Who is the manufacturer of INSTAFLO BOWEL CATHETER SYSTEM KIT?

Hollister, Inc. filed the 510(k) submission for INSTAFLO BOWEL CATHETER SYSTEM KIT (K100273).

What is the FDA product code for INSTAFLO BOWEL CATHETER SYSTEM KIT?

KNT. It is classified under 21 CFR 876.5980 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for INSTAFLO BOWEL CATHETER SYSTEM KIT?

510(k) clearance (submission type: Special).

What are the predicate devices for INSTAFLO BOWEL CATHETER SYSTEM KIT?

ActiFlo Indwelling Bowel Catheter System Kit (K083153).

Who can help prepare an FDA 510(k) submission like INSTAFLO BOWEL CATHETER SYSTEM KIT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INSTAFLO BOWEL CATHETER SYSTEM KIT

K100273 · Hollister, Inc. · KNT · Apr 22, 2010 · Gastroenterology, Urology

Device Facts

Record ID	K100273
Device Name	INSTAFLO BOWEL CATHETER SYSTEM KIT
Applicant	Hollister, Inc.
Product Code	KNT · Gastroenterology, Urology
Decision Date	Apr 22, 2010
Decision	SESK
Submission Type	Special
Regulation	21 CFR 876.5980
Device Class	Class 2
Attributes	Therapeutic

Intended Use

For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

Device Story

InstaFlo Bowel Catheter System Kit; indwelling catheter system for fecal management. Device consists of catheter with retention cuff and collection bag. Insertion end features retention cuff; other end has twist lock fitting for bag attachment. Blue connector inflates/deflates retention cuff; clear connector allows irrigation of device tubing. Used in clinical settings for patients with little or no bowel control; diverts liquid/semi-liquid stool directly from rectum to collection bag. Simplifies fecal management by removing irrigation and medication administration indications present in predicate. Healthcare providers manage device; output is diverted fecal matter. Benefits include minimized external contact with patient and facilitated stool collection.

Clinical Evidence

No clinical data. Biocompatibility testing performed per ISO 10993 and FDA G95-1 standards.

Technological Characteristics

Non-sterile indwelling bowel catheter system. Features: retention cuff (external balloon), blue inflation/deflation connector, clear irrigation connector (for tubing only), mid-line silicone access port for sampling/flushing, and blue transphincteric zone for migration monitoring. Materials evaluated via ISO 10993 biocompatibility standards. No intraluminal (ARV) balloon.

Indications for Use

Indicated for patients with little or no bowel control requiring diversion and collection of liquid or semi-liquid stool.

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

ActiFlo Indwelling Bowel Catheter System Kit (K083153)

Related Devices

K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT · Hollister, Inc. · Apr 17, 2013
K221400 — hygh-tec drainage · Creative Balloons GmbH · Feb 9, 2023
K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 · Hollister, Inc. · Feb 4, 2009
K190114 — Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) · Convatec Limited · Apr 30, 2019
K150350 — Flexi-Seal Signal Fecal Management System · Convatec, Ltd. · Jul 21, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ K100273 Page 1 of 2 Image /page/0/Picture/1 description: The image shows the word "Hollister" in a serif font next to a geometric symbol. The symbol is a black shape that resembles a stylized snowflake or asterisk. The word "Hollister" is in a bold, black font and is positioned to the right of the symbol. The overall image has a clean and simple design. ## 510(k) Summary | Submitted By: | Ben Lichtenwalner Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 847-680-1000 | APR 22 2010 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Date Summary Prepared: | March 5, 2010 | | | Device Name: | Classification Name - Gastrointestinal Tube and accessories Common/Usual Name - Rectal Catheter Proprietary Name - InstaFlo Bowel Catheter System Kit | | | Predicate Device: | The InstaFlo Bowel Catheter System Kit is a modification to the following device: | | | | Product | 510(k) | | | ActiFlo Indwelling Bowel Catheter System Kit | K083153 | | Device Description: | The InstaFlo Bowel Catheter System Kit contains two main parts: the catheter and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed. | | | Intended Use: | For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control. | | {1}------------------------------------------------ Technological Characteristics: K100273 Page 2 of 2 | FUNCTION | ActiFlo Indwelling Bowel Catheter System Kit (Current Device) | InstaFlo Catheter System Kit (Modified Device) | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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. | For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control. | | 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) InstaFlo Catheter • (1) 60cc Syringe • (1) Closed Collection Bag • (1) Instructions for Use • (1) Quick Reference Insertion Guide | | Bowel Retention | External Balloon | External Balloon | | Bowel Irrigation | Silicone funnel that is cath-tip syringe compatible; also comes with removable barbed connector for attachment to Luer-tip syringe. | Removing bowel irrigation indications from IFU. Irrigation bag will not be provided in kit. IRRG connection will only be recommended for irrigation of the bowel catheter tubing. | | Port Access | Sampling / fluid administration | Sampling / fluid administration | | Drainage Flow Suspension | Intraluminal (ARV) balloon | No Intraluminal (ARV) balloon. | | Anti-Internal Migration | External silicone retention faceplate with anchor straps | Blue colored collapsible transphincteric zone to be used as a visual indicator | | Flush / Stool Sampling | 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. | Removing the instructions for Enema / Medication Administration from IFU to simplify usage of the device. An irrigation bag will not be supplied in the InstaFlo kit. | | Sterile | Non-Sterile | Non-Sterile | Performance Testing Conclusions: Biocompatibility testing was performed 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 device for its intended clinical use. {2}------------------------------------------------ Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Mr. Benjamin Lichtenwalner Senior Regulatory Affairs Specialist Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048 APR 22 2010 Re: K100273 Trade/Device Name: InstaFlo Bowel Catheter System Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 22, 2010 Received: March 23, 2010 Dear Mr. Lichtenwalner: 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 accordance 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 been defermined 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., unfinished) 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, 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 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. {3}------------------------------------------------ Page 2 - Mr. Benjamin Lichtenwalner 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 (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.htm 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 tolloffree 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, Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _ K100273 Device Name: InstaFlo Bowel Catheter System Kit Indications for Use: For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control. 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, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ K100273