I.V. CATHETER SYSTEM

{0}------------------------------------------------ K980493 510(k) - I.V. Catheter System APR 28 1998 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for I.V. Catheter System Johnson & Johnson Medical 2500 Arbrook Boulevard P.O. Box 90130 Arlington, Texas 76004-3130 Date: February 6, 1998 # 1. REGULATORY AUTHORITY Safe Medical Devices Act of 1990, 21 CFR 807.92 ## 2. CONTACT PERSON Linda G. Hill (817) 784-4791 ### 3. NAME OF MEDICAL DEVICE: Catheter, Intravascular, Short Term Classification Name: Common/Usual Name: I.V. Catheter Proprietary Name: To be determined #### 4. DEVICE CLASSIFICATION: The General Hospital Panel has classified Intravascular Catheters (21 CFR 880.5200) into Class II, Special Controls under section 513 of the Act. ### 5. STATEMENT OF SUBSTANTIAL EQUIVALENCE: The I.V. Catheter System is substantially equivalent to JJM's existing CRITIKON* OCR I.V. Catheter and to Bio-Plexus' existing Punctur-Guard® Blood Collection Needle. See attached Comparison Matrix, Table 1. ### 6. INTENDED USE: The I.V. Catheter System is designed to gain access to and deliver a short term (<30 days) intravascular catheter into the patient's vascular system to sample blood, monitor blood pressure, or administer fluids. {1}------------------------------------------------ ### 510(k) SUMMARY (continued) ## 7. DESCRIPTION OF DEVICE: The I.V. Catheter System contains a short term intravascular catheter and a catheter introducer. The intravascular catheter consists of a slender catheter tube and a catheter hub. The catheter introducer consists of a housing that contains a flash chamber, a flash plug, a stainless steel needle and a needle safety mechanism. The I.V. Catheter System is designed to reduce the risk of accidental needlesticks. # 8. SUMMARY OF MATERIAL TESTING: The I.V. Catheter System meets ISO 10993-1 requirements for material safety and biocompatibility. The introducer needle meets the requirements of ISO 10555-5. The I.V. catheter has previously received FDA clearance. ## 9. SUMMARY OF SIMULATED USE STUDY: There were 50 participants and a total of 500 I.V. Catheter Systems were successfully inserted and evaluated. No sharps injuries or failures of the protective feature occurred. The results of this study support the claim that the I.V. Catheter System can reduce the risk or accidental needlestick injuries. The positive responses from the 50 participants reqarding insertion and use characteristics indicate the the I.V. Catheter System is intuitive in nature, requires little or no change in usual technique, and meets customer requirements. ### 10.CONCLUSION: The material testing and simulated use data indicate that the I.V. Catheter System is safe and effective for it's intended use. {2}------------------------------------------------ # TABLE 1. COMPARISON MATRIX A comparison matrix for various factors is presented below for the J.V. Catheter System in comparison with CRITIKON* OCR I.V. Catheter and Punctur-Guard® Blood Collection Needle. | Factor | I.V. Catheter System | CRITIKON* OCR<br>I.V. Catheter | Punctur-Guard®<br>Blood Collection<br>Needle | |-----------------------------------------------------------------------|----------------------|--------------------------------|----------------------------------------------| | Intended Use and Claims | | | | | Same Intended Use | Yes | Yes | No | | Venipuncture Device | Yes | Yes | Yes | | Sharps Injury Prevention Feature | Yes | No | Yes | | Reduces Risk of Accidental Needlesticks | Yes | No | Yes | | Delivers Short Term Intravascular Catheter | Yes | Yes | No | | Conventional Venipuncture Technique | Yes | Yes | Yes | | Radiopaque Catheter | Yes | Yes | Not Applicable | | Catheter Insertion Technique | 1-handed or 2-handed | 1-handed or 2-handed | Not Applicable | | Technological Features | | | | | Same Technological Features | Yes | No | Yes | | Sharps Injury Prevention Mechanism | Passive | None | Active | | Self-Blunting Needle | Yes | No | Yes | | Blunt Locks in Place | Yes | Not Applicable | Yes | | Sharps Injury Prevention Feature Remains<br>Activated During Disposal | Yes | Not Applicable | Yes | | Flashback Visualization | Yes | Yes | Yes | | Removable Flashplug and Luer Adapter | Yes | Yes | Not Applicable | {3}------------------------------------------------ | Factor | I.V. Catheter System | CRITIKON* OCR<br>I.V. Catheter | Punctur-Guard®<br>Blood Collection<br>Needle | |-------------------------------------------------------------------|----------------------|--------------------------------|----------------------------------------------| | <b>Specifications</b> | | | | | Multiple Gauge Sizes and Needle Lengths | Yes | Yes | Yes | | EtO Sterilized | Yes | Yes | Yes | | <b>Other</b> | | | | | Sharps Injury Prevention Feature is an<br>Integral Part of Device | Yes | Not Applicable | Yes | | Minimal User Training | Yes | Yes | Yes | {4}------------------------------------------------ Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 28 1998 Ms. Linda G. Hill ·Sr. Manager, Regulatory Affairs Johnson & Johnson Medical 2500 Arbrook Boulevard Arlington, Texas 76004-3130 Re : K980493 I.V. Catheter System Trade Name: Requlatory Class: II Product Code: FOZ Dated: February 6, 1998 Received: February 9, 1998 Dear Ms. Hill: 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 of the Act. The general controls provisions 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 Requlations, Title 21, Parts 800 to 895. ਸ 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 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 {5}------------------------------------------------ Page 2 - Ms. Hill the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. 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, Timothy A. Ulatowski Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## INDICATIONS FOR USE #### Applicant Johnson & Johnson Medical P.O. Box 90130 Arlington, Texas 76004-3130, USA ### 510(k) Number This is a new submission and FDA has not assigned a number at this time #### Device Name I.V. Catheter System #### Indications for Use A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self=------------------------------------------------------------------------------------------------blunting needle system activated automatically as the catheter is threaded into the vessel. (Please do not write below this line-Continue on another page if needed) Concurrence of CDRH Office of Deyice Evaluation (ODE) > Palman (Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K980423 Prescription Use V OR Per 21 CFR 801.109 (Optional Format 1-2-96)_ Over-the-Counter iV