MED-LOK

{0}------------------------------------------------ 093176 STA-MED, LLC 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562 Attachment 2 - 510(k) Summary # 5. 510(k) Summary APR - 6 2010 #### STA-MED, LLC. 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562 ### SUMMARY Submitter's name: Address: Phone: Fax number: Name of contact person: STA-MED, LLC. 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562 951-445-4601 951-445-4602 Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 greg@regulatoryspecialists.com | Name of the device: | Med-Lok, Safety Needle | |----------------------|------------------------| | Classification name: | Piston Syringe | | Product code | MEG | | Device Class | Class 2 | Date December 21, 2009 The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: | Reference # ! | Device Name | Company of Canadian Company of Concession Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Comp<br>Applicant | |---------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K063755 Portex Hypodermic Needle-Pro SMITHS MEDICAL ASD, INC | | Description of the device: The Med-Lok is a hypodermic needle with protection device that allows full use of the needle and covers the needle after use to help prevent needle sticks and touch contamination. {1}------------------------------------------------ 093176 page 2 of 2 Indications: The Med-Lok Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks. Summary of the technological characteristics of our device compared to the predicate device: Technological Characteristics This proposed device has the same technological characteristics as the predicate device. Indications for Use The Indications for Use for this proposed device has the same Indications for Use as the predicate device. Performance Testing Testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent. These tests included extensive laboratory testing. ## Clinical Testing Simulated clinical use studies were conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use. ## CONCLUSION Based on the design, technology, performance, functional testing, and intended use, the Med-Lok, Safety Needle is substantially equivalent to the predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. The Med-Lok, Safety Needle raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of Med-Lok, Safety Needle. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three stripes on its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 STA-MED. LLC C/O Mr. Greg Holland Regulatory Consultant Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606 APR - 6 2010 Re: K093176 Trade/Device Name: Med-Lok Regulation Number: 21CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 19, 2010 Received: March 23, 2010 Dear Mr. Holland: 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {3}------------------------------------------------ Page 2- Mr. Holland 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, far. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### STA-MED, LLC 41197 Golden Gate Circle, Suite 102 Murrieta, CA 92562 Attachment 1 - Revised Indications for Use Statement. # 4. Indications for Use Statement Indications for Use 510(k) Number (if known): K093176 Device Name: Med-Lok Indications for Use: The Med-Lok™ Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) *(Division Sign-Off)* Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K093176 Page 1 of 1 Page 10 of 18