hygh-tec drainage

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 9, 2023 Creative Balloons GmbH Michael Nilo President and Principal Consultant Nilo Medical Consulting Group 3491 Denny St. Pittsburgh, PA 15201 Re: K221400 Trade/Device Name: hygh-tec drainage Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: January 10, 2023 Received: January 11, 2023 Dear Michael Nilo: 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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, Image /page/1/Picture/5 description: The image shows the text "Je An-S" in a simple, sans-serif font. The letters are black and stand out against a white background. There is a faint, light blue watermark in the background that is partially obscured by the text. The text appears to be a title or heading. Je Hi An, Ph.D. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221400 Device Name hygh-tec drainage Indications for Use (Describe) The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liguid stools and to provide access for the administrations. The device is not intended for use on pediatric patients. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ### 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}------------------------------------------------ Prepared: January 10, 2023 ## I. SUBMITTER Creative Balloons GmbH Bruchsaler Straße 22 68753 Waghäusel Germany Phone: +49 (0)7254.40397-0 Contact: Michael Nilo Nilo Medical Consulting Group 3491 Denny St. Pittsburgh, PA 15201 Phone: (717) 421-4396 e-mail: michael.nilo@nilomedicalconsulting.com ## II. DEVICE | Name of Device: | hygh-tec drainage | |-----------------------|------------------------------------------------| | Common/Usual Name: | Fecal Management System | | Regulation Numbers: | 21 CFR 876.5980 | | Regulation Name: | Gastrointestinal tubes and accessories | | Regulatory Class: | II | | Product Codes: | KNT, Tubes, Gastrointestinal (And Accessories) | | III. PREDICATE DEVICE | | | Primary Predicate | Flexi-Seal® SIGNAL™ Fecal Management System | | | K150350 | {4}------------------------------------------------ ## IV. DEVICE DESCRIPTION The hygh-tec drainage is sold as a kit to include a main catheter component, collection bag, inflation syringe, and closure strap. The catheter component consists of a retaining and sealing balloon element, a trans-anal segment, drainage shaft, an elastically deformable tip, a colored positioning ring, a stool irrigation tube, an irrigation line, and an air filling line. ### V. INDICATIONS FOR USE The hygh-tec drainage is a fecal management system that is intended for continuous, transanal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following table identifies technological characteristics shared between the predicate and subject device: | Parameter | Subject Device | Predicate | |----------------------------------|--------------------------------|---------------------------------------------------| | | hygh-tec drainage<br>(K221400) | FlexiSeal<br>Fecal Management System<br>(K150350) | | FDA Product Code | KNT | KNT | | FDA Classification<br>Regulation | 21 CFR 876.5980 | 21 CFR 876.5980 | ## Table 1: Comparison of Technological Characteristics with Predicate Device {5}------------------------------------------------ | Classification | Class II | Class II | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The hygh-tec drainage is a fecal<br>management system that is<br>intended for continuous, trans-anal<br>drainage and collection of liquid or<br>semi-liquid stools and to provide<br>access for the administration of<br>medications. The device is not<br>intended for use on pediatric<br>patients. | To manage fecal incontinence<br>through the collection of liquid to<br>semi liquid stool to provide access<br>to administer medications | | Functional<br>Configuration | A head unit with collapsible wave-<br>shaped hose section enveloped<br>with a sealed balloon segment on<br>the distal end secured in the<br>rectum and proximal end<br>connected to a collection bag | Collapsible catheter with distal end<br>secured in the rectum and<br>proximal end connected to a<br>collection bag | | Retention Feature | Low pressure contoured cuff for<br>patients anatomy and facilitating<br>sealing. | Soft annular Balloon | | Balloon material | Thermoplastic Polyurethane (TPU) | Silicone rubber (Elastomere) | | Inflation management | Sealed air-filled balloon<br>(low-pressure Cuff) | Sealed water filled balloon | | Retention balloon<br>inflation medium | Air (85ml) | Water/saline (45ml) | | Catheter tube length | 1730 mm | 1550mm - 1670mm | | Length of<br>trans-anal area | ~ 49 mm (length of the trans-anal<br>balloon segment) | ~ 7 cm (from Balloon to black<br>Position marking) | | Position marking | Yes<br>(Yellow ring) | Yes<br>(Black marking on catheter tube) | | Inflation and<br>irrigation port<br>connections | Luer | Luer | | Inflation lines | 1 | 2 | | Irrigation lines | 1 | 1 | | Sampling port | Closable snap seal for catheter<br>syringe access – natural color | Closeable snap seal for catheter<br>syringe access - natural color | | Collection bag<br>configuration | Disposable with vent and<br>connector | Disposable with integrated cap and<br>vent | | Collection bag size | 2 litre | 1 litre | | Method of bed<br>connection | Hanging strap and a hook-on bag<br>connector | Hanging Strap on bag connector | | Flow stop<br>mechanism | External Strap | External Tube Strap | | Sterility status | Non-sterile | Non-sterile | | Max Usage of Device | 29 days | 29 days | | Medication Delivery | Yes | Yes | | Packaging | Thermoformed plastic<br>clamshell | Thermoformed plastic<br>clamshell | {6}------------------------------------------------ The following differences between the subject and predicate device were evaluated to support a substantial equivalence determination: - The filling medium of the retention balloons is different (air vs. water) ● {7}------------------------------------------------ - The materials utilized in the subject and predicate device are different. ● ### VII. PERFORMANCE TESTING The following performance testing was conducted to support substantial equivalence: ### Performance Testing The following design verification activities have been performed to ensure the appropriate functionality of the system: - Shelf-Life Testing . - Simulation of Transport Loads ● - Leak Tightness Testing ● - Retention Testing ● - Overfilling Testing ● - Flow Rate Measurement Testing ## Biocompatibility Biocompatibility testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'." ### VIII. CONCLUSIONS The differences that exist between the hygh-tec drainage and its predicate do not raise different questions of safety or effectiveness. The results of performance and biocompatibility testing demonstrate that the hygh-tec drainage will perform safely as intended and support a determination of substantial equivalence to the predicate device which is marketed for the same intended use. {8}------------------------------------------------ K221400 Page 6 of 6