(301 days)
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.
Not Found
It appears there might be a misunderstanding of the provided text. The document is a 510(k) Pre-market Notification Summary for a medical device called the "Indwelling Fecal Management System (IFMS)."
This document DOES NOT contain information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance, expert involvement, adjudication methods, or ground truth establishment.
- MRMC comparative effectiveness studies or standalone algorithm performance.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, not on presenting performance data from a clinical or analytical study. It compares the IFMS's indications for use and device features to those of predicate devices.
Therefore, I cannot provide the requested information because the provided text does not contain any data related to performance criteria, studies, sample sizes, expert involvement, or ground truth establishment relevant to the device's efficacy or safety.
The document's purpose is to satisfy regulatory requirements for marketing a new medical device by showing it's as safe and effective as a legally marketed predicate device, not to showcase direct performance metrics from a study.
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510(k) Summary
Indwelling Fecal Management System (IFMS)
Bowel Management Systems, LLC
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
| Chad CoberlyBowel Management Systems, LLC | |||
|---|---|---|---|
| 1886 South 14th Street, Suite 6 | |||
| Fernandina Beach, FL 32034 | |||
| Phone: | (904) 261-2169 | ||
| Facsimile: | (904) 261-2172 | ||
| Contact Person: | Colleen Hittle, Official Correspondent - (317) 849-1916 ext. 102Carri Graham - (317) 849-1916 ext. 103 | ||
| Date: | February 1, 2002 | ||
| 807.92(a)(2) | |||
| Trade Name: | Indwelling Fecal Management System (IFMS) | ||
| Common Name: | Rectal Irrigation tube | ||
| Classification Name(s): | Tubes, Gastrointestinal | ||
| Classification Number: | 78KNT | ||
| 807.92(a)(3) | |||
| Predicate Device(s) | |||
| HDC | Colo-Vage System | K841289 | |
| Leon's Fecal SanitaryTube Manufacture | Leon's Fecal Sanitary Tube | K813526 | |
| Bard | Virden Rectal Catheter | Exempt per 21CFR 876.5980(barium enema retentioncatheter) |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
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807.92(a)(5)
Intended Use(s)
The Indwelling Fecal Management System (IFMS) is indicated for 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.
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510(k) Summary
Indwelling Fecal Management System (IFMS)
Bowel Management Systems, LLC
on Chart for Substantial Equivalence
| Function | ||||
|---|---|---|---|---|
| Device Feature | ||||
| IFMS Catheter(Zassi Medical Evolutions) | Colo-Vage System(HDC Corporation) | Virden RectalCatheter(Bard) | Fecal Sanitary Tube(Leon's Fecal SanitaryTube) | |
| This submission | K841289 | Exempt per21CFR876.5980(barium enemaretention catheter) | K813526 | |
| Indications for Use | Diversion of fecal matter tominimize external contactwith the patient, to facilitatethe collection of fecal matterfor patients requiring stoolmanagement, and to provideaccess for colonic irrigationto trigger a defecatoryresponse, and administrationof enema/medications. | Colonic irrigation anddrainage of fecalmatter. | Administration ofbarium duringradiopaque evaluation. | Collection of fecalexcretion |
| Bowel Retention | External BalloonSilicone lumen with flared,capped port termination | External BalloonSilicone lumen withflared termination | External BalloonNo irrigation | External RingNo irrigation |
| Bowel Irrigation | Intraluminal (ARV) balloon | |||
| Drainage Flow Suspension | External silicone retentionfaceplate w/ anchor tabs | No drainage suspension | No drainage suspension | |
| Anti-Internal Migration | Mid-line silicone access port | No anti-internalmigration | No anti-internalmigration | |
| Flush / Stool Sampling | compatible with catheter tipsyringe | No flush / stoolsampling | No flush / stool sampling | |
| IFMS Catheter(Zassi Medical Evolutions) | Colo-Vage System(HDC Corporation) | Virden RectalCatheter(Bard) | Fecal Sanitary Tube(Leon's Fecal SanitaryTube) | |
| This submission | K841289 | K813526 | ||
| Enema / MedicationAdministration | Silicone lumen with flared,capped port termination | Silicone lumen withflared termination | Natural rubber latexlumen with flaredtermination | No enema / medicationadministration |
| Drainage / Collection | Waste collection bag notprovided in kit | Sterile drainage unitnot provided | No drainage /collection | Waste collection bagintegral to the device |
| Port Access | Sampling / fluidadministration | Sampling / fluidadministration | Not specified | Not specified |
| Sterile | Yes | Yes | No | Yes |
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Footactes: Allows for temporary closure of catheter drains of bowel irrigation or for retention of enemalmedications
after administration. :
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0-3-2002
Bowel Management Systems, LLC c/o Ms. Colleen J. Densmore Official Correspondent The Anson Group, LLC 7992 Castleway Drive Indianapolis, Indiana 46250
Re: K012113
Trade/Device Name: Indwelling Fecal Management System (IFMS) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: February 1, 2002 Received: February 4, 2002
Dear Ms. Densmore:
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). 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 determined 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.
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Page 2 - Ms. Colleen Densmore
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of activitied that I Drivistion that your device complies with other requirements of the Act that I Drinas made a actuations administered by other federal agencies. You must or any it coloral statutes and regainents, including, but not limited to: registration (21 CFR Part eomply with an alle 110 - 100 - 104 - 10 - 10 - 10 - 2011 - 10 - 10 - 10 - 2011 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 200 007), noung (21 CF Reason the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) r ms letter will and w you to organ maing of substantial equivalence of your device to a legally prematic notification: "I results in a classification for your device and thus, permits your marketed proceed to the market. If you desire specific advice for your device on the labeling ucerio to proced to the manew additionally Part 809.10 for in vitro diagnostic devices), please rogulation office of Compliance at (301) 594-4616. Additionally, for questions on the contact the Office of Compilance and evice, please contact the Office of Compliance at promotion and acrossible se note the regulation entitled, "Misbranding by reference to (2011) 371 1057. 1180, pread 807.97). Other general information on your responsibilities promation act may be obtained from the Division of Small Manufacturers, International and ander the Ace may be obtained from and ber (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
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
510(k) Number (if known): _ K012113
Device Name:_Indwelling Fecal Management System (IFMS)
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 enemas/medications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maurice Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K012113
510(k) Number(Optional Format 3-10-98)
Prescription Use (Per 21 CFR 801.109)
§ 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.