(174 days)
This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel. The device is supplied sterile and is intended for single use only.
The proposed Nasal Jejunal Feeding Tube is a single lumen, radiopaque PVC tube. The 8Fr and 10Fr diameter tubes are intended to be introduced endoscopically and are supplied with a wire guide. The 14FR tube with flaps is intended to be introduced manually in conjunction with peristalsis into the jejunum. The distal portions of all tubes have feed ports for delivery of liquid nutrition and/or medication. All tube kits include a nasal transfer tube and feeding adapters.
The provided text is a 510(k) Summary for the Wilson-Cook Nasal Jejunal Feeding Tubes. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria, detailed study designs, performance data (other than a general statement of "performance characteristics tested"), sample sizes, or expert involvement.
Therefore, I cannot provide the requested table and information based on the given text.
The only "performance data" mentioned is:
"We believe the proposed device to be substantially equivalent to the named predicate based on performance characteristics tested." This statement is too vague to extract any specific acceptance criteria or study details.
In summary, the document lacks the necessary information to answer your questions thoroughly.
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K043203 poy 1041
Wilson-Cook Nasal Jejunal Feeding Tubes
Page 1 of 1
MAY 1 1 2005
510(k) Summary
510(K) SUMMARY
| SPONSOR: | Wilson-Cook Medical4900 Bethania Station RoadWinston-Salem, NC 27105 |
|---|---|
| CONTACT/SUBMITTER: | Marge Walls-WalkerRegulatory Affairs Specialist800-245-4707 |
| DATE OF SUBMISSION: | November 15, 2004 |
| DEVICE:Trade Name(s): | Nasal Jejunal Feeding Tube, Nasal JejunalFeeding Tube w/Flaps, Cook Inc. "Tiger Tube" ™ |
| Common Name: | Nasal Jejunal Feeding Tube, Enteral FeedingTube |
| Classification: | 21 CFR § 876.5980. 78 KNT |
| PREDICATE DEVICES: | Wilson-Cook Enteral Feeding Tube (K 874393) |
| INTENDED USE: | This device is intended to provide short-termenteral access for delivery of nutrition and/ormedications to the small bowel.The device is supplied sterile and is intended forsingle use only. |
| DEVICE DESCRIPTION: | The proposed Nasal Jejunal Feeding Tube is asingle lumen, radiopaque PVC tube. The 8Frand 10Fr diameter tubes are intended to beintroduced endoscopically and are supplied witha wire guide. The 14FR tube with flaps isintended to be introduced manually inconjunction with peristalsis into the jejunum. Thedistal portions of all tubes have feed ports fordelivery of liquid nutrition and/or medication. Alltube kits include a nasal transfer tube andfeeding adapters. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to besubstantially equivalent to the currentlymarketed Wilson Cook Nasal Jejunal FeedingTubes with respect to Intended Use, Indicationsfor Use and Technological Characteristics |
| PERFORMANCE DATA: | We believe the proposed device to besubstantially equivalent to the named predicatebased on performance characteristics tested. |
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Public Health Service
MAY 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K043203
K043203
Trade/Device Name: Wilson-Cook Nasal Jejunal Feeding Tubes and Nasal Jejunal Feeding Tube with Flaps Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 31, 2005 Received: April 4, 2005
Dear Ms. Walls-Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your Security promatics is substantially equivalent (dor interests a for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regary management date of the Medical Device Amendments or to commerce prior to May 26, 1976, the excordance with the provisions of the Federal Food. Drug, devices that have been reclassified in accords.net the device, subject to the general controls and and Cosmetic Act (Act). Tou may, merersponsible to determine that the medical devices your provisions of the Act. Trowever, you are responseers and stantially equivalent under the use as components in the Kirchart entire overse begally on the act), or were legally on the market prior to premarket notification process (Section Process (Device Amendments. Please note: If you May 28, 1970, the chacinent and of the Medical Bookshed) and further process (The secrilize) purchase your device components in ount (in these components in your kit. The general you must sublim a new 510(tr) betere include requirements for annual registration, listing of devices, controls provisions of the Fee metabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (300 above) into ating major regulations affecting your device can be It hay be subject to additional controllar and the 21, Parts 800 to 898. In addition, FDA may found in the Code of Feaching your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hiat FDA 3 issualles of a states complies with other requirements of the Act that IDA has made a determination that your intered by other federal agencies. You must or any Federal Statutes and regulations as animations but not limited to: registration (21 CFR Part Comply with an the Net 3 requiremeling (21 CFR Part 801); good manufacturing practice 807), listing (21 CFR Part 807), lastin systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of extral (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) This letter will anow you to oven maneting of substantial equivalence of your device to a legally premarket nouriedulon. "The sults in a classification for your device and thus, permits your marketed proceed to the market. If you desire specific advice for your device on the labeling device to ploced to the market. In Joa Compliance at (240) 276-0115. Also, please note the regulation, prease contact the Office of erence to premarket notification" (21 CFR Part 807.97). Tegulation childed, "Misoranaing of other on your responsibilities under the Act from the 1 ou inay outan other general mionnational and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K043203 page 1 of 1
510(k) Number (if known): K043203
Device Name: Wilson-Cook Nasal Jejunal Feeding Tubes and Nasal Jejunal Feeding Tube with Flaps
Indications for Use:
The Wilson-Cook Nasal Jejunal Feeding Tube and Nasal Jejunal Feeding Tube with The Wilson-Gook Nasal Jejunar Pooding Pass and Press of r delivery of nutrition and/or medications to the small bowel.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use Only
(Per 21 CFR § 801.109
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number _
Over-the-Counter_
§ 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.