← Product Code [KNT](/productcode/KNT) · K961884

# CATH CADDIE (K961884)

_Mark-Clark · KNT · Aug 1, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K961884

## Device Facts

- **Applicant:** Mark-Clark
- **Product Code:** [KNT](/productcode/KNT.md)
- **Decision Date:** Aug 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5980
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Pediatric

## Indications for Use

The Cath Caddie is intended to cover and secure Hickman catheters and PEG tubes, eliminating the need for taped dressings.

## Device Story

Device: fabric cover for Hickman catheters and PEG tubes; replaces adhesive tape/gauze dressings. Input: physical catheter/tube site. Operation: mechanical covering/securing of site. Usage: clinic/home; patient/caregiver application. Benefit: prevents skin irritation/sores; reduces infection risk; improves patient comfort; lowers costs by eliminating tape/gauze supplies.

## Clinical Evidence

No clinical data; anecdotal evidence provided via letters from physicians and administrators regarding 1,500+ units used for Hickman catheters and PEG tubes.

## Technological Characteristics

Mechanical fabric cover; non-adhesive; form-fitting design for catheter/tube site protection.

## Regulatory 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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K 96/884

AUG 1996

510(k) Summary - Cath Caddie, submitted by Mark-Clark, a division of M-C Industries, Inc.

The Cath Caddie was developed by the grandmother of a pediatric cancer patient who received chemotherapy via a Hickman Catheter placed in his chest. Constant removal of taped dressings resulted in skin irritations to the youth.

The inventor created the Cath Caddie for her grandchild to eliminate the need for tape. Subsequently, she provided Cath Caddies for several additional patients of Dr. David Rosen. She estimates that Dr. Rosen has issued as many as 1,500 of the covers through his practice and through the Children's Miracle Network. (See attached photo-copy of letter from Dr. David Rosen.)

Additional prototypes of the Cath Caddie were provided to Dr. Jerry H. Feagan who in turn passed them on to the Endoscopy and Surgery Center of Topeka. This practice utilized the Cath Caddie to cover and secure PEG tubes of enteral feeding tubes in the abdomens of some of their patients. Elizabeth Thomas, administrator of the center found the Cath Caddie to be superior and much more convenient than the use of taped dressings for this purpose.

This product - both in theory and in actual practice - appears to provide an actual benefit to patient and doctor alike. The elimination of tape prevents typical skin irritation caused by adhesives. Obviously, this provides improved patient comfort while also avoiding the risk of infection possible with skin sores. This helps to avoid additional healthcare costs associated with treating secondary problems (skin sores) and eliminates ongoing expense of tape and gauze dressings to the physician's practice.

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**Source:** [https://fda-staging.innolitics.com/device/K961884](https://fda-staging.innolitics.com/device/K961884)

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