EMBEDDING TOOL, MODEL TE-1000

{0}------------------------------------------------ K060897 Page 1 of 2 Image /page/0/Picture/1 description: The image shows the logo for MEDIGROUP, Inc. The logo consists of a stylized heart shape formed by two interlocking shapes, with diagonal lines filling the lower portion of the heart. Below the heart is the text "MEDIGROUP, Inc." in a serif font. JUL 18 2006 #### 510(k) Summary #### Basic Information Submitter: Medigroup, Inc. 14 A Stonehill Road Oswego, IL 60543 Establishment Registration Number: #1450420 Contact: Telephone: Fax: E-mail Date of Submission John A. Navis, President (630) 554-5533 (630) 554-5535 inavis@medigroupinc.com March 30, 2006 #### Device Information Trade Name: Common Name: Classification Name: Class: II Embedding TM Tool. Catheter Tunneling Device. 78 FJS, accessory. #### Predicate Devices 510(k) 823331 Tunnelor® Tool, issued January 26, 1983. #### Product Description The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap. #### Intended Use The Embedding TM Tool is used to "embed" about 30cm of the external portion of a peritoneal dialysis catheter into the subcutaneous tissue immediately following the initial tunneling step of catheter implantation in order to be retrieved at a later time to begin peritoneal dialysis. After this secondary tunneling step, the titanium tip is unscrewed from the tool handle and functions as a plug at the catheter end. The titanium cap is then screwed onto the open end of the titanium tip to close it off. This Embedding™ Tool is intended to be used by the same physician at the same time and setting when he is implanting the catheter initially. As such, it can be used with any patient who is a suitable candidate for delaved peritoneal dialysis catheter utilization. #### Substantial Equivalence The "handle" or tunneling part of this Embedding™ Tool is made of the same rigid polyvinyl compound (RPVC) and has a similar configuration as the Tunnelor® Tool, predicate device 510(k) 823331. The configuration of the tip of the new device is similar to the shape of the tip in the predicate device, but made of titanium instead of RPVC. #### MEDIGROUP, Inc. (Division of Janin Group, Inc.) 7-1 Image /page/0/Picture/26 description: The image contains three logos related to quality assurance. The first logo on the left is the Lloyd's Register Quality Assurance logo with the letter R in the center and the text "ISO 13485" at the bottom. The middle logo is the UKAS Quality Management logo with the number 001 at the bottom. The third logo on the right is the Lloyd's Register Quality Assurance logo with the letter R in the center and the text "ISO 9001" at the bottom. {1}------------------------------------------------ ### 510(k) Summary ## Testing Functional testing has been performed to demonstrate mechanical integrity. Clinical evaluation at a dialysis center showed the Embedding™ Tool functioned as intended. ## Conclusions The Embedding™ Tool works as designed and intended. Its use is intended for use by physicians familiar with proper catheter tunneling techniques. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 ## JUL 18 2006 Mr. John A. Navis President Medigroup, Inc. 14 A Stonehill Road OSWEGO IL 60543-9400 Re: K060897 Trade/Device Name: TE-1000 Embedding™ Tool Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: June 26, 2006 Received: June 27, 2006 Dear Mr. Navis: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) produce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreater to regally that of the Medical Device Amendments, or to devices that prior to way 20, 1770, the onloanent and the provisions of the Federal Food, Drug, and Cosmetic liave bech toolassified in accordation was a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the device, salgos to annual registration, listing of devices, good Controls provibions of allabeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is elassified (500 accreen additional controls. Existing major regulations affecting your Apploval, it that be sacreer to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular and contains the letters FDA in a stylized font. {3}------------------------------------------------ Page 2 - 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |----------------|---------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.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}------------------------------------------------ # Indications for Use 510(k) Number (if known): K060897 Device Name: TE-1000 Embedding™ Tool Indications For Use: This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation. The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that: - The embedding procedure is done immediately following PD . catheter implantation. - Catheter patency has been completely established. . - The normally external part of the PD catheter can be embedded. . - The patient is a candidate for delayed onset of PD treatment. . - The patient is a candidate for PD. . Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C brogdon 510(k) Number Page 1 of 1