The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

Device Description

The subject device, Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector), has the same intended use as the predicate device (K162906). Both devices include a low-profile retention balloon, a finger pocket to allow for easy balloon insertion, a green dome to indicate the optimal fill status of the retention balloon, a red dome to indicate the over inflation status, and the ability to administer medication through the use of a cinch clamp. In addition, the subject device incorporates new features, including: add a self-closing ENFit port for irrigation/medication and provide an ENFit (1) syringe in the kit, (2) add a sub-assembled self-closing quick connector to the catheter end, and add a matching bag connector in the collection bag with an option of (3) incorporating Diamonds™ gelling and odor control sachet (4 sachets per kit) to solidify and deodorize the fecal contents in the collection bag.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study proving device performance, as requested.

Important Note: The provided document is an FDA 510(k) Summary for a medical device (Flexi-Seal™ PROTECT PLUS Fecal Management System). This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, many of the typical "acceptance criteria" and "study" details associated with AI/software devices (like sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment methods for AI algorithms) are not applicable here.

The "studies" conducted for this device are primarily benchtop performance tests to ensure the new features do not negatively impact the device's function or safety.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Given this is a 510(k) submission for a physical medical device with modifications, the "acceptance criteria" are implied to be that the modified device performs similarly to or better than the predicate device and that the new features do not introduce new safety or efficacy concerns. The "study" involves non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and the "acceptance criteria" are not explicitly listed as quantitative metrics in the document but rather as functional equivalence, I will infer them from the performance tests conducted and the claim of substantial equivalence.

Acceptance Criteria (Inferred from device modifications and predicate comparison)	Reported Device Performance (Summary from Section 6 and 7 of the document)
Functional Equivalence to Predicate Device (K162906): Maintain intended use, technological characteristics, and principles of operation.	"The subject device, Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector), has the same intended use as the predicate device (K162906)." "The device specifications are identical to those of the predicate device K162906, except for the new features described above." "The intended use, technological characteristics and principles of operation of the subject device remain the same as those of the predicate device."
Biocompatibility: Device materials must be biocompatible.	"Biocompatibility Testing: See Section 15" (Details not provided in the excerpt, but it indicates this testing was performed and presumably met standards).
Sterilization & Shelf-life: Device must remain sterile and functional over its shelf life.	"Sterilization & Shelf-life Testing: See Section 14" (Details not provided in the excerpt, but indicates testing was performed and met standards).
Integrity of New ENFit™ Connector Joint (to catheter): Must withstand typical forces without failure.	"Joint strength of new ENFit™ connector to the catheter" was performed. Conclusion: "Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness." (Implies acceptance criteria were met).
Integrity of ENFit™ Connector Joint (to irrigation port housing): Must withstand typical forces without failure.	"Joint strength of ENFit™ connector to the irrigation port housing" was performed. Conclusion: "Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness." (Implies acceptance criteria were met).
Drug Efficacy through ENFit™ Connector: Administration of medications should not be hindered or compromised by the new connector.	"Drug efficacy in ENFit™ connector" was performed. Conclusion: "Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness." (Implies acceptance criteria were met).
Water Leakage of ENFit™ Connector: No leakage during intended use.	"Water leakage test of the ENFit™ connector" was performed. Conclusion: "Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness." (Implies acceptance criteria were met).
Water Leakage of Self-Closing Catheter Connector: No leakage during use or when the bag is removed.	"Water leakage test of the self-closing catheter connector (both during use or when the bag is removed)" was performed. Conclusion: "Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness." (Implies acceptance criteria were met).
Overall Safety and Effectiveness: Modifications do not introduce new questions of safety and efficacy compared to the predicate device.	"Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness." and "The modifications made to the existing device do not alter its intended use, change fundamental performance, or introduce new questions of safety and efficacy when compared with the predicate device. This comparison demonstrates that Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is substantially equivalent to ConvaTec's previously cleared Flexi-Seal™ PROTECT Fecal Management System (K162906)."

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: Not explicitly stated in terms of number of devices tested for each bench test, but the document confirms these tests were "performed" and "results are detailed in Section 18 of this Submission" (which is not included in the provided excerpt). For a physical device's bench testing, this typically involves a defined number of units to ensure statistical confidence, often guided by internal quality procedures or relevant standards.
Data Provenance: The tests were non-clinical benchtop performance tests conducted to support the 510(k) submission. The location of testing is not specified, but the applicant (ConvaTec Limited) is based in the United Kingdom. The data is prospective in the sense that it was generated specifically for this premarket submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

N/A. This information is relevant for AI/software devices where human expert consensus establishes ground truth. For this physical device, ground truth is established through objective physical measurements and observations during bench testing (e.g., measuring joint strength, observing leakage). No "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for these types of engineering/material tests.

4. Adjudication Method for the Test Set:

N/A. Adjudication (e.g., 2+1, 3+1) is a process used when multiple human readers interpret data to resolve disagreements and establish a consensus "ground truth," typically for complex medical images or diagnoses. This process is not applicable to the objective physical bench testing performed for this device.

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:

No. An MRMC study is specific to evaluating the impact of AI algorithms on human reader performance. This device is a physical fecal management system, not an AI or software product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This question applies to AI/software. There is no standalone algorithm for this physical device. Section 6 explicitly states "Software Verification and Validation Testing: Not Applicable."

7. The Type of Ground Truth Used:

Objective Physical Measurements and Engineering Standards: The "ground truth" for the performance tests (joint strength, leakage, drug efficacy) are the results of controlled laboratory experiments and measurements against predefined engineering specifications (e.g., minimum strength thresholds, zero leakage, successful drug delivery simulation). These are objective, measurable outcomes, not subjective interpretations.

8. The Sample Size for the Training Set:

N/A. This device is not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.

9. How the Ground Truth for the Training Set Was Established:

N/A. As there is no AI training set, this question is not applicable.

Summary

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April 30, 2019

ConvaTec Limited Jason Skramsted Senior Regulatory Affairs Specialist GDC, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom

Re: K190114

Trade/Device Name: Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: April 3, 2019 Received: April 4, 2019

Dear Jason Skramsted:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

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) K190114

Device Name

Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector)

Indications for Use (Describe)

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

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

1. Applicant: ConvaTec Limited GDC, First Avenue Deeside Industrial Park Deeside Flintshire, CH5 2NU UK
  Establishment Registration number 1000317571
Contact: Jason Skramsted ConvaTec, Inc. Senior Regulatory Affairs Specialist Tel: 336-542-4753 Email: Jason.Skramsted@ConvaTec.com
23 January 2019 Date Prepared:

2. Device Identification:

Trade Name:	Flexi-Seal™ PROTECT PLUS Fecal ManagementSystem (with ENFit™ connector)
Common Name:	Fecal Management System
Regulation Number:	21 CFR §876.5980
Classification Panel:	Gastroenterology and Urology
Classification Name:	Gastrointestinal tube and accessories
Regulatory Class:	II
Product Classification Code:	KNT, PIF

Predicate Devices:

Predicate Manufacturer: Predicate Trade Name: Predicate 510 (k):

ConvaTec Limited Flexi-Seal™ PROTECT Fecal Management System K162906

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4. Device Description

add a self-closing ENFit port for irrigation/medication and provide an ENFit (1) syringe in the kit,
(2) add a sub-assembled self-closing quick connector to the catheter end, and
add a matching bag connector in the collection bag with an option of (3) incorporating Diamonds™ gelling and odor control sachet (4 sachets per kit) to solidify and deodorize the fecal contents in the collection bag.

The subject device is comprised of the following components (in a clamshell pack with label card, IFU and 5 date labels) see Figure 1.

Figure 1: Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector)

Image /page/4/Figure/8 description: The image shows a medical device with various components labeled with numbers. The device includes a tube-like structure labeled 4, with additional parts such as a connector labeled 7, a drainage bag labeled 11, and syringes labeled 9 and 10. There is also a small packet labeled 13, which appears to be a Diamonds ICE pack.

Catheter Irrigation and Medication Port
Balloon Inflation Port with 2-Dome Fill Indicator and Cap
Sampling Por
tention Balloon with
ENFit Syrir
11 Collection Bag
12 Cinch Clamp
13 Diamonds™ gelling and odor control sachet

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Figure 2 represents an overview of the predicate device:

Image /page/5/Figure/2 description: The image shows a diagram of a catheter and its components. The components are labeled with numbers 1 through 11, and a corresponding list describes each component. Some of the components include a catheter irrigation and medication port, a balloon inflation port, a sampling port, and a Luer-lock syringe. Other components include a collection bag with an integrated cap and a cinch clamp.

Figure 2: Flexi-Seal™ PROTECT Fecal Management System

5. Intended Use

The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

6. Performance Testing - Bench

There are no differences in the intended use or performance of the subject device and the predicate device. The device specifications are identical to those of the predicate device K162906, except for the new features described above. In addition to biocompatibility and stability tests, the following performance tests of the subject device were performed (results are detailed in Section 18 of this Submission):

(1) Joint strength of new ENFit™ connector to the catheter

(2) Joint strength of ENFit™ connector to the irrigation port housing

(3) Drug efficacy in ENFit™ connector

(4) Water leakage test of the ENFit™ connector

(5) Water leakage test of the self-closing catheter connector (both during use or when the bag is removed)

Based on non-clinical testing of the subject device for functional and structural parameters, the modifications in the subject device do not affect the safety and effectiveness. Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) described in this submission is, in our opinion, substantially equivalent to the predicate device. Flexi-Seal™ PROTECT Fecal Management System (K162906).

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7. Comparison of technological characteristic with the predicate device

It has been demonstrated through comparison of design features and performance testing, that the proposed device and its predicate have been found to be substantially equivalent.

The intended use, technological characteristics and principles of operation of the subject device remain the same as those of the predicate device.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Sterilization & Shelf-life Testing

See Section 14

Biocompatibility Testing

See Section 15

Electrical safety and electromagnetic compatibility (EMC) Not Applicable

Software Verification and Validation Testing Not Applicable

Mechanical and acoustic Testing

Not Applicable

Animal Study

Animal performance testing was not required to demonstrate the safety and effectiveness of the proposed device.

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the proposed device. Instead, substantial equivalence is based upon benchtop performance testing.

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Table 1: Comparison of Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) vs Flexi-Seal™ PROTECT Fecal Management System (K162906), Bard™ DigniShield™ Stool Management System ENFit™ and Bard™ DigniShield™ Stool Management System

Name	Subject Device:Flexi-Seal™PROTECT PLUS FecalManagement System (withENFit™ connector)	Predicate Device:Flexi-Seal™PROTECT FecalManagement System(K162906)	Bard™ DigniShield™ StoolManagement SystemENFit™	Bard™ DigniShield™ StoolManagement System(K133251)
Intended Use	Fecal Management	Fecal Management	Fecal Management	Fecal Management
Indications	The Flexi-Seal™PROTECT PLUS FecalManagement System is anindwelling fecalmanagement catheterintended for use to managefecal incontinence throughthe collection of liquid orsemi-liquid stool and toprovide access to administermedications.	The Flexi-Seal™PROTECT FecalManagement System is anindwelling fecalmanagement catheterintended for use to managefecal incontinence throughthe collection of liquid orsemi-liquid stool and toprovide access to administermedications.	Bard DigniShield™ StoolManagement System isintended for fecalmanagement by divertingand collecting liquid andsemi-liquid stool tominimize skin contact inbedridden patients and toprovide access for theadministration ofmedications. Adult UseOnly.	Bard DigniShield™ StoolManagement System isintended for fecalmanagement by divertingand collecting liquid andsemi-liquid stool tominimize skin contact inbedridden patients and toprovide access for theadministration ofmedications. Adult UseOnly.
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile
Max Usage of Device	29 days	29 days	29 days	29 days
Balloon fill volumeper IFU	35 - 45 ml based onfill indicator	35 - 45 ml based onfill indicator	45 ml	45 ml
Optimal balloon fillvolume to beindicated by a visualfill indicator	Yes	Yes	No	No
Over-inflationindicator	Yes	Yes	No	No
Odor Barrier Catheter	Yes	Yes	Yes	Yes
Catheter Material	Silicone with Zeolite	Silicone with Zeolite	Thermoplastic Elastomer and Silicone	Thermoplastic Elastomer and Silicone
Medication Delivery	Yes	Yes	Yes	Yes
ENFitTM Port for irrigation and medication (ISO 80369-3)	Yes	No (Luer)	Yes	No (Luer)
Self-Closing ENFitTM Port	Yes	No	No	No
ENFitTM Syringe in the kit	Yes	No	No	No
Self-Closing Catheter Connector	Yes	No	Yes	Yes
Collection Bag	Close with a cap (not self-closing)	Close with a cap (not self-closing)	Close with a cap (not self-closing)	Close with a cap (not self-closing)
Odor Control Sachet or Spray	DiamondsTM Gelling and odor control sachets for collection bag	No	Odor eliminator spray	Odor eliminator spray

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Note: Bard DigniShield™ Stool Management System ENFit™ is used as a comparison device for the ENFit and self-closing catheter connector only

ENFit™ is a trademark of Global Enteral Device Supplier Association (GEDSA)

Flexi-Seal™, Signal™, Diamonds™ - Trademark of ConvaTec Inc., NJ

BardTM and DigniShield™- Trademark of CR Bard, Inc. Covington,

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9. Conclusion

The modifications made to the existing device do not alter its intended use, change fundamental performance, or introduce new questions of safety and efficacy when compared with the predicate device. This comparison demonstrates that Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is substantially equivalent to ConvaTec's previously cleared Flexi-Seal™ PROTECT Fecal Management System (K162906).

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.