BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM

K133251 · C.R. Bard, Inc. · KNT · May 9, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133251
• Device Name: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: May 9, 2014
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® DigniShield® Stool Management System with odor barrier properties is intended for fecal management by diverting and collecting liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications. Adult use only.

Device Story

DigniShield Stool Management System is a rectal catheter kit for fecal diversion in bedridden adult patients. The device consists of a silicone retention cuff and trans-sphincteric zone, TPE drainage tubing, and a collection bag. It is used in clinical settings to manage liquid or semi-liquid stool, thereby minimizing skin contact and facilitating medication administration. The system includes accessories such as a syringe, lubricating jelly, odor eliminator, and tube clamp. The device is inserted by a clinician to provide a closed system for fecal collection, which helps maintain hygiene and skin integrity for patients with limited bowel control. It is intended for short-term use (up to 29 days).

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including performance testing and biocompatibility testing for prolonged exposure.

Technological Characteristics

Catheter constructed from silicone (retention cuff, trans-sphincteric zone) and TPE (drainage tubing). Includes collection bag, syringe, lubricating jelly, odor eliminator, and tube clamp. Designed for 29-day usage. Features odor barrier properties and medication delivery port. Sterile and non-sterile components.

Indications for Use

Indicated for fecal management in bedridden adult patients to divert/collect liquid or semi-liquid stool, minimize skin contact, and provide access for medication administration.

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® DigniShield® Stool Management System (K102391)
• Bard® DigniCare Stool Management System (K073598)
• ConvaTec Flexi-Seal® Signal™ Fecal Management System (K112342)
• Hollister InstaFlo Bowel Catheter System Kit (K123804)

Submission Summary (Full Text)

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**MAY 09 2014**

Traditional 510(k) | DigniShield Stool Management System

Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

# AIRD MEDICAL

## 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the DigniShield Stool Management System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:

BARD Medical Division C. R. BARD, Inc. 8195 Industrial Blvd. Covington, GA 30014 Establishment Registration Number: 1018233

| Contact: | Michele Davis, RAC<br>Regulatory Affairs Project Manager<br>Bard Medical Division |
|----------------------|-----------------------------------------------------------------------------------|
| Tel: | 770-784-6274 |
| Fax: | 770-385-4706 |
| Date: | May 8, 2014 |
| Subject Device: | |
| Trade Name: | Bard® DigniShield® Stool Management System |
| Common Name: | Rectal catheter |
| Classification Name: | Gastrointestinal tube and accessories |
| Regulation: | 21 CFR 876.5980 |
| Classification: | Class II |
| Product Code: | KNT |

Legally marketed devices to which substantial equivalence is claimed:

- Bard® DigniShield® Stool Management System, K102391 .
- Bard® DigniCare Stool Management System, K073598 .
- ConvaTec Flexi-Seal® Signal™ Fecal Management System, K112342 .
- Hollister InstaFlo Bowel Catheter System Kit, K123804 .

### Device Description

The Bard® DigniShield® Stool Management System is sold as a tray (kit) including a catheter, collection bag and stand alone components. The catheter consists of a retention cuff, transsphincteric zone, drainage tubing, inflation arm, irrigation arm, flush arm and piston valve connector. The retention cuff and trans-sphincteric zone are constructed from silicone and the drainage tubing is constructed from a Thermoplastic Elastomer (TPE) material. The system includes a collection bag which is manufactured from the same TPE material as the drainage tubing. The collection bag interfaces with the catheter and allows for the collection of fecal

K133251 Page 1 of 3

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10(k) Summar

K133251
Page 2 of

ditional 510(k) | DigniShield Stool Management

nater. Additionally, the your, syning, whiching jelly and odrimiator. The tue clam is use to retain
nelication during annes is ne spinge is used to facilitate of the caller

ntended Use
The Bard" Dienthied Stool Management System with odor barrier properties is intended for the and cline on collecting and collecting and collections.
Adult use onl

ummary of Technological Characteristics
he table below summarizes the technological characteristics of the device as compared to the predicate dev

| Characteristic | Subject Device | Predicate Device<br>(K102391) | Predicate Device<br>(K073598) | Predicate Device<br>(K112342) | Predicate Device<br>(K123804) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Bard DigniShield Stool<br>Management System | Bard DigniShield Stool<br>Management System | Bard DigniCare Stool<br>Management System | Flexi-Seal Signal Fecal<br>Management System | Hollister InstaFlo Bowel<br>Catheter System Kit |
| Intended Use | Fecal management | Fecal management | Fecal management | Fecal management | Fecal management |
| Indications for Use | Bard DigniShield Stool<br>Management System<br>with odor barrier<br>properties is intended<br>for fecal management<br>by diverting and<br>collecting liquid or<br>semi-liquid stool to<br>minimize skin contact in<br>bedridden patients and<br>to provide access for<br>the administration of<br>medications. Adult use<br>only. | Bard DigniShield Stool<br>Management System is<br>intended for fecal<br>management by<br>diverting and collecting<br>liquid or semi-liquid<br>stool to minimize skin<br>contact in bedridden<br>patients. Adult use<br>only. | Bard DigniShield Stool<br>Management System is<br>intended for fecal<br>management by<br>diverting and collecting<br>liquid or semi-liquid<br>stool to minimize skin<br>contact in bedridden<br>patients. Adult use<br>only. | For use to manage fecal<br>incontinence through<br>the collection of liquid<br>to semi-liquid stool and<br>to provide access to<br>administer medications | A bowel catheter<br>system kit with odor<br>barrier properties for<br>diversion of liquid or<br>semi-liquid stool to<br>facilitate the collection<br>of fecal matter in<br>patients with little or no<br>bowel control. |
| Characteristic | Subject Device | Predicate Device<br>(K102391) | Predicate Device<br>(K073598) | Predicate Device<br>(K112342) | Predicate Device<br>(K123804) |
| Name | Bard DigniShield Stool<br>Management System | Bard DigniShield Stool<br>Management System | Bard DigniCare Stool<br>Management System | Flexi-Seal Signal Fecal<br>Management System | Hollister InstaFlo Bowel<br>Catheter System Kit |
| Device use, Sterility | Sterile Use, Non Sterile, | Sterile Use, Non Sterile, | Sterile Use, Non Sterile, | Sterile Use, Non Sterile, | Sterile Use, Non Sterile, |
| Max Usage of Device | 29 days | 29 days | 29 days | 29 days | 29 days |
| Odor Barrier Properties | Yes | No | No | No | Yes |
| Medication Delivery | Yes | No | No | Yes | No |
| Catheter Material | Thermoplastic<br>Elastomer and Silicone | Thermoplastic<br>Elastomer | Silicone | Silicone | Thermoplastic |
| Accessories | Collection Bag<br>Syringe<br>Lubricating Jelly<br>Odor Eliminator<br>Tube Clamp | Collection Bag<br>Syringe<br>Lubricating Jelly<br>Odor Eliminator | Collection Bag<br>Syringe<br>Lubricating Jelly<br>Odor Eliminator | Collection Bag (3)<br>Syringe<br>Cinch Clamp | Collection Bag<br>Syringe |

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l0(k) Summa

tional 510(k) | DigniShield Stool Management

sumary of Performance (Nonction) characteristic has ben performed. The sipet devies as sbtan
equiral to the suice for for times in and trent testing berhind performance tes

ocomptiblity testing of the requirements for a maces contacting device with prologed exposure an
bject device tam met to requirements on and cince with imited exposure and tr

subject device has been shown to be as safe and effective and substantially equivalent to the legally marketed, predicate

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three curved lines representing the wings or body. The logo is black and white.

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

May 9, 2014

C.R. Bard, Inc. Michele Davis Regulatory Affairs Project Manager 8195 Industrial Blvd. Covington, GA 30014

Rc: K133251

> Trade/Device Name: DigniShield Stool Management System Regulation Number: 21 CFR\$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: April 4. 2014 Received: April 7. 2014

Dear Michele Davis.

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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. However, vou are responsible to determine that the medical devices you use as components in the kit have cither 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.. unlinished) 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, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract fiability 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.

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### Page 2 - Michele Davis

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdagov/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,

# Joyce M. Whang -S

for 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

Traditional 510(k) | DigniShield Stool Management System

## Section 4

# Indications for Use Statement .

510(k) Number:

K133251

DigniShield Stool Management System Device Name:

## INDICATIONS FOR USE:

The Bard® DigniShield® Stool Management System with odor barrier properties is intended for fecal management by diverting and collecting liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications.

Adult use only.

Prescription Use X (Part 21 CFR 801, Subpart D) and/or

Over-the-Counter Use (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)

Joyce M. Whang -S

Confidential

Section 4