The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults.
The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.

Device Description

The Bowel Management Device is an indwelling low profile catheter used to promote evacuation of the lower bowel through antegrade colonic flushing. It consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlock irrigation port, and safety plug. The catheter is inserted through the stoma and into the colon and is secured by the internal retention balloon when inflated. The Bowel Management Irrigation Set has a connector on one end that connects to the interlock on the catheter and an adapter on the other end to connect to the irrigation/enema delivery system. Fluids can then be instilled directly into the colon through the catheter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Bowel Management Device and Irrigation Set." It includes information about the device's intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to predicate devices.

However, the document does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

Missing Information:

Specific Acceptance Criteria Table and Reported Device Performance: While the document states, "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate," it does not provide a table outlining these acceptance criteria or the specific performance metrics achieved by the device against those criteria. It only lists the types of tests performed (e.g., Strap Tensile Testing, Flow Rate Test, Balloon Integrity).
Detailed Study Information:
- Sample size used for the test set and data provenance: The document mentions "bench tests have been carried out," but does not specify sample sizes (e.g., number of devices tested, number of individual measurements) or the origin of any data (e.g., country, retrospective/prospective).
- Number of experts used to establish ground truth and qualifications: This information is not relevant for the type of bench testing described.
- Adjudication method: Not relevant for bench testing.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The document describes bench testing comparing device performance (mechanical and functional aspects) to a predicate, not a clinical study involving human readers or AI. Therefore, no effect size of human readers improving with/without AI is present.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: For the bench tests, the "ground truth" would be established by the design specifications and performance of the predicate device, but this isn't explicitly detailed as a ground truth methodology.
- Sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.

What the document does provide regarding performance testing:

Performance Testing Overview: AMT conducted various performance tests on components.
Comparison to Predicate: Bench tests were carried out to compare performance to the primary predicate (Cook Chait Cecostomy Catheter, K982500).
Specific Tests Performed:
- Strap Tensile Testing
- Tube Tensile Testing
- Minimum Overmold Bond Strength
- Stoma Pullout
- 2 Minute Leak Test
- Flow Rate Test
- Testing per ASTM F2528-06 (Balloon Integrity in Simulated Gastric Fluid, Balloon volume maintenance, Balloon size and shaft size, Balloon concentricity, Balloon integrity)
- Testing per ISO 80369-3 (Fluid leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing)
General Performance Conclusion: "The Bowel Management Devices meet all the acceptance criteria and performed comparable to or better than the primary predicate."

In summary, while the document states that the device met acceptance criteria based on performance testing comparable to a predicate, it does not provide the granular detail requested in your prompt regarding specific numeric acceptance criteria, detailed study parameters (like sample size or data provenance), or clinical/reader study information typical for AI or diagnostic devices. This document focuses on the engineering and material performance of a physical device for a 510(k) submission.

Summary

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June 1, 2018

Applied Medical Technology, Inc. Joshua Meinke Quality / Regulatory Affairs Supervisor 8006 Katherine Boulevard Brecksville, OH 44141

Re: K180026

Trade/Device Name: Bowel Management Device and Irrigation Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, EXD, PIF Dated: April 23, 2018 Received: April 26, 2018

Dear Joshua Meinke:

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. 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/tray. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180026

Device Name Bowel Management Device and Irrigation Set

Indications for Use (Describe)

The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION - 5

510(k) Summary

Bowel Management Device and Irrigation Set

Date Prepared:	May 31, 2018
Submitter:	Applied Medical Technology, Inc.8006 Katherine BoulevardBrecksville, OH 44141Phone: 440-717-4000Fax: 440-717-4200Contact Person: Joshua Meinke – Quality / Regulatory Affairs SupervisorEmail: Joshua.meinke@appliedmedical.net
DeviceInformation:	Trade/Device Name: Bowel Management Device and Irrigation SetCommon Name: Gastrointestinal TubeClassification Name: 21 CFR 876.5980: Gastrointestinal tube andaccessories;21 CFR 876.5895: Ostomy irrigator.Product Code: KNT, EXD, PIFRegulatory Class: IIReview Panel: Gastroenterology and Urology
PredicateDevice:	Primary Predicate: Cook Chait Cecostomy Catheter (K982500)Reference Device: AMT Low Profile Balloon Feeding Device (K161413)
Intended Use:	The Bowel Management Device is intended to instill fluids through a stomainto the colon to promote evacuation of the contents of the lower bowelthrough the anus and is intended to be an aid in the management of fecalincontinence. The catheter is placed and maintained in a percutaneouslyprepared opening, such as a cecostomy or appendicostomy. The BowelManagement Device is intended to be used in children and adults.The Bowel Management Irrigation Set is intended to allow connectionbetween a compatible bowel management device and the delivery tubing of anirrigation/enema bag system.
DeviceDescription:	The Bowel Management Device is an indwelling low profile catheter used topromote evacuation of the lower bowel through antegrade colonic flushing. Itconsists of an internal retention balloon and a flexible external bolster with aballoon fill-valve, interlock irrigation port, and safety plug. The catheter isinserted through the stoma and into the colon and is secured by the internalretention balloon when inflated. The Bowel Management Irrigation Set has aconnector on one end that connects to the interlock on the catheter and anadapter on the other end to connect to the irrigation/enema delivery system.Fluids can then be instilled directly into the colon through the catheter.
TechnologicalCharacteristics:	Antegrade colonic irrigation is the technological principle for both the subjectand predicate device. It is based on the use of a stoma to instill fluids into thecolon to evacuate the contents of the lower bowel through the anus. At a highlevel, the subject and predicate devices are based on the following sametechnological elements:• Catheter tubing – to instill fluids into the colon• External and internal bolster – to secure the device to the abdominalwall and prevent inward or outward migration of the device• Plug on external bolster – to prevent leakage• Introducer/stiffener – to facilitate placement of the device• Irrigation set/access adapter - connects the catheter to the delivery systemThe following technological differences exist between the subject andpredicate device:• The subject device is made of a soft, flexible silicone, while thepredicate is made of urethane/polyurethane• The subject device uses a balloon as the internal bolster instead of thecatheter coiling like the predicate• The subject device features one central outlet instead of having threeside ports like the predicate device• The subject device comes in various sizes to accommodate differentstoma diameters and lengths and the predicate device is available inthree adjustable sizes• The subject device has an anti-reflux valve• The subject device has an irrigation set that rotates to lock into place• The subject device has an ENFit connector option for the irrigationset• The subject device is MR conditional
BiocompatibilityTesting:	The Bowel Management Tube in its final finished form is identical to the LowProfile Balloon Feeding Device (K161413) in formulation, processing,sterilization, and geometry, and no other chemicals have been added (eg.plasticizers, fillers, additives, cleaning agents, and mold release agents), so noadditional testing was required for this submission.
PerformanceTesting:	AMT conducted various performance tests on the components containedwithin the Bowel Management Device. Testing found that all componentsand materials met or exceeded design specifications established by AMT.In addition to testing included in K161413, bench tests have been carried outon to compare performance to the primary predicate. The additional testscarried out included:Strap Tensile Testing Tube Tensile Testing Minimum Overmold Bond Strength Stoma Pullout 2 Minute Leak Test Flow Rate Test Testing per ASTM F2528-06: Balloon Integrity in Simulated Gastric Fluid Balloon volume maintenance Balloon size and shaft size Balloon concentricity Balloon integrity Testing per 80369-3: Fluid leakage Stress cracking Resistance to separation from axial load Resistance to separation from unscrewing Resistance to overriding Disconnection by unscrewing The Bowel Management Devices meet all the acceptance criteria andperformed comparable to or better than the primary predicate.
Conclusion:	The Bowel Management Device can be found substantially equivalent to thepredicate device cleared under K982500 in intended use, performance, andprinciples of operation. The AMT Bowel Management Device is alsoidentical to the LPBFD cleared in K161413, so the technologicalcharacteristics do not raise different questions of safety and effectiveness.

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SECTION - 5

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SECTION - 5

Regulation Number and Section

§ 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.