SIMPLICITY EURO QD INFUSION SET

{0}------------------------------------------------ AUG 1 0 2001 Sterling Medivations, Inc. 25285 La Loma Drive Los Altos Hills, CA 94022 650-949-0470 (voice) 650-949-0342 (fax) K012330 PAGE 1 OF 2 ## 510(k) SUMMARY | Date Submitted: | July 20, 2001 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Sterling Medivations, Inc. 180 Ferndale Road South, Wayzata, MN 55391 Company Phone 952-473-7971, Company fax 952-473-4758 | | Contact: | Joel Douglas, Chief Technology Officer<br>Sterling Medivations, Inc.<br>Applicant Phone 650-949-0470, Applicant Fax 650-949-0342 | | Trade Name of Device: | Simplicity™ Euro QD Euro Infusion Set for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. | | Common Name of Device: | Intravascular administration set. | | Classification Name: | Percutaneous intravascular catheter. | | Predicate Device: | The predicate device for Sterling's Simplicity™ Euro QD Infusion set is the MiniMed® Sof-Set Ultimate MMT 315 and MMT-316 Infusion Set, K974163. | Description of the New Device: Sterling Medivations, Inc.'s ("SMI") Simplicity ™ Euro QD Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. The Simplicity ™ Euro QD Infusion Set proposed for commercial distribution is similar in all significant respects to the existing the MiniMed® Sof-Set Ultimate MMT 315 and MMT-316 Infusion Set, K974163 and it has the intended use. The device consists of four main parts: (1) an infusion catheter made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a female Luer pump connector. The Simplicity Euro QD Infusion Set is an infusion administration set, connecting to a pump or syringe and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity Euro QD Infusion Set may infusion device that delivers continuous or intermittent flow. The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube. The 27 gauge-indwelling catheter is introduced into the subcutaneous tissue. A connector needle is attached to the hub fixed to the indwelling catheter. This connector needle pierces a septum forming a seal that permits the infusion of medication without leakage. The connected to the 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. Intended Use of the New Device: The intended use of the Simplicity Euro QD Infusion Set is to infuse or inject insulin subcutaneously when the device is attached to a pump or syringe Page 1 of 2 {1}------------------------------------------------ K012330 page 2 of 2 ## Comparisons of the Technological Features of the New Device and Predicate Device: The Simplicity Euro QD Infusion Set proposed for commercial distribution is similar in all significant respects to the Tile Simplicity Laro QD Infrasion Set proposition of Sand MMT-316 Infusion Set 510(k) K974163. The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent and it has I lie materials and manufacturing procession as successions of the may - 1 6 Infusion Set FDA 510(k) K974163. The differences that exist between the new and predicate device are as follows: 1) The Simplicity Euro QD Infusion Set has a connecting tube of Polyethylene and the predicate device has a connecting tube of co-extruded connecting tube Polyethylene id and PVC OD. 2) The Simplicity Euro QD Infusion Set has a quick disconnect that is built into the infusion housine. The predicate device has a quick disconnect fitting spliced into the connecting tube. The ability for the Sterling predivations Simplicity Euro QD Infusion Set to connect at the infusion site makes for an easier to use and more comfortable device than the predicate device. 3) The Simplicity Euro QD Infusion Set has an AISI 304 stainless steel infusion neede and the predicate device has a soft cannula made from Fluorinated Ethylene Propylene (FEP). The AISI 304 stainless steel infusion needle is substantially equivalent to the Sterling Medivations Simplicity with Wings Infusion Set FDA 510(k) K003283 Performance Data Supporting Substantial Equivalence: To provide substantial equivalence the Simplicity Euro QD 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 594-1: 1986 Conical fittings with a 6% )Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements, ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings, 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** el S. Douglas Chief Technology Officer Page 2 of 2 {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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 0 2001 Mr. Joel S. Douglas Chief Technology Officer Sterling Medivations, Incorporated 25285 La Loma Drive Los Altos Hills, California 94022-4583 K012330 Re: Simplicity Euro QD Infusion Set Trade/Device Name: Requlation Number: 880.5440 Requlatory Class: II Product Code: FPA Dated: July 20, 2001 Received: July 23, 2001 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ 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 regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements {3}------------------------------------------------ Page 2 - Mr. Douglas concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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 predicate device results in a classification for your marress and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and 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 International 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, Timothy A. Ulatowski Ulatowski Tim 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 Euro QD Infusion Set Indications For Use: The intended use of the Simplicity Euro QD Infusion Set is to provide a means to infuse insulin subcutaneously from a pump or syringe. (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) Plasan Currant (Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number _