SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)

{0}------------------------------------------------ K041034 Bayer Ltd. #### AUG 3 1 2004 GENERAL INFORMATION ### Device Name | Trade Name: | Skin Level Gastrostomy Tube Kit (ECSL | |----------------------|---------------------------------------| | Common/Usual Name: | Gastrostomy Tube Kit | | Classification Name: | Gastrointestinal tube and accessories | #### Registration Number The Device Establishment Registration Number is 1931566. #### Sponsor Name and Address EntraCare, LLC 11315 Strang Line Road Lenexa, KS 66215 Phone: 913-451-2234 Fax: 913-451-2363 Contact Name: Cary Dikeman Title: President ### Submission Correspondent: Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 FAX: 949-552-2821 Email: grace@regulatoryspecialists.com #### Classification | Class: | II (Two) | |----------------|----------| | Procode: | KNT | | CFR Reference: | 876.5980 | #### Device Description The EntraCare Skin Level Gastrostomy Tube Kit (ECSL) is used as a replacement tube in an established stoma tract for patients who cannot consume an adequate diet orally. The kit consists of: Gastrostomy Tube {1}------------------------------------------------ Elbow Connector Extension Set Bolus Connector Extension set Stoma Measuring Device Universal Adapter Subassembly Items within the kit that are supplied by an outside source: 35 ml Catheter Tipped Syringe 6 ml Slip Luer Syringe 4" X 4" Gauze Item sod separately Stoma Measuring Device The Gastrostomy Tube consists of a Feeding Port Valve Subassembly that contains a valve used to open the fluid pathway allowing enteral feeding solutions to enter into the stomach. An inflatable balloon at the distal end secures the tube in the stomach through a stoma. The Gastrostomy Tube size variations include 14-24 French sizes and 0.8-4.5 cm length sizes. There are two slightly different valve designs available, Version 1 and Version 2. The design concept for the Gastrostomy Tube valve Version 1 utilizes a specially designed rubber mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed rubber valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. When the connections are removed, the valve will reseal immediately preventing leakage of fluids. The design concept for the Gastrostomy Tube valve Version 2 utilizes a specially designed silicone mechanism that opens the fluid pathway when a bolus or elbow connector is inserted into the device. This specially designed valve will seal around the connectors preventing leakage and allow unrestricted access into the fluid pathway. The Gastrostomy Tube also consists of an Inflation Valve Subassembly that contains a valve and spring mechanism. When the syringe is inserted into the Inflation Valve Subassembly, the tip pushes against the valve, which compresses the spring and opens the fluid path to inflate the balloon. The Skin Level Gastrostomy Tube Kit contains all delivery items (accessories) necessary for enteral feeding applications. The accessories provided in the kit are two Extension Sets; one that allows continuous feeding from a pump, and the other that allows feeding from a catheter tip syringe. Two syringes are supplied (which have either been previously cleared for marketing by the FDA or are pre amendment devices); the 6 ml syringe is used to inflate the balloon of the gastrostomy tube and the 35 ml catheter tip syringe is used for bolus feeding. Sterile gauze is provided for {2}------------------------------------------------ absorbency. A universal luer adapter is included for mating connections that require a female luer. # Equivalent Legally Marketed Device Mic-Key® "G" Low Profile Gastrostomy Tube submitted by Ballard Medical Products Inc., K993138. ## Performance Standards As of the present time there have been no Performance Standards promulgated for this specific device. The product does meet the following industry standards: - The Skin Level Gastrostomy Tube Kit (ECSL) is sterilized by ETO . in conformance with ANSI/AAMI/ISO 11135:1994 Medical Devices Validation and Routine Control Of Ethylene Oxide Sterilization (ETO) and EN 550 Sterilization Standards. - The device complies with ANSI/AAMI/ISO 10993-1:1997;Class VI . Biocompatibility Standards Concerning Cytotoxicity, Sensitization, Intracutaneous, Systemic Toxicity, and Hemocompatibility. - The device is packaged in accordance with the ANSI/AAMI/ISO . 11607:1997, Packaging For Terminally Sterilized Devices Standard. The product also meets the following: - The Elbow and Bolus Connector when connected to the feeding . port valve withstands 20 inch ounces of torque. - The feeding port valve assembly bond to the skin level . Gastrostomy Tube main body bond withstands 20 inch ounces of torque. - The device functions after 120 inflation valve flexes at 45 degrees . from center line. - The Gastrostomy Tube is able to maintain an inflated balloon for up . to seven days. - The valve in the feeding port valve assembly withstands a low . backpressure of 0.05 psig (3.5 cm H2O) after 360 insertions. - The valve closes at a low backpressure of 0.22 psig (15 cm H2O) . after 7 days of continuous insertion. - The Gastrostomy Tube fluid pathway and related elbow and bolus . connections withstands a positive pressure of 15 psig after 360 insertions. {3}------------------------------------------------ - The Gastrostomy Tube fluid pathway and related elbow and bolus . connections withstands a positive pressure of 15 psig after 7 days of continuous insertion. - The device is labeled in accordance with federal regulations. . - The device is Latex free. . - The Materials used to fabricate the Skin Level Gastrostomy Tube . are of FDA cleared medical grade materials. - Acid balloon test . {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing the bird's body and wings. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 3 1 2004 EntraCare, Inc. c/o Ms. Grace Holland Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606 Re: K041034 Trade/Device Name: Skin Level Gastrostomy Tube Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: June 30, 2004 Received: July 1, 2004 Dear Ms. Holland: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to tegains and of the Medical Device Amendments or to conniered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been reclassitiou in acefore, market the device, subject to the general controls and Cosmette Act (rec). " ou may, meters, not are responsible to determine that the medical devices you provisions of the Act. "Towever, you are been determined as substantially equivalent under the use as components in the arrials ection 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you May 26, 1970, the onaoment and in bulk (i.e., unfinished) and further process (e.g., sterilize) purchase your device components in other these components in your kit. The general you must submit a new 9 requirements for annual registration, listing of devices, confors provisions of uctice, and labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your ac vice is etassified (500 above) . 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. {5}------------------------------------------------ ### Page 2 - Ms. Grace Holland Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri 3 losames of our device complies with other requirements of the Act that I DA has made a determinations administered by other federal agencies. You must or any i ederal statuates and states and the mot limited to: registration (21 CFR Part Comply with an the Fet 3 requiremeling (21 CFR Part 801); good manufacturing practices (200 807), insting (21 CFR Part 877), within the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quarty by station control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This icler will anow you to begin maneling of substantial equivalence of your device to a legally promatics notification: "The PUts in a classification for your device and thus, permits your marketed production device in a esire specific advice for your device on the labeling device to proceed to the maker. In Joa Compliance at (301) 594-4616. Also, please note the regulation, prease contact the Oritor of Creme to premarket notification"(21 CFR Part 807.97). regulation chined, "Misoration on your responsibilities under the Act from the 1 ou may obtain other general mismational and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Bugdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Page_ 1_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): K041034 Device Name: EntraCare Skin Level Gastrostomy Tube Kit (ECSL) Indications For Use: The ECSL is a low profile balloon gastrostomy tube indicated for use as a The LOOL is a low promo balloched stoma tract for pediatric, adult and elderly replacement tabe in an octublished technique diet orally. Gastrostomy feeding may be patients who outmor outbanis an anioning gut who require long term feeding support. Indicated for pationto whom malnutrition already exists or may result, r his may inolude pations for threases resulting in an abnormality in swallowing; tumors secondary to hearbidgiour alouse or upper airway diseases or oropharyngeal trauma on the noda, nook of overhing swallowing. Some patients who require chronic use of supplemental fluids are also candidates for gastrostomy tube use. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96) Nancy C Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K041034