(160 days)
For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.
The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer-lock syringe, a collection bag with cap and a cinch clamp to pinch off flow in the catheter when required for medication retention or to stop waste flow. The components are contained in a rigid thermoformed plastic clamshell. The catheter main drain tube is fabricated from collapsible silicone rubber with the addition of an odor adsorber, which is added in order to help contain the fecal odor which often permeates through the wall of the catheter. The drain tube has a low-pressure silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and also available separately) at the proximal end. There is a recess (pocket) under the balloon for the clinician's finger, which allows the device to be positioned digitally. Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication if prescribed. An additional sampling port is located on the side of the catheter, which allows access to clinicians for stool sample collection. A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal. The device, collection bag and syringe are intended for single us, are provided non-sterile and contain no components made with animal products, natural rubber latex or DEHP.
The provided document is a 510(k) premarket notification for a medical device called the Flexi-Seal® Signal™ Fecal Management System. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in the manner one might find for a novel device or AI/software.
However, I can extract and infer information relevant to your request based on the content available.
Here's an analysis of the acceptance criteria and the study as described in the document, framed around your specific questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific thresholds and reported performance against those thresholds like one might see for a diagnostic device's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device (Flexi-Seal® SIGNAL™ Fecal Management System, K112342). The performance is reported as being "substantially equivalent" in various parameters.
| Parameter (Implied Acceptance Criteria) | Reported Device Performance (Subject Device K150350) | Comparison to Predicate (K112342) |
|---|---|---|
| Intended Use (Collect liquid to semi-liquid stool, administer medications) | Manage fecal incontinence through collection of liquid to semi-liquid stool and provide access to administer medications | Same as predicate |
| Functional Configuration (Collapsible catheter, distal end secured, proximal to collection bag) | Collapsible catheter with distal end secured in rectum and proximal end connected to a collection bag | Same as predicate |
| Retention Feature (Soft annular balloon) | Soft annular balloon | Same as predicate |
| Balloon Material (Silicone rubber) | Silicone rubber | Same as predicate |
| Inflation Management (Sealed water-filled balloon) | Sealed water-filled balloon | Same as predicate |
| Retention Balloon Inflation Material (Water/saline - 45ml) | Water/saline (45ml) | Same as predicate |
| Catheter Tube Length (1,550mm - 1,670mm) | 1,550mm - 1,670mm | Same as predicate |
| Length of Sphincter Section (>10cm) | >10cm | Same as predicate |
| Drain Channel (Large main drain tube) | Large main drain tube | Same as predicate |
| Inflation/Irrigation Port Connections (Luer) | Luer | Same as predicate |
| Inflation Lumen Diameter (Two lumens at 1.45 mm) | Two lumens at 1.45 mm | Same as predicate |
| Inflation Lines (2) | 2 | Same as predicate |
| Irrigation Lines (1) | 1 | Same as predicate |
| Sampling Port (Closable snap seal for catheter syringe access) | Closable snap seal for catheter syringe access | Same as predicate |
| Collection Bag Configuration (Disposable with gas filter) | Disposable with gas filter | Same as predicate |
| Collection Bag Size (1 liter disposable) | 1 litre disposable | Same as predicate |
| Method of Bed Connection (Hanging strap on bag connector) | Hanging strap on bag connector | Same as predicate |
| Accessory Components (Syringe and cinch clamp) | Syringe and cinch clamp | Same as predicate |
| Flow Stop Mechanism (External cinch clamp) | External cinch clamp | Same as predicate |
| Sterility Status (Non-sterile) | Non-sterile | Same as predicate |
| Packaging (Thermoformed plastic clamshell) | Thermoformed plastic clamshell | Same as predicate |
| Material Softness | Maintained/evaluated via bench testing | Substantially equivalent |
| Catheter Tube Diameter | Evaluated via bench testing | Substantially equivalent |
| Catheter Tube Hardness | Evaluated via bench testing | Substantially equivalent |
| Catheter Tube Tensile Strength | Evaluated via bench testing | Substantially equivalent |
| Balloon-Catheter Bonding | Evaluated via bench testing | Substantially equivalent |
| Biocompatibility | Tested per ISO-10993 | Found safe for intended use |
| Odor Adsorbing Properties (Added feature) | Incorporates odor adsorber to help contain fecal odor | Difference (Advantageous to patient wellbeing) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical bench testing rather than human clinical studies with a test set of patients. Therefore, specific sample sizes for a "test set" in the context of patient data are not applicable. The testing was conducted by ConvaTec Ltd. which is based in the UK. The document does not specify if the testing was done at their UK facility or elsewhere, nor does it refer to "retrospective" or "prospective" as these terms typically apply to clinical studies using patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The device is a physical medical device, not a diagnostic algorithm requiring expert "ground truth" for interpretation. The evaluation involved bench testing of physical properties and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when interpreting ambiguous results, often involving multiple readers. This premarket notification describes bench testing for substantial equivalence, not such a clinical study.
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
This question is not applicable. The device is a physical fecal management system, not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and functional parameters, the "ground truth" is established by bench testing against engineering specifications and performance standards. For biocompatibility, the "ground truth" is established by adherence to ISO-10993 standards. These are objective, measurable physical properties, not subjective interpretations or clinical outcomes in the typical sense of "ground truth".
8. The sample size for the training set
This question is not applicable. This is a physical device clearance, not an AI/ML submission that would involve a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this type of device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
ConvaTec, Ltd. Clare Williamson Regulatory Affairs Documentation Compliance Manager Unit 20, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU UK
Re: K150350 Trade/Device Name: Flexi-Seal® Signal™ Fecal Management System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 18, 2015 Received: June 24, 2015
Dear Clare Williamson,
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. 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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K150350 |
|---|---|
| Device Name | Flexi-Seal® Signal™ Fecal Management System |
| Indications for Use (Describe) | For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. |
| 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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| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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Image /page/3/Picture/0 description: The image shows the logo for ConvaTec. The logo consists of the word "ConvaTec" in blue, followed by a blue circle with a stylized image of a building with three columns inside. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
Unit 20, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU Telephone: 01244 584000 Facsimile: 01244 584011
510(k) Summary
Subject Device: Flexi-Seal® SIGNAL™ Fecal Management System
Date Prepared: February 06, 2015
Applicant: ConvaTec Ltd.
First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK
Contact: Clare Williamson
Regulatory Affairs Documentation Compliance Manager Tel: +44 (0)1244 584155 Fax: +44 (0)1244 584311 Email: clare.williamson@convatec.com
Device Trade Name: Flexi-Seal® SIGNAL™ Fecal Management System
Common Name: Fecal Management System
Classification Name: Gastrointestinal Tube and Accessories (21 CFR §876.5980, Product Code: KNT)
Device Class: Class II
Predicate Device:
Device Trade Name: Flexi-Seal® SIGNAL™ Fecal Management System -ConvaTec Inc.
Common Name: Fecal Management System
Classification Name: Gastrointestinal Tube and Accessories (21 CFR §876.5980, Product Code: KNT)
Device Class: Class II
510(k) Substantial Equivalence: K112342 - determined substantially equivalent on April 26, 2012
Device Description:
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The Flexi-Seal® SIGNAL™ Fecal Management System is comprised of a soft catheter tube assembly, a Luer-lock syringe, a collection bag with cap and a cinch clamp to pinch off flow in the catheter when required for medication retention or to stop waste flow. The components are contained in a rigid thermoformed plastic clamshell.
The catheter main drain tube is fabricated from collapsible silicone rubber with the addition of an odor adsorber, which is added in order to help contain the fecal odor which often permeates through the wall of the catheter.
The drain tube has a low-pressure silicone retention balloon at the distal end and a connector for attaching a collection bag (provided with the device and also available separately) at the proximal end. There is a recess (pocket) under the balloon for the clinician's finger, which allows the device to be positioned digitally.
Two ports are attached to the side of the catheter. One port is used to inflate the retention balloon with water or saline after the device has been inserted into the patient's rectum. This port also provides a visual and tactile signal of when the low pressure retention balloon is filled to its optimal volume. The other port is used to flush the device if needed and administer medication if prescribed.
An additional sampling port is located on the side of the catheter, which allows access to clinicians for stool sample collection.
A syringe (provided with the device) is used to fill and evacuate the retention balloon for insertion and removal.
The device, collection bag and syringe are intended for single us, are provided non-sterile and contain no components made with animal products, natural rubber latex or DEHP.
This Traditional 510(k) concerns modifications which do not alter the indications for use of the predicate device, the Flexi-Seal® SIGNAL™ Fecal Management System (ref. K112342).
Intended use:
The Flexi-Seal® SIGNAL™ Fecal Management System 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 not intended for use on pediatric patients.
Summary of Technological Characteristics:
The Flexi-Seal® SIGNAL™ Fecal Management System has the same intended use and indications for use as the predicate device, however the tubing now incorporates odor adsorbing properties. The adsorber reduces the odor which often permeates through the wall of the catheter. These unpleasant odors during catheter use can cause major discomfort to the patients, caregivers and visitors. Therefore, the reduction of odor is advantageous to overall patient wellbeing.
The device specifications are essentially identical to those of the predicate device, although minor adjustments have been made to the catheter tubing to
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ensure that the material softness remains. Catheter tube diameter, catheter tube hardness, catheter tube tensile strength, and balloon-catheter bonding were evaluated via bench testing and are substantially equivalent to the predicate device. There are no differences in operation between the Flexi-Seal® SIGNAL ™ Fecal Management System and the predicate device.
Summary of Performance (Non-Clinical Testing) Data:
Non-clinical testing of the subject device for functional and structural parameters has been performed. In this testing, the device's performance has been found to be substantially equivalent to the aforementioned predicate device both functionally and structurally (material strength, catheter size, balloon size, etc.). The device has also been evaluated for biocompatibility in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', issued May 1, 1995, and has been found safe in such respect for its intended use.
In conclusion, the subject device has been demonstrated as safe and effective and substantially equivalent to the predicate device.
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Summary of Technological Characteristics
The following table summarises the technological characteristics of the subject and predicate devices (ref. K112342, determined substantially equivalent on April 26, 2012) and outlines the product characteristics and specifications which form the basis of the substantial equivalence discussion.
The intended use, technological characteristics and principles of operation of the Flexi-Seal® SIGNAL™ Fecal Management System remains the same as those of the predicate device.
| Subject Device | Predicate | Comparison | ||
|---|---|---|---|---|
| Parameter | Flexi-Seal® SIGNAL™ Fecal ManagementSystem | Flexi-Seal® SIGNAL™ Fecal ManagementSystem(K112342) | Similarities | Differences |
| FDA ProductCode | KNT | KNT | Both devices are the same | None |
| FDAClassificationRegulation | 21 CFR 876.5980 | 21 CFR 876.5980 | Both devices are the same | None |
| RegulatoryClass | Class II | Class II | Both devices are the same | None |
| Intended Use | To manage fecal incontinence through thecollection of liquid to semi-liquid stool and toprovide access to administer medications | To manage fecal incontinence through thecollection of liquid to semi-liquid stool and toprovide access to administer medications | Both devices are the same | None |
| Functionalconfiguration | Collapsible catheter with distal end secured inthe rectum and proximal end connected to acollection bag | Collapsible catheter with distal end secured inthe rectum and proximal end connected to acollection bag | Both devices are the same | None |
| Retentionfeature | Soft annular balloon | Soft annular balloon | Both devices are the same | None |
| Balloon material | Silicone rubber | Silicone rubber | Both devices are the same | None |
| Inflationmanagement | Sealed water filled balloon | Sealed water filled balloon | Both devices are the same | None |
| Retentionballoon inflationmaterial | Water/saline (45ml) | Water/saline (45ml) | Both devices are the same | None |
| Catheter tubelength | 1,550mm - 1,670mm | 1,550mm - 1,670mm | Both devices are the same | None |
| Length ofsphincter section | >10cm | >10cm | Both devices are the same | None |
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| Parameter | Subject Device | Predicate | Comparison | |
|---|---|---|---|---|
| Flexi-Seal® SIGNAL™ Fecal ManagementSystem | Flexi-Seal® SIGNAL™ Fecal ManagementSystem(K112342) | Similarities | Differences | |
| Drain channel | Large main drain tube | Large main drain tube | Both devices are the same | None |
| Inflation andirrigation portconnections | Luer | Luer | Both devices are the same | None |
| Inflation lumendiameter | Two lumens at 1.45 mm | Two lumens at 1.45 mm | Both devices are the same | None |
| Inflation lines | 2 | 2 | Both devices are the same | None |
| Irrigation lines | 1 | 1 | Both devices are the same | None |
| Sampling port | Closable snap seal for catheter syringe access | Closable snap seal for catheter syringe access | Both devices are the same | None |
| Collection bagconfiguration | Disposable with gas filter | Disposable with gas filter | Both devices are the same | None |
| Collection bagsize | 1 litre disposable | 1 litre disposable | Both devices are the same | None |
| Method of bedconnection | Hanging strap on bag connector | Hanging strap on bag connector | Both devices are the same | None |
| Accessorycomponents | Syringe and cinch clamp | Syringe and cinch clamp | Both devices are the same | None |
| Flow stopmechanism | External cinch clamp | External cinch clamp | Both devices are the same | None |
| Sterility status(how provided) | Non-sterile | Non-sterile | Both devices are the same | None |
| Packaging | Thermoformed plastic clamshell | Thermoformed plastic clamshell | Both devices are the same | None |
§ 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.