BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

K102391 · C.R. Bard, Inc. · KNT · Dec 22, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102391
• Device Name: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 22, 2010
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BARD® DigniShield™ Stool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients.

Device Story

The BARD® DigniShield™ Stool Management System is a single-use, non-sterile rectal catheter kit used for fecal management in bedridden adult patients. The system consists of a retention cuff, a trans-sphincteric zone, and a drainage tube, all constructed from Styrenic-based Thermoplastic Elastomer (TPE). A collection bag, also made of TPE, interfaces with the catheter to collect fecal matter. The kit includes a syringe for inflating the retention cuff and lubricating jelly to facilitate insertion into the rectal vault. The device features self-sealing mechanisms on both the catheter and the collection bag that engage when disconnected to minimize leakage. The system is operated by healthcare providers in clinical settings to divert liquid or semi-liquid stool, thereby protecting the patient's skin from contact with fecal matter.

Clinical Evidence

Bench testing only. Functional and structural integrity testing (tensile strength, dimensional, cuff inflation) and biocompatibility testing in accordance with ISO 10993 were performed to demonstrate safety and substantial equivalence.

Technological Characteristics

Materials: Styrenic-based Thermoplastic Elastomer (TPE). Components: Retention cuff, trans-sphincteric zone, drainage tube, collection bag, syringe, lubricating jelly. Principle: Indwelling rectal catheter with inflatable cuff for fecal diversion. Connectivity: None. Sterilization: Non-sterile. Software: None.

Indications for Use

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

• BARD® DigniCare™ Stool Management System (K073598)
• ActiFlo™ Indwelling Catheter System Kit (K083153)

Submission Summary (Full Text)

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K102391
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BARD® DigniShield™ Stool Management System Traditional 510(k) Submission

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

DEC 2 2 2010

The following information is provided as required by 21 CFR § 807.87 for the BARD® DigniShield™ Stool Management System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| Sponsor: | BARD Medical Division<br>C. R. Bard, Inc.<br>8195 Industrial Blvd.<br>Covington, Georgia 30014 | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact: | Scott Pease<br>BARD Medical Division<br>C. R. Bard, Inc.<br>8195 Industrial Blvd.<br>Covington, Georgia 30014<br>Ph: 770-784-6774<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Date of Submission: | August 18, 2010 | |
| Proprietary Name: | BARD® DigniShield™ Stool Management System | |
| Common Name: | Rectal catheter | |
| Regulation: | 21 CFR § 876.5980 | |
| Regulatory Class: | II | |
| Product Code: | 78 KNT - Gastrointestinal tube and accessories | |
| Predicate Device(s): | | |
| BARD® DigniCare™ Stool<br>Management System | C. R. Bard, Inc. | K073598 |
| ActiFlo™ Indwelling Catheter<br>System Kit | Hollister Inc. | K083153 |

Device Description: The BARD® DigniShield™ Stool Management System is sold as a tray (kit). The catheter portion of the system consists of a retention cuff, a trans-

C.R. Bard, Inc.

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sphincteric zone and a drainage tube which are constructed from a Styrenic-based Thermoplastic Elastomer (TPE) material. The system includes a collection bag which is also manufactured from the same TPE material. Additionally, the tray (kit) contains stand alone finished components, a syringe, lubricating jelly, and an odor eliminator. The collection bag interfaces with the catheter and allows for the collection of the fecal matter. The syringe is used to facilitate the inflation of the retention cuff portion of the catheter. The lubricating jelly is provided to minimize patient discomfort and irritation of the rectum while the device is being inserted into the rectal vault.

The catheter is connected to a collection bag. When the catheter is disconnected from the collection bag, the self-sealing mechanisms of both the catheter and collection bag are engaged. This minimizes the leakage of fecal matter from either the catheter or the collection bag.

The device is single-use, non-sterile, and has no components made of natural rubber latex.

Intended Use: The BARD® DigniShield™ 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 Summary: The subject BARD® DigniShield™ Stool Management System has the same intended use, similar indications, technological characteristics, and principles of operation as the predicate devices. The only technological difference between the subject device and the DigniCare™ predicate device is that the catheter and collection bag material composition of the subject device is TPE and the predicate device catheter is silicone with a low density polyethylene collection bag. The use of the TPE material does not raise any new issues of safety or effectiveness. Therefore, the BARD® DigniShield™ Stool Management System is substantially equivalent to currently marketed fecal management systems.

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BARD® DigniShield™ Stool Management System Traditional 510(k) Submission

Performance Data Summary: Functional and structural integrity testing characteristic of devices of this type (e.g., tensile strength, dimensional, cuff inflation, etc.,}, including biocompatibility testing in accordance with ISO 10993 has been performed on the subject device demonstrating that it is as safe and effective, and is substantial equivalent to legally marketed predicate device(s).

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

C. R. Bard, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, N.W. BUFFALO MN 55313

FEB - 9 2011

Re: K102391

Trade/Device Name: BARD® DigniShield™ Stool Management System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: December 9, 2010 Received: December 10, 2010

Dear Mr. Job:

This letter corrects our substantially equivalent letter of December 22, 2010.

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 (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 (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.

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. You must

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Page 2 - Mr. Mark Job

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.html 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Velasquez

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BARD® DigniShield™ Stool Management System Traditional 510(k) Submission

## Indications for Use Statement

510(k) Number (if known): K102391

DEC 2 2 2010

Device Name: BARD® DigniShield™ Stool Management System

Indications for Use: The BARD® DigniShield™ 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 (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

The Lto

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

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C.R. Bard, Inc.