(175 days)
Not Found
No
The description focuses on mechanical components and functions, with no mention of AI/ML terms or capabilities.
No.
The device manages fecal matter and minimizes skin contact, which is a supportive function and not a direct therapeutic treatment for a disease or condition.
No
Explanation: The device is described as a "Stool Management System" intended for fecal management by diverting and collecting stool to minimize skin contact in bedridden patients. Its function is to manage and collect bodily waste, not to diagnose a medical condition.
No
The device description clearly outlines multiple hardware components including a catheter, collection bag, syringe, lubricating jelly, underpad, and biological odor eliminator.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Bard® DigniCare Stool Management System is a device that is inserted into the body (rectally) to manage and collect fecal matter. It is a physical device for containment and diversion, not for performing diagnostic tests on samples.
- Intended Use: The intended use clearly states "for fecal management by diverting and collecting liquid or semi-liquid stool." This is a therapeutic/management function, not a diagnostic one.
The device description and intended use clearly indicate it's a system for managing bodily waste, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / 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
Product codes
KNT
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-free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult Use Only
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional, biocompatibility and predicate device comparative testing have demonstrated that the subject device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
KO72594 ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
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
3
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.
4
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
5
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