AMT T-FASTENER ANCHOR KIT

K120587 · Applied Medical Technology, Inc. · KGC · May 25, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120587
• Device Name: AMT T-FASTENER ANCHOR KIT
• Applicant: Applied Medical Technology, Inc.
• Product Code: KGC · Gastroenterology, Urology
• Decision Date: May 25, 2012
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Device Story

AMT T-Fastener Anchor Kit is a gastropexy device used to affix the gastric wall to the anterior abdominal wall. It facilitates the formation of a new stoma tract for the subsequent placement of a percutaneous gastrostomy device. The device is intended for use in clinical settings by healthcare professionals during the initial placement of feeding tubes for patients requiring long-term enteral nutrition.

Indications for Use

Indicated for patients with a functioning gut requiring long-term tube feeding, including those with existing or potential malnutrition due to concurrent conditions, undergoing initial percutaneous gastrostomy placement.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Ms. Elizabeth Meyer Engineer Applied Medical Technology, Inc. 8000 Katherine Boulevard BREEKSVILLE OH 44141

MAY 2 5 2012

Re: K120587

Trade/Device Name: AMT T-Fastener Anchor Kit Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KGC Dated: February 23, 2012 Received: February 29, 2012

Dear Ms. Meyer: ·

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 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) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the 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 – Ms. Elizabeth Meyer

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## SECTION - 4

## c. - INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120587

AMT T-Fastener Anchor Kit Trade Name: Common Name: Gastropexy Device

Indications For Use:

The AMT T-Fastener Anchor Kit is to be used to affix the gastric wall to the anterior abdominal wall for formation of a new stoma tract and subsequent placement of a percutaneous gastrostomy device. Gastropexy during initial placement of a percutaneous gastrostomy device may be indicated for patients with a functioning gut who require long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER
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| Division Sign-Off) | |
|--------------------------------------------------------------------------------------------------------------------------|---------|
| Division of Reproductive, Gastro-Renal, and<br>Urological Devices concurrence of CDRH, Office of Device Evaluation (ODE) | |
| 510(k) Number | K120587 |

510(k) Number Applied Medical Technology, Inc. -510(k) Submission AMT T-Fastener Anchor Kit

Section 4 - Page 4.2