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 Description

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

AI/ML Overview

The provided text describes a 510(k) submission for the Bard® DigniCare Stool Management System. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing separate acceptance criteria and proving performance through a distinct study.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The submission does not outline specific, quantitative acceptance criteria for the Bard® DigniCare Stool Management System in terms of performance metrics (e.g., success rate, leakage rate, etc.). Instead, the performance data provided focuses on demonstrating substantial equivalence to existing predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Summary from Document)
Substantial Equivalence to Predicate Devices	Functional, biocompatibility, and predicate device comparative testing have demonstrated that the subject device is as safe and effective as the predicate devices. The technological differences between the subject device and its predicate devices raise no new issues of safety or effectiveness. The device is substantially equivalent to currently marketed fecal management systems.

Study Details

The document states that a study was conducted, but it's not a traditional clinical performance study with predefined acceptance criteria that are numerically reported. Instead, it's a comparative effectiveness assessment against predicate devices to establish substantial equivalence.

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set or any clinical study.
- It does not specify the country of origin of the data or whether it was retrospective or prospective. The term "predicate device comparative testing" suggests a comparison, but details are absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided in the document. The study described is not one that would typically involve expert-established ground truth in this manner (e.g., image interpretation).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided in the document.
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:
- This information is not applicable and not provided in the document. The device is a physical medical device (stool management system), not an AI imaging or diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided in the document. The device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document indicates that "functional, biocompatibility and predicate device comparative testing" was performed. This implies engineering and laboratory testing, and potentially some form of clinical comparison to predicate devices, but the specific "ground truth" (e.g., patient outcomes, pathology) for these tests is not detailed. The goal was to show similarity to existing devices, so the ground truth would inherently be derived from the performance profiles of the predicate devices.
The sample size for the training set:
- This information is not applicable and not provided. The device is not an AI/ML device that requires a "training set."
How the ground truth for the training set was established:
- This information is not applicable and not provided.

Summary

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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 (770) 784-6722, Fax (770) 385-4768 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 (770) 784-6722, Fax (770) 385-4768

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 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150, 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

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.