INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE

K023344 · Bowel Management Systems, LLC · KNT · Nov 6, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K023344
• Device Name: INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
• Applicant: Bowel Management Systems, LLC
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 enemas/medications.

Device Story

Indwelling Fecal Management System (IFMS) is a non-sterile rectal catheter used for fecal diversion and management. Device features an external retention balloon to secure position in the rectum. Silicone lumen provides access for colonic irrigation, enema/medication administration, and fecal collection. Used in clinical settings to minimize external contact with fecal matter and facilitate patient hygiene. Healthcare providers operate the device to manage stool, trigger defecatory responses, or deliver therapeutic agents. Output is the diversion and collection of fecal matter, which reduces skin contact and simplifies patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone construction; rectal catheter with external retention balloon; flared capped port termination for irrigation and medication administration; non-sterile; Class II gastrointestinal tube.

Indications for Use

Indicated for patients requiring stool management for the diversion of fecal matter, colonic irrigation to trigger a defecatory response, and administration of enemas or medications.

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

• IFMS (K012113)
• Colo-Vage System (K841289)
• Virden Rectal Catheter (CR Bard)
• Leon's Fecal Tube (K813526)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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.

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K023344
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# 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.

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| Function | Device Feature | Indications for Use | Materials | Bowel Retention | Bowel Irrigation | Enema/Medication<br>Administration | Port Access | Sterile |
|-------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------|---------|
| IFMS -Non Sterile<br>(Bowel Mgt Sys)<br>(This Submission) | IFMS Catheter<br>(Bowel Mgt Sys)<br>K012113 | Diversion of fecal<br>matter to minimize<br>external contact<br>with the patient, to<br>facilitate the<br>collection of fecal<br>matter for patients<br>requiring stool<br>management, and to<br>provide access for<br>colonic irrigation to<br>trigger a defecatory<br>response, and<br>administration of<br>enema/medications. | Silicone | External balloon | Silicone Lumen<br>with flared capped<br>port termination | Silicone Lumen<br>with flared capped<br>port termination | Sampling/fluid<br>administration | No |
| Colo-Vage System<br>(HDC Corp.)<br>K841289 | Virden Rectal<br>Catheter (Bard)<br>Exempt per<br>21CFR 876.5980 | Colonic Irrigation<br>and drainage of<br>fecal matter. | Silicone | External balloon | Silicone lumen with<br>flared termination | Silicone lumen with<br>flared termination | Sampling/fluid<br>administration | Yes |
| Fecal Sanitary<br>Tube<br>(Leon's Fecal Tu<br>mfg.) K813526 | | Administration of<br>barium during<br>radiopaque<br>evaluation. | Natural Rubber | External balloon | No Irrigation | Natural rubber latex<br>lumen with flared<br>termination | Not Specified | No |
| Collection of fecal<br>Excretion. | | | Natural Rubber | External Ring | No Irrigation | No<br>enema/medication<br>administration | Not Specified | Yes |

K02334/4
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# 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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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