(171 days)
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.
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.
I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.
The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Flexi-Seal AIR (with ENFit Connector). While it details the device, its intended use, technological comparisons, and the rationale for substantial equivalence to a predicate device, it does not contain information about specific "acceptance criteria" for a study that proves the device meets these criteria in the way you've outlined.
Specifically, the document states:
- "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."
This indicates that various performance tests (functional, structural, biocompatibility) were done to demonstrate substantial equivalence to a predicate device, which is the primary requirement for 510(k) clearance. However, it does not specify:
- A table of explicit "acceptance criteria" and "reported device performance" in a quantitative manner as you've requested.
- Sample sizes for a test set proving a specific performance goal.
- Data provenance, number of experts, adjudication methods, or ground truth establishment as would be present in a clinical performance study for an AI/ML device or a device requiring specific clinical performance metrics to be proven.
- MRMC studies or standalone algorithm performance.
The document is a regulatory submission for a medical device that appears to be a physical product (fecal management catheter), not an AI/ML software device. Thus, the questions regarding "AI vs. without AI assistance," "standalone (algorithm only) performance," and ground truth establishment for a training set are not applicable here.
Therefore, I cannot extract the information you've requested as it is not present in the provided text.
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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"
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(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.
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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
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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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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 lowpressure foam-filled 100% silicone rectal retention balloon fixed tothe distal end of a soft collapsible silicone catheter tube with alabelled white inflation port and an auto Inflate valve, Luer lockinflation syringe, an ENFit connector for irrigation/medication portwith an ENFit compatible syringe, cinch clamp, date formatted labels,a sub-assembled self-closing quick connector to the catheter end, amatching collection bag, and "Diamonds" gelling and odor controlsachets (4 sachets per kit). The components are contained in a rigidthermoformed plastic clamshell.The following is a list of design changes in the subject device, Flexi-Seal Air™ versus the primary predicate device, Flexi-Seal® PROTECTPlus Fecal Management System ref K190114. | ||
| (1)A new foam filled retention balloon which is similar to theexisting balloon in function and use. A single pilot balloonindicator is used to assess if the balloon is fully deflated or |
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| approximately filled. Air is used instead of water for ballooninflation. | |
|---|---|
| (2) | Addition of an auto-valve to automatically inflate the balloon,self-regulate the balloon pressure to 0 mm Hg, and release ofexcessive balloon pressure to prevent balloon over-inflationduring bowl/patient movement. |
| (3) | Addition of an odor barrier outer polyurethane tube to theexternal of the current silicone tube using the tube-in-tubedesign except the first 10cm of the balloon end which is still a100% silicone tube without polyurethane. |
| (4) | A revised blue color silicone cover with fingertip grips and ataller key at the bag flange to mitigate use errors in couplingthe bag upside down and trapping the bag film and minorprint edits in the catheter connector. These printmodifications include a blue arrow (catheter side) thatcorresponds 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 BalloonIndicator3 Auto Inflate Valve4 Sampling Port5 Catheter (including Tube-in-Tube after Black Mark)6 Position Indicator Line7 Low-Pressure Retention Balloon with Finger Pocket8 Self-Closing Connector9 Hanging Strap10 Luer-Lock Syringe11 ENFit™ Syringe12 Collection Bag13 Blue Key14 Fingertip Grips15 Cinch Clamp16 4 ConvaTec Diamonds™ gelling and odor control sachets | |
| Indications for Use | Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecalmanagement catheter intended to manage fecal incontinencethrough the collection of liquid to semi-liquid stool and to provideaccess to administer medications. The device is intended for use inadult patients. |
| Performance Data | Performance testing for Flexi-Seal Air™ was conducted for functionaland structural parameters. In this testing, the device's performance hasbeen found to be substantially equivalent to the predicate device bothfunctionally and structurally (balloon, auto inflate valve, joint strength,mechanical properties, odor barrier, etc).The device has also been evaluated for biocompatibility in accordancewith the US Food and Drug Administration's guidance entitled Use ofInternational Standard ISO 10993-1:2018, ‘Biological Evaluation ofMedical Devices Part 1: Evaluation and Testing within a RiskManagement Process’ , issued September 8, 2023, and has been foundsafe in such respect for its intended use.In conclusion, the subject device has been demonstrated as safe andeffective and substantially equivalent to the predicate device K190114. |
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| 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. |
|---|---|
| -------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Device Comparison Table
| Characteristic | Subject Device | Primary Predicate Device (K190114) | regulate balloon pressure to lessthan 22 mm Hg | corresponding pressure above 50 -70 mm Hg) | |
|---|---|---|---|---|---|
| Name | Flexi-Seal Air™ ENFit | Flexi-Seal™ PROTECT Plus FMS | Balloon Insertion DepthMarking | 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 (polyurethaneouter tube and silicone innertube) | Silicone with Zeolite |
| Sterility | Non-Sterile | Non-Sterile | Medication Delivery | Yes | Yes |
| Max Usage of Device | 29 days | 29 days | ENFitTM Port forirrigationand 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 CatheterConnector | 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 orSpray | DiamondsTM Gelling and odorcontrol sachets for collection bag | DiamondsTM Gelling and odorcontrol 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 |
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- 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.
§ 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.