SMARTLOCK SAFETY SYRINGE

{0}------------------------------------------------ ATTACHMENT D \$\times\$ 9 73888 3 1998 JUN # 510(k) Summary # Applicant 1. Medical Innovations Limited Exchange House Athol Street Douglas Isle of Man Contact Persons: Daniel Kracov USA: Patton Boggs LLP 2550 M Street, N.W. Washington, D.C. 20037 (202) 457-5623 (202) 457-6315 (fax) South Africa: John Tyler Medical Innovations Limited c/o Design Equity (Pty) Ltd 7th Floor Norwich Life Towers 13 Fredman Drive Sandton +27 11 884 0614 +27 11 884 4163 (fax) # 2. Device Details Smartlock TM Syringe Trade Name: hypodermic syringe, safety syringe, Common Names: piston syringe with safety mechanism Classification Name: piston syringe ll Class: {1}------------------------------------------------ #### Predicate Devices 3. The Smartlock™ safety syringe is substantially equivalent to the Becton Dickinson Plastipak™ standard syringe in use. The Smartlock™ safety syringe is also substantially equivalent to the Becton Dickinson Safety-Lok™ safety syringe # Product Description 4. The Smartlock™ safety syringe is a sterile, single use hypodermic syringe incorporating an innovative safety mechanism. It is designed to withdraw the needle into the safety shield after use and to lock it in this position. Image /page/1/Figure/5 description: The image shows a black and white drawing of a syringe. The syringe has a needle on the left side and a plunger on the right side. The barrel of the syringe has markings that indicate the volume of fluid inside. The plunger is partially depressed, indicating that some fluid has already been expelled from the syringe. # Smartlock™ Safety Syringe - 5ml The Smartlock™ safety syringe is a slight departure from standard syringes in that whilst it consists of three parts i.e. a safety shield, a barrel and a plunger, there are differences in their design. There is no rubber piston. The syringe is packaged fully assembled and no set-up action or pre-use motion is necessary. Needles are attached in the standard luerslip method and can be changed during a procedure, if necessary. The materials used in production are medical grade polypropylene and polyethylene. As the last of the medication is delivered, the plunger rim will disengage the safety clips from the shoulder. As the plunger is retracted (as if to refill), the needle will also retract. The plunger must be retracted fully until a "click" sound is heard and no movement is possible. Disposal is then simple and safe. The functioning of the 3ml, 5ml and 10ml Smartlock ™ Safety Syringes are identical in all respects, save the amount of fluid which can be aspirated. {2}------------------------------------------------ #### 5. Intended Use The Smartlock™ safety syringe is intended as a sterile, single use, disposable syringe to be used for injecting medications or fluids into the patient by attached cannula or via intravenous therapy, or to draw samples or fluids by the same means. Only once the medication has been administered or the sample taken, should the safety mechanism be activated. The intention of the safety mechanism is, after use of the syringe, to bring the needle within the safety shield in one motion and to lock it in that position. rendering the syringe unusable. The safety mechanism has no effect on the efficacy of the syringe in regard to its performing the function of a standard syringe. The 3ml, 5ml and 10ml Smartlock™ syringes all function using the same principle and all have the same intended use. The Smartlock™ syringes are not intended to be used with syringe pumps. The appropriate warnings are printed on the syringe labeling. #### 6. Comparison {3}------------------------------------------------ # -4-COMPARISON OF SYRINGES | COMPARISON | Smartlock™ SAFETY SYRINGE | B-D SAFETY-LOK™ | B-D PLASTIPAK™ | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | Syringe Size | 5ml - single use | 5 ml - single use | 5ml - single use | | Syringe Type | Safety | Safety | Standard | | Number of Parts | 3 | 6 | 3 | | Materials | Safety shield and Plunger -<br>Polypropylene<br>Barrel - Polyethylene<br>All components silicone free | Plunger, Barrel, Safety shield,<br>Locking Ring - Polypropylene<br>Piston - Silicone Rubber | Plunger and Barrel - Polypropylene<br>Piston - Silicone Rubber | | Connection Type | Luerslip | Luerlock | Luerlock | | Scales and<br>Markings | Graduations as per ISO 7886 with scale<br>intervals of 0.5ml.<br>Blue indicator arrow at base of safety<br>shield.<br>All graduations can be clearly read.<br>Use once only.<br>Trademark symbol | Graduations as per ISO 7886with<br>scale intervals of 0.2ml.<br>Green strip around safety shield.<br>Graduations can only be read through<br>the safety shield.<br>Sterile single use.<br>Trademark symbol. | Graduations as per ISO 7886 with scale<br>intervals of 0.5ml.<br>Graduations can be clearly read.<br>Trademark symbol. | | Color | Parts - virgin material (clear)<br>Printing - blue | Parts - virgin material (clear)<br>- red locking ring<br>Printing - black and green | Parts - virgin material (clear)<br>Printing - black | | Safety Feature | Needle retracts into safety shield and<br>locks in one operation.<br>Mechanism activated manually on<br>dispensing of medication. | Safety shield is pulled over needle<br>and locks in one operation.<br>Mechanism activated manually on<br>dispensing of medication. | No safety feature. | | -5- | | | | | Numbering | Read in reverse off plunger. | Read forward off barrel. | Read forward off barrel. | | Aspiration | Fluid fills into the plunger as the plunger<br>is withdrawn. | Fluid fills into the barrel as the<br>plunger is withdrawn. | Fluid fills into the barrel as the plunger<br>is withdrawn. | | Volume<br>Determination | Read off the arrow indicator at the base<br>of the safety shield. | Read off the top edge of the black<br>rubber piston. | Read off the top edge of the black<br>rubber piston. | | Warnings | Not to be autoclaved.<br>Not suitable for blood gassing.<br>Only to be used with needles 1½" or<br>shorter. Not to be used with syringe<br>pumps. | Not to be autoclaved.<br>Only to be used with needles 1½" or<br>shorter. Not to be used with syringe<br>pumps. | Do not re-sterilise.<br>Not to be used with paraldehyde. | | Intended Use | As a single use, hypodermic syringe.<br>Safety feature protects after<br>administration. | As a single use, hypodermic syringe.<br>Safety feature protects after<br>administration. | As a single use, hypodermic syringe. No<br>safety feature. | | Operation | 6 steps to operate :<br>1. attach needle / remove needle cap<br>2. draw medication<br>3. expel air<br>4. administer medication<br>5. pull to lock safety mechanism<br>6. dispose | 6 steps to operate :<br>1. attach needle / remove needle<br>cap<br>2. draw medication<br>3. expel air<br>4. administer medication<br>5. pull to lock safety mechanism<br>6. dispose | 5 steps to operate :<br>1. attach needle / remove needle cap<br>2. draw medication<br>3. expel air<br>4. administer medication<br>5. dispose | | Re-usability | Cannot re-use | Cannot re-use | Easy to re-use | | Sterilisation | EO gas (non-flammable) | Gamma radiation. | EO gas. | | Labeling | 1. On primary syringe packaging<br>2. On dispensing box | 1. On primary syringe packaging<br>2. On dispensing box | 1. On primary syringe packaging<br>2. On dispensing box | -- {4}------------------------------------------------ : and the same {5}------------------------------------------------ # Clinical Trial 7. Clinical trials were held in three South African hospitals to compare the Smartlock™ safety syringe to the Becton Dickinson Plastipak™ standard syringe. The primary hypothesis was that the Smartlock™ safety syringe would be substantially equivalent to the conventional syringe in respect of comparable characteristics. The information collected was comprehensive and extremely detailed and included both the objective and subjective experiences of the participating nurses. Monitoring of the actual use of syringes by the nurses, was by experienced personnel and evaluation of the number of svringes which functioned successfully was by an independent auditor. The results were largely clear cut. The nurses ranked both types of syringes similarly and positively, and this was confirmed by the monitors and the auditor. The Smartlock™ safety svringe proved substantial equivalence to the Plastipak™ syringe in use. #### 8. Simulated Use Study A simulated use study was conducted at three separate American hospitals. The Smartlock™ safety syringe was compared to the Becton Dickinson Safety syringe. The success rates in correctly using the Smartlock™ safety syringe did not significantly differ from the rates seen with the Becton Dickinson Safety svringe among nurses who received instruction from the package insert. When a verbal "inservice" training session was added, the Safety-Lok™ was scored at a slightly higher level, The study documented that the Smartlock™ safety syringe is substantially equivalent to the Safety-Lok™ safety syringe with respect to the rates of correct usage. The study also documented that "in-service" training sessions prior to introducing the syringes to hospitals would enhance the rate of correct usage. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 3 1998 Medical Innovation Limited ·C/O Mr. Daniel A. Kracov Counsel to Medical Innovations Limited Patton Boggs, L.L.P. 2550 M Street N.W. Washington, DC 20037-1350 Re : K973888 Trade Name: Smartlock Safety Syringe Regulatory Class: II Product Code: MEG Dated: March 31, 1998 Received: March 31, 1998 Dear Mr. Kracov: 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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {7}------------------------------------------------ Page 2 - Mr. Kracov the Act for devices under the Electronic Product Radiation Control 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 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Tim thy Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ 510(k) Number (if known): Smartlock™ Safety Syringe Device Name: Indications For Use: A sterile, single-use hypodermic syringe, incorporating a safety mechanism designed to withdraw the needle back into the safety shield after use and lock it in this position. To be used for injecting medications or fluid into the patient by attached cannula or via IV therapy or to draw samples or fluids by the same means. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Patricia Crescenti (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K973888 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)