(30 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.
IFMS Catheter (Bowel Mgt Sys) K012113
This document is a 510(k) summary for the "Indwelling Fecal Management System - Non-Sterile" (IFMS) manufactured by Bowel Management Systems, LLC. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the typical sense for a medical device with an AI component.
Therefore, much of the requested information regarding acceptance criteria, performance metrics, and study details for an AI-powered device is not applicable or available in this specific 510(k) submission.
Here's a breakdown of the information that can be extracted and where the document falls short for an AI-focused request:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable in the traditional sense for an AI device. This 510(k) is for a basic medical device (rectal irrigation tube) and does not involve AI or software performance metrics like sensitivity, specificity, or accuracy.
- The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to predicate devices by matching or favorably comparing features, indications for use, and materials.
| Feature/Function | Predicate Device (Example: IFMS Catheter K012113) | This Device (IFMS - Non Sterile) |
|---|---|---|
| Intended Use/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. | 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. |
| Material: | Silicone | Silicone |
| Bowel Retention Mechanism: | External balloon | External balloon |
| Bowel Irrigation Feature: | Silicone Lumen with flared capped port termination | Silicone Lumen with flared capped port termination |
| Enema/Medication Administration Feature: | Silicone Lumen with flared capped port termination | Silicone Lumen with flared capped port termination |
| Port Access for Sampling/Fluid Administration: | Sampling/fluid administration | Sampling/fluid administration |
| Sterility: | No | No |
| Conclusion of Equivalence (FDA determination): | "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (This is the "reported device performance" in the context of a 510(k) for this type of device). | Substantially Equivalent |
2. Sample size used for the test set and the data provenance
- Not applicable. This document describes a physical medical device, not an AI algorithm. There is no "test set" in the context of evaluating algorithm performance. The "testing" would have focused on biocompatibility, integrity, and functional aspects through engineering tests, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth generation by experts is relevant for AI model training and validation. This device is not an AI model.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical tube, not an AI software. MRMC studies are for evaluating human-AI interaction in diagnostic or interpretative tasks.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware; there is no standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. There is no "ground truth" in the context of an AI algorithm's performance for this submission. The "ground truth" for a physical device would relate to its physical properties and functionality meeting design specifications and safety standards, typically assessed through engineering tests and material evaluations.
8. The sample size for the training set
- Not applicable. There is no AI model, therefore no training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary:
This 510(k) submission is for a conventional, non-AI medical device (Rectal Irrigation Tube). The document focuses on demonstrating substantial equivalence to pre-existing devices by comparing physical characteristics, materials, and intended uses. It does not contain any information related to AI acceptance criteria, study methodologies for AI performance, or data sets for AI training/testing. The "study" here refers to the process of demonstrating substantial equivalence to predicate devices, which primarily involves comparing features and functions as presented in the table provided.
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KO23344
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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.
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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/MedicationAdministration | Port Access | Sterile |
|---|---|---|---|---|---|---|---|---|
| IFMS -Non Sterile(Bowel Mgt Sys)(This Submission) | IFMS Catheter(Bowel Mgt Sys)K012113 | Diversion of fecalmatter to minimizeexternal contactwith the patient, tofacilitate thecollection of fecalmatter for patientsrequiring stoolmanagement, and toprovide access forcolonic irrigation totrigger a defecatoryresponse, andadministration ofenema/medications. | Silicone | External balloon | Silicone Lumenwith flared cappedport termination | Silicone Lumenwith flared cappedport termination | Sampling/fluidadministration | No |
| Colo-Vage System(HDC Corp.)K841289 | Virden RectalCatheter (Bard)Exempt per21CFR 876.5980 | Colonic Irrigationand drainage offecal matter. | Silicone | External balloon | Silicone lumen withflared termination | Silicone lumen withflared termination | Sampling/fluidadministration | Yes |
| Fecal SanitaryTube(Leon's Fecal Tumfg.) K813526 | Administration ofbarium duringradiopaqueevaluation. | Natural Rubber | External balloon | No Irrigation | Natural rubber latexlumen with flaredtermination | Not Specified | No | |
| Collection of fecalExcretion. | Natural Rubber | External Ring | No Irrigation | Noenema/medicationadministration | 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 | (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
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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
§ 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.