MEDIGROUP KEY TUBE

{0}------------------------------------------------ KO13017 Page 10f1 ## DEC 0 6 2001 #### 7.1. 510(k) Summary of Safety and Effectiveness 7.1.1 Basic Data | Date Prepared: | September 6, 2001 | |----------------|--------------------------| | Company: | MEDIGROUP, Inc | | Contact: | John A. Navis, President | | Phone: | (630) 428-4143 | | Fax: | (630) 428-4148 | | E-mail: | jnavis@medigroupinc.com | 7.1.2 Device Information: > Classification Name: Common Name: Peritoneal Catheter Accessory Catheter Implantation Device #### 7.1.3 Predicate Device This device (Key Tube™) is an adaptation (not replacement) for an existing tool, Cuff Implantor®, currently produced by Medigroup and included in two of its Y-TEC® kits, VP-112 and VP-210, 510(k)883303A and adapted in April 7, 1993 letter to FDA. An early prototype Key Tube version was designed and used during the Ash Advantage™ clinical trials [510(k)991042]. - Ash Advantage™ catheter clinical trials were conducted in three dialysis centers. 7.1.4 A total of fourteen catheters were implanted in thirteen patients via the peritoneoscopic or laprascopic method (doctor's choice). All implanting doctors used the prototype version of the Key Tube™ to implant the Ash Advantage™ catheter. Clinical results were that all catheters were successfully implanted; the Key Tube™ functioned as designed. That is, the T junction of the Ash Advantage™ was against the parietal peritoneum; the distal cuff was within the rectus sheath; incision of the rectus sheath was avoided. - 7.1.5 Device Description and Intended Use Stainless steel, quasi tubular (U shape) device, approximately 200 mm long and 8.0 mm diameter. It is designed to be used to implant the Ash Advantage catheter. {1}------------------------------------------------ Image /page/1/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that converge and then separate into wavy lines at the bottom. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 0 6 2001 Mr. John A. Navis President Medigroup, Inc. 505 Weston Ridge Drive NAPERVILLE IL 60563-3932 Re: K013017 Trade/Device Name: Key Tube™ (KT-2580) Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FJS Dated: September 6, 2001 Received: September 7, 2001 Dear Mr. Navis: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premexice is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate 101 use stated in the cholosure) to regars actment date of the Medical Device Amendments, or to conmente province to May 20, 1978, the enaounce with the provisions of the Federal Food, Drug, devices mat have been reculted in avee approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require appro the general controls provisions of the Act. The 1 ou may, diciolor, manov of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (300 above) and 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 I lease be advised that I Dri 3 issualite of our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I coord statutes and roguirements, including, but not limited to: registration and listing Compry with an the Act 3 requirements, models. good manufacturing practice requirements as set manie (21 OF IC Part 801), faceming (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The PDA midmis of successification 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 811), please II you desire specific advice for your de rest of ollowing numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on and prosses of the regulation entitled, "Misbranding Office of Comphanee at (301) 39 ( 1057) Part 807.97). Other general information on by reletence to premarket notification (2) obtained from the Division of Small Manufacturers, your responsibilities the Act Her May of other of other (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 {3}------------------------------------------------ ### 510(k) Number: K013017 Device Name: Medigroup Key Tube™ Indications for Use: The Key Tube is designed to be used to implant the Ash Advantage™ catheter. No usage change from original Ash Advantage catheter 510(k) 991042. # (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) David le. Segerson Division of Ophthalmic, Anesthesia, and Neurological Devices 510(k) Number K013017