(301 days)
Not Found
No
The summary describes a device for fecal management and irrigation, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The predicate devices are also simple mechanical devices.
Yes
The device is described as facilitating defecation through colonic irrigation and administration of enemas/medications, which are therapeutic actions for bowel management.
No
Explanation: The device's intended use is to manage fecal matter, facilitate collection, provide access for colonic irrigation, and administer enemas/medications. These are therapeutic or management functions, not diagnostic ones. There is no mention of identifying or characterizing diseases or conditions.
No
The 510(k) summary describes a device for fecal management and colonic irrigation, which are physical processes. The predicate devices listed are also physical devices (systems, tubes, catheters). There is no mention of software as the primary or sole component of the 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 externally or internally within the body to manage fecal matter, facilitate collection, and provide access for irrigation and administration of substances. This is a therapeutic or management function, not a diagnostic one.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device's function does not involve any such analysis of specimens.
- Predicate Devices: The listed predicate devices (HDC Colo-Vage System, Leon's Fecal Sanitary Tube, Bard Virden Rectal Catheter) are all devices used for managing fecal matter or providing rectal access, which are not IVD devices.
Therefore, the intended use and the nature of the device as described clearly indicate it is a medical device used for patient management and access, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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
| 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 | ||
| 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 | |||
| Tube Manufacture | Leon's Fecal Sanitary Tube | K813526 | |
| Bard | Virden Rectal Catheter | Exempt per 21CFR 876.5980 | |
| (barium enema retention | |||
| catheter) |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
1
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 | ||||
| (Zassi Medical Evolutions) | Colo-Vage System | |||
| (HDC Corporation) | Virden Rectal | |||
| Catheter | ||||
| (Bard) | Fecal Sanitary Tube | |||
| (Leon's Fecal Sanitary | ||||
| Tube) | ||||
| This submission | K841289 | Exempt per | ||
| 21CFR876.5980 | ||||
| (barium enema | ||||
| retention catheter) | K813526 | |||
| 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. | Colonic irrigation and | |||
| drainage of fecal | ||||
| matter. | Administration of | |||
| barium during | ||||
| radiopaque evaluation. | Collection of fecal | |||
| excretion | ||||
| Bowel Retention | External Balloon | |||
| Silicone lumen with flared, | ||||
| capped port termination | External Balloon | |||
| Silicone lumen with | ||||
| flared termination | External Balloon | |||
| No irrigation | External Ring | |||
| No irrigation | ||||
| Bowel Irrigation | Intraluminal (ARV) balloon | |||
| Drainage Flow Suspension | External silicone retention | |||
| faceplate w/ anchor tabs | No drainage suspension | No drainage suspension | ||
| Anti-Internal Migration | Mid-line silicone access port | No anti-internal | ||
| migration | No anti-internal | |||
| migration | ||||
| Flush / Stool Sampling | compatible with catheter tip | |||
| syringe | No flush / stool | |||
| sampling | No flush / stool sampling | |||
| IFMS Catheter | ||||
| (Zassi Medical Evolutions) | Colo-Vage System | |||
| (HDC Corporation) | Virden Rectal | |||
| Catheter | ||||
| (Bard) | Fecal Sanitary Tube | |||
| (Leon's Fecal Sanitary | ||||
| Tube) | ||||
| This submission | K841289 | K813526 | ||
| Enema / Medication | ||||
| Administration | Silicone lumen with flared, | |||
| capped port termination | Silicone lumen with | |||
| flared termination | Natural rubber latex | |||
| lumen with flared | ||||
| termination | No enema / medication | |||
| administration | ||||
| Drainage / Collection | Waste collection bag not | |||
| provided in kit | Sterile drainage unit | |||
| not provided | No drainage / | |||
| collection | Waste collection bag | |||
| integral to the device | ||||
| Port Access | Sampling / fluid | |||
| administration | Sampling / fluid | |||
| administration | Not specified | Not specified | ||
| Sterile | Yes | Yes | No | Yes |
Page ್ರಿ of 4
3
Footactes: Allows for temporary closure of catheter drains of bowel irrigation or for retention of enemalmedications
after administration. :
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘ
1
す Page 4 of
: ・
4
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
6
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)