INSTAFLO BOWEL CATHETER SYSTEM KIT

K123804 · Hollister, Inc. · KNT · Apr 17, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K123804
• Device Name: INSTAFLO BOWEL CATHETER SYSTEM KIT
• Applicant: Hollister, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Apr 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

Device Story

InstaFlo Bowel Catheter System Kit facilitates fecal management. Device consists of thermoplastic catheter with retention cuff and odor barrier film, and 2500 mL collection bag with filter. Clinician inserts catheter into rectum; retention cuff inflated via blue connector to secure position. Stool drains through tube into collection bag. Clear connector allows irrigation. Device diverts liquid/semi-liquid stool, reducing skin contact and odor. Used in clinical settings to manage fecal incontinence. Output is collection of fecal matter. Benefits include improved hygiene and odor control for patients with bowel control issues.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 and FDA G95-1. Odor barrier capabilities verified via comparative testing. Mechanical integrity of connections and joints (bond strength, leakage) verified through bench testing.

Technological Characteristics

Thermoplastic catheter with odor barrier film; 2500 mL collection bag with filter. Retention cuff inflated via blue connector; irrigation via clear connector. Biocompatibility per ISO 10993. Single-use. No software or electronic components.

Indications for Use

Indicated for patients with little or no bowel control requiring diversion and collection of liquid or semi-liquid stool.

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

• InstaFlo Bowel Catheter System Kit (K100273)

Submission Summary (Full Text)

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APR 1 7 2013

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# 510(k) Summary

510(k) Owner: Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048' Submitted By: Chris Stukel Hollister Incorporated 2000 Hollister Drive Libertyville. IL 60048 847-680-1000 (phone) 847-847-918-3981.

Date Summary Prepared:

December, 7, 2012

Device Name:

Classification Name - Gastrointestinal tube and accessories 21 CFR 876.5980-KNT Common/Usual Name - Rectal Catheter Proprietary Name - InstaFlo Bowel Catheter System Kit

Predicate Device:

Modifications are being made to the following predicate device:

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Device Description:

The InstaFio Bowel Catheter System Kit contains two main parts: the catheter (made with odor barrier film) and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.

Intended Use:

A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

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InstaFlo (Odor Barrier Tube) Traditional 510(k) Submission

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K123804
PG. 2 of 2

Technological Characteristics:

The table below summarizes the technological characteristics of the device as compared to the predicate devices.

| Characteristics | InstaFlo Bowel Catheter System Kit<br>(K100273) | InstaFlo Bowel Catheter System Kit<br>MODIFIED DEVICE |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For diversion of liquid or<br>semi-liquid stool to facilitate the<br>collection of fecal matter in patients<br>with little or no bowel control. | A bowel catheter system kit with odor<br>barrier properties for diversion of liquid<br>or semi-liquid stool to facilitate the<br>collection of fecal matter in patients<br>with little or no bowel control. |
| Condition of<br>Use | Single Use | |
| Kit Contents | (1) Catheter (1) 60cc Syringe (1) Collection Bag (1) Instructions for Use (1) Quick Reference Insertion Guide | (1) Odor Barrier Catheter (1) 60cc Syringe (1) Disposable Collection Bag with Filter (1) Instructions for Use (1) Quick Reference Insertion Guide |
| Catheter<br>Material | Silicone | Thermoplastic |
| Catheter Odor<br>Barrier<br>Properties | No | Yes |
| Closed Waste<br>Bag | Approximate Volume- 2000 mL<br>Side catheter connector port<br>No Filter | Approximate Volume- 2500 mL<br>Top catheter connector-port<br>Filter |

Performance Testing Conclusions:

Non-clinical testing of the proposed device for functional and structural parameters has been completed.

Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard.

Odor testing was performed compared to the predicate to verify the odor barrier capabilities which the test results confirmed.

Connections and joints affected by the change in tubing were tested for bond strength and leakage to verify no impact to product design. Acceptable results were obtained, thereby demonstrating substantial equivalence.

In conclusion, based on the above information, the proposed device has been shown to be as safe and effective and substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### April 17, 2013

Hollister Incorporated % Ms. Chris Stukel Sr. Global Regulatory Affairs Specialist 2000 Hollister Drive LIBERTYVILLE, IL 60048

Re: K123804

Trade/Device Name: InstaFlo Bowel Catheter System Kit Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 5, 2013 Received: April 10, 2013

Dear Ms. Stukel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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.

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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 (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.

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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The letters "DA" are stylized with a geometric design, appearing to be interwoven with the rest of the name. The text is horizontally oriented and appears to be a signature or title.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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## Indications for Use

510(k) Number (if known): K123804

Device Name: InstaFlo Bowel Catheter System Kit

Indications for Use:

A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

Prescription Use ਮ (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, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.04.17 13:46:20 -04'00'

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(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123804 510(k) Number _

InstaFlo (Odor Barrier Tube) Traditional 510(k) Submission