(103 days)
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.
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.
The provided text is a 510(k) summary for the ActiFlo™ Indwelling Catheter System Kit, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results in the manner requested.
Therefore, the requested information regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.
The document primarily compares the technological characteristics and indications for use of the ActiFlo™ system to two predicate devices (K023344 and K012113). It mentions "Accessory Performance Testing Conclusions" stating that "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." However, this is a general statement about biocompatibility, not a detailed study of the device's primary function against specific performance acceptance criteria.
Key takeaways from the document:
- Device: ActiFlo™ Indwelling Catheter System Kit.
- Purpose: Diversion of fecal matter, collection of fecal matter for stool management, access for colonic irrigation, and administration of enema/medications.
- Regulatory Pathway: 510(k) submission, demonstrating substantial equivalence to predicate devices.
- Predicate Devices: K023344 (Indwelling Fecal Management System- Non-Sterile) and K012113 (Indwelling Fecal Management System (IFMS)).
- Testing Mentioned: Biocompatibility testing for accessories, conforming to G95-1 and ISO 10993 standards. This confirms material safety but not the functional performance of the device in its intended clinical use.
In summary, the provided text does not contain the specific details required to answer your questions about acceptance criteria and a study proving the device meets them because the 510(k) submission primarily relies on substantial equivalence to predicate devices, not on a new clinical performance study with detailed acceptance criteria.
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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 ManagementSystem- Non-Sterile | K023344 |
| Indwelling Fecal ManagementSystem (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
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Technological Characteristics:
:
K083153
| FUNCTION | ActiFlo™ Indwelling BowelCatheter System Kit | Indwelling FecalManagement System-Non-Sterile (K023344) | Indwelling FecalManagement System(IFMS)K012113 |
|---|---|---|---|
| Indications forUse | The ActiFlo Indwelling BowelCatheter System is intendedfor diversion of fecal matter tominimize external contact withthe patient's skin, to facilitatethe collection of fecal matterfor patients requiring stoolmanagement, to provide accessfor colonic irrigation and toadminister enema/medications. | Diversion of fecal matter tominimize external contact withthe patient, to facilitate thecollection of fecal matter forpatients requiring stoolmanagement, and to provideaccess for colonic irrigation totrigger a defecatory response,and administration ofenema/medications | Diversion of fecal matter tominimize external contact with thepatient, to facilitate the collectionof fecal matter for patientsrequiring stool management, and toprovide access for colonicirrigation to trigger a defecatoryresponse, and administration ofenema/medications |
| Kit Contents | (1) ActiFlo Catheter (1) 60cc Syringe (2) 5g Packet Water SolubleLube (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 WaterSoluble Lube (1) Instructions for Use | (1) IFMS Catheter (1) 60cc Syringe (1) 30cc Syringe (2) 5g Packet Water SolubleLube (1) Instructions for Use |
| Bowel Retention | External Balloon | Same | Same |
| Bowel Irrigation | Silicone funnel that is cath-tipsyringe compatible; also comes withremovable barbed connector forattachment to luer-tip syringe. | Silicone lumen with flared,capped port termination | Silicone lumen with flared, cappedport termination |
| Port Access | Sampling / fluid administrationIntraluminal (ARV) balloon | Same | Same |
| Drainage FlowSuspension | |||
| Anti-InternalMigration | External silicone retention faceplatewith 4 tape slots, 2 on each side | External silicone retentionfaceplate w/anchor tabs | External silicone retentionfaceplate w/anchor tabs |
| Flush / StoolSampling | Same | Mid-line silicone access portcompatible with catheter tipsyringe | Mid-line silicone access portcompatible with catheter tipsyringe |
| Enema /MedicationAdministration | Silicone funnel that is cath-tipsyringe compatible; also comes withremovable barbed connector forattachment to luer-tip syringe. | Silicone lumen with flared,capped port termination | Silicone lumen with flared, cappedport 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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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Indications for Use
510(k) Number (if known): _|< 08 3 | 5 3
Device Name: ActiFlo™ Indwelling Bowel Catheter System Kit
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Offige of Device Evaluation (ODE)
Hules Stemer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
ActiFlo™ Special 510(k) Submission Page 15 of 41
§ 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.