VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY

{0}------------------------------------------------ K1008852 # 510(k) Summary of Safety & Effectiveness Pursuant to CFR 807.92, the following 510(k) Summary is provided: | 1. (a) | Submitter<br>Address: | George J. Hattub<br>MedicSense, USA<br>291 Hillside Avenue<br>Somerset, MA 02726<br>www.medicsense.com | AUG '09 2010 | |--------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | 1. (b) | Manufacturer<br>Address: | T.A.G. Medical Products Corporation, Ltd.<br>D. N. Ashrat<br>Kibbutz Gaaton 25130, Israel | | | | Mfg. Phone: | Tel.: 972-3-647-4840 | | | | Contact Person: | Dan Moor | | | | Date: | August 5, 2010 | | | 2. | Device &<br>Classification<br>Name: | Sterilization Container, class II device (product code KCT).<br>VersiTomic ™ACL Flexible Reamer System Sterilization Tray | | | 3. | Predicate Device: | Paragon Medical Surgical Instrumentation Delivery System (K032119) | | | 4. | Description: | The VersiTomic ™ACL Flexible Reamer System Sterilization Tray is a<br>reusable sterilization container system intended to be used to enclose other<br>medical devices that are to be sterilized by a healthcare provider. It is<br>intended to allow sterilization of the enclosed devices and also (when<br>properly wrapped) maintain their sterility device until used. This device is<br>made of durable materials and designed with perforations or slots to allow<br>for steam penetration. It is constructed of machined and formed metal. | | | 5. | Intended Use: | The VersiTomic™ ACL Flexible Reamer System Sterilization Tray is indicated<br>to enclose the VersiTomic ACL Flexible Reamer System instruments that are<br>to be sterilized by a health care provider. | | | | | The Sterilization Tray consists of an interlocking tray and lid, which are both<br>perforated to allow the passage of the sterilizing agent from outside the tray<br>to the devices placed inside. | | | | | The VersiTomic™ ACL Flexible Reamer System Sterilization tray has been<br>validated with a load that consists of various metallic instruments and<br>implants up to a length of 340 mm and minimum internal diameter of 1.4<br>mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within<br>the tray. | | {1}------------------------------------------------ The VersiTomic™ ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters: Gravity #### Gravity-Displacement Steam Sterilization - Sterilizer Type: . . . - Minimum Temperature: 132°C (270°F) . - Minimum Exposure Time: 10 minutes - Minimum Dry Time: 40 minutes #### Pre-Vacuum Steam Sterilization - Sterilizer Type: Pre-Vacuum . - . Minimum Temperature: 132°C (270°F) - . Minimum Exposure Time: 4 minutes - Minimum Dry Time: . 15 minutes - 6. Comparison of Technological Characteristics: With respect to its indication for use, the VersiTomic™ ACL Flexible Reamer System Sterilization Trav is substantially equivalent to its predicate device in that it intended for the same clinical purpose. With respect to technology, the design is similar as confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that its device is safe and effective because it performs the same function in the same manner. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping, curved shapes that resemble abstract human figures or waves. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 T.A.G. Medical Products C/O Mr. George J. Hattub MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726 Alls De 2010 Re: K100887 Trade/Device Name: VersiTomic "" ACL Flexible Reamer System Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: July 19, 2010 Received: July 29, 2010 Dear Mr Hattub: 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. {3}------------------------------------------------ ### Page 2- Mr. Hattub 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely vours, Susan Runov Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, . Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Indications for Use ## AUG 09 2010 ### 510(k) Number (if known): K100887 ### Device Name: VersiTomic™ ACL Flexible Reamer System Sterilization Tray Indications For Use: The VersiTomic™ ACL Flexible Reamer System Sterilization Trav is indicated to enclose the VersiTomic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider. The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside. The VersiTomic™ ACL Flexible Reamer System Sterilization tray has been validated with a load that consists of various metallic instruments and implants up to a length of 340 mm and minimum internal diameter of 1.4 mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within the tray. The VersiTomic™ ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters: ### Gravity-Displacement Steam Sterilization - Sterilizer Type: Gravity . - 132°C (270°F) Minimum Temperature: . - 10 minutes Minimum Exposure Time: . - Minimum Dry Time: 40 minutes . ### Pre-Vacuum Steam Sterilization - Pre-Vacuum Sterilizer Type: . - Minimum Temperature: 132°C (270°F) ● - Minimum Exposure Time: 4 minutes . - 15 minutes Minimum Dry Time: . Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | | <div> <p>(Division Sign-Off)</p> <p>Division of Anesthesiology, General Hospital</p> <p>Infection Control, Dental Device 1 of 1</p> </div> | | 510(k) Number: | K100887 |