(131 days)
Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.
Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile)
The provided document is a 510(k) premarket notification approval letter for a Nasogastric Feeding Tube. It does not contain any information about acceptance criteria, device performance studies, or AI/software validation.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sizes or data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a regulatory approval notice, confirming that the FDA found the device (a physical medical device, not a software or AI product) substantially equivalent to a predicate device. It focuses on regulatory compliance rather than detailed performance study results.
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OCT 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gene Boyd Medical Device Engineer Biosearch Medical Products 35 Industrial Parkway SOMERVILLE NJ 08876
Re: K051480
Trade/Device Name: Nasogastric Feeding Tube (4Fr, 6Fr, 10Fr and 12Fr; sterile and non-sterile) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: BSS Dated: September 15, 2005 Received: September 16, 2005
Dear Mr. Boyd:
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 requirements 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 Approval), it may be subject to such 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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with anow you to begin manisms of substantial equivalence of your device to a legally prematication. "The PDF mailig of Station for your device 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 11 you desire specific active for your activer in the following numbers, based on 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 notification" (21 CFR Also, please note togenation entires), formation on your responsibilities under the Act from the 007.77). Tour may ootain one general missistance 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. Hogdon
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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Image /page/2/Picture/0 description: The image shows the logo for "biosearch MEDICAL PRODUCTS INC.". The word "biosearch" is in a bold, sans-serif font, with the "o" in "bio" stylized to resemble a flask. The words "MEDICAL PRODUCTS INC." are in a smaller, sans-serif font and are located directly below "biosearch". There is a trademark symbol to the right of the word "biosearch".
a subsidiary of Hydromer, Inc.
Indications for Use
510(k) Number (if known): Kos 1480
Device Name: Nasogastric Feeding Tube
Indications for Use:
Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.
Prescription Use (Part 21 CFR 801 Subpart D)
480
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
David b. Segarm
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
Biosearch Medical Products Inc. 35 Industrial Pkwy, Somerville, NJ. 08876 (USA) TEL: 908-722-5000 FAX: 908-722-5024 www.biosearch.com
§ 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.