(83 days)
Not Found
No
The summary describes a physical medical device (feeding tube) with a modified connector. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an infant feeding tube used to introduce fluids into the stomach, which is a supportive function for nutrition, not a treatment for a disease or condition. While essential for infant health, it does not directly treat or cure a medical condition, nor does it restore a damaged part of the body.
No
The device is described as an infant feeding tube for introducing fluids into the stomach, not for diagnosing medical conditions.
No
The device description clearly details a physical medical device (feeding tube with connectors) and its components, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an infant feeding tube with a non-IV connector. Its purpose is to deliver fluids directly into the stomach. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for introducing fluids into the stomach via a feeding tube. This is a therapeutic/supportive function, not a diagnostic one.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stornach to permit the introduction of fluids as directed by the physician. Intended for nasogastric placement. Limited to
§ 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
Non-Confidential Summary of Safety and Effectiveness
| Page 1 of 2 | |
|---|---|
| 26-Sept-07 |
| ProMedic, Inc. | Tel (239) 498-2155 |
|---|---|
| 3460 Pointe Creek Court #102. | Fax (239) 236-0354 |
| Bonita Springs, FL 34134 |
| Official Contact: | Paul Dryden |
|---|---|
| ------------------- | ------------- |
| DEC 1 9 2007 | |
|---|---|
| -- | -------------- |
| Proprietary or Trade Name: | Infant Feeding Tube with Non-IV fittings |
|---|---|
| Common/Usual Name: | Feeding Tube or NG /OG Tube |
| Classification Name: | Tubes, Gastrointestinal (and Accessories) |
| Predicate Devices: | ProMedic - Infant Feeding Tubes - K052903 |
Device Description:
The proposed modification to Infant Feeding Tube is to change the fittings from a standard slip fit luer to a non-IV (luer) size connector. The feeding tubes are a small diameter tube of various diameters, 5, 6, and 8 French, and lengths, 14.5", 35" and 41". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile. We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of a kit.
Indications for Use:
A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stornach to permit the introduction of fluids as directed by the physician. Intended for nasogastric placement. Limited to Trade/Device Name: Feeding tube adapter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: September 26, 2007 Received: September 27, 2007
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Paul Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh.dsmamain.html.
Sincerely yours,
Herbert Lemon for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
1072756
Indications for Use Statement
Page 1 of 1
(To be assigned) 510(k) Number:
Device Name:
Feeding tube adapter
Indications for Use:
A non-IV connector for use with Infant Feeding tubes that are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to