Flexi-Seal PROTECT Fecal Management System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of interconnected profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 7, 2017 ConvaTec Karen Howes Regulatory Affairs Manager GDC, First Avenue, Deeside Industrial Park Deeside, Flintshire CH5 2NU United Kingdom Re: K162906 > Trade/Device Name: Flexi-Seal® PROTECT™ Fecal Management System Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: February 2, 2017 Received: February 6, 2017 Dear Karen Howes: 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. {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 (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, Joyce M. Whang -S 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) Unknown K162906 Device Name Flexi-Seal® PROTECT TM Fecal Management System #### Indications for Use (Describe) 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 stool and to provide access to administer medications. The device is not intended for use on pediatric 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) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 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." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 243-1741 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image features the logo of ConvaTec, a global medical products and technologies company. The logo consists of two distinct elements: a circular icon on the left and the company name "ConvaTec" on the right. The circular icon is a blue circle with a white graphic inside, resembling a building with columns. The text "ConvaTec" is written in a bold, sans-serif font, also in blue, matching the color of the circular icon. # Section 5 510(k) Summary Applicant: ConvaTec Limited. Applicant Address: GDC, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK The Establishment Registration number is 1000317571 Contact: Karen Howes Regulatory Affairs Manager ConvaTec Ltd. GDC, First Avenue, Deeside industrial Park Deeside Flintshire, CH5 2NU UK Tel: +44(0) 1244832195 Date Prepared: 1 December 2016 Device Identification: Trade Name: Flexi-Seal® PROTECT™ Fecal Management System 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 Code: KNT Predicate Devices: 510(K) number: K150350 Flexi-Seal® SIGNAL™ Fecal Management System {4}------------------------------------------------ ### Device Description The new device is called Flexi-Seal® PROTECT™ Fecal Management System which is an upqrade to the predicate device K150350. Flexi-Seal® Signal™ Fecal Management System (also known as Flexi-Seal® Signal™ Fecal Management System with Odor Barrier), launched in October 2015. The new device uses the same design and components except - (1) the change from the 1-dome fill indicator to a new 2-dome fill indicator to provide visual cue by using - (a) a green color dome to indicate an optimal fill status of retention balloon which is similar to the existing fill indicator except the color, and - (b) a red color dome to indicate the over inflation status of retention balloon, - (2) adding a white cap that can close off the inflation port, - (3) adding a dark blue color in the sample port, and - (4) Privacy bag (one bag instead of 3). The device is comprised of the following components (in a clamshell pack with label card, IFU and 5 date labels): see diagram Image /page/4/Figure/9 description: The image shows a medical catheter with different parts labeled with numbers 1-11. The parts include the catheter irrigation and medication port, balloon inflation port, sampling port, catheter, position indicator line, low-pressure retention balloon, connector, hanging strap, luer-lock syringe, collection bag, and cinch clamp. The catheter is a long, flexible tube that is inserted into the body to drain fluids or deliver medications. # New device Flexi-Seal® PROTECT™ Fecal Management System {5}------------------------------------------------ Predicate device: Flexi-Seal® SIGNAL™ Fecal Management System Image /page/5/Figure/1 description: This image shows a diagram of a catheter system with different parts labeled with numbers 1-11. The numbers correspond to the following parts: Catheter Irrigation and Medication Port, Balloon Inflation Port with Fill Indicator, Sampling Port, Catheter, Position Indicator Line, Low-Pressure Retention Balloon with Finger Pocket, Connector, Hanging Strap, Luer-lock Syringe, Collection Bag with Integrated Cap, and Cinch Clamp. The diagram shows the different parts of the catheter system and how they are connected. ### Intended Use The Flexi-Seal PROTECT FMS 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. # Performance Testing - Bench There are no differences in the intended use or performance of the subject and the predicate device. Non clinical testing has been conducted on the predicate and subject devices. The list of non-clinical testing for which the results are detailed in Sec. 18 includes: - 1. Fill indicator testing: - a. Fill indication for optimal inflation volume of retention balloon - b. Fill Indictor for overfilling status of retention balloon - c. Fill Indicator joint strength to catheter - d. Luer valve joint strength to Inflation Port - e. Green ink adhesion - Red ink adhesion f. - 2. Inflation port cap testing: - a. Cap joint strength to the fill indicator - b. Cap removal force - c. Cap repeated removal 5 times - 3. Sampling port testing: - a. Sampling port seal against air - b. Sampling port seal against water - 4. Privacy bag testing: {6}------------------------------------------------ - a. Width of clear window at 10 25 mm - b. Graduation at 500 ml is within ± 15% - c. Graduation at 1000 ml is within ± 15% - d. Pouch has 1 Liter capacity - e. Ink Adhesion - 5. Journey hazard testing: - a. Journey hazard testing - b. Post-JHT Product Release Testing Visual, Color, and Cap - c. Post-JHT Product Release Testing Fill indication for optimal inflation volume of retention balloon - d. Post-JHT Product Release Testing Fill Indictor for overfilling status of retention balloon 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 of the predicate device. Flexi-Seal® PROTECT™ Fecal Management System described in this submission is, in our opinion, substantially equivalent to the predicate device, Flexi-Seal® SIGNAL™ Fecal Management System per K150350. ### Substantial Equivalence Conclusion 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; see following pages. {7}------------------------------------------------ ### Substantial Equivalence Discussion The following table compares the similarities and differences between the subject device: Flexi-Seal® PROTECT™ Fecal Management System and the predicate device: Flexi-Seal® SIGNAL™ Fecal Management System (ref; K150350) 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 fecal management system remains the same as those of the predicate device. | | Subject Device | Predicate | Comparison | | |----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Parameter | Flexi-Seal® PROTECT™ Fecal Management<br>System | Flexi-Seal® SIGNAL™ Fecal Management System<br>(K150350) | Similarities | Differences | | FDA Product Code | KNT | KNT | Both devices are the same | None | | FDA Classification<br>Regulation | 21 CFR 876.5980 | 21 CFR 876.5980 | Both devices are the same | None | | Regulatory Class | Class II | Class II | Both devices are the same | None | | Intended Use | To manage fecal incontinence through the<br>collection of liquid to semi-liquid stool and to<br>provide access to administer medications | To manage fecal incontinence through the collection<br>of liquid to semi-liquid stool and to provide access to<br>administer medications | Both devices are the same | None | | Functional<br>configuration | Collapsible catheter with distal end secured<br>in the rectum and proximal end connected to<br>a collection bag | Collapsible catheter with distal end secured in the<br>rectum and proximal end connected to a collection<br>bag | Both devices are the same | None | | Retention feature | Soft annular balloon | Soft annular balloon | Both devices are the same | None | | Balloon material | Silicone rubber | Silicone rubber | Both devices are the same | None | | Inflation<br>management | Sealed water filled balloon | Sealed water filled balloon | Both devices are the same | None | | Retention balloon | Water/saline (45ml) | Water/saline (45ml) | Both devices are the same | None | | inflation material | | | same | | | Retention balloon<br>inflated diameter | 56.82mm | 56.82mm | Both devices are the<br>same | None | | Retention balloon<br>inflated height | 25.96mm | 25.96mm | Both devices are the<br>same | None | | Catheter tube<br>material | Silicone rubber plus 3% zeolite, by weight | Silicone rubber plus 3% zeolite, by weight | Both devices are the<br>same | None | | Catheter tube<br>surface roughness | <15µm | <15µm | Both devices are the<br>same | None | | Fill indication for<br>optimal inflation<br>volume of<br>retention balloon | Green dome inflated at 35 - 45 ml | White dome inflated at 35 - 45 ml | Except color, both<br>devices provided the<br>same visual indication<br>for optimal balloon<br>inflation volume. The<br>dimension of the fill<br>indicator is similar. | Color | | Fill Indictor for<br>overfilling status of<br>retention balloon | Red dome inflated beyond 45 ml and above | None | A new feature in the<br>subject device using a<br>similar fill indicator<br>design | A new feature in the<br>subject device | | Cap for inflation<br>port | A removable silicone cap to close off the<br>inflation port with sufficient removal force<br>and joint strength | None | A new feature in the<br>subject device to<br>differentiate the<br>inflation port from the<br>irrigation port | A new feature in the<br>subject device | | Catheter tube<br>hardness | Shore A 38.5 - 51 | Shore A 38.5 - 51 | Both devices are the<br>same | None | | Catheter tube wall<br>thickness | 0.40 - 0.65mm | 0.40 - 0.65mm | Both devices are the<br>same | None | | Catheter tube<br>tensile strength | 245N | 245N | Both devices are the<br>same | None | | Balloon-to-tube<br>bonding strength | 25.4N | 25.4N | Both devices are the<br>same | None | | Catheter tube<br>length | 1,550mm - 1,670mm | 1,550mm - 1,670mm | Both devices are the<br>same | None | | Length of<br>sphincter section | >10cm | >10cm | Both devices are the<br>same | None | | Drain channel | Large main drain tube | Large main drain tube | Both devices are the<br>same | None | | Inflation and<br>irrigation port<br>connections | Luer | Luer | Both devices are the<br>same | None | | Inflation lumen<br>diameter | Two lumens at 1.45 mm | Two lumens at 1.45 mm | Both devices are the<br>same | None | | Inflation lines | 2 | 2 | Both devices are the<br>same | None | | Irrigation lines | 1 | 1 | Both devices are the<br>same | None | | Irrigation lumen<br>size | 8mm x 1.6mm (collapsible) | 8mm x 1.6mm (collapsible) | Both devices are the<br>same | None | | Sampling port | Closable snap seal for catheter syringe<br>access - dark blue color | Closable snap seal for catheter syringe access -<br>natural color | Except color, both<br>devices provided the<br>same seal against<br>water and air. | Color | | Waste lumen<br>diameter collapsed | 10mm | 10mm | Both devices are the<br>same | None | | Collection bag<br>configuration | Disposable with gas filter | Disposable with gas filter | Both devices use the<br>same filter, flange,<br>and film panels in the<br>collection bag. | One bag in the subject<br>device vs. three bags in<br>the predicate device | | Collection bag size | 1 litre disposable | 1 litre disposable | Both devices are the<br>same | None | | Collection bag<br>material | Ethyl vinyl acetate | Ethyl vinyl acetate | Both devices are the<br>same | None | | Collection bag -<br>front panel color | White with a clear window | Clear | Except color in the<br>front panel, both bags<br>perform the same | Color | | Method of bed<br>connection | Hanging strap on bag connector | Hanging strap on bag connector | Both devices are the<br>same | None | | Accessory<br>components | Syringe and cinch clamp | Syringe and cinch clamp | Both devices are the<br>same | None | | Flow stop<br>mechanism | External cinch clamp | External cinch clamp | Both devices are the<br>same | None | | Sterility status<br>(how provided) | Non-sterile | Non-sterile | Both devices are the<br>same | None | | Packaging | Thermoformed plastic clamshell PETG<br>(POLYETHYLENE TEREPHTHALATE<br>GLYCOL-MODIFIED) or APET<br>(AMORPHOUS POLYETHYLENE<br>TEREPHTHALATE), both sides coated with<br>2% silicone. | Thermoformed plastic clamshell PETG<br>(POLYETHYLENE TEREPHTHALATE GLYCOL-<br>MODIFIED) or APET (AMORPHOUS<br>POLYETHYLENE TEREPHTHALATE), both sides<br>coated with 2% silicone. | Both devices use the<br>same packaging<br>material | None | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------