(103 days)
Not Found
No
The device description and performance studies focus on the mechanical and material aspects of a bowel catheter system, with no mention of AI or ML capabilities.
Yes
Explanation: The device is intended for the diversion and collection of fecal matter, colonic irrigation, and administration of enemas/medications. These functions address a medical condition by managing symptoms or providing a therapeutic intervention, aligning with the definition of a therapeutic device.
No
Explanation: The device is intended for the diversion and collection of fecal matter, colonic irrigation, and medication administration. These are therapeutic and management functions, not diagnostic ones.
No
The device description clearly outlines physical components like a rectal catheter, retention cuff, intraluminal balloon, and accessories (waste collection bag, irrigation bag, etc.), indicating it is a hardware-based medical device.
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).
- ActiFlo Function: The ActiFlo Indwelling Bowel Catheter System is designed to manage fecal matter within the body (specifically, the rectum) and collect it externally. It's a device for managing a bodily function and collecting waste, not for performing diagnostic tests on samples.
- Intended Use: The intended use clearly states its purpose is for diversion, collection, irrigation, and medication administration related to fecal matter management. None of these activities are diagnostic testing.
- Device Description: The description details a catheter system for managing waste flow, not for analyzing biological samples.
Therefore, based on the provided information, the ActiFlo Indwelling Bowel Catheter System is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The ActiFlo Indwelling Bowel Catheter System consists of a rectal catheter and accessories (waste collection bag, irrigation bag, skin barriers, syringe and lubricating jelly). The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectum
Indicated Patient Age Range
Not Found
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)
Biocompatibility testing was performed on the additional accessories based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the added accessories for their intended clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the Hollister logo. The logo consists of a stylized, geometric symbol to the left of the word "Hollister". The symbol is a complex, symmetrical design resembling a stylized snowflake or asterisk. The word "Hollister" is written in a bold, sans-serif font.
FEB - 4 2009
510(k) Summary
Submitted By:
Chris Stukel Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60018 847-680-1000
Date Summary Prepared:
October 23, 2008
Device Name:
Classification Name- Gastrointestinal tube and accessories
Common/Usual Name-Rectal Irrigation Tube
Proprietary Name-ActiFloTM Indwelling Catheter System Kit
Predicate Device:
The ActiFlo™ Indwelling Catheter System Kit is equivalent to the following devices:
| Product | 510(k) |
|---|---|
| Indwelling Fecal Management | |
| System- Non-Sterile | K023344 |
| Indwelling Fecal Management | |
| System (IFMS) | K012113 |
Device Description:The ActiFlo Indwelling Bowel Catheter System consists of a rectal catheter and accessories (waste collection bag, irrigation bag, skin barriers, syringe and lubricating jelly). The insertion end of the catheter contains a retention cuff and an intraluminal balloon, each with its own Luer connector used for inflation and deflation. A third connector provides a way to administer medications into the rectum and provides access for colonic irrigation. The ActiFlo Indwelling Bowel Catheter System allows stool to drain directly from the rectum into a closed or drainable collection bag.
Intended Use:
The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.
ActiFloTM Special 510(k) Submission Page 17 of 41
page 1 of 2
1
Technological Characteristics:
:
K083153
| FUNCTION | ActiFlo™ Indwelling Bowel
Catheter System Kit | Indwelling Fecal
Management System-
Non-Sterile (K023344) | Indwelling Fecal
Management System
(IFMS)
K012113 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The ActiFlo Indwelling Bowel
Catheter System is intended
for diversion of fecal matter to
minimize external contact with
the patient's skin, to facilitate
the collection of fecal matter
for patients requiring stool
management, to provide access
for colonic irrigation and to
administer enema/medications. | Diversion of fecal matter to
minimize external contact with
the patient, to facilitate the
collection of fecal matter for
patients requiring stool
management, and to provide
access for colonic irrigation to
trigger a defecatory response,
and administration of
enema/medications | Diversion of fecal matter to
minimize external contact with the
patient, to facilitate the collection
of fecal matter for patients
requiring stool management, and to
provide access for colonic
irrigation to trigger a defecatory
response, and administration of
enema/medications |
| Kit Contents | (1) ActiFlo Catheter (1) 60cc Syringe (2) 5g Packet Water Soluble
Lube (1) Drainable Collection Bag or
(2) Closed Collection Bags (2) Skin Barriers (1) Irrigation Bag (1) Instructions for Use | (1) IFMS Catheter (1) 60cc Syringe (1) 30cc Syringe (2) 5g Packet Water
Soluble Lube (1) Instructions for Use | (1) IFMS Catheter (1) 60cc Syringe (1) 30cc Syringe (2) 5g Packet Water Soluble
Lube (1) Instructions for Use |
| Bowel Retention | External Balloon | Same | Same |
| Bowel Irrigation | Silicone funnel that is cath-tip
syringe compatible; also comes with
removable barbed connector for
attachment to luer-tip syringe. | Silicone lumen with flared,
capped port termination | Silicone lumen with flared, capped
port termination |
| Port Access | Sampling / fluid administration
Intraluminal (ARV) balloon | Same | Same |
| Drainage Flow
Suspension | | | |
| Anti-Internal
Migration | External silicone retention faceplate
with 4 tape slots, 2 on each side | External silicone retention
faceplate w/anchor tabs | External silicone retention
faceplate w/anchor tabs |
| Flush / Stool
Sampling | Same | Mid-line silicone access port
compatible with catheter tip
syringe | Mid-line silicone access port
compatible with catheter tip
syringe |
| Enema /
Medication
Administration | Silicone funnel that is cath-tip
syringe compatible; also comes with
removable barbed connector for
attachment to luer-tip syringe. | Silicone lumen with flared,
capped port termination | Silicone lumen with flared, capped
port termination |
| Sterile | Non-Sterile | Non-Sterile | Sterile |
Accessory Performance Testing Conclusions:
Biocompatibility testing was performed on the additional accessories based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the added accessories for their intended clinical use.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border. The text is in all caps and is evenly spaced around the circle.
FFB - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine L. Stukel Sr. Global Regulatory Affairs Analyst Hollister, Inc. 2000 Hollister Drive LIBERTYVILLE IL 60048
Re: K083153
Trade/Device Name: ActiFio"" Indwelling Bowel Catheter System Kit Models 32004, -005, -006, and -007 Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 26, 2009 Received: January 29, 2009
Dear Ms. Stukel:
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 accordinan 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 teeen deternined 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., untinished) and further process (e.g., sterilize) you must submit a new 510(k) before including there 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 devir cean 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. Christine Stukel
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.dsmaldsmamain.html.
Sincerely vours.
. Haberlenn
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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