I-PORT

{0}------------------------------------------------ K052389 (P.10A3 Image /page/0/Picture/1 description: The image shows the logo for Patton Medical Devices. The logo features a stylized letter 'p' enclosed in a circle, followed by the word 'PATTON' in bold, sans-serif font. Below 'PATTON' are the words 'medical devices' in a smaller, sans-serif font. SEP - 9 2005 # Section 3.0 510(K) SUMMARY #### Company and Contact Information 3.1 | Submitters Name: | Regulatory Resources, LLC for<br>Patton Medical Devices, LP | |------------------|-------------------------------------------------------------| | Address: | P.O. Box 1490<br>Eagle, ID 83616 | | Contact person: | Fred Schlador | | Title: | President | | Telephone: | 208.939.3447 | | Fax: | 208.939.3448 | | Email: | fs@regulatoryresources.com | #### 3.2 Device Identification | Trade Name: | I-PORT TM | |------------------------|-------------------------------------| | Regulation Name: | Intravascular Catheter | | Common Name: | Catheter, Intravascular, Short-Term | | Regulation Number: | 21 CFR 880.5200 | | Device Classification: | Class II | | Product Code: | FOZ | #### 3.3 Predicate Devices - · Unomedical, Inc. Insuflon™, Intravascular Catheter (K881767) - = Medtronic MiniMed Paradigm® Sof-set® Infusion Sets (K030149) #### Device Description 3.4 The 1-PORT™, Injection Port is a sterile, single use, low profile injection port through which physician prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual iniection device. The device is designed to reduce the hardships of multiple daily subcutaneous injections by allowing users to receive physician prescribed medication, including insulin, without repeated needle punctures of the skin. The I-PoRT™, Injection Port may remain in place for up to 72 hours to accommodate multiple drug injections without additional needle sticks. #### 3.5 Intended Use The I-PORT™, Injection Port is a disposable, low profile, injection port through which physician prescribed medications, including insulin, can be injected subcutaneously from a standard syringe and needle, pen or alternative manual injection device. The I-PORT™, Injection Port allows users to manually inject physician prescribed medication without repeated needle punctures of the skin over a 72 hour time period. The intended environments include home use and use in health care facilities. {1}------------------------------------------------ K\$\psi\$52389 (P.R. of 3) Image /page/1/Picture/1 description: The image shows the logo for "PATTON medical devices". The logo features a stylized letter "p" in black, with the rest of the word "ATTON" in bold, black letters. Below "PATTON" are the words "medical devices" in a smaller, sans-serif font. The logo appears to be for a company that manufactures or distributes medical devices. #### Indications for Use 3.6 The I-PoRT™, Injection Port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. This device may be used on a wide range of patients, including adults and children. ### Performance Data and Comparison of the I-PoRT™, Injection Port to 3.7 Predicate Devices The I-PORT™, Injection Port and the predicate devices have similar, and in many cases, the same: - · Intended use and indications for use - · Principals of operation - · Dimensional and mechanical characteristics - · Performance characteristics - · Components and materials Laboratory testing verified that the performance of the I-PORT™, Injection Port met both internal specifications and user needs. Representative samples of the device underwent bench testing to verify functional and performance characteristics. #### 3.8 Risk Management Risk Management activities included the identification and evaluation of risks associated with the use of this device. Fault Tree Analysis (FTA) and Failure Modes and Effects, and Criticality Analysis (FMECA) were conducted. No risks that are not common to the use of this type of device were identified. All of the identified risks reside in the As Low as Reasonably Practicable (ALARP) and/or Broadly Acceptable regions. #### 3.9 Biocompatibility Materials used in the I-PORT™, Injection Port are biocompatible. These materials meet the requirements of ANSI/AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing for a prolonged body contact, external communicating device and/or contain the same components used in a similar legally marketed device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for Patton Medical Devices. The logo features a stylized letter 'p' in a bold, black font, with the rest of the company name, 'ATTON,' in a similar bold font. Below 'ATTON' is the phrase 'medical devices' in a smaller, sans-serif font. # 3.10 Compliance with Guidance and Consensus Standards The I-PORT™, Injection Port conforms to relevant portions of applicable guidance and standards that include the following: - = 1SO 10555-1:1995 Sterile Single-use Intravascular Catheters Part 1:General Requirements - · ANSI/AAMI/ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1:Evaluation and Testinq - = ANSI/AAMI/ISO 14971:2000 Medical Devices Application of Risk Management to Medical Devices - · ANSI/AAMI/ISO 14971/A1:2000 Medical Devices Application of Risk Management to Medical Devices - Amendment 1:Rationale for Requirements - = ANSI/AAMI/ISO 11607:2000 Packaging for Terminally Sterilized Medical Devices - · ANSI/AAMI/ISO 11135:1994 Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization, 3ed - · ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices Part 7:Ethylene Oxide Sterilization Residuals - = ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - = ASTM F1980:2002 Standard Guide for Accelerated Aging of Sterile Medical Device Packages - · ASTM D4169-04a Standard Practice for Performance Testing of Shipping Containers and Systems - ASTM F88-05 Standard Test Method for Seal Strength of Flexible Barrier Materials ### 3.11 Sterilization The I-PORT™, Injection Port will be sterilized using Ethylene Oxide (EO). The sterilization process will be conducted following appropriate AAMI/ANSI/ISO Guidelines. The 1-PORT™, Injection Port will have a SAL of 10-6 and the fluid path will be Pyrogen free as tested by limulus amebocyte lysate (LAL). The packaging will be tested to applicable standards to ensure integrity and durability. ### 3.12 Conclusion The I-PoRT™, Injection Port is substantially equivalent to the relevant aspects of the predicate devices in terms of principals of operation, mechanical characteristics, performance characteristics and components and materials. The understanding of the application and use of the I-PORT™, Injection Port by healthcare professionals and potential users make the I-PORT™, Injection Port equivalent to or easier to use than the predicate devices. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle. Public Health Service SEP - 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Patton Medical Devices c/o Ms. Laura Danielson TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112-1891 Re: K052389 Trade/Device Name: I-Port Regulation Number: 880.5220 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: August 30, 2005 Received: August 31, 2005 Dear Ms. Danielson: We have reviewed your Section 510(k) premarket notification of intent to market the device vice nave 10.10.10.10.2 Jourse 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 mendments, 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 the Fought I vous, I vagy therefore, market the device, subject to the general approvisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {4}------------------------------------------------ # Page 2 – Ms. Laura Danielson Please be advised that FDA's issuance of a substantial equivalence determination does not I Trass be advisod that I DTP o lesames on that your device complies with other requirements modi that + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = or the Act or any I subtal bet's requirements, including, but not limited to: registration r ou inust compry with art 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF R Far 807), as ality 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. This letter will allow you to begin marketing your device as described in your Section 510(k) rine reter notification. The FDA finding of substantial equivalence of your device to a promation notification - In device results in a classification for your device and thus, permits vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Aso, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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, Syrite Y. M., Oken Om.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ KψS2339 # 2.0 INDICATIONS FOR USE ### Device Name: I-PORT™, Injection Port ## Indications for Use: The I-PoRT™, Injection Port is indicated for patients who administer, or to whom is The Firent myouther daily subcutaneous injections of physician prescribed auministered, " manaple" daily "Contri", Injection Port may remain in place for up medications, including theating injections without the discomfort of additional needle sticks. This device may be used on a wide range of patients, including adults and children. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Cuntis Vms Page 1 of ____________________________________________________________________________________________________________________________________________________________________ (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital, Division of Antol, Dental Devices K452389 510(k) Number _