HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is a simple, abstract design, and the text is in a sans-serif font. The logo is a symbol of the U.S. government's commitment to health and human services. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 # MAY : 1 : Mr. John Tartal Quality/Regulatory Affairs Director Horizontal Medical Products, Incorporated 1 Horizon Wav Manchester. Georgia, 31816 Re: K994196 Trade/Device Name: Horizon Medical Products Microport 2 Peripheral Access System Regulation Number: 21 CFR 800.5965 Regulation Name: Subcutaneous, implanted, intravascular infusion port and catheter Regulatory Class: Class II Product Code: LJT Dated: December 10, 1999 Received: December 13, 1999 Dear Mr. Tartal: This letter corrects our substantially equivalent letter of February 10, 2000. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements {1}------------------------------------------------ Page 2 - Mr. John Tartal as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Image /page/1/Figure/7 description: The image shows the text "Sincerely yours," followed by a signature and the letters "FDA". The signature appears to be illegible, but the name "Tina Kiang" is written next to it. The letters "FDA" are large and stylized, with the signature overlapping them. Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K994196 510(k) NUMBER (IF KNOWN): Microport 2 Peripheral Access System DEVICE NAME: INDICATIONS FOR USE: The MicroPort 2 System is indicated for peripheral placement in the midarm, above the anticubital space and well below the subaxillary area, when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. (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 Patrica Cucerti (Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number {3}------------------------------------------------ ## EXHIBIT F # 510(k) NOTIFICATION FEB 1 0 2000 K994196 ## SAFETY AND EFFECTIVENESS #### Product Description The Horizon Medical Products MicroPort 2 system consist of a low profile ellipsoidal port made of Titanium and an attachable Polyurethane catheter. The catheter is attached to the port body by placing the catheter and strain relief connector over the barbed stem (outlet tube) of the body. The port body is implanted in the mid-arm (above the elbow). Implantation in the mid-arm avoids the bend in the elbow, which could place the catheter under added stress. The catheter reaches the central venous circulation via either the basilic or axillary vein. The veins in the upper arm are larger and offer a less tortuous path to the central venous circulation, making insertion easier. Additionally, this catheter route lessens the danger of pneumothorax, hemopneumothorax, air embolism, as well as catheter shear (Note: Catheter does not pass between the clavicle and the first rib.). The MicroPort 2 Peripheral Access System is packaged without and with kit introducer components. The kit contains basic components required for percutaneous. The system is sterilized by ethylene oxide gas and is labeled as a sterile as well as a single use only device. #### Statement of Sterilization The MicroPort 2 Peripheral Access System products will be included in the Infuse-A-Port product line. The system is labeled as a sterile and nonpyrogenic device. Pursuant to the 510(k) sterility review guidance for sterilized medical devices (February 12, 1990), the following information is provided. - 1. Sterilization Method Used: The sterilization method used for the Infuse-A-Port product line is treatment with ethylene oxide gas. - 2. Description of Sterilization Validation Cycle: The validation study for the Infuse-A-Port product line was designed to conform with the March 1988 AAMI "Guideline for Industrialized Ethylene Oxide Sterilization of Medical Devices: Process design, Validation, Control of Routine Sterilization." Specifically the sections dealing with Overkill sterilization. - 3. Sterility Assurance Level (SAL); HMP will utilize the AAMI overkill method with a SAL of 106. 210(k) {4}------------------------------------------------ - Description of Package: The MicroPort 2 Peripheral Access System 4. products will be packaged in the same way and use the same materials as the Infuse-A-Port product line. The configurations are a tray containing device/component(s) sealed with Tyvek that is sealed in a Tyvek bag or outer trav. - న్. Ethylene Oxide Residuals: The ethylene oxide residual levels will comply with current ANSI/AAMI/ISO 10993-7:1995 guidelines for residual limits for permanent contact devices. - 6. Pyrogenicity Evaluation: Each sterilization lot will be tested for the presence of pyrogens using the Limulus Amebocyte Lysate Test. The products will be routinely tested in accordance with USP 85, endotoxin test. ## Indications For Use The MicroPort 2 device is indicated for peripheral placement in the arm when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. ## Contraindications The MicroPort 2 device should not be prescribed for patients in which the planned drug therapy requires the use of substances known to be incompatible with the materials of construction. The MicroPort 2 device should not be implanted in patients suspected to have an allergic reaction to the materials of construction or who have exhibited prior intolerance to device implants. The MicroPort 2 system should not be implanted in the presence of known or suspected infections, bacterium, septicemia or peridonitis, unless access to the vascular system with the MicroPort 2 device is the method by which the infection or sepsis is to be treated. ## Substantial Equivalence The MicroPort 2 Peripheral Access System (Model #'s P11150 and P11150K) is substantially equivalent to the following devices: - 1. Sims Deltec P.A.S. Port, Peripheral Access System Model #'s 21-4501 & 21-4502 {5}------------------------------------------------ Bard Access Systems BardPort Slim Titanium Low Profile Implanted Port Model # 0605550 2. 3. Medi-Tech R-Port Premier Implantable Vascular Access System Model # 45-100 A detailed grid comparing the subject device to the substantially equivalent devices is shown in table 4. The MicroPort 2 Peripheral Access System is packaged without and with kit introducer components. The kit contains basic components required for percutaneous placement. These components are similar to those currently distributed with other HMP port products. All kit components are either pre-amendment devices, or have received a determination of substantial equivalence via the pre-market notification process (See Table 3.). The intended use of each component is the same as for the predicate device on which it is currently used. ## Certification, Summary, and Bibliography for the MicroPort 2 System Horizon Medical Products hereby certifies that a reasonable search has been conducted of scientific information known or otherwise available to it regarding peripherally implantable intravascular access technology. To the best of our knowledge, set out below as part of the 510(k) submission is a summary of and citation to all adverse safety and effectiveness data regarding peripherally implantable intravascular ports, including the MicroPort 2 System. The summary and bibliography are derived from published scientific literature and from unpublished laboratory, preclinical, and clinical data from other peripherally implantable vascular access systems. It should be noted that the data below does not reflect the rate of incidence of the complications and therefore is not an accurate representation of complication rates of peripheral vascular access ports. #### Types and Potential Reported Problems #### Reported Patient Events - Surgical complications (i.e., Risks normally associated with local or ♪ general anesthesia, surgery and post-operative recovery.). - Intolerance reaction to implanted device. - Vascular thrombosis; asymptomatic partial thrombosis. - Erosion/perforation of the port through the skin. - Infection: exit site, catheter tunnel, port pocket. - Systemic infection or sepsis; bacteremia. - Obstruction/occlusion: thrombosis, precipitation, malposition. ## 210(k) HORIZON MEDICAL PRODUCTS CONFIDENTIAL 57 {6}------------------------------------------------ Dislodgement due to Twiddler's Syndrome. ♪ Skin erosion, cracking, irritation, necrosis; edema/erthyma; minor ♪ skin breakdown at the site of needle insertion; hematosis. - Extravasation causing local inflammatory reaction with or without ♪ which may lead to tenderness, pain, and/or parathesia; burning or stinging at the infusion site. - Phlebitis. ♪ - Embolus. ♪ - Brachial nerve plexus. ♪ - ♪ Difficulty accessing port. - Thrombophlebitis. ♪ - ♪ Bleeding. - Local cellulitus around the exit site of the catheter. ♪ - Persistent withdrawal occlussion; may be related to thrombotic ♪ occlusion of the catheter tip. - Tendon or nerve damage. ♪ - Cardiac decompensation. ♪ - Respiratory distress. ♪ - Pain during infusion; pain in the access extremity. ♪ - Cardiac arrythmias ♪ - Right atrial puncture. ♪ - ♪ Vein puncture. - Hemothorax. ♪ - Cardiac tamponade. ♪ ## Reported device events - ♪ Extryasation/infiltration from port due to: needle dislodgement. catheter tip dislodgement/displacement, inadequate needle stabilization, inadequate location of the portal body, or catheter damage. - Catheter kinking/knotting. ♪ - Catheter embolus. ♪ - Insertion malposition. ♪ - ♪ Thrombosis of catheter. - Embolism of catheter. ▼ - Device occlusion. - Catheter disconnection between portal and catheter. - Catheter migration; port leakage: septal rupture. - Fragmentation of the silicone septum. - Poor catheter placement. - Fibrin sheath formation on the catheter and/or catheter tip. - Device movement, rotation, or extrusion. - Catheter malposition, shear, fracture, occlusion, dislodgement, leakage, or rupture. - Resistance to infusion-catheter not patent; difficulty drawing blood. - Needle puncture to catheter. - Catheter shear, fracture, pinch-off 510(k) #### HORIZON MEDICAL PRODUCTS CONFIDENTIAL દક {7}------------------------------------------------ 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - ## REFERENCES FOR IMPLANTABLE PERIPHERAL VASCULAR ACCESS PORTS Andrews, J.C., Walker -Andrews, S.C. and Ensminger, W. Long-term venous access with a peripherally placed subcutaneous infusion port: Initial Results. Radiology 1990; 176: 45-47 Camp-Sorrell, D. Implantable ports-Everything You Always Wanted to Know. Journal of Intravenous Nursing September/October, 1992; 15(5): 262-273 Finney, R., Albrink, M.H., Hart, M. and Rosemurgy, A. A Cost-effective Peripheral Venous Port System Placed at the Bedside. J Sur Res, 1992; 53: 17-19 Krawazak, H.W., Strosche, H., Buchholz, J. and Jakel, F. Implantation technique and complications of totally implanted arterial access systems for long-term therapy in patients with occlusive vascular disease. Journal of Cardiovascular Surgery, Nov-Dec, 1989; 30(6): 921-4 McKee, J. Future Dimension in Vascular Access Peripheral Implantable Ports. Journal of Intravenous Nursing, Nov-Dec, 1991; 14(6): 387-93 McIntosh, B. and Dulchavsky, S. Peripheral Vascular Cutdown. Procedures in the ICU, Oct, 1992; 8(4): 807-818 Walker-Andrews S.C., Andrews J.C., Knutsen C. et al. A new Subcutaneous Infusion Port for Simplified Long-term Venous Access. In: Ensminger, W.D., Selam, J.L., eds. Update in drug delivery systems. Mt Kisco, NY: Futura, 1989; 45-52 Winters, V., Peters, B., Coila, S. and Jones, L. A trial with a new Peripheral implanted Vascular Access Device. Oncology Nursing Forum, 1990; 17(6): 891-૪૭૨ 510(k)