DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W

{0}------------------------------------------------ OCT 1 9 2001 BARD ENDOSCOPIC TECHNOLOGIES BARD KO13144 1042 C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989 ## VI. 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows. - A. Submitter Information | Submitter's Name: | Bard Endoscopic Technologies<br>C.R. Bard, Inc. | |-----------------------------------------|-------------------------------------------------------------------| | Address: | 129 Concord Road, Bldg. #3<br>Billerica, MA 01821 | | Phone: | 978 - 262 - 4867 | | Fax: | 978 - 262 - 4878 | | Contact Person: | Marion Gordon, R.A.C. | | Date of Preparation: | September 17, 2001 | | B. Device Name | | | Trade Name: | Dual Port Wizard™ Low Profile Replacement | | Common/Usual Name: | Gastrostomy Device & Feeding/Decompression Tube<br>Feeding Device | | Classification Name: | Gastrointestinal tube and accessories | | C. Predicate Device Name<br>Trade Name: | Wizard™ Low Profile Replacement Gastrostomy Device | ## D. Device Description: The Wizard™ is a low profile, balloon-type, feeding device designed for percutaneous insertion through an established, appropriately sized stoma tract. The device is held in place by the distal balloon, which remains in situ within the stomach, and an external bolster. Within the bolster are two ports. One side port is used to inflate the retention balloon and the second, surface port mates with the accompanying feeding/decompression tube to administer enteral nutritional fluid or expel gas or gastric contents. - E. Intended Use: The Dual Port Wizard™ replacement gastrostomy device is indicated for percutaneous placement of a low-profile gastrostomy feeding and decompression device into an established, appropriately sized stoma. The Dual Port Wizard™ Feeding/Decompression Tube (REF 00220W) is the only device which should be {1}------------------------------------------------ used for feeding, gastric decompression or medication administration with the Dual Port Wizard replacement gastrostomy device. - F. Technological Characteristics Summary: The fundamental scientific technology of the modified device has not changed. The only dimensional modification to the Wizard™ Low Profile Replacement Gastrostomy Device is related to the mating of an interlocking feeding/decompression tube. The feeding/decompression tube will consist of a proximal dual port adapter, which is friction fitted into a shorter length of the same tubing. The distal 90° adapter is one piece and includes a central stem, which inserts into the feeding port of the modified Wizard™, and a locking lip. All correlating material changes are within the same classification as other cleared feeding tubes. - G. Performance Data Bench testing, biocompatability, and post risk analysis assessment of the modifications to the Wizard™ demonstrate that design verification/validation activities meet the predetermined acceptance criteria for a safe and effective device. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. OCT 1 9 2001 Marion Gordon, R.A.C. Senior Regulatory Affairs Coordinator C. R. Bard, Inc. Bard Endoscopic Technologies 129 Concord Road P.O. Box 7031 BILLERICA MA 01821-7031 Re: K013144 Trade/Device Name: The Wizard™ Low Profile Replacement Gastrostomy · Device Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: September 17, 2001 Received: September 20, 2001 Dear Ms. Gordon: 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 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 purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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), 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 (21 CFR Part 807); listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {3}------------------------------------------------ Page 2 - Ms. Marion Gordon This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse of substantial equivalence of your device to a legally promatic liculicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling don'to to proceed to the most and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at promotion and as returning or note the regulation entitled, "Misbranding by reference to (2017) 594 4059. Plast from 2019.97). Other general information on your responsibilities promation is and may be obtained from the Division of Small Manufacturers, International and ander the Fee 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. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## D. Indications for Use | 510(k) Number (if known): | TBD K013144 | |---------------------------|--------------------------------------------------------------| | Device Name: | Dual Port Wizard™ Low Profile Replacement Gastrostomy Device | Indications For Use: The Dual Port Wizard™ replacement gastrostomy device is indicated for percutaneous placement of a low-profile gastrostomy feeding and decompression device into an established, appropriately sized stoma. The Dual Port Wizard™ Feeding/Decompression Tube (REF 00220W) is the only device which should be used for feeding, gastric decompression or medication administration with the Dual Port Wizard replacement gastrostomy device. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use | (Optional Format 1-2-96) | |------------------------------------------|------------------------------------------|----------------------|--------------------------| |------------------------------------------|------------------------------------------|----------------------|--------------------------| | | <img alt="Signature" src="signature.jpg"/> | |------------------------------------------------------------------|--------------------------------------------| | (Division Sign-Off) | Nancy Brogdon | | Division of Reproductive, Abdominal,<br>and Radiological Devices | | | 510(k) Number | K013144 |