.
TECNOLOGICAL CHARACTERISTICS:
The NeoMed Gastrointestinal Tube and Accessories have similar technological characteristics when compared to the predicate devices. They have similar indications for use, materials, product design, and principles of operation. Bench testing has demonstrated that the NeoMed Gastrointestinal Tube and Accessories is functionally equivalent to the proposed predicate feeding tubes. Any minor differences do not affect safety or effectiveness of the NeoMed Gastrointestinal Tube and Accessories.
DESCRIPTION OF THE DEVICE:
The NeoMed Gastrointestinal Tube and Accessories is a PVC single lumen catheter that is used to deliver liquid nutritional media. This NeoMed PVC feeding tube is designed to connect with other NeoMed accessories such as the NeoMed Extension tubing under FDA clearance K100288 and NeoMed oral syringe under FDA clearance K092908.
The device consists of the following main components: a feeding tube single lumen catheter and a one-piece molded enteral only connector hub with integral tethered connection closure plug. The catheter tubing has an orange radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The tip is closed. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.
INTENDED USE/INDICATIONS FOR USE:
The NeoMed Gastrointestinal Tube and Accessories is intended for short-term use