(171 days)
Not Found
No
The summary describes a mechanical fecal management system with no mention of AI or ML components or functions.
No.
A therapeutic device is one that treats a disease or condition. This device is intended to manage fecal incontinence by collecting liquid stool and providing access for medication administration, which is a management tool rather than a therapeutic treatment.
No
Explanation: The device is intended for managing fecal incontinence and administering medications, not for diagnosis. It collects liquid stool and provides access for medication, which are therapeutic and management functions.
No
The device description clearly outlines multiple physical components including a catheter, balloon, syringes, collection bag, and sachets, indicating it is a hardware-based medical device.
Based on the provided information, the Flexi-Seal AIR™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "manage fecal incontinence through the collection of liquid stool and to provide access to administer medications." This is a direct management of a physiological condition and administration of substances within the body.
- Device Description: The device is a catheter system designed for insertion into the rectum to collect stool. This is a physical device interacting with the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Flexi-Seal AIR™ does not perform any such analysis of specimens.
Therefore, the Flexi-Seal AIR™ is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended 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 (comma separated list FDA assigned to the subject device)
KNT, PIF
Device Description
The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low pressure foam-filled 100% silicone rectal retention balloon fixed to the distal end of a soft collapsible silicone catheter tube with a labelled white inflation port and an auto Inflate valve, Luer lock inflation syringe, an ENFit connector for irrigation/medication port with an ENFit compatible syringe, cinch clamp, date formatted labels, a sub-assembled self-closing quick connector to the catheter end, a matching collection bag, and "Diamonds" gelling and odor control sachets (4 sachets per kit). The components are contained in a rigid thermoformed plastic clamshell.
The following is a list of design changes in the subject device, Flexi-Seal Air™ versus the primary predicate device, Flexi-Seal® PROTECT Plus Fecal Management System ref K190114.
(1) A new foam filled retention balloon which is similar to the existing balloon in function and use. A single pilot balloon indicator is used to assess if the balloon is fully deflated or approximately filled. Air is used instead of water for balloon inflation.
(2) Addition of an auto-valve to automatically inflate the balloon, self-regulate the balloon pressure to 0 mm Hg, and release of excessive balloon pressure to prevent balloon over-inflation during bowl/patient movement.
(3) Addition of an odor barrier outer polyurethane tube to the external of the current silicone tube using the tube-in-tube design except the first 10cm of the balloon end which is still a 100% silicone tube without polyurethane.
(4) A revised blue color silicone cover with fingertip grips and a taller key at the bag flange to mitigate use errors in coupling the bag upside down and trapping the bag film and minor print edits in the catheter connector. These print modifications include a blue arrow (catheter side) that corresponds with the taller blue key (bag side) and a red 'no-entry' symbol to show when the connector is in the upside-down orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum (implied by rectal retention balloon)
Indicated Patient Age Range
adult patients. Not intended for use on pediatric 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 for Flexi-Seal Air™ was conducted for functional and structural parameters. In this testing, the device's performance has been found to be substantially equivalent to the predicate device both functionally and structurally (balloon, auto inflate valve, joint strength, mechanical properties, odor barrier, 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 10993-1:2018, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process’ , issued September 8, 2023, and has been found safe in such respect for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2025
Convatec Michael Chitiyo Regulatory Affairs Specalist First Avenue, Deeside Industrial Estate Deeside Flintshire, CH5 2NU United Kingdom
Re: K243228
Trade/Device Name: Flexi-Seal AIR (with ENFit Connector) Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: KNT, PIF Dated: October 24, 2024 Received: February 28, 2025
Dear Michael Chitiyo:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anthony Lee -S
Anthony C. Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Flexi-Seal AIR (with ENFit ™ Connector)
Indications for Use (Describe)
Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended 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)
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4
510(k) Summary
This summary of 510(k) safety and effectiveness information us submitted in accordance with the requirements of 21 CFR §807.92:
1. Applicant:
ConvaTec Limited, GDC Building First Avenue Deeside Flintshire, GB CH5 2NU Establishment Registration number 3008806809
- Contact: Courtney Smith ConvaTec, Inc. Senior Director Regulatory Affairs Ostomy Care & Continence Care Tel: 239-7762947 Email: courtney.smith@convatec.com
2. Device Identification:
| Trade Name | Flexi-Seal AIR (with ENFit Connector) | ||
|---|---|---|---|
| Common Name | Fecal Management System | ||
| Regulation Number | 21 CFR §876.5980 | ||
| Classification Name | Gastrointestinal tube and accessories | ||
| Regulatory Class | II | ||
| Product Classification Code | KNT | ||
| Device Description | The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low | ||
| pressure foam-filled 100% silicone rectal retention balloon fixed to | |||
| the distal end of a soft collapsible silicone catheter tube with a | |||
| labelled white inflation port and an auto Inflate valve, Luer lock | |||
| inflation syringe, an ENFit connector for irrigation/medication port | |||
| with an ENFit compatible syringe, cinch clamp, date formatted labels, | |||
| a sub-assembled self-closing quick connector to the catheter end, a | |||
| matching collection bag, and "Diamonds" gelling and odor control | |||
| sachets (4 sachets per kit). The components are contained in a rigid | |||
| thermoformed plastic clamshell. | |||
| The following is a list of design changes in the subject device, Flexi- | |||
| Seal Air™ versus the primary predicate device, Flexi-Seal® PROTECT | |||
| Plus Fecal Management System ref K190114. | |||
| (1) | |||
| A new foam filled retention balloon which is similar to the | |||
| existing balloon in function and use. A single pilot balloon | |||
| indicator is used to assess if the balloon is fully deflated or |
5
| | approximately filled. Air is used instead of water for balloon
inflation. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (2) | Addition of an auto-valve to automatically inflate the balloon,
self-regulate the balloon pressure to 0 mm Hg, and release of
excessive balloon pressure to prevent balloon over-inflation
during bowl/patient movement. |
| (3) | Addition of an odor barrier outer polyurethane tube to the
external of the current silicone tube using the tube-in-tube
design except the first 10cm of the balloon end which is still a
100% silicone tube without polyurethane. |
| (4) | A revised blue color silicone cover with fingertip grips and a
taller key at the bag flange to mitigate use errors in coupling
the bag upside down and trapping the bag film and minor
print edits in the catheter connector. These print
modifications include a blue arrow (catheter side) that
corresponds with the taller blue key (bag side) and a red 'no-
entry' symbol to show when the connector is in the upside-
down orientation. |
| | Image: Product diagram with labels |
| | 1 Catheter Irrigation and Medication Port – ENFit™
2 Balloon Inflation/Deflation Port with Pilot Balloon
Indicator
3 Auto Inflate Valve
4 Sampling Port
5 Catheter (including Tube-in-Tube after Black Mark)
6 Position Indicator Line
7 Low-Pressure Retention Balloon with Finger Pocket
8 Self-Closing Connector
9 Hanging Strap
10 Luer-Lock Syringe
11 ENFit™ Syringe
12 Collection Bag
13 Blue Key
14 Fingertip Grips
15 Cinch Clamp
16 4 ConvaTec Diamonds™ gelling and odor control sachets |
| Indications for Use | Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal
management catheter intended 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. |
| Performance Data | Performance testing for Flexi-Seal Air™ was conducted for functional
and structural parameters. In this testing, the device's performance has
been found to be substantially equivalent to the predicate device both
functionally and structurally (balloon, auto inflate valve, joint strength,
mechanical properties, odor barrier, 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 10993-1:2018, ‘Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing within a Risk
Management Process’ , issued September 8, 2023, 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 K190114. |
6
| Technological Comparison | Fecal management system is the intended technological principle for both the subject and predicate devices.
At a high level Flexi-Seal Air™ and the primary predicate Flexi-Seal Protect Plus are based on the following same technological elements: Indications for use Low profile retention balloon A finger pocket to allow for easy balloon insertion. A silicone catheter A pilot balloon at the inflation/deflation port to indicate the fill status of the retention balloon. A quick connector that self-closes when bag is connected Ability to administer the medication through the use of a cinch clamp. The following is a list of design changes in the subject device, Flexi-Seal Air™ versus the predicate device, Flexi-Seal® PROTECT Plus Fecal Management System ref K190114: A new foam filled retention balloon, which is inflated with air. Addition of an auto-valve to automatically inflate the balloon. Addition of an odor barrier outer polyurethane tube A revised blue color silicone cover with fingertip grips and a taller key at the bag flange and minor print edits in the catheter connector, a matching blue arrow that corresponds with the taller blue key and a red 'no-entry' symbol to show the connector is upside down. |
| -------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
7
Device Comparison Table
| Characteristic | Subject Device | Primary Predicate Device (K190114) | | regulate balloon pressure to less
than 22 mm Hg | corresponding pressure above 50 -
70 mm Hg) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|
| Name | Flexi-Seal Air™ ENFit | Flexi-Seal™ PROTECT Plus FMS | Balloon Insertion Depth
Marking | Yes | Yes |
| Intended Use | Fecal Management | Fecal Management | Odor Barrier Catheter | Yes | Yes |
| Indication for Use | Flexi-Seal Air™ 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. | The Flexi-Seal™ PROTECT Plus Fecal Management System is an indwelling fecal management catheter with odor barrier intended for use to manage fecal incontinence through the collection of liquid or semi-liquid stool and to provide access to administer medications. The device is not intended for use on pediatric patients. | Catheter Material | Tube-in-Tube (polyurethane
outer tube and silicone inner
tube) | Silicone with Zeolite |
| Sterility | Non-Sterile | Non-Sterile | Medication Delivery | Yes | Yes |
| Max Usage of Device | 29 days | 29 days | ENFitTM Port for
irrigation
and medication
(ISO 80369-3) | Yes | Yes |
| Inflated Balloon Height for anchoring in rectum, mm | 36 | 26 | Self-Closing ENFitTM Port | Yes | Yes |
| Retention Balloon Diameter for anchoring in rectum | 60 - 61 | 57 | ENFitTM Syringe in the kit | Yes | Yes |
| Substance to inflate balloon | Air | Water/Saline | Self-Closing Catheter
Connector | Yes | Yes |
| Balloon fill volume per IFU | NA – Auto inflate by connecting Auto inflate Valve | 35 - 45 ml based on fill indicator | Collection Bag | Close with a cap
(not self-closing),
1 Liter | Close with a cap
(not self-closing),
1 Liter |
| Balloon fill volume customized for each patient | Yes, automatically based on auto inflate valve | Yes, passively using fill indicator by HCP providers | Odor Control Sachet or
Spray | DiamondsTM Gelling and odor
control sachets for collection bag | DiamondsTM Gelling and odor
control sachets for collection bag |
| Marked Balloon inflation visual indicator | Yes White dome shows inflation or deflation | Yes Green dome shows the optimal fill volume, and the red dome indicates over inflation. | | | |
| Active Balloon Pressure Management | Yes - Balloon pressure less than 22 mm Hg | No – Only passive balloon pressure management using indicator | | | |
| Automatic Excessive Pressure Relief | Yes | No | | | |
| Means to mitigate balloon over-inflation | The device has an auto inflate valve with pressure relief to self- | Red dome signals over-inflation beyond 45 ml and above (or | | | |
8
- ENFit™ is a trademark of Global Enteral Device Supplier Association (GEDSA). Flexi-Seal™, Diamonds™– Trademark of ConvaTec Inc., NJ
Overall Conclusions
There are no differences in the intended use or performance of the subject and 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 its safety and effectiveness. Flexi-Seal Air™ described in this submission is substantially equivalent to the predicate device of Flexi-Seal™ PROTECT Plus Fecal Management System K190114.