ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007

K083153 · Hollister, Inc. · KNT · Feb 4, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083153
• Device Name: ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
• Applicant: Hollister, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 4, 2009
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.

Device Story

ActiFlo Indwelling Bowel Catheter System is a rectal catheter kit for fecal management. Components include rectal catheter with retention cuff and intraluminal balloon, waste collection bag, irrigation bag, skin barriers, syringe, and lubricating jelly. Device allows stool to drain from rectum into collection bag; provides access for colonic irrigation and medication administration via dedicated ports. Used in clinical settings for patients requiring stool management. Healthcare providers operate the system to divert fecal matter, minimizing skin contact and facilitating collection. System includes external silicone retention faceplate for anti-migration. Benefits include improved patient hygiene and simplified bowel care management.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed on all accessories in accordance with ISO 10993 and FDA G95-1 standards. No clinical data was required or provided.

Technological Characteristics

Rectal catheter system with intraluminal balloon and retention cuff. Materials include silicone. Features external silicone retention faceplate with tape slots. Includes irrigation/medication port with funnel/barbed connector. Non-sterile kit components. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring stool management for fecal diversion, colonic irrigation, and administration of enemas or medications.

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

• Indwelling Fecal Management System- Non-Sterile (K023344)
• Indwelling Fecal Management System (IFMS) (K012113)

Submission Summary (Full Text)

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K083153

Image /page/0/Picture/1 description: The image shows the Hollister logo. The logo consists of a stylized, geometric symbol to the left of the word "Hollister". The symbol is a complex, symmetrical design resembling a stylized snowflake or asterisk. The word "Hollister" is written in a bold, sans-serif font.

FEB - 4 2009

# 510(k) Summary

Submitted By:

Chris Stukel Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60018 847-680-1000

Date Summary Prepared:

October 23, 2008

Device Name:

Classification Name- Gastrointestinal tube and accessories

Common/Usual Name-Rectal Irrigation Tube

Proprietary Name-ActiFloTM Indwelling Catheter System Kit

Predicate Device:

The ActiFlo™ Indwelling Catheter System Kit is equivalent to the following devices:

| Product | 510(k) |
|----------------------------------------------------|---------|
| Indwelling Fecal Management<br>System- Non-Sterile | K023344 |
| Indwelling Fecal Management<br>System (IFMS) | K012113 |

Device Description:The ActiFlo Indwelling Bowel Catheter System consists of a rectal catheter and accessories (waste collection bag, irrigation bag, skin barriers, syringe and lubricating jelly). The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.

## Intended Use:

The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.

ActiFloTM Special 510(k) Submission Page 17 of 41

page 1 of 2

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#### Technological Characteristics:

:

# K083153

| FUNCTION | ActiFlo™ Indwelling Bowel<br>Catheter System Kit | Indwelling Fecal<br>Management System-<br>Non-Sterile (K023344) | Indwelling Fecal<br>Management System<br>(IFMS)<br>K012113 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The ActiFlo Indwelling Bowel<br>Catheter System is intended<br>for diversion of fecal matter to<br>minimize external contact with<br>the patient's skin, to facilitate<br>the collection of fecal matter<br>for patients requiring stool<br>management, to provide access<br>for colonic irrigation and to<br>administer enema/medications. | Diversion of fecal matter to<br>minimize external contact with<br>the patient, to facilitate the<br>collection of fecal matter for<br>patients requiring stool<br>management, and to provide<br>access for colonic irrigation to<br>trigger a defecatory response,<br>and administration of<br>enema/medications | Diversion of fecal matter to<br>minimize external contact with the<br>patient, to facilitate the collection<br>of fecal matter for patients<br>requiring stool management, and to<br>provide access for colonic<br>irrigation to trigger a defecatory<br>response, and administration of<br>enema/medications |
| Kit Contents | (1) ActiFlo Catheter (1) 60cc Syringe (2) 5g Packet Water Soluble<br>Lube (1) Drainable Collection Bag or<br>(2) Closed Collection Bags (2) Skin Barriers (1) Irrigation Bag (1) Instructions for Use | (1) IFMS Catheter (1) 60cc Syringe (1) 30cc Syringe (2) 5g Packet Water<br>Soluble Lube (1) Instructions for Use | (1) IFMS Catheter (1) 60cc Syringe (1) 30cc Syringe (2) 5g Packet Water Soluble<br>Lube (1) Instructions for Use |
| Bowel Retention | External Balloon | Same | Same |
| Bowel Irrigation | Silicone funnel that is cath-tip<br>syringe compatible; also comes with<br>removable barbed connector for<br>attachment to luer-tip syringe. | Silicone lumen with flared,<br>capped port termination | Silicone lumen with flared, capped<br>port termination |
| Port Access | Sampling / fluid administration<br>Intraluminal (ARV) balloon | Same | Same |
| Drainage Flow<br>Suspension | | | |
| Anti-Internal<br>Migration | External silicone retention faceplate<br>with 4 tape slots, 2 on each side | External silicone retention<br>faceplate w/anchor tabs | External silicone retention<br>faceplate w/anchor tabs |
| Flush / Stool<br>Sampling | Same | Mid-line silicone access port<br>compatible with catheter tip<br>syringe | Mid-line silicone access port<br>compatible with catheter tip<br>syringe |
| Enema /<br>Medication<br>Administration | Silicone funnel that is cath-tip<br>syringe compatible; also comes with<br>removable barbed connector for<br>attachment to luer-tip syringe. | Silicone lumen with flared,<br>capped port termination | Silicone lumen with flared, capped<br>port termination |
| Sterile | Non-Sterile | Non-Sterile | Sterile |

Accessory Performance Testing Conclusions:

Biocompatibility testing was performed on the additional accessories based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the added accessories for their intended clinical use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border. The text is in all caps and is evenly spaced around the circle.

FFB - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christine L. Stukel Sr. Global Regulatory Affairs Analyst Hollister, Inc. 2000 Hollister Drive LIBERTYVILLE IL 60048

Re: K083153

Trade/Device Name: ActiFio"" Indwelling Bowel Catheter System Kit Models 32004, -005, -006, and -007 Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 26, 2009 Received: January 29, 2009

Dear Ms. Stukel:

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 accordinan 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 teeen deternined 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., untinished) and further process (e.g., sterilize) you must submit a new 510(k) before including there 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 devir cean 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. Christine Stukel

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.dsmaldsmamain.html.

Sincerely vours.

. Haberlenn

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

# 510(k) Number (if known): _|< 08 3 | 5 3

Device Name: ActiFlo™ Indwelling Bowel Catheter System Kit

Indications for Use:

The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.

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 PAGE OF NEEDED)

Concurrence of CDRH, Offige of Device Evaluation (ODE)

Hules Stemer

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

ActiFlo™ Special 510(k) Submission Page 15 of 41