(96 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Applicable" and the device description focuses on mechanical and material changes.
Yes
Explanation: The device is intended to manage fecal incontinence and provide access to administer medications, which are therapeutic actions.
No
Explanation: The device is described as an indwelling fecal management catheter used for collecting liquid stool and administering medications, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a catheter, balloon, domes, ports, and a collection bag, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "managing fecal incontinence through the collection of liquid stool and to provide access to administer medications." This is a direct interaction with the patient's body for collection and administration, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter, balloon, collection bag, and connectors. These are all components of a system for managing bodily waste and administering substances in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes typically associated with diagnostic testing performed on samples in vitro.
Therefore, the Flexi-Seal™ PROTECT PLUS Fecal Management System is a medical device used for patient care and management, not an IVD.
N/A
Intended Use / Indications for 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 stool and to provide access to administer medications. The device is intended for use in adult patients.
Product codes
KNT, PIF
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.
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)
- Catheter Irrigation and Medication Port
- Balloon Inflation Port with 2-Dome Fill Indicator and Cap
- Sampling Port
- Retention Balloon with
- ENFit Syringe
- Collection Bag
- Cinch Clamp
- Diamonds™ gelling and odor control sachet
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
The device is intended for use in adult patients.
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)
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).
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Biocompatibility Testing
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
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.
1
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
2
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)
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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for ConvaTec. The logo consists of a blue circle with a white building icon inside, followed by the word "ConvaTec" in blue. The building icon has three columns and a triangular roof.
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:
-
- Applicant: ConvaTec Limited GDC, First Avenue Deeside Industrial Park Deeside Flintshire, CH5 2NU UK
Establishment Registration number 1000317571
- Applicant: ConvaTec Limited GDC, First Avenue Deeside Industrial Park Deeside Flintshire, CH5 2NU UK
-
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 Management
System (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
4
4. 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.
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
5
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).
6
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.
7
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 Fecal
Management System (with
ENFit™ connector) | Predicate Device:
Flexi-Seal™
PROTECT Fecal
Management System
(K162906) | Bard™ DigniShield™ Stool
Management System
ENFit™ | Bard™ DigniShield™ Stool
Management System
(K133251) |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Fecal Management | Fecal Management | Fecal Management | Fecal Management |
| Indications | The Flexi-Seal™
PROTECT PLUS Fecal
Management System is an
indwelling fecal
management catheter
intended for use to manage
fecal incontinence through
the collection of liquid or
semi-liquid stool and to
provide access to administer
medications. | The Flexi-Seal™
PROTECT Fecal
Management System is an
indwelling fecal
management catheter
intended for use to manage
fecal incontinence through
the collection of liquid or
semi-liquid stool and to
provide access to administer
medications. | Bard DigniShield™ Stool
Management System is
intended for fecal
management by diverting
and collecting liquid and
semi-liquid stool to
minimize skin contact in
bedridden patients and to
provide access for the
administration of
medications. Adult Use
Only. | Bard DigniShield™ Stool
Management System is
intended for fecal
management by diverting
and collecting liquid and
semi-liquid stool to
minimize skin contact in
bedridden patients and to
provide access for the
administration of
medications. Adult Use
Only. |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Max Usage of Device | 29 days | 29 days | 29 days | 29 days |
| Balloon fill volume
per IFU | 35 - 45 ml based on
fill indicator | 35 - 45 ml based on
fill indicator | 45 ml | 45 ml |
| Optimal balloon fill
volume to be
indicated by a visual
fill indicator | Yes | Yes | No | No |
| Over-inflation
indicator | 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 |
8
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,
9
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).