AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE

K992719 · Amsino Intl., Inc. · KNT · Jan 12, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K992719
• Device Name: AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
• Applicant: Amsino Intl., Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jan 12, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AMSure Enteral Delivery Pump Set with Spike is a device intended to deliver, through an enteral feeding pump, liquid nutrition formulas from a container to an enteral access device (a feeding tube).

Device Story

AMSure Enteral Delivery Pump Set with Spike functions as a fluid delivery conduit; connects liquid nutrition containers to enteral feeding tubes. Operated by clinicians or caregivers in clinical or home settings; used in conjunction with compatible enteral feeding pumps. Device facilitates controlled administration of nutritional formulas to patients unable to ingest food orally. Mechanical design ensures secure connection and flow path integrity for enteral feeding.

Clinical Evidence

Bench testing only.

Technological Characteristics

Enteral delivery pump set; includes spike for container access and tubing for connection to feeding tubes. Materials are medical-grade plastics suitable for enteral nutrition delivery. Non-electronic, passive fluid transfer component.

Indications for Use

Indicated for patients requiring enteral nutrition delivery via a feeding pump, facilitating the transfer of liquid nutritional formulas from a container to an enteral access device.

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

{0}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2000

Richard Y. Li, Ph.D. President & CEO Amsino International, Inc. 833 Towne Center Drive Pomona, CA 91767

Re: K992719 AMSure™ Enteral Delivery Pump Set with Spike Dated: November 19, 1999 Received: December 7, 1999

Regulatory Class: II 21 CFR §876.5980/Procode: 78 KNT

Dear Dr. Li:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act indude 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and -Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 our labeling regulation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

ENCLOSURE # 6

510(k) Number (if known):

AMSure Enteral Delivery Pump Set with Spike evice Name: (

Indications For Use:

AMSure Enteral Delivery Pump Set with Spike is a device intended to deliver, through an enteral feeding pump, liquid nutrition formulas from a container to an enteral access device (a feeding tube).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number.

Over-The-Counter Use

(Optional Format 1-2-96)

નું