PARSET, MODEL A10001E

{0}------------------------------------------------ AUG 23 1999 # RD MEDICAL MANUFACTURING, Inc. Culebra, P.R. Abbreviated 510(k) K 992104 Page 8 of 28 Proposed Device: PARSET® I.V. Administration Set, Vented/Non-vented, one injection site, 80 in., Latex Free. #### 8. 510(k) Summary #### Submitted by: RD Medical Manufacturing, Inc., PO Box 899, Calle Escudero Final, Bo. Fulladosa, Culebra. Puerto Rico, 00775. Contact: Carlos A. Rodríguez-García, Ph.D., Product Development Director. #### Date of Summary: June 18, 1999 #### Trade Name of Proposed Device: PARSET® I.V. Administration Set, Vented/Non-vented, one injection site, 80 in., Latex Free Common Name: Infusion Set #### Classification Name: Intravascular Administration Set (§880.5440). ## Predicate Device: Baxter Vented Solution Set, Catalog # 2C5419s. ## Description of Proposed Device: The proposed administration set will be used for intravascular administration of fluids and medication. The proposed device contains a vent with filter such that it can be used with non-collapsible fluid containers. The vent also has a cap to close the vent when using a collapsible fluid container (e.g., IV bag) which does not require a vent. The proposed device also contains an injection site 8 in. from the distal luer slip connector. ## Intended Use: The intended use of the proposed device is for the intravascular administration of fluids and medication by trained health care personnel. The administration of fluids is achieved through gravity from collapsible or non-collapsible fluid containers through a venipuncture device (not included in the proposed device). ## Summary of Technological Characteristics of Proposed Device to Predicate Device The proposed device is composed of the same type of components and intended use of the predicate device. The differences between the proposed and predicate devices include {1}------------------------------------------------ # RD MEDICA MANUFACTURING. Inc. Culebra, P.R. Abbreviated 510(k) Page 9 of 28 Proposed Device: PARSET® I.V. Administration Set, Vented/Non-vented, one injection site. 80 in., Latex Free. a latex-free injection site: composed of polyisoprene, a synthetic polymer; vent cap, to use the set with fluid bags: drops / mL. which is 20 for the proposed device and 10 for the predicate device. The predicate device contains a slide clamp, which is a feature that does not add any functional advantage. The results of the biocompatibility tests and chemical tests. conducted as per ISO 10993-1 and ISO 8536-4 respectively, indicate that the polyisoprene used in the injection site is well within the safe operational limits for the intended use of the proposed device. The product performance, illustrated by the flow rate data, indicates that the installation of the cap is a beneficial feature that complies with the flow rate specification in ISO 8536-4. ## Discussion of Non-clinical Tests Testing of the proposed device was conducted as per the Recognized Consensus Standards: - ISO 8536-4: 1987, Infusion equipment for medical use infusion sets for single . use, gravity feed - ANSI/AAMI/ISO 10993-1, Guidance on selection of tests - ANSI/AAMI/ISO 11607: 1997, Packaging for terminally sterilized products . - ANSI/AAMI/ISO 11137: 1994. Sterilization of health care products- requirements . for validation and routine control- radiation sterilization. The results of the tests conducted for compliance to Recognized Consensus Standards have been provided. All data indicate that the proposed administration set meets or exceeds all functional requirements and therefore supports the suitability of the proposed device for its intended use. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines representing hair or movement above them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 23 1990 Carlos A. Rodriguez-Garcia, Ph.D. Product Development Director RD Medical Manufacturing Incorporated Calle Escudero Final, Bo Fulladose Cuebra, Puerto Rico 00775 K992104 Re : Parset, Model A10001E Trade Name: Regulatory Class: II FPA Product Code: Dated: June 18, 1999 Received: June 22, 1999 #### Dear Dr. Garcia: 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {3}------------------------------------------------ Page 2 - Dr. Garcia 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 Ehus, permits your device to proceed to the market. If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at Additionally, for questions on the promotion and (301) 594-4692. advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). 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.qov/cdrh/dsmamain.html" . Sincerely yours, Timothy A. Ulatowski Timothy Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # SIO (K) NUMBER (IF KNOWN) : KASZIO4 PARSET I.V. Administration Set Vented/Non-DEVICE NAME: PARSET I.V. Adminiscracion Set Tented, N. . . . . . . Vented, One Injection Site, 80 in., Latex Free INDICATIONS FOR USE: The device is used to supply medication and fluids. The supply to patients through a needle or The device is used to sappy marough a needle or intravascularly to patients the wate intravabcurary of the vein. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) 1 OR Over-The-Counter-Use (Optional Format 1-2 Patricio Accente (Division Sign-Off) Division of Dental, I and General Hosph 51 (k) Number