(199 days)
Not Found
No
The device description and performance studies focus on the physical components and their function in managing stool, with no mention of AI or ML technologies.
No
The device is described as a stool management system intended to collect and divert fecal matter to minimize skin contact. While it manages a bodily function, its primary purpose is not to cure, mitigate, treat, or prevent a disease, but rather to manage waste in bedridden patients.
No
The device is intended for fecal management by diverting and collecting stool and for administration of medications, not for diagnosis.
No
The device description clearly outlines physical components such as a catheter, collection bag, syringe, lubricating jelly, and odor eliminator, all made from various materials like silicone and TPE. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Bard® DigniShield® Stool Management System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a system for managing fecal matter within the body (diverting and collecting stool from the rectum). IVD devices are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The description details a physical system with a catheter, collection bag, and related components designed for insertion into the body. This is consistent with a medical device used for physical management, not for diagnostic testing of samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze or test the collected stool for diagnostic purposes. Its function is purely for containment and management.
Therefore, the Bard® DigniShield® Stool Management System falls under the category of a medical device used for patient care and management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KNT
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 mater. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal
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)
The subject device has met biocompatibility testing of the requirements for a medical device contacting device with prolonged exposure and limited exposure.
The subject device has been shown to be as safe and effective and substantially equivalent to the legally marketed, predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102391, K073598, K112342, K123804
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.
0
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, RAC
Regulatory Affairs Project Manager
Bard 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
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
K133251 Page 1 of 3
1
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 Stool
Management System | Bard DigniShield Stool
Management System | Bard DigniCare Stool
Management System | Flexi-Seal Signal Fecal
Management System | Hollister InstaFlo Bowel
Catheter System Kit |
| Intended Use | Fecal management | Fecal management | Fecal management | Fecal management | Fecal management |
| Indications for Use | 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. | 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. | 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. | For use to manage fecal
incontinence through
the collection of liquid
to semi-liquid stool and
to provide access to
administer medications | A bowel catheter
system kit with odor
barrier properties for
diversion of liquid or
semi-liquid stool to
facilitate the collection
of fecal matter in
patients with little or no
bowel control. |
| Characteristic | Subject Device | Predicate Device
(K102391) | Predicate Device
(K073598) | Predicate Device
(K112342) | Predicate Device
(K123804) |
| Name | Bard DigniShield Stool
Management System | Bard DigniShield Stool
Management System | Bard DigniCare Stool
Management System | Flexi-Seal Signal Fecal
Management System | Hollister InstaFlo Bowel
Catheter 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 | Thermoplastic
Elastomer and Silicone | Thermoplastic
Elastomer | Silicone | Silicone | Thermoplastic |
| Accessories | Collection Bag
Syringe
Lubricating Jelly
Odor Eliminator
Tube Clamp | Collection Bag
Syringe
Lubricating Jelly
Odor Eliminator | Collection Bag
Syringe
Lubricating Jelly
Odor Eliminator | Collection Bag (3)
Syringe
Cinch Clamp | Collection Bag
Syringe |
5 - 2
2
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
3
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.
4
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
5
Indications for Use
Traditional 510(k) | DigniShield Stool Management System
Section 4
Indications for Use Statement .
510(k) Number:
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