ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE

{0}------------------------------------------------ K130611 pg 1 of 3 Image /page/0/Picture/1 description: The image shows the word "xeridiem" with a circular logo to the left of the word. The logo is a circle with two arrows pointing in opposite directions. The word "xeridiem" is in a bold, sans-serif font. There is a registered trademark symbol to the right of the word. DEC 1 9 2013 # 510(k) Summary As required by 21 CFR 807.92, this "510(k) Summary" provides a basis for the substantial equivalence determination of the device listed below. ### General Information | Date Prepared: | April 5, 2013 | |--------------------|---------------------------------------------| | Submitter Name: | Xeridiem Medical Devices | | | [formerly Manufacturing and Research, Inc.] | | Submitter Address: | 4700 S. Overland Dr. | | | Tucson, Az 85714 | | Contact Person: | Michelle Lott, RAC | | Phone Number: | (520) 882-7794 | | Fax Number: | (520) 882-6894 | ### Device Information | Trade Name: | Entuit ^TM Thrive Balloon Retention Gastrostomy Feeding Tube | |-----------------------|----------------------------------------------------------------------------------| | Common Name: | Gastrostomy Tube | | Classification Name: | Tubes, gastrointestinal (and accessories)<br>[21 CFR 876.5980, Product Code KNT] | | Classification Panel: | Gastroenterology/Urology | ### Predicate Device Information | Trade Name: | EndoVive™ Standard Replacement Gastrostomy Tube (K083684) | |-----------------------|----------------------------------------------------------------------------------| | Common Name: | Gastrostomy Tube | | Classification Name: | Tubes, gastrointestinal (and accessories)<br>[21 CFR 876.5980, Product Code KNT] | | Classification Panel: | Gastroenterology/Urology | #### Device Description The Entuit The Thrive Balloon Retention Gastrostony Feeding Tube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shall. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place. Entuit Thrive Balloon Retention Gastrostomy Feeding Tube Xeridiem 510(k) Application - K130611 Appendix B Page 1 of 3 {1}------------------------------------------------ K130611 pg 2 of 3 Image /page/1/Picture/1 description: The image contains the word "xeridiem" in a stylized font, with a circled R symbol next to the word. To the left of the word is a circular graphic with a white center and a black border. The text is in black and the background is white. The image appears to be a logo. # Intended Use/Indications for Use The Entuil™ Thrive Balloon Retention Gastrostomy Feeding Tube is intended to provide gastric access for enteral feeding, medication and decompression through an established gastrointestinal stoma traci. The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is indicated for use in perculaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract. # Technological Characteristics The table below provides a general summary of the technological characteristics of the Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube compared to the predicate device. | Technological Characteristics | | | |-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | EntuitTM Thrive Balloon<br>Retention Gastrostomy Feeding<br>Tube (Submitted device) | EndoViveTM Standard<br>Replacement Gastrostomy Tube<br>(Predicate Device)<br>K083684 | | | Product Range<br>(FR size) | 12 - 24 FR | 12 - 28 FR | | Product Range<br>(Length) | 10 cm | 10 cm | | Product Range<br>(Balloon Size) | 5 cc for 12 - 18 FR devices<br>20cc for 20 - 24 FR devices | 4 cc for 12 FR device<br>6 cc for 14 - 28 FR devices | | Funnel | Similar - Silicone with 3 ports: one for feeding, one for medication and the other for balloon inflation. Adapter added to medication port plug. | Silicone with 3 ports: one for feeding, one for medication and the other for balloon inflation | | Bolster | Silicone 40 durometer in straight configuration - different bolster profile | Silicone 60 durometer in two configurations: one straight and one right angle | | Inflation valve | Similar - Thermoplastic housing with silicone valve (low profile valve) | Thermoplastic housing with silicone valve | | Balloon | Same materials as K083684, different balloon profile | Silicone pancake shaped balloon | | Shaft | Same as K083684 | Silicone 65 durometer | | Barium stripe | Barium sulfate without colorant | Barium sulfate with blue colorant | | Kit Contents | No accessory devices included with device | Inflation syringe, gauze and lubricating jelly | | Packaging System/Materials | Same as K083684 | Tyvek Pouch. Polybag. IFU, Corrugate Case & Shipper | Entuit TM Thrive Balloon Retention Gastrostomy Feeding Tube Xeridiem 510(k) Application - K130611 Appendix B Page 2 of 3 સ્ક {2}------------------------------------------------ # K130611 # pg 3 of 3 ## Performance Characteristics The table below provides a general summary of the performance testing that was conducted for the Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube. | Test | Method | Conclusion | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | -Flow rate<br>-Balloon Burst Volume<br>-Balloon Volume Maintenance<br>-Balloon Concentricity<br>-Balloon Over Shaft Size<br>-Balloon Integrity<br>-Balloon Integrity in simulated gastric fluid | All in accordance to ASTM<br>F2528-06<br>(Procedures A through G) | Candidate device met all<br>performance requirements.<br>Where acceptance criteria<br>were not defined in the<br>standard, the candidate device<br>performed equivalent to or<br>better than the predicate<br>device. | #### Test Method Conclusion In all instances the Entuit ™ Thrive Balloon Retention Gastrostomy Feeding Tube performed as intended. #### Substantial Equivalence - Comparison to Predicate Device Among the information and summary tables presented in the 510(k) submission to support substantial equivalence of the Entuit ™ Thrive Balloon Retention Gastrostomy Feeding Tube to the legally marketed predicate device are: 1.) device description, 2.) indications for use, 3.) device comparison tables, 4.} material information, 5.) bench test results, and 6.) labeling. In particular, bench testing demonstrates that there was no difference in the performance, safety, or effectiveness between the Fintuit 11 Thrive Balloon Retention Gastrostomy Feeding Tube and the EndoVive " Standard Replacement Gastrostomy Tube. The Entuit "M Thrive Balloon Relention Gastrostomy Feeding Tube is substantially equivalent to the EndoVive™ Standard Replacement Gastrostomy Tube (K083684). The subject device and predicate device have the same intended use and similar indications. (echnological characteristics and principles of operation. The minor differences in technological characteristics have been identified and do not present any new issues of safety or effectiveness. Thus, the Entuit ™ Thrive Balloon Retention Gastrostomy Feeding Tube is substantially equivalent to the Endo Vive " Standard Replacement Gastrostomy Tube (K083684). Entuit 7M Thrive Balloon Retention Gastrostomy Feeding Tube Xeridiem 510(k) Application - K130611 Appendix B Page 3 of 3 {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 19, 2013 Xeridiem Medical Devices . Michelle Lott RA/QA Director, RAC 4700 S. Overland Drive Tucson, AZ 85714 Re: K130611 > Trade/Device Name: Entuit™ Thrive Balloon Retention Gastronomy Feeding Tube Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 27, 2013 Received: November 29, 2013 Dear Michelle Lott, . . 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. 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 {4}------------------------------------------------ Page 2 - Michelle Lott 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Glenn Bell-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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Xeridiem Medical Devices. The logo consists of a circular symbol with arrows pointing inward, followed by the company name "xeridiem" in a bold font, with the words "MEDICAL DEVICES" underneath in a smaller font. Below the logo is the company's address, which is 4700 South Overland Drive, Tucson, Arizona 85714, along with their phone number 520-882-7794 and website www.xeridiem.com. # Indications for Use 510(k) Number (if known): K130611 Device Name: Entuit TM Thrive Balloon Retention Gastrostomy Feeding Tube Indications For Use: The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is intended to provide gastric access for enteral feeding; medication and decompression through an established gastrointestinal stoma tract. The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract. Prescription Use AND/OR Over-The-Counter Use X = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Glenn B. Bell -S Page 1 of ્રિક