(121 days)
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.
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-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.
Here's an analysis of the provided text regarding the BARD® DigniShield™ Stool Management System, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria (e.g., a certain percentage of successful insertions, a specific rate of leakage reduction) are not explicitly stated. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through functional and structural integrity testing.
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Functional and Structural Integrity | "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)." |
| Material Compatibility (Biocompatibility) | Biocompatibility testing performed in accordance with ISO 10993. |
| Equivalent Safety and Effectiveness to Predicate Devices | The device "is as safe and effective, and is substantial equivalent to legally marketed predicate device(s)." The only technological difference (TPE material vs. silicone/LPDE) "does not raise any new issues of safety or effectiveness." |
| Intended Use Compatibility | "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." The device is deemed substantially equivalent for this intended use. |
| Minimization of Fecal Leakage (during disconnection) | "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." (This is a design feature claimed, but not explicitly measured with performance criteria in the provided text). |
| Patient Comfort/Irritation (during insertion) | "The lubricating jelly is provided to minimize patient discomfort and irritation of the rectum while the device is being inserted into the rectal vault." (A design provision, not a measured performance metric in the text). |
Summary of Study Information:
The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial with specific performance endpoints. Therefore, many of the requested details about a clinical study are not present in this submission.
2. Sample Size Used for the Test Set and Data Provenance
The document only states that "Functional and structural integrity testing... has been performed." It does not specify:
- The sample size of devices used for this testing.
- The data provenance (e.g., country of origin, retrospective or prospective). This testing appears to be bench testing or in-vitro performance evaluation, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The study described is functional and structural integrity testing (bench testing, biocompatibility), not a clinical study requiring expert assessment of patient data.
4. Adjudication Method for the Test Set
Not applicable. There's no indication of a clinical test set or subjective assessments that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of a multi-reader multi-case comparative effectiveness study or human readers improving with or without AI assistance. This device is a physical medical device, not an AI software.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
For the functional and structural integrity testing, the "ground truth" would be established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the ISO 10993 standards for biological evaluation of medical devices.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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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 DivisionC. R. Bard, Inc.8195 Industrial Blvd.Covington, Georgia 30014 | |
|---|---|---|
| Contact: | Scott PeaseBARD Medical DivisionC. R. Bard, Inc.8195 Industrial Blvd.Covington, Georgia 30014Ph: 770-784-6774Fax: 770-385-4706E-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™ StoolManagement System | C. R. Bard, Inc. | K073598 |
| ActiFlo™ Indwelling CatheterSystem 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.
§ 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.