KIMBERLY-CLARK INTRODUCER KITS

K080253 · Kimberly-Clark Corp. · KGC · Feb 26, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080253
• Device Name: KIMBERLY-CLARK INTRODUCER KITS
• Applicant: Kimberly-Clark Corp.
• Product Code: KGC · Gastroenterology, Urology
• Decision Date: Feb 26, 2008
• Decision: SESK
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

The Kimberly-Clark* MIC* G Introducer Kits are intended to facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC* brand of Gastrostomy Feeding Tubes. The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended to facilitate primary placement of Kimberly-Clark* and Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding Tubes. The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC* Transgastric-Jejunal Introducer Kit is intended to facilitate primary placement of Kimberly-Clark* MIC* Jejunal Feeding Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal Feeding Tube. The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark* MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to facilitate primary placement of Kimberly-Clark* MIC-KEY* Low-Profile Jejunal Feeding Tube and the Kimberly-Clark* MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube.

Device Story

Introducer kits facilitate primary placement of balloon-retained enteral feeding tubes. Used in interventional radiology or endoscopy suites by clinicians. Kit components include gastropexy device, dilator with peel-away sheath, syringe, hemostat, introducer needle, seeking catheter, scalpel, guidewire, and stoma measuring device. Device functions by dilating the tract and attaching the gastric wall to the anterior abdominal wall to allow tube insertion. Output is the successful placement of the feeding tube, enabling enteral nutrition delivery. Benefits include standardized, essential components for clinical procedure efficiency.

Clinical Evidence

Bench testing only. Biocompatibility, sterilization, and functional testing demonstrated safety and effectiveness. No clinical data presented.

Technological Characteristics

Kit containing mechanical components for percutaneous tube placement: gastropexy, dilator, sheath, syringe, hemostat, needle, catheter, scalpel, guidewire, and measuring device. Materials have established history in medical devices. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for facilitating primary placement of various Kimberly-Clark brand gastrostomy, jejunal, and transgastric-jejunal feeding tubes in patients requiring enteral nutrition.

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.

Predicate Devices

• MIC* Gastrostomy Tube Percutaneous Insertion Kit (K852363)
• MIC* Gastro-Enterostomy Tube Modification (K921370)
• MIC* Transgastric Jejunal Tube Kit (K926581)

Submission Summary (Full Text)

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT | Kimberly-Clark*<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 | FEB 26 2008 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------|
| OFFICIAL<br>CORRESPONDENT | Sherry Saurini<br>Associate Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] | |
| TRADE NAME: | KIMBERLY-CLARK* Introducer Kits | |
| CLASSIFICATION<br>NAME: | Gastrointestinal tube and accessories | |
| DEVICE<br>CLASSIFICATION<br>AND PRODUCT<br>CODE | Class II per 21 CFR §876.5980<br>Product Code - KNT | |

### SUBSTANTIAL EQUIVALENCE:

The new Kimberly-Clark* Introducer Kits are substantially equivalent to the MIC* Gastrostomy Tube Percutaneous Insertion Kit cleared under K852363, the MIC* Gastro-Enterostomy Tube Modification cleared under K921370 and the MIC* Transgastric Jejunal Tube Kit cleared under K926581. Both the Kimberly-Clark* Introducer Kits and the predicate kit have the same intended use and basic scientific technology.

Both kits have the same intended use, and utilize the same scientific principles, dilation and attachment of the gastric wall to the anterior abdominal wall. Bench testing has demonstrated that the new Kimberly-Clark* Introducer Kits performs the same function as the predicate kits, and that any minor differences between the modified device and the predicate device do not affect safety or efficacy.

8.

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SUMMARY OF SAFETY & EFFECTIVE

#### DESCRIPTION OF THE DEVICE:

The Introducer Kits consists of a group of essential components required to facilitate placement of a balloon-retained enteral feeding tube. The kit contains these essential components in an easy to use tray and is configured for use in an interventional radiology and /or endoscopy suite.

This device consists of the following components and accessories:

- 1. Gastropexy
- 2. Dilator with Peel-away sheath
- 3. Syringe
- 4. Hemostat
- 5. Introducer Needle
- 6. Seeking Catheter
- 7. Scalpel
- 8. Guidewire
- 9. Stoma Measuring Device

The device consists of the following main components and accessories: list components and accessories.

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SUMMARY OF SAFETY & EFFECTIVENESS

# INDICATIONS FOR USE:

| Kit Configuration | Indications for Use Statement |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For the Kimberly-<br>Clark* MIC*G<br>Introducer Kit | The Kimberly-Clark* MIC* G Introducer Kits are intended to<br>facilitate primary placement of Kimberly-Clark* and Kimberly-<br>Clark* MIC* brand of Gastrostomy Feeding Tubes. |
| For the Kimberly-<br>Clark* MIC-KEY*G<br>Introducer Kit | The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended<br>to facilitate primary placement of Kimberly-Clark* and<br>Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding<br>Tubes. |
| For the Kimberly-<br>Clark* MIC*J-TJ<br>Introducer Kit | The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC*<br>Transgastric-Jejunal Introducer Kit is intended to facilitate<br>primary placement of Kimberly-Clark* MIC* Jejunal Feeding<br>Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal<br>Feeding Tube. |
| For the Kimberly-<br>Clark* MIC-KEY*J-<br>TJ Introducer Kit | The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark*<br>MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to<br>facilitate primary placement of Kimberly-Clark* MIC-KEY*<br>Low-Profile Jejunal Feeding Tube and the Kimberly-Clark*<br>MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube. |

## PERFORMANCE DATA:

All components that come in direct contact with the patient have a history of use in medical devices and are biocompatibility, sterilization and functional test results demonstrate that the device is safe and effective for use in humans. Biocompatibility summaries can be found in Attachment D.

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Summary of Safety & E

# CONCLUSION:

Based on the performance testing, it can be concluded that the new Kimberly-Clark* Introducer Kits are equivalent to the predicates MIC* Gastrostomy Tube Percutaneous Insertion Kit (K852363), MIC* Enterostomy Tube Modification (K921370) and MIC* Transgastric Jejunal Tube Kit (K926581) with respect to intended use and technological characteristics.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and its head turned to the left. The eagle is a symbol of the United States, and its presence on the seal indicates the department's role in protecting the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2008

Ms. Sherry Saurini Associate Director, Regulatory Affairs Kimberly-Clark* Corporation 1400 Holcomb Bridge Road ROSWELL GA 30076

Re: K080253

Trade/Device Name: Kimberly-Clark* MIC* G, MIC-KEY* G, MIC* Jejunal, MIC* Transgastric-Jejunal, MIC-KEY* Jejunal and MIC-KEY* Transgastric-Jejunal Introducer Kits Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KGC Dated: January 30, 2008 Received: January 31, 2008

Dear Ms. Saurini:

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. Sherry Saurini

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.

This letter will allow you to begin marketing your device as described in your Section 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR Part 807.97). 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/cdrh.dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. B. rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K080253
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# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K080253

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

| Kit Configuration | Indications for Use Statement |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For the Kimberly-<br>Clark* MIC*G<br>Introducer Kit | The Kimberly-Clark* MIC* G Introducer Kits are intended to<br>facilitate primary placement of Kimberly-Clark* and Kimberly-<br>Clark* MIC* brand of Gastrostomy Feeding Tubes. |
| For the Kimberly-<br>Clark* MIC-KEY*G<br>Introducer Kit | The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended<br>to facilitate primary placement of Kimberly-Clark* and<br>Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding<br>Tubes. |
| For the Kimberly-<br>Clark* MIC*J-TJ<br>Introducer Kit | The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC*<br>Transgastric-Jejunal Introducer Kit is intended to facilitate<br>primary placement of Kimberly-Clark* MIC* Jejunal Feeding<br>Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal<br>Feeding Tube. |
| For the Kimberly-<br>Clark* MIC-KEY*J-<br>TJ Introducer Kit | The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark*<br>MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to<br>facilitate primary placement of Kimberly-Clark* MIC-KEY*<br>Low-Profile Jejunal Feeding Tube and the Kimberly-Clark*<br>MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube. |

Prescription Use × (Part 21 CFR 801 Subpart D) ANDYOR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-t Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number,

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