AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM

K042300 · Applied Medical Technology, Inc. · KNT · Oct 25, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042300
• Device Name: AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
• Applicant: Applied Medical Technology, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Oct 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

To assist in the placement of AMT MINI Button feeding devices by providing temporary feeding tube stability during insertion through patient stoma tract.

Device Story

The AMT Introducer: MINI Button Delivery System is a mechanical accessory used to facilitate the placement of AMT MINI Button feeding devices. It provides temporary stability to the feeding tube during insertion through a patient's stoma tract. The device is used in a clinical setting by healthcare professionals. It functions as a guide or support tool to ensure proper positioning of the feeding device, thereby assisting in the clinical procedure of enteral access placement. It does not involve electronic components, software, or automated analysis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical delivery system/introducer for feeding tubes. No electronic, software, or energy-based components. Materials and design are consistent with standard gastrointestinal tube accessories.

Indications for Use

Indicated for patients requiring placement of AMT MINI Button feeding devices; assists in providing temporary feeding tube stability during insertion through the stoma tract.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2004

Mr. Chris Zantopulos Quality Assurance/Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway CLEVELAND OH 44128

Re: K042300

Trade/Device Name: AMT Introducer: MINI Button Delivery System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tubes and accessories Regulatory Class: II Product Code: 78 KNT Dated: August 20, 2004 Received: August 24, 2004

Dear Mr. Zantopulos:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave review 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 for use stated in the ences, 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 and Council Fre Act. However, you are responsible to determine that the medical devices you pro ristens or morents in the kit have either been determined as substantially equivalent under the ass we component in the arrocess (Section 510(k) of the act), or were legally on the market prior to play 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) purender your it a new 510(k) before including these components in your kit. The general you mast bacinin a new > 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.

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Page 2 - Mr. Chris Zantopulos

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dris issuance or or device complies with other requirements of the Act that I DA has made a determination as administered by other federal agencies. You must of any I edelar statutes and registments, including, but not limited to: registration (21 CFR Part comply with an the Fet 8 requirement (21 CFR Part 801); good manufacturing practice 807), fisming (21 OF RT Parces), quality systems (QS) regulation (21 CFR Part 820); and if requirements as set lorth in the quarty by would 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) This icher with and w you'ls cognification of substantial equivalence of your device to a legally prematication for results 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 de vice to problem to and interest in the Office of Compliance at [phone]. Also, ETT Parcel Contract regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). regulation other general information on your responsibilities under the Act from the r out may other before, International and Consumer Assistance at its toll free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy 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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K042300

f. Indications for use statement:

510(k) Number (if known): not assigned yet

Device Name: AMT Introducer: MINI Button Delivery System

Indications for Use:

To assist in the placement of AMT MINI Button feeding devices by providing temporary feeding tube stability during insertion through patient stoma tract.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C brogdon

510k) Nu

Applied Medical Technology, Inc. - 510(k) Submission AMT Introducer: MINI Button Delivery System Section G - Page G.7