(183 days)
The Anti-I.V. Enteral Feeding System is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentic route. The Anti-I.V. Enteral Feeding Extension Set is intended to be connected to the nutritional source to the Anti-I.V. Enteral Feeding Tube. The Anti-I.V. Enteral Feeding System is for pediatric and neonatal use only.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Anti-I.V. Enteral Feeding System". This document establishes that the device is substantially equivalent to a predicate device already on the market. It is not a study report and does not contain the detailed information necessary to describe acceptance criteria, device performance, or the methodologies of a study as requested in your prompt.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance: This letter is a notification of clearance, not a performance report.
- Sample size used for the test set and data provenance: No study details are provided.
- Number of experts and their qualifications for ground truth: No study details are provided.
- Adjudication method for the test set: No study details are provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: This type of study is not mentioned.
- Standalone (algorithm only) performance: This device is a physical medical device, not an algorithm.
- Type of ground truth used: No study details are provided.
- Sample size for the training set: Not applicable for this type of device and document.
- How ground truth for the training set was established: Not applicable for this type of device and document.
In summary, the provided FDA 510(k) clearance letter confirms that the "Anti-I.V. Enteral Feeding System" is cleared for marketing based on substantial equivalence to predicate devices, but it does not describe the specific studies, acceptance criteria, or performance metrics in the way you've outlined for AI/algorithm-based devices.
To obtain the information you requested, you would typically need to refer to the original 510(k) submission document or any referenced clinical study reports, which are not included in this FDA clearance letter.
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MAY - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stephanie Wasielewski VP, Regulatory Affairs/Quality VIASYS Healthcare MedSystems 100 Chaddick Drive WHEELING IL 60090
Re: K043044
Trade/Device Name: Anti-I.V. Enteral Feeding System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 14, 2005 Received: April 14, 2005
Dear Ms. Wasielewski:
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 (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 Joural), it may be subject to such additional controls. Existing major regulations affecting your I apportury, it 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I case be advisou 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 I caral statues and rogularing but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, modeling 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hanketing of substantial equivalence of your device to a legally premarket nothication. The PDA munities of Sacsantal vice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of our learning of one of the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notifications" (21 CFR Also, please note the regulation entitled, "Historiation on your responsibilities under the Act from the 807.97). You may obtain other general monitation on Jour of Ssistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer Assistance at Division of Small Manufacturers, Internet address http://www.fda.gov/cdrb/dsmadsmamain.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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INDICATIONS FOR USE
The Anti-I.V. Enteral Feeding System is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentic route. The Anti-I.V. Enteral Feeding Extension Set is intended to be nasoonale router "The nutritional source to the Anti-I.V. Enteral Feeding Tube. The Anti-I.V. Enteral Feeding System is for pediatric and neonatal use only.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use 1 (Per 21 CFR 801.109) or Over-the-counter 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.