SIMPLICITY SOFT QD SILVER INFUSION SET

{0}------------------------------------------------ ## Sterling Medivations, Inc. 180 Ferndale Road South Wayzata, Minnesota 55391 952-473-7971 (voice) 952473-4758 (fax) | 510(k) SUMMARY | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Submitted: | May 21, 2001 | | Submitter: | Sterling Medivations, Inc. 180 Ferndale Road South, Wayzata, MN 55391 Company Phone<br>952-473-7971, Company fax 952-473-4758 | | Contact: | Joel Douglas, Chief Technology Officer<br>Sterling Medivations, Inc.<br>Applicant Phone 650-949-0470 or 650-814-4083, Applicant Fax 650-949-0342 | | Trade Name of Device: | Simplicity™ Soft QD Silver Infusion Set intended use is to provide a means to infuse or<br>inject insulin subcutaneously when used with any infusion device that delivers<br>continuous or intermittent flow. | | Common Name of Device: | Intravascular administration set. | | Classification Name: | Percutaneous intravascular catheter. | | Predicate Device: | The predicate device for Sterling's Simplicity™ Soft QD Silver Infusion set is the<br>Sterling Simplicity™ Soft QD Easy Infusion set FDA 510(k) K 010788 | Description of the New Device: Sterling Medivations, Inc.'s ("SMI") Simplicity ™ Soft QD Silver Infusion Set is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow. The Simplicity ™ Soft QD Silver Infusion Set proposed for commercial distribution is similar in all significant respects to the existing the Simplicity Soft QD Easy Infusion Set, K010788 and it has the same intended use. The device consists of four main parts: (1) an infusion catheter made from FEP, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded reservoir connector. The Simplicity Soft QD Silver Infusion administration set, is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity Soft QD Silver Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded reservoir connector, and subcutaneously in the patient through an indwelling catheter made of Fluorinated Ethylene Propylene (FEP). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge insertion needle made of AISI 304 stainless steel. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector needle pierces a septum formits the infusion of medication without leakage. The connector needle is connecting tubing and a connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connector. The quick disconnect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes. {1}------------------------------------------------ Intended Use of the New Device: The intended use of the Simplicity Soft QD Silver Infusion Set is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow. ## Comparisons of the Technological Features of the New Device and Predicate Device: The Simplicity Soft QD Silver Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Soft OD Easy Infusion Set 510(k) K010788. The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent and it has the same intended use as the Simplicity Soft QD Easy Infusion Set FDA 510(k) K010788. The differences that exist between the new and predicate device are as follows: 1) The Simplicity Soft QD Silver Infusion Set has a threaded reservoir connector and the predicate device has a luer connector. The threaded reservoir connector is identical to the connector used on the Sterling Medivations Simplicity Silver Soft Infusion Set FDA K 010846. Performance Data Supporting Substantial Equivalence: To provide substantial equivalence the Simplicity Soft QD Silver Infusion Set meets the catheter requirements of: CDRH 21 C.F.R. section 880.54400 Intravascular administration set, ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements), and ISO 10555 Sterile, single use intravascular catheters (Part 5: peripheral catheters)., ISO 9626 Stainless steel needle tubing for the manufacture of medical devices, ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization, ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization. ISO 11607: 1997 Packaging for terminally sterilized medical devices, ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin, ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization, ISO 11138-2: 1994 Sterilization of health care products - Biological indicators - Part 2:Biological indicators for ethylene oxide sterilization. FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. ODE Blue Book Memorandum #K90-1. The design process adhered to is the Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS. This Guidance relates to FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001. This is substantially equivalent to the predicate device. Signed KLO Joel S. Douglas Chief Technology Officer {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 5 2001 Mr. Joel S. Douglas Chief Technology Officer Sterling Medivations, Incorporated 180 Ferndale Road South 22391 Wayzata, Minnesota K011580 Re : Simplicity Soft QD Silver Trade/Device Name: Infusion Set 880.5440 Requlation Number: Requlatory Class: II Product Code: FPA Dated: May 21, 2001 May 22, 2001 Received: Dear Mr. Douglas: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. {3}------------------------------------------------ Page 2 - Mr. Douglas concerning your device in the Federal Register. Please note: this response to your premarket notification submission does chis responde co four might have under sections 531 through 542 of the Act for devices under the Electronic chrough 542 or cho notrol provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtribud in your alence of your device to a legally rinding of babboan device results in a classification for your marketed predicator mits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulacion ostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on comprrance at (30) advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcarned from chonomis (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, L.A. Alatrist Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: Simplicity Soft QD Silver Infusion Set Indications For Use: The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR (PER 21 CFR 801.109) (Division Sign-Off) (Division of Dental, Infection Control and General Hospital Device 510(k) Number - Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) Page 7 of 102