SAFEPASS STERILIZATION POUCH

{0}------------------------------------------------ JAN 2 9 1998 K973981 510(k) Summary Adroit Medical Systems, Inc. a(1) Submitted by: 1146 Carding Machine Rd. Loudon, TN 37774 423-458-8600 Contact Person: Richard L. Studer 423-458-8600 Prepared on: October 10, 1997 | a(2) | Proprietary Name: | SafePASS Sterilization Pouch | |------|----------------------|------------------------------| | | Common Name: | Sterilization Bag | | | Classification Name: | Sterilization Wrap | - Adroit Medical Systems, Inc. believes that SafePASS Sterilization Pouches are a(3) substantially equivalent to the various sizes of SupraShield hospital sterilization wrap, 510(k) number K921243, marketed by V. Mueller, a division of Allegiance Healthcare Corporation (formerly a division of Baxter International Corporation). - SafePASS Sterilization Pouches are pouches made of previously 510(k) cleared a(4) sterilization wrap material. SafePASS Sterilization Pouches are provided to the end user in a partially folded condition, representing the first step of a patented folding system. After inserting the item or items to be sterilized, the pouch is closed by making the final two folds as described in the instructions for use. Once closed in this method and sterilized, the pouch allows convenient aseptic presentation of the enclosed device by following that section of the instructions for use. SafePASS Sterilization Pouches are provided in both single and double thickness versions. Included in this section is the draft labeling and instructions for use. - SafePASS Sterilization Pouches are intended for use as sterility barrier packaging in a(5) the steam sterilization of various medical devices, kits, instruments, etc. - Safe PASS Sterilization Pouches are manufactured using the same material that is used a(6) to produce the SupraShield Sterilization Wrap product. The difference is how the finished device is presented to the end user. For a SafePASS Sterilization Pouch, a sheet of material is folded over and sealed along two edges forming a pouch. This pouch then has a portion of the open end folded concentrically back over itself, thereby forming a cuff. From this point, the user inserts the item or items to be sterilized and closes the pouch by making the final two folds as instructed in 510(k) Number K973981 510(k) Summary Page # 1 of 5 Rev. 1 {1}------------------------------------------------ the directions for use. The SupraShield Sterilization Wrap is provided to the end user as a flat sheet with the user folding it around the item to be sterilized as desired. In some situations it is desired that two layers of sterilization wrap be used. For those situations SafePASS Sterilization Pouches will be available in both a single thickness and a double thickness version. - This section is not required for this submission because substantial equivalence is based b on intended use and device characteristics and specifications, and not on an assessment of performance data. {2}------------------------------------------------ Draft Carton Labeling Size, Reorder No., and Contents Qty. modified for specific products ## SafePASS ™ Sterilization Cover & Presentation System For Steam Sterilization Only Reorder Number 1211R Size - 12" x 11" Reinforced Contents 100 each Manufactured by: Adroit Medical Systems 1146 Carding Machine Road Loudon, TN 37774 423-458-0880 U.S. Patent No. 5,638,661 510(k) Summary page # 3 of 5 {3}------------------------------------------------ Draft Instructions for use # SafePASS ™ SofePASS Sterilization Pouches are intended for use as sterility barrier packaging in the steam sterilization of various medical devices, kits, instruments, etc. #### SIZING GUIDELINES - Measure the circumference of the longest dimension and divide by 2. 1. An item where the longest dimension is 22" in circumference would Example: require a SafePASS ™ that is at least 12" wide; 22 divided by 2 equals 11. - Measure the circumference of the shortest dimension and divide by 2. 2. An item where the shortest dimension is 20" in circumference would Example: require a SafePASS ™ that is at least 10" wide; 20 divided by 2 equals 10. The most efficient SafePASS The for this example would be model 1211 or 1211R ### PACKAGING INSTRUCTIONS - Place item to be sterilized inside pre-cuffed SafePASS™ with the longest dimension 1. positioned sidewise from left to right. Ensure that the top of the item to be sterilized does not extend past the "DO NOT FILL PAST THIS LINE" line. - Place SafePASS ™ with label side down and the open end facing toward you. 2. - 3. Fold open end back so that the "TUCK THIS LINE UNDER CUFF" line is past the edge of the cuff. - 4. Secure by tucking open end underneath cuff past the "TUCK THIS LINE UNDER CUFF" line. - Complete by applying CSR tape across locking fold. ഗ് #### ASEPTIC PRESENTATION INSTRUCTIONS - 1. Remove CSR tape across locking fold by pulling downward. {4}------------------------------------------------ - Turn package over and hold with dominant hand. 2. - Position thumb of dominant hand and hold SafePASS ™ as indicated on label. 3. - Locate edge of cuff between thumb and forefingers of free hand. 4. - Slide free hand along edge of the cuff to the far end of either side. 5. - Grasp the cuff between thumb and forefingers and pull firmly downward towards you. ર. - Release grip and slide free hand along edge of the cuff to the opposite side. 7. - At opposite end , grasp cuff between thumb and forefingers and pull firmly 8. downward towards you. - ರು. Repeat this pulling motion by alternating from side to side with your free hand until the "locking fold" releases. - As the "locking fold" releases, fully extend SafePASS ™ by pulling downward to 10. invert over the hand and forearm holding the package. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 9 1998 Mr. Richard L. Studer Adroit Medical Systems, Incorporated 1146 Carding Machine Road Loudon, Tennessee 37774 K973981 Re : SafePass Sterilization Pouch Trade Name: Requlatory Class: II Product Code: KCT December 1, 1997 Dated: December 3, 1997 Received: Dear Mr. Studer: 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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set --forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {6}------------------------------------------------ Page 2 - Mr. Studer through 542 of 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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, thy A. Ulatowski Timo Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ 510(k) Number K973981 Indications For Use: . · SafePASS Sterilization Pouches are intended for use as sterility barrier packaging in the steam sterilization of various medical devices, kits, instruments, etc. A SafePASS Sterilization Pouch is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Olin S. Lim (Division Sign-Off) Division of Dental, Infection Control. and General Hospital De 510(k) Number Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over - The Counter Use X 1 (Per 21 CFR 801.109) (Optional Format 1-2-96) 510(k) Number K973981 Indications For Use Rev. 1