BARD DIGNICARE STOOL MANAGEMENT SYSTEM

K073598 · C.R. Bard, Inc. · KNT · Jun 13, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073598
• Device Name: BARD DIGNICARE STOOL MANAGEMENT SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jun 13, 2008
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® DigniCare Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adult Use Only

Device Story

The Bard DigniCare Stool Management System is a single-use, latex-free rectal catheter system designed for fecal management in bedridden adult patients. The device consists of a retention cuff, a trans-sphincteric zone, and a drainage tube connected to a collection bag. The system includes a syringe, lubricating jelly, an underpad, and a biological odor eliminator. The catheter is inserted rectally to divert liquid or semi-liquid stool away from the patient, minimizing skin contact. When the catheter is disengaged from the collection bag, it automatically closes to prevent leakage; a plug is provided for the collection bag to contain fecal matter. The device is intended for use in clinical settings by healthcare providers to manage fecal output and protect patient skin integrity.

Clinical Evidence

No clinical data. Substantial equivalence is supported by functional, biocompatibility, and predicate device comparative bench testing.

Technological Characteristics

Single-use, latex-free rectal catheter system. Components include retention cuff, trans-sphincteric zone, drainage tube, collection bag, syringe, lubricant, underpad, and odor eliminator. Mechanical operation; no energy source or software.

Indications for Use

Indicated for fecal management in bedridden adult patients to divert and collect liquid or semi-liquid stool and minimize skin contact.

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

• Convatec Fecal Management System (K032734)
• Indwelling Fecal Management System (K023344)

Submission Summary (Full Text)

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Ko73598

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C.R. Bard, Inc. Bard® DigniCare Stool Management System Traditional 510(k) Submission

#### 510(k) Summary of Safety and Effectiveness 5.0

### Product:

# JUN 1 3 2008

Submitter's Information:

Michelle Gudith Director, Regulatory Affairs Bard Medical Division C.R. Bard Inc. 8195 Industrial Blvd. Covington, Georgia 30014 USA Phone [phone], Fax [phone] E-mail michelle.gudith(@crbard.com

December 12, 2007 Date Prepared:

Name of Device and Name/Address of Sponsor:

Bard® DigniCare Stool Management System

C.R. Bard Inc. Bard Medical Division 8195 Industrial Blvd. Covington, Georgia 30014 USA Phone [phone], Fax [phone]

#### COMMON OR USUAL NAMES

Rectal catheter

#### CLASSIFICATION NAME

Gastrointestinal tube and accessories

#### PREDICATE DEVICES

K032734 Convatec Fecal Management System

K023344 Indwelling Fecal Management System

C.R. Bard, Inc.

5-2

Confidential

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# INTENDED USE AND INDICATIONS FOR USE

The Bard® DigniCare Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adult Use Only

#### TECHNOLOGICAL CHARACTERISTICS

The device is composed of a catheter which consists of a retention cuff, a trans-sphincteric zone and a drainage tube. In addition, the system contains a collection bag, a syringe, lubricating jelly, an underpad and a biological odor eliminator.

The catheter is connected to a collection bag. When the catheter is disengaged from the bag, the catheter automatically closes to prevent leakage. A plug is placed on the collection bag to contain the fecal matter within the bag.

The device is single-use and latex-frec

#### PERFORMANCE DATA

Functional, biocompatibility and predicate device comparative testing have demonstrated that the subject device is as safe and effective as the predicate devices.

C.R. Bard, Inc.

Confidential

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# SUBSTANTIAL EQUIVALENCE

The Bard® DigniCare Stool Management System is as safe and effective as the predicate devices with the same intended use, similar indications, technological characteristics, and principles of operation. The technological differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. Therefore, the

Bard® DigniCare Stool Management System is substantially cquivalent to currently marketed fecal management systems.

C.R. Bard, Inc.

Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 3 2008

Ms. Michelle Gudith Director, Regulatory Affairs Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014

Re: K073598

Trade/Device Name: Bard DigniCare Stool Management System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 14, 2008 Received: April 15, 2008

Dear Ms. Gudith:

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. Gudith

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.dsma/dsmamain.html.

Sincerely yours,

Herbert Lemmer

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

Enclosure

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# KO 73598

C.R. Bard, Inc. Bard® DigniCare Stool Management System Traditional 510(k) Submission

Indications for Use Statement

510(k) Number (if known): K072598

Device Name: Bard® DigniCare Stool Management System

Indications for Use: The Bard® DigniCare Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients.

Adult Use Only

Prescription Use: __ X

AND/OR

Over-the-Counter Use:

(21 CFR 801 Subpart D)

(21 CFR. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K073598