(30 days)
Not Found
No
The summary describes a physical catheter system for fecal management and does not mention any AI or ML components or functionalities.
No
The device is used for the "diversion of fecal matter," "collection of fecal matter," "colonic irrigation," and "administration of enemas/medications," which are management and supportive functions rather than directly treating a medical condition or disease.
No
The device's intended use is to manage fecal matter, not to diagnose a condition.
No
The device description explicitly states "IFMS Catheter (Bowel Mgt Sys)", indicating a physical catheter, which is a hardware component. The intended use also describes a physical process of diverting and collecting fecal matter, further suggesting a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that is used in vivo (within the patient's body) for managing fecal matter, facilitating collection, and providing access for irrigation and administration of substances. This is a direct interaction with the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are performed outside the body.
- Device Description: The description "IFMS Catheter (Bowel Mgt Sys)" further reinforces that this is a device used within the body for management purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples, laboratory procedures, or diagnostic information being generated from the device's use.
Therefore, this device falls under the category of a medical device used for patient management and treatment, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Diversion of fecal matter to minimize external contact with the patient, to facilitate the c ollection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.
Product codes
78KNT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
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
KO23344
1 of 3
6 2002 NUV
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to 21 CFR807.92(a).
Submitter Information
Chad Coberly Bowel Management Systems, LLC 1886 South 14th Street, Suite 6 Fernandina Beach, FL 32034 Phone: (904)261-2169 Fax: (904)261-2172
Date: September 27, 2002
807.92(a)(2)
| Trade Name: | Indwelling Fecal Management System- Non-Sterile |
|---|---|
| Common Name: | Rectal Irrigation Tube |
| Classification Name(s): | Tubes, Gastrointestinal |
| Classification Number: | 78KNT |
| 807.92(a)(3) |
Predicate Device(s)
| IFMS | Bowel Management Systems, LLC |
|---|---|
| Colo-Vage System | HDC Corp. |
| Virden Rectal Catheter | CR Bard |
| Leon's Fecal Tube | Leon's Fecal Tube Mfg. |
Additional Substantial Equivalence Information is provided in the following substantial equivalence table.
1
K023344
2 of 3
510(k) Summary: Indwelling Fecal Management System Bowel Management Systems, LLC
807.92(a)(5)
Intended Use(s)
Diversion of fecal matter to minimize external contact with the patient, to facilitate the c ollection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.
2
| Function | Device Feature | Indications for Use | Materials | Bowel Retention | Bowel Irrigation | Enema/Medication
Administration | Port Access | Sterile |
|-------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------|---------|
| IFMS -Non Sterile
(Bowel Mgt Sys)
(This Submission) | IFMS Catheter
(Bowel Mgt Sys)
K012113 | 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. | Silicone | External balloon | Silicone Lumen
with flared capped
port termination | Silicone Lumen
with flared capped
port termination | Sampling/fluid
administration | No |
| Colo-Vage System
(HDC Corp.)
K841289 | Virden Rectal
Catheter (Bard)
Exempt per
21CFR 876.5980 | Colonic Irrigation
and drainage of
fecal matter. | Silicone | External balloon | Silicone lumen with
flared termination | Silicone lumen with
flared termination | Sampling/fluid
administration | Yes |
| Fecal Sanitary
Tube
(Leon's Fecal Tu
mfg.) K813526 | | Administration of
barium during
radiopaque
evaluation. | Natural Rubber | External balloon | No Irrigation | Natural rubber latex
lumen with flared
termination | Not Specified | No |
| Collection of fecal
Excretion. | | | Natural Rubber | External Ring | No Irrigation | No
enema/medication
administration | Not Specified | Yes |
K02334/4
3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002 NOV
Mr. Chad A. Coberly Director of Intellectual Property and Business Development Bowel Management Systems, LLC 1886 South 14th Street, Suite 6 FERNANDINA BEACH FL 32034 Re: K023344
Trade/Device Name: Indwelling Fecal Management System, Non-Sterile Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: September 27, 2002 Received: October 7, 2002
Dear Mr. Coberly:
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. 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.
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.
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.
4
This letter will allow you to begin marketing your device as described in your 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1 of 1
510(k) Number (if known):
Device Name:Indwelling Fecal Management System, Bowel Management Systems, LLC
Indications For Use:
Diversion of fecal mater 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 enemas/medication.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023344