FLASHPAK STERILIZATION CONTAINER SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in black. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 2, 2015 Symmetry Surgical, Inc. Mr. Christopher Smith, RAC Senior Director of QA/RA 3034 Owen Drive Antioch, TN 37013 Re: K141826 Trade/Device Name: FlashPak® Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 18, 2015 Received: February 23, 2015 Dear Mr. Smith: 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. {1}------------------------------------------------ Page 2 - Mr. Smith 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 (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 Part 801), 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141826 Device Name FlashPak® Sterilization Container System # Indications for Use (Describe) FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The containle with pre-vacum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak® is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length). FlashPak® Model/Maximum Instrument Load Weight Recommendation: 9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg) 9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg) 9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg) 9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg) Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) 区 Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. រៀត {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Symmetry Surgical. The logo consists of a stylized letter "S" made up of red and gray shapes, followed by the text "symmetry surgical" in a gray, sans-serif font. The logo is simple and modern, with a focus on the company name. # 510K Summary of Safety and Effectiveness (Per 21 CFR 807.92) # General Company Information | Company Name: | Symmetry Surgical | |---------------------------------------------------|---------------------------------------------------| | Company Address: | 3034 Owen Drive | | | Antioch, TN 37013 | | Company Telephone: | 615-964-5392 | | | | | Contact: | Christopher M. Smith | | | Sr. Director of QA/RA | | | | | Contact Address & Telephone: | 3034 Owen Drive | | | Antioch, TN 37013 | | | 615-964-5392 | | | | | Date: | April 2, 2015 | | | | | Device Trade Name: | FlashPak® Sterilization Container System | | | | | Common Name: | Wrap, Sterilization | | | | | Classification, Regulation # and<br>Product Code: | Class II - 880.6850 - FRG | | | | | Predicate Device: | FlashPak® Sterilization Container System, K113776 | Image /page/3/Picture/5 description: The image is a solid red color. The shape is a rectangle that is slightly distorted. The right side of the rectangle is curved inward. 3034 Owen Drive, Antioch, TN 37013 Office 800.251.3000 615,964,5567 Fax = symmetrysurgical.com Image /page/3/Picture/7 description: The image is a close-up shot of a dark, textured surface. The surface appears to be made of a rough material, possibly stone or concrete. The lighting is dim, which accentuates the texture and creates shadows. The left side of the image has a curved edge, while the rest of the image is more rectangular. {4}------------------------------------------------ # ymmetry surgical ### Device Description: The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle. ## Intended Use: The intended use of the predicate device was changed to add additional steam sterilizations. The 3 minute gravity displacement cycle at 132 ºC and 3 minute dynamic-air removal cycle at 132 ºC were validated and added to the following intended use statement. "FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length). FlashPak® Model/Maximum Instrument Load Weight Recommendation: | 9020 w/9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg) | |--------------------------------------------------------------------------------------| | 9030 w/9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55Kg) | | 9040 w/9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg) | | 9050 w/9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg) | # Substantial Equivalence Discussion The predicate device is the FlashPak Sterilization Container System cleared under 510(k) #K113776. The predicate device and the subject device are physically identical. They are the same device. The differences between the predicate and the subject device involve the steam sterilization parameters recommended in the instructions for use (IFU) and intended use statement. The subject device has additional immediate use steam sterilization parameters recommended for its use that were taken from ANSI/AAMI ST79 and were validated for efficacy. Image /page/4/Picture/10 description: The image is a solid red color. The shape is rectangular, but the right side is slightly curved. The red color is uniform throughout the image. 34 Owen Drive, Antioch, TN 37013 615 964 5567 symmetry surgical.com Image /page/4/Picture/12 description: The image is a close-up shot of a dark, textured surface. The surface appears to be slightly curved on the left side, creating a rounded edge. The texture is grainy and uneven, with subtle variations in shading that suggest depth and dimension. The overall impression is one of a solid, unyielding material with a rough, natural finish. {5}------------------------------------------------ etry surgical" A comparison of the similarities and differences between the predicate device and the subject device is provided in the table below. The table follows the elements of interest defined in the guidance for Industry and FDA—Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities of March 7, 2002. | ELEMENT | PREDICATE | SUBJECT DEVICE | |---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | FlashPak® is a reusable rigid<br>container system to be used during<br>flash sterilization by hospitals and<br>healthcare facilities. It is intended<br>to enable flash sterilization of the<br>enclosed devices and prevent<br>recontamination during immediate<br>transport to the point of use. The<br>container is compatible with<br>gravity-displacement flash<br>sterilization using a 10 minute cycle<br>at 132° C and with pre-vacuum<br>flash sterilization using a 4 minute<br>cycle at 132° C. FlashPak is<br>recommended for surface<br>sterilization of stainless steel<br>instruments and for lumens with<br>the following limits: gravity-<br>displacement (5.5mm inner<br>diameter or larger and up to<br>184mm in length), pre-vacuum<br>(1mm inner diameter or larger and<br>up to 203mm in length). | FlashPak® is a reusable rigid<br>container system to be used during<br>immediate use steam sterilization<br>(IUSS or flash) by hospitals and<br>healthcare facilities. It is intended<br>to enable sterilization of the<br>enclosed devices and prevent<br>recontamination during immediate<br>transport to the point of use. The<br>container is compatible with<br>gravity-displacement steam<br>sterilization using a 10 minute cycle<br>at 132° C for porous items and<br>items with lumens or a 3 minute<br>cycle at 132° C for nonporous items<br>like routine metal instruments. The<br>container is also compatible with<br>pre-vacuum steam sterilization<br>using a 4 minute cycle at 132° C for<br>porous items and items with<br>lumens or a 3 minute cycle for<br>nonporous items like routine metal<br>instruments. FlashPak is<br>recommended for sterilization of<br>lumens with the following limits:<br>gravity-displacement (5.5mm inner<br>diameter or larger and up to<br>184mm in length), pre-vacuum<br>(1mm inner diameter or larger and<br>up to 203mm in length). | | | Container:<br>Radel R5000 series base and lid;<br>SS (304) Instrument Basket; | | | ELEMENT | PREDICATE | SUBJECT DEVICE | | Material Composition | SS (304) Latches; | Same as predicate | | | Clear Medical Grade Silicone Gasket<br>and Valve Seal; | | | | SS (300) Hardware; | | | | Sintered SS Filter Disk; | | | | Silicone Lid Vent Button | | | | Valve: | | | | SS (304) Bellows; | | | | SS (316) Bracket | | | | | | | Physical Properties | Materials used in the FlashPak are<br>commonly used in many other<br>legally marketed sterilization trays<br>and cases. Physical properties of<br>the system materials and<br>construction have a demonstrated<br>long history of safe and effective<br>use for this application. | Same as predicate | | | | | | | | | | Chemical Properties | Materials used in the FlashPak are<br>commonly used in many other<br>legally marketed sterilization trays<br>and cases. Chemical properties of<br>the system materials and<br>construction have a demonstrated<br>long history of safe and effective<br>use for this application. | Same as predicate | | | | | | | | | | Configurations/Dimensions | Container Sizes:<br>(11" x 11" x 7") #9020<br>(20" x 11" x 8"), #9030<br>(24" x 11" x 9") #9040<br>(24" x 13" x 9") #9050 | Same as predicate | | | | | | | | | | ELEMENT | PREDICATE | SUBJECT DEVICE | | Air Permeance | N/A<br>Container operates with valves, no<br>filters, wraps or perforations | N/A | | Percent of Surface<br>Perforations | N/A<br>Container is not perforated | N/A | | PERFORMANCE | PREDICATE | NEW DEVICE | | Sterilant Penetration | Sterilization Efficacy<br>Gravity-displacement Cycle:<br>10 minutes at 132°C(270°F) for porous and cannulated devicesDynamic-air-removal Cycle4 minutes at 132°C(270°F) for porous and cannulated devices | Same as predicate with the added indications for:<br>Gravity-displacement Cycle:3 minutes at 132°C(270°F) for nonporous and routine metal devicesDynamic-air-removal Cycle3 minutes at 132°C(270°F) for nonporous and routine metal devices | | | Sterilant Penetration<br>Three thermal mapping studies for each of the two sterilization modes demonstrating a precise match (within seconds) between the chamber and container temperature profiles. | | | Microbial Barrier Properties<br>(Packaging Integrity) | The container completely encapsulates the items sterilized inside with the use of a silicone lid gasket, a silicone lid vent, sintered SS microfilter and silicone valve seals to provide an effective microbial barrier during transport to the point of use immediately | Same as predicate | | ELEMENT | PREDICATE | SUBJECT DEVICE | | | after sterilization. | | | | Container passed a microbial aerosol challenge test by preventing microbial ingress during a one hour exposure to aerosolized microbes in a closed chamber. | | | Material Compatibility | Materials used in the FlashPak are commonly used in many other legally marketed sterilization trays and cases. The system materials and construction have a demonstrated long history of safe and effective use for this application. | Same as predicate…