(83 days)
Not Found
No
The device description and performance studies focus on the mechanical function and biocompatibility of a bowel catheter system, with no mention of AI or ML technologies.
No
The device is described as a bowel catheter system for the collection of fecal matter, which primarily serves a containment and collection function, rather than directly treating a disease or condition. While it manages a symptom (lack of bowel control), it doesn't aim to cure or rehabilitate.
No
Explanation: The device is used for the collection of fecal matter, which is a facilitative action, not a diagnostic one. It does not analyze or interpret biological signals or data to identify a medical condition.
No
The device description clearly outlines physical components (catheter, collection bag, connectors, retention cuff, drain tube) and their functions, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the diversion and collection of fecal matter from patients with little or no bowel control. This is a physical process of managing waste, not a diagnostic test performed in vitro (outside the body) on a sample to determine a medical condition.
- Device Description: The device is a catheter and collection bag system designed to physically channel stool. It does not involve any reagents, assays, or analysis of biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze the collected stool for any diagnostic markers, pathogens, or other substances. The purpose is purely for collection.
IVD devices are used to examine specimens (like blood, urine, tissue, or in some cases, stool) in vitro to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the physical management of waste.
N/A
Intended Use / 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.
Product codes
KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bowel / 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K100273
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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. | |
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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.
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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
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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