SIMS PORTEX ANESTHESIA CATHETER

{0}------------------------------------------------ K994275 Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo is composed of two lines of text. The first line reads "SMITHS INDUSTRIES" in a bold, sans-serif font. The second line reads "Medical Systems" in a serif font. FEB 2 2 2000 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS #### 510(K) SUMMARY: ### COMPANY INFORMATION: SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Director of Regulatory Compliance #### PREPARATION DATE OF SUMMARY: February 16, 2000 ## TRADE NAME: SIMS Portex Anesthesia Catheter #### COMMON NAME: Anesthesia Conduction Catheter ### PRODUCT CLASS/CLASSIFICATION: Class II, 79 MEB, accessory to 21 CFR 880.5725 (infusion pump) #### SIMS Portex Inc. 10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703 {1}------------------------------------------------ #### PREDICATE DEVICE(S): SIMS Portex Inc., Epidural Catheter; 4910-18, 21g nylon, closed-end, three-eyed This device is marketed under 510(k), K992471. - B. Braun Medical Inc., PERIFIX® Epidural Catheter Set, EC20-C This device is marketed under 510(k), K813186 and the indications for use are as specified in I-Flow Corporation's 510(k)s, K980558 and K991543. #### DESCRIPTION: The SIMS Portex Anesthesia Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks. The catheter is available as 21g (O.D. .033"/I.D. .019"). The catheters have a nominal length of 38 inches. The catheters may include a stylete. The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017). #### INDICATIONS FOR USE: The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Roures of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use. ### TECHNICAL CHARACTERISTICS: The design of the catheter and materials are identical to our current catherer. The catheter has been evaluated and demonstrated equivalency to the predicate devices for the following dimensional and functional characteristics: ID, OD, length, flow rate, leakage, eye patency, tensile strength, percentage elongation, luer taper, and security of connection of the catheter to the catheter connector. {2}------------------------------------------------ #### NON-CLINICAL DATA: Data submitted demonstrates that the catheter performs equivalently to the predicate devices. Data submitted covers; dimensional characteristics, flow rate, leakage, hub/catheter detachment, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993. ## CLINICAL DATA: Not applicable ### CONCLUSION: The comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices. Very truly yours, SIMS PORTEX INC. Timothy J. Fallon Timothy J. Talcott Director of Regulatory Compliance {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 2 2 2000 Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Incorporated 10 Bowman Drive P.O. Box 0724 Keene, New Hamphshire 03431 Re : K994275 SIMS Portex Anesthesia Catheter Trade Name: Regulatory Class: II Product Code: FRN Dated: December 17, 1999 December 20, 1999 Received: 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 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 (Premarket Approval), 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 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in {4}------------------------------------------------ Page 2 - Mr. Talcott 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 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 diaqnostic 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.fdag.gov/cdrh/dsmamain.html". Sincerely yours, U. Whitcomb Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ b 510(k) Number (if known): Unknown 13994275 Page 1 of 1 Device Name: Anesthesia Catheter Indications For Use: The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 510(k) Number. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Use **__** (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices Controly 994225