MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "MEDRAD" in a stylized, bold, sans-serif font. The letters are all capitalized and appear to be slightly slanted to the right. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the letter "D". ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SS K980417 Submitters Name: Submitters Address: Phone Number: Fax Number: Contact Person: Date: Medrad, Inc. One Medrad Drive Indianola, PA 15051 (412) 767-2400, ext. 3212 (412) 767-8899 Sandra A. Pavlovic January 30, 1998 Classification Name: Common Name: Proprietary Name: Unknown Sterile Disposables Kit Medrad Disposable MRI Kit with Check Valve Substantial Equivalence: The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following: - 2- 65 ml syringes (K935668) - 96" Low Pressure Connector Tube/T-connector assembly (K943189) . - . Fluid Delivery Device (Spike) - (K810624) - Normally closed check-valve B. Braun/Burron (K790062) ● - Female/Female Luer Adapter B.Braun/Burron (K942391) . The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed. The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process. Image /page/0/Picture/15 description: The image shows a stylized letter Q in white against a dark, textured background. Below the letter, there is some faint text that is difficult to read due to its small size and blurriness. The text appears to be in a sans-serif font and is arranged in two lines. MAY {1}------------------------------------------------ The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device. All other components of the kit are identical to those in K943189. The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines. Medrad believes that the Medrad Disposable MRI Kit with Check valve and individual components introduces no new safety or efficacy concerns. It is my hope that the information provided here is sufficient to determine substantial equivalence for these devices. ### STERILIZATION DATA The Medrad Disposable MRI Kit with Check-valve and its components are sterilized by Medrad, Inc. using Oxyfume 2000 (8.4 % Ethylene Oxide and 91.6 % HCFC-124). The sterilization process is the same one used to sterilize the complete line of Medrad sterile disposable devices. #### Sterility Validation: The sterilization validation is done using a Microbial Challenge-Overkill Method as described in the "Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices," by the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI). Reference ANSI/AAMI ST27-1988. Annual re-validations are performed for established cycles of master product/load configurations as well as periodic product sterility determinations for fluid pathways, following routine sterilization's. #### Sterility Assurance Level (SAL): The Microbial Challenge System is represented by packaged product containing commercially prepared biological indicators of Bacillus Subtilis var. niger with spores numbering 1 x 10°. Fifty test products are sterilized in each of three half cycle verification runs in the full load configuration. A Sterility Assurance Level (SAL) of 10to is established. {2}------------------------------------------------ #### Sterility Product Safety: Residual levels: Residual Ethylene Oxide measurements are made to ensure patient safety and the safety of attending medical personnel. Measurements for Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol by: 1). Simultated-use aqueous extractions for product safety considerations. 2). Headspace for process characterization. Reference: ANSI/AAMI ST29-1988 and ST30-1989. Limits are as practiced in industry and as presented in the Federal Register, Vol. 43, No. 122 - June 23, Pre-release testing for EtO residuals have shown the following levels after 8 days of outgassing: Ethylene Oxide (vis simulated-use aqueous extractions) = < 4ppm Ethylene Chlorohydrin (via aqueous extraction) =< 4ppm Ethylene Glycol (via aqueous extraction) = < 18 ppm Pvrogenicity: Pyrogen (Endotoxin) testing is conducted per USP Rabbit Testing and/or USP Limulus Amebocyte Lysate (LAL) test methods. Reference US Pharmacopeia XXII, <151> Pyrogen Test, and <85> Bacterial Endotoxin Test. Biocompatibility: ANSI-AMMI(ISO) testing as well as USP testing is conducted to assure Biocompatibility of sterile product with living biological systems. Reference: ANSI/AMMI/ISO 10993-1 through 11 and US Pharmacopoeia XXII, <87 & 88> Biological Reactivity Test Invitro and Invivo. - · Cytotoxicity MEM - · Sensitization - · Systemic Tox - · Intracutaneous Tox - · Pyrogen Mat'l Mediated - · Hemolysis - · Particulate analysis - · Bacterio-/Fungistasis - · Physiochemical analysis -aqueous #### -non-aqueous - . Infrared analysis - ID "fingerprint" {3}------------------------------------------------ #### Packaging: The packaging used for the Medrad Disposable MRI Kit with Check-valve consists of a polystyrene tray and a coated Tyvek lid that is heat sealed to the styrene tray. The entire package is compatible with an EtO Sterilization Cycle. #### Shelf Life: At this point the ongoing Shelf Life testing process has confirmed that the kit has at least a two year Shelf Life from the date of sterilization. The testing will continue until it can be concluded that the product has a five year Shelf Life, which is standard for all Medrad sterile products. The Shelf Life test method is based on the "Ethox Protocol for Accelerated aging" tests and uses the following sequence to simulate ambient storage: > 1 week at 130° and 70-80% RH 1 day at -4°F 1 week at 130°F and <15% RH This accelerated sequence is equivalent to 6 months of normal aging. The following tests will be conducted to ensure product efficacy: > Flow tests Pressure tests #### ARO tests {4}------------------------------------------------ ## COMPARISON DATA FEMALE/FEMALE LUER ADAPTER | FEATURE | FEMALE/FEMALE<br>LUER ADAPTER | QUICK FILL TUBE | |-----------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------| | Intended use | Fluid transfer from one vessel having a male termination to a syringe with a male termination. | Transfer of fluid from a bottle or vial to a syringe. | | Material | Transparent ABS | Polyethylene | | Disposable | Yes | Yes | | Standard Luer Fitting | Yes - ANSI 70.1 | No | | Where used | MRI | MRI, CT, Angiography, Cardiology | | Sterilized | Yes | Yes | | Single Use | Yes | Yes | 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - : : {5}------------------------------------------------ # COMPARISON DATA LOW PRESSURE CONNECTOR TUBE WITH CHECK VALVE : | FEATURE | Medrad 96" LLPCT | Medrad 96" LLPCT with<br>Check Valve | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Disposable device<br>connected to a syringe<br>and IV catheter for the<br>administration of contrast<br>media and flushing<br>solutions. | Disposable device<br>connected to a syringe<br>and IV catheter for the<br>administration of contrast<br>media and flushing<br>solutions. | | Luer fitting | ANSI 70.1 | ANSI 70.1 | | T- connector | Yes | Yes | | Tubing Material | Clear Polyvinyl Chloride | Clear Polyvinyl Chloride | | Luer Fitting Material | Clear Polycarbonate | Clear Polycarbonate | | Check-valve | No | Yes | | Where used | MRI | MRI | | Sterilized | Yes | Yes | | Single Use | Yes | Yes | | Disposable | Yes | Yes | {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. 1 1998 MAY Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Sandra A. Pavlovic Senior Regulatory Affairs Associate MEDRAD, Inc. One Medrad Drive Indianola. Pennsylvania 15051 Re: K980417 Disposable MRI Kit with Check Valve Dated: February 3, 1998 Received: February 3, 1998 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH Dear Ms. Pavlovic: 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, vou are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterlize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. {7}------------------------------------------------ Page -2 - Ms. Sandra Pavlovic 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/dsma/dsmamain.html". Sincerely yours, David A. Legum Lillian Yin, Ph.D. Director, Divsion of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {8}------------------------------------------------ Page 1 of 1 510(k) NUMBER (IF KNOWN): K980417 DEVICE NAME: Medrad Disposable MRI Kit with Check Valve INDICATIONS FOR USE: ThE Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates. (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) OR Over-The-Counter-Use (Optional Format 1-2-96) David le Seymour (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number