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

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 matter. Additionally, the kit includes a syringe, lubricating jelly and odor eliminator. The tube clamp is used to retain medication during administration and the syringe is used to facilitate inflation of the catheter cuff.

AI/ML Overview

The provided text describes the Bard® DigniShield® Stool Management System. This is a medical device, and the submission is a Traditional 510(k) for premarket notification, indicating it is a Class II device. The document focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a novel performance claim through a clinical study. Therefore, the information requested for acceptance criteria, device performance, and study details like sample size, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or provided in this type of submission.

The section titled "Summary of Performance (Nonclinical)" states that "The subject device as substantially equivalent to the predicate device for all functions and relevant testing for performance testing and biocompatibility has been performed." This implies that the device was evaluated against established standards or predicate device performance, but specific quantitative acceptance criteria and detailed study results are not elaborated in the summary.

Here's a breakdown of the available information in relation to your request:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics in this summary. The submission aims to demonstrate substantial equivalence to predicate devices, meaning it must meet the same safety and effectiveness profiles. This would typically involve non-clinical performance testing (e.g., fluid dynamics, strength, material compatibility) and biocompatibility, but specific numerical targets are not provided here.
- Reported Device Performance: The summary states that "The subject device as substantially equivalent to the predicate device for all functions and relevant testing for performance testing and biocompatibility has been performed." This indicates successful performance against relevant benchmarks, but specific data points or results are not included in this document.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This 510(k) summary does not describe a clinical study with a test set of patient data. The evaluation would have been based on non-clinical (benchtop) testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided, as there is no clinical test set requiring expert ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This device is a stool management system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. The "ground truth" for this device would relate to engineering specifications, material properties, and functionality standards, not clinical outcomes in the context of expert diagnosis or pathology.
The sample size for the training set
- Not applicable/Not provided, as this is not an AI/machine learning device.
How the ground truth for the training set was established
- Not applicable/Not provided.

In summary, this 510(k) submission is for a physical medical device (stool management system) and relies on demonstrating substantial equivalence through non-clinical performance and biocompatibility testing, rather than clinical studies requiring patient data, expert review, or AI model training/testing. Therefore, most of the detailed information requested regarding clinical study design and performance metrics is not found in this type of regulatory document.

Summary

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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, RACRegulatory Affairs Project ManagerBard 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

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(K102391)	Predicate Device(K073598)	Predicate Device(K112342)	Predicate Device(K123804)
Name	Bard DigniShield StoolManagement System	Bard DigniShield StoolManagement System	Bard DigniCare StoolManagement System	Flexi-Seal Signal FecalManagement System	Hollister InstaFlo BowelCatheter System Kit
Intended Use	Fecal management	Fecal management	Fecal management	Fecal management	Fecal management
Indications for Use	Bard DigniShield StoolManagement Systemwith odor barrierproperties is intendedfor fecal managementby diverting andcollecting liquid orsemi-liquid stool tominimize skin contact inbedridden patients andto provide access forthe administration ofmedications. Adult useonly.	Bard DigniShield StoolManagement System isintended for fecalmanagement bydiverting and collectingliquid or semi-liquidstool to minimize skincontact in bedriddenpatients. Adult useonly.	Bard DigniShield StoolManagement System isintended for fecalmanagement bydiverting and collectingliquid or semi-liquidstool to minimize skincontact in bedriddenpatients. Adult useonly.	For use to manage fecalincontinence throughthe collection of liquidto semi-liquid stool andto provide access toadminister medications	A bowel cathetersystem kit with odorbarrier properties fordiversion of liquid orsemi-liquid stool tofacilitate the collectionof fecal matter inpatients with little or nobowel control.
Characteristic	Subject Device	Predicate Device(K102391)	Predicate Device(K073598)	Predicate Device(K112342)	Predicate Device(K123804)
Name	Bard DigniShield StoolManagement System	Bard DigniShield StoolManagement System	Bard DigniCare StoolManagement System	Flexi-Seal Signal FecalManagement System	Hollister InstaFlo BowelCatheter 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	ThermoplasticElastomer and Silicone	ThermoplasticElastomer	Silicone	Silicone	Thermoplastic
Accessories	Collection BagSyringeLubricating JellyOdor EliminatorTube Clamp	Collection BagSyringeLubricating JellyOdor Eliminator	Collection BagSyringeLubricating JellyOdor Eliminator	Collection Bag (3)SyringeCinch Clamp	Collection BagSyringe

5 - 2

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.