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.
Device Story
Indwelling Fecal Management System (IFMS) is a rectal irrigation and drainage catheter; used for fecal diversion to minimize external contact and facilitate collection. Device features include an external retention balloon, silicone lumen with flared capped port, intraluminal (ARV) balloon for irrigation, and external silicone faceplate with anchor tabs for drainage flow suspension. Operates by insertion into the rectum; allows for colonic irrigation to trigger defecatory response and administration of enemas/medications via port access. Compatible with catheter-tip syringes for flushing and sampling. Designed for clinical use to manage patient bowel function; provides a closed system for waste management. Benefits include reduced skin contact with fecal matter and controlled access for therapeutic bowel interventions.
Clinical Evidence
No clinical data provided; substantial equivalence is based on bench testing and design comparison.
Technological Characteristics
Silicone catheter with external retention balloon, intraluminal (ARV) irrigation balloon, and external silicone faceplate for drainage suspension. Features a flared, capped port for sampling and fluid administration. Sterile, single-use device. No electronic components or software.
Indications for Use
Indicated for patients requiring stool management for fecal diversion, colonic irrigation, or administration of enemas/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.
Virden Rectal Catheter (Exempt per 21CFR 876.5980)
Submission Summary (Full Text)
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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 Coberly<br>Bowel 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. 102<br>Carri 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 Sanitary<br>Tube Manufacture | | Leon's Fecal Sanitary Tube | K813526 |
| Bard | | Virden Rectal Catheter | Exempt per 21CFR 876.5980<br>(barium enema retention<br>catheter) |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
K012113
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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.
{2}------------------------------------------------
510(k) Summary
Indwelling Fecal Management System (IFMS)
Bowel Management Systems, LLC
on Chart for Substantial Equivalence
| Function | | | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------|
| | | Device Feature | | |
| | IFMS Catheter<br>(Zassi Medical Evolutions) | Colo-Vage System<br>(HDC Corporation) | Virden Rectal<br>Catheter<br>(Bard) | Fecal Sanitary Tube<br>(Leon's Fecal Sanitary<br>Tube) |
| | This submission | K841289 | Exempt per<br>21CFR876.5980<br>(barium enema<br>retention catheter) | K813526 |
| Indications for Use | Diversion of fecal matter to<br>minimize external contact<br>with the patient, to facilitate<br>the collection of fecal matter<br>for patients requiring stool<br>management, and to provide<br>access for colonic irrigation<br>to trigger a defecatory<br>response, and administration<br>of enema/medications. | Colonic irrigation and<br>drainage of fecal<br>matter. | Administration of<br>barium during<br>radiopaque evaluation. | Collection of fecal<br>excretion |
| Bowel Retention | External Balloon<br>Silicone lumen with flared,<br>capped port termination | External Balloon<br>Silicone lumen with<br>flared termination | External Balloon<br>No irrigation | External Ring<br>No irrigation |
| Bowel Irrigation | Intraluminal (ARV) balloon | | | |
| Drainage Flow Suspension | External silicone retention<br>faceplate w/ anchor tabs | | No drainage suspension | No drainage suspension |
| Anti-Internal Migration | Mid-line silicone access port | | No anti-internal<br>migration | No anti-internal<br>migration |
| Flush / Stool Sampling | compatible with catheter tip<br>syringe | | No flush / stool<br>sampling | No flush / stool sampling |
| | IFMS Catheter<br>(Zassi Medical Evolutions) | Colo-Vage System<br>(HDC Corporation) | Virden Rectal<br>Catheter<br>(Bard) | Fecal Sanitary Tube<br>(Leon's Fecal Sanitary<br>Tube) |
| | This submission | K841289 | | K813526 |
| Enema / Medication<br>Administration | Silicone lumen with flared,<br>capped port termination | Silicone lumen with<br>flared termination | Natural rubber latex<br>lumen with flared<br>termination | No enema / medication<br>administration |
| Drainage / Collection | Waste collection bag not<br>provided in kit | Sterile drainage unit<br>not provided | No drainage /<br>collection | Waste collection bag<br>integral to the device |
| Port Access | Sampling / fluid<br>administration | Sampling / fluid<br>administration | 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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1
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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.
{5}------------------------------------------------
#### 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)
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
