MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE

{0}------------------------------------------------ 1032517 MAY 1 8 2004 # 510(k) Summary As Required by 21 section 807.92 ( c ) Mansour Consulting LLC 1-Submitter Name: 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA (770) 777- 4146 3-Phone: 4-Fax: (678) 623- 3765 6-Date summary prepared: March 29th, 2004 7-Device Trade or Proprietary Name: MEDSAFE ClickSafe™ Safety Antistick Syringe with hypodermic needle 8-Device Common or usual name: Safety Syringe with hypodermic needle 9-Device Classification Name: Syringe, AntiStick, with hypodermic needle 10-Substantial Equivalency is claimed against the following device: - VANISHPOINT SYRINGE from RETRACTABLE TECHNOLOGIES, INC. . 510k# K946219, cleared at that time under the tradename of Pop-N-Lok syringe. #### 11-Description of the Device: The MedSafe ClickSafe™ Syringe is a 3cc, sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, Anti-Stick syringe with integral hypodermic needle, as detailed within this submission and in relevant patents. The primary intended use of the device is to give safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries. The MedSafe Safety Syringe operates in the same manner as standard hypodermic syringes, prior to the actuation of the safety mechanism. The plunger is retracted as the medication is drawn up to the desired amount. Next, the medication is administered to the patient in the usual way, by inserting the needle into the patient's tissue and depressing the plunger. Figure 1 shows the syringe in its configuration after the medication has been expelled and before the actuation of the safety mechanism. The various parts are identified therein, including the plunger, the boot, the body (barrel) and the needle, all of which are common to standard syringes. The difference is that the boof in the MedSafe syringe is rupturable and the plunger is hollow. The needle is held by the needle hub, which is in turn held in place by the base, which also serves to seal the medication in the syringe. The base is held in place at its plunger-end by an {1}------------------------------------------------ interior shelf in the body. There is a spring around the needle which is held in place by the nose and bears against the needle hub. Once the medication is expelled, the continued depression of the plunger causes the base (which contains the entire needle assembly) to slide, thereby compressing the spring. Continued depression of the plunger drives the needle hub against the nose and pushes the base over the needle hub. As the needle hub exits the base, it stretches the boot which subsequently ruptures. At this time, the compressed spring propels the needle and hub into the hollow plunger, where it is caught and secured by the needle catch (integral to the plunger). Thus, the "dirty" needle is securely held out of harm's way inside the plunger, as depicted in Figure 2. After use, the healthcare worker disposes of the syringe in a sharps container in accordance with OSHA regulations. The following size variations are listed below. Refer to main section of the submission for complete details. | Syringe | Needle | Product<br>Reorder<br>No. | |---------|------------|---------------------------| | 3cc | 25G x 5/8" | SB3506 | | | 25G x 1" | SB3510 | | | 23G x 1" | SB3310 | | | 22G x 1" | SB3210 | | | 22G x 1 ½" | SB3215 | | | 21G x 1" | SB3110 | | | 21G x 1 ½" | SB3115 | | | 20G x 1" | SB3010 | | | 20G x 1 ½" | SB3015 | {2}------------------------------------------------ Image /page/2/Figure/0 description: This image is a technical drawing of a syringe. The different parts of the syringe are labeled, including the plunger, body (barrel), base, nose, needle, needle catch, boot, hub, and spring. The drawing provides a detailed view of the syringe's internal components and their arrangement. FIG. 1 MedSafe Safety Syringe After Medication Expended and Before Safety Mechanism Actuated {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a technical drawing of a device, possibly a syringe or a similar instrument. It features a cylindrical body with internal components, including a spring-like structure running along the central axis. The drawing includes cross-sectional views to reveal the inner mechanisms and construction details of the device. FIG. 2 MedSafe Safety Syringe After Safety Mechanism Actuated {4}------------------------------------------------ ### 12-Intended use of the device: (refer to FDA form attached) The MedSafe ClickSafe™ Syringe is a 3cc, sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, Anti-Stick syringe with integral hvpodermic needle. Its primary intended use of the device is to provide a safe, accurate and reliable method of injecting medication into a patient, subcutaneous as well as intramuscular. Needle retraction is activated by the syringe user AFTER REMOVING THE needle from the Patient FIRST Its secondary intended use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries that would be occurring between removing the needle from the patient and disposing it into sharps container. #### 13-Safety and Effectiveness of the device: This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below) #### 14-Summary comparing technological characteristics with predicate device: Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission. {5}------------------------------------------------ | FDA file reference number | K946219 | |--------------------------------------------------|----------------------------| | TECHNOLOGICAL CHARACTERISTICS | Comparison result | | Indications for use | Identical | | Target population | Identical | | Design | Similar | | Materials | Similar | | Performance | Identical | | Sterility | Similar | | Biocompatibility | Similar | | Mechanical safety | Identical | | Chemical safety | Similar | | Anatomical sites | Identical | | Human factors | Similar | | Energy used and/or delivered | Identical | | Compatibility with environment and other devices | Identical | | Where used | Identical | | Standards met | Similar | | Electrical safety | Identical (not applicable) | | Thermal safety | Identical (not applicable) | | Radiation safety | Identical (not applicable) | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread, and three lines extending from the eagle's head. The eagle is facing to the left. MAY 1 8 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Public Health Service MedSafe Technologies LLC C/O Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022 Re: K032517 Trade/Device Name: MedSafe™ ClickSafe Safety Antistick Syringe with Hypodermic Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 29, 2004 Received: April 6, 2004 Dear Mr. Mansour: 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, thereforc, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 rir 1, it is a 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. {7}------------------------------------------------ Page 2 -- Mr. Mansour 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. or the Fet of any 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 and ilouing (s 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) Frider mixfication. 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), 11 Jease contact the Office of Compliance at (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Kosasin ## Indications for Use 510(k) Number (if known): K032517 Device Name: MedSafe ClickSafe™ Safety Antistick Syringe with hypodermic needle Indications For Use: The MedSafe ClickSafe™ syringe is a 3cc sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, anti-stick syringe with integral hypodermic needle. lts primary intended use and indication for use is to provide safe, accurate and reliable nethod of injecting medication into a patient, subcutaneous as well as intramuscular. methou of injoung modified by the syringe user after removing the needle from the patient first. lts secondary intended use and indication for use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operation method, for the purpose of introducing any accidental needle stick injuries that would be occurring between anding in the provention and disposing it into the Sharps container. Prescription Use (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) fine Nannar for Adw 5/13/04 (Division Sign-oll) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices Page 1 of 510(k) Number: