PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES

{0}------------------------------------------------ K981035 Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo is divided into two parts. The left side of the logo has the letters "SIMS" in a bold, stylized font. The right side of the logo has the words "SMITHS INDUSTRIES" in a bold, sans-serif font, with the words "Medical Systems" in a smaller, serif font below. # J: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS # APR 21 1998 # 510(K) SUMMARY: ## COMPANY INFORMATION: SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs ## PREPARATION DATE OF SUMMARY: March 13, 1998 ### TRADE NAME: Pro-Vent® and Pulsator® Arterial Blood Sampling Syringes ## COMMON NAME: Arterial Blood Sampling Syringes ## PRODUCT CLASS/CLASSIFICATION: Class II, 75 GJE, 21 CFR 862.1675. ## PREDICATE DEVICE(S): Our Arterial Blood Sampling syringes with Calcium Neutralized Dry Lithium Heparin (K952516). #### SIMS Portex Inc. 10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703 {1}------------------------------------------------ ### DESCRIPTION: A commercially available hypodermic needle is modified by dispensing sodium heparin into the hub and cannula and then drying the heparin. The total recoverable volume of the heparin is approximately 5 U.S.P. units. The needle is then attached to a Pro-Vent® or Pulsator® Arterial Blood Sampling Syringe, which contains approximately 25 U.S.P. units of Calcium Neutralized Dry Lithium Heparin. The device is packaged and sterilized by Ethylene Oxide. ### INDICATIONS FOR USE: The arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of p02, pCO2, pH, CO-oximetry, electrolytes (Ca++, Na+, K+, Cl+, and Mg++), Total Magnesium, and the metabolites (Glucose and Lactate). ## TECHNICAL CHARACTERISTICS: The proposed syringe with heparinized needle has dry calcium neutralized lithium heparin in the syringe and dried sodium heparin in the needle. Calcium Neutralized Dry Lithium Heparin is used in our Arterial Blood Gas Sampling Syringes, currently legally marketed (K952516). Sodium Heparin is used in our liquid filled Arterial Blood Gas Sampling Syringes, currently marketed (K952516). Materials of the svringe and needle are unchanged from our current Arterial Blood Gas Sampling Syringes. Sterilization is by the same methods employed in our existing Arterial Blood Gas Sampling Syringes, as authorized by FDA in 510(k) K952516. ### NON-CLINICAL DATA: The proposed syringes were tested in a side-by-side comparison to our current Arterial Blood Sampling Syringes with Calcium Neutralized Dry Lithium Heparin. The testing consisted of the sampling of arterial blood and the subsequent measurement of p02, pCO2, pH, CO-oximetry, Ca++, Mg++, Na+, K+, C1-, Total Magnesium, Glucose, and Lactate. The results of the measurements were compared. There was no statistical difference between the proposed syringes and the predicate device. {2}------------------------------------------------ # CONCLUSION: The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device. Very truly yours, SIMS Portex Inc dba Concord/Portex Timothy J. Ickes Timothy J. Talcott Manager, Regulatory Affairs {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a human figure. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 APR 2 1 1998 Timothy J. Talcott . Manager, Regulatory Affairs SIMS Portex Inc. 10 Bowman Drive P.O. Box 0724 Keene, New Hampshire 03431 K981035 Re : Pro-Vent® and Pulsator® Arterial Blood Sampling Syringes Regulatory Class: II Product Code: JKA Dated: March 13, 1998 Received: March 19, 1998 Dear Mr. Talcott: 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, Drug, 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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 regulations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {4}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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, Steven Bitman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # B: INTENDED USE OF DEVICE # PROPOSED INDICATIONS FOR USE: The arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of p02, pCO2, pH, CO-oximetry, electrolytes (Ca++, Na+, K+, Cl+, and Mg++), Total Magnesium, and the metabolites (Glucose and Lactate). Patricia Bernhart (for A. Montgomery) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. prescription use. ✓