MANUEL SAFTEY SYRINGE PARTS 1 & 2

{0}------------------------------------------------ # OCT 16 2006 # H 510(k) Summary – Traditional Submission # 510(k) Owner | Establishment: | MedSafe ASA | |----------------|-----------------------------------------| | Address: | Forskningsveien 2A, N-0373 Oslo, Norway | | Phone: | +47 23 22 36 14 | | Fax: | +47 22 14 02 55 | # Contact Person | Name: | Nils Gunnarsson | |----------------|-----------------------------------------| | Establishment: | MedSafe ASA | | Address: | Forskningsveien 2A, N-0373 Oslo, Norway | | Phone: | +47 23 22 36 14 | | Fax: | +47 22 14 02 55 | #### Date of Preparation March 9, 2006 ### ldentification of the Device | 1. Proprietary Name: | Manual Safety Syringe (2-parts),<br>Manual Safety Syringe (3-parts) | |-------------------------|-----------------------------------------------------------------------------------------| | 2. Common Name: | Sharps Injury Prevention Piston Syringe | | 3. Classification Name: | Antistick Syringe | | 4. Class II, Procodes: | FMF - Piston Syringe<br>MEG – Antistick Syringe<br>FMI – Hypodermic Single Lumen Needle | ## Equivalent Legally Marketed Device Claim of Substantial Equivalence is made to BIOTOP DJT-A Safety Syringe (K032747). #### Intended Use The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. {1}------------------------------------------------ # Description of the Device The Manual Safety Syringe is a single-use safety hypodermic syringe, which is very similar to a traditional syringe, with the exception that it possesses an integral needle retracting mechanism. The device comes in two variations: - 3. Manual Safety Syringe (2-parts) 5ml - 4. Manual Safety Syringe (3-parts) 5ml The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back. The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated. The Manual Safety Syringe is only available in one size (5ml). | | The Manual Safety Syringe | BIOTOP DJT-A Safety Syringe | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Syringe type | Antistick syringe | Antistick syringe | | Intended use | The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. | Similar | | Principle of operation | Activation of safety feature consists of three steps:<br>1) Press the plunger to the bottom position to complete injection.<br>2) Retract the plunger to full stop to drag the needle into the barrel.<br>3) Brake plunger off. | Identical | | Volume (ml/cc) | 5ml | 1ml/3ml/5ml | | Nozzle type | Luer | Luer Lock Tip | | Barrel | | Identical | #### Safety and Effectiveness, Comparison to Predicate Device {2}------------------------------------------------ | marking | | | |-----------|------------------------------------------------------|----------------------------------| | Reuse | Non-reusable | Identical | | Materials | 1. Barrel:<br>Polypropylene | Polypropylene | | | 2. Plunger:<br>Polyethylene | Polypropylene | | | 3. Snare<br>Polypropylene | N/A | | | 4. Needle:<br>Stainless steel | Stainless steel | | | 5. Cone:<br>Polycarbonate | N/A | | | 6. Nozzle:<br>Polycarbonate | Polypropylene | | | 7. Sealing<br>Thermoplastic Elastomer Compound | Unknown | | | 8. Lubrication<br>Silicon lubrication | Unknown | | | 9. Needle cap<br>Polypropylene | Unknown | | | 10. Primary container:<br>Peel-packs made of plastic | Unknown | | | 11. Secondary container:<br>Cardboard box | Unknown | | | 12. Transport container:<br>Corrugated cardboard | Unknown | | Sterility | Sterilized by ethylene oxide gas | Sterilized by ethylene oxide gas | | | SAL < $10^{-6}$ | SAL = $10^{-6}$ | Table 10 Table of Comparison #### Conclusion In all material respects, the Manual Safety Syringe is substantially equivalent to the m an material respects) also hambabased on biocompatibility testing, compliance with production and comparison to the predicate device. A clinical evaluation has volunary standards, and the results show that the Manual Safety Syringe 5ml is clinically acceptable. End of 510(k) summary {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 0C1 16 2006 Mr. Jan-Erik Mikkelborg Managing Director MedSafe ASA Forskningsveien 2A N-0373 Oslo, Norway Re: K060772 Trade/Device Name: Manual Safety Syringe MS 1178-2 (5ml, 22G, 1 1/4") Manual Safety Syringe MS 1178-3 (5ml, 22G, 11/4") Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 13, 2006 Received: September 18, 2006 Dear Mr. Mikkelborg: 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. 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 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. {4}------------------------------------------------ Page 2 – Mr. Mikkelborg 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); good manufacturing practice requirements 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) premarket notification. 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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html. Sincerely yours, Chris Liu, Ph.D. 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the word "medsafe" in a stylized, futuristic font. To the right of the word is a square-shaped logo with a line extending from the top right corner. The text and logo are both in black and stand out against a white background. #### C Indications for Use 510(k) Number (if known): _____K060772_ Manual Safety Syringe_MS 1178-2 (5 ml, 22G, 1 1/4")_ Device Name: Manual Safety Syringe_MS 1178-3 (5 ml, 22G, 1 1/4")_ Indications for Use: The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication. This device aids in prevention of needle stick injuries. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (PLEASE.DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Solllll for Anthony D. Watson (0)1/6/2004 of Anesthesiology, General Hospital on Control, Dental Devices umber: K66722 Side: 12 of 12