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
Therapeutic, 3rd-Party Reviewed
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.
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.
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)
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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: 770-385-4706<br>E-mail: scott.pease@crbard.com | |
| 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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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the left, and its wings are spread upwards and outwards. The text is in all capital letters and is evenly spaced around the circle.
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 (800) 638-2041 or (301) 796-7100 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)
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
