ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 31, 2016 ConMed Corporation Ms. Dionne Sanders, MS. COA. RAC Manager, Regulatory Affairs 11311 Concept Blvd. Largo, Florida 33773 Re: K152969 Trade/Device Name: Enhance Allograft Wedge Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 02, 2016 Received: March 03, 2016 Dear Ms. Sanders: 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 {1}------------------------------------------------ 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. 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) K152969 ### Device Name Enhance Allograft Wedge Instrument Tray ### Indications for Use (Describe) The Enhance Allograft Wedge Instrument on Tray (7903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments: | REF | Description | REF | Description | |--------|------------------|--------|------------------| | 903106 | Evans Trial 6mm | 903206 | Cotton Trial 6mm | | 903108 | Evans Trial 8mm | 903207 | Cotton Trial 7mm | | 903110 | Evans Trial 10mm | 903208 | Cotton Trial 8mm | | 903112 | Evans Trial 12mm | 903006 | Mallet | | 903010 | Tamp Evans | 903008 | Distractor | | 903012 | Tamp Cotton | 903002 | Osteotome 16mm | | 903205 | Cotton Trial 5mm | 903004 | Osteotome 10mm | The Enhance Allograft Wedge Instrumentation Tray (T903) is not intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to mainal instruments. Sterilize the instrument. Sterilize the instrument tray using the following sterilization parameters: | Method | Cycle | Temperature | Exposure | Dry Cycle | Cool Down | Duration | |--------------------|------------|---------------|------------|------------|--------------|------------| | Steam<br>(wrapped) | Pre-vacuum | 270°F (132°C) | 4 minutes | 20 minutes | 118°F (48°C) | 25 minutes | | Steam<br>(wrapped) | Gravity | 250°F (121°C) | 30 minutes | 15 minutes | 118°F (48°C) | 37 minutes | Double wrap tray using an FDA cleared wrap. ] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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PSC Publishing Services (301) 443-6740 EF Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square is the word "CONMED" in black, sans-serif font. Below the word "CONMED" is a thin blue line, and below that is the word "CORPORATION" in a smaller, sans-serif font. # 510(k) SUMMARY #### I. SUBMITTER CONMED Corporation 11311 Concept Blvd. Largo, Florida 33773 Phone: 727-399-5564 Fax: 727-399-5264 Contact Person: Dionne Sanders, RAC Date Prepared: March 25, 2016 510k#: K152969 #### II. DEVICE | Name of Device: | Enhance Allograft Wedge Instrument Tray | |----------------------|-------------------------------------------| | Common Name: | Sterilization Tray | | Classification Name: | Sterilization Wrap (21 CFR Part 880.6850) | | Regulatory Class: | Class II | | Product Codes: | KCT | #### III. PREDICATE DEVICE | Device Name: | ConMed Linvatec Anodized Aluminum Sterilization Trays | |---------------|-------------------------------------------------------| | Company Name: | ConMed Linvatec | | 510(k) #: | K090560 | #### IV. DEVICE DESCRIPTION The Enhance® Allograft Wedge Instrumentation Tray (T903) is constructed primarily of aluminum with perforations to facilitate sterilant penetration, evacuation and drying. The tray dimensions are approximately 21 x 10" and it is designed to fit any standard autoclave. The tray is manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the tray is perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although the tray is reusable it will not be serviced or repaired. Interior structures of the trays have the ability to separately hold individual instruments during the entire duration they are in contact with the tray. #### V. INTENDED USE / INDICATIONS FOR USE The Enhance Allograft Wedge Instrumentation Tray (T903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, curved shape inside on the left. To the right of the square, the word "CONMED" is written in black, sans-serif font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, sans-serif font, with a blue line above it. Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. | REF | Description | REF | Description | |--------|------------------|--------|------------------| | 903106 | Evans Trial 6mm | 903206 | Cotton Trial 6mm | | 903108 | Evans Trial 8mm | 903207 | Cotton Trial 7mm | | 903110 | Evans Trial 10mm | 903208 | Cotton Trial 8mm | | 903112 | Evans Trial 12mm | 903006 | Mallet | | 903010 | Tamp Evans | 903008 | Distractor | | 903012 | Tamp Cotton | 903002 | Osteotome 16mm | | 903205 | Cotton Trial 5mm | 903004 | Osteotome 10mm | This tray is intended for use with the following instruments: The Enhance Allograft Wedge Instrumentation Tray (T903) is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. Sterilize the instrument tray using the following sterilization parameters: | Method | Cycle | Temperature | Exposure | Dry Cycle | Cool Down | Duration | |--------------------|----------------|------------------|------------|------------|-----------------|------------| | Steam<br>(wrapped) | Pre-<br>vacuum | 270°F<br>(132°C) | 4 minutes | 20 minutes | 118°F<br>(48°C) | 25 minutes | | Steam<br>(wrapped) | Gravity | 250°F<br>(121°C) | 30 minutes | 15 minutes | 118°F<br>(48°C) | 37 minutes | Validation was conducted using an FDA cleared sterilization wrap with a maximum load 14 lbs. (6.4 kg). Only single unstacked trays may be used during the sterilization process. Double wrap tray using an FDA cleared wrap. ### VI. COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE ConMed's Enhance Allograft Wedge Instrument Tray is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Anodized Aluminum Sterilization Trays, specifically the Hip Arthroscopy Master Tray, and raises no new issues of safety or effectiveness. The similarities and differences between the predicate and proposed sterilization trays are the following- {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue square with a white curved shape inside, followed by the word "CONMED" in black, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller, thinner letters, with a blue line above it. | | Proposed Device<br>Enhance Allograft Wedge<br>Instrument Tray | Predicate Device<br>ConMed Linvatec Anodized Aluminum<br>Sterilization Tray (K090560) | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Same | A family of containment devices for<br>medical device sterilization. | | Indications for<br>Use | Same | The trays are intended for use only with<br>the instruments sets listed in the IFU. | | Contraindications | None Known | None known | | Materials of<br>Construction | Tray lid, base and internal tray:<br>5052-H32 grade aluminum,<br>anodized<br>Rivets, Handle Wire, Handle<br>Clip, Latch Component, Channel:<br>301SS, 302SS, 304SS, Silicone<br>Latches, Screws, Nuts, Washers<br>and Brackets: 17-4 PH SS, 304-<br>2B SS, 316SS, 18-8 SS<br>Brackets, Internal: Silicone<br>Silk Screen Ink: Sericoil 301 TP<br>Black | Tray lid, base and internal tray: 5052-H32<br>grade aluminum, anodized<br>Handles: 304SS<br>Latches: 304SS<br>Brackets and protective mat: Silicone<br>(21 CFR177.2600) | | Design | Same | Perforated tray and lid used to organize,<br>sterilize, transport, and store instruments<br>between uses | | Overall<br>Dimensions | 21.29" x 10.03" x 3.30" | 20.77" x 10.02" x 6.00" | | Filled Weight | 11.70lbs | 18.20lbs | | Gaskets, Filters,<br>Valves, Seals | Same | None | | Latches | Same | Yes, to secure the tray lid to the base | | Sterilization<br>Method | Same | Steam sterilization using a<br>FDA-cleared sterilization wrap | | External Stacking | Same | Do not stack | | | Same w/added cool down time | Min temperature: 270° F (132° C) | | Pre-vacuum cycle<br>Steam (wrapped) | Cool down: 48° C for 25 minutes | Min exposure: 4 min<br>Min dry cycle: 20 min | | | Method: Steam (wrapped) | Method: Steam (wrapped) | | Gravity cycle<br>Steam (wrapped) | Temperature: 250° F (121° C)<br>Exposure: 30 min<br>Dry Cycle: 15 min<br>Cool Down: 48° C for 37 min | Min temperature: 270° F (132° C)<br>Min exposure: 15 min<br>Min dry cycle: 25 min | | Sterility<br>Assurance Level<br>(SAL) | SAL 10-6 | SAL 10-6 | | Tamper Evident | Same | Secured with autoclave tape | | Instrumentation | Same | For use with specific instrumentation | | Packaging | Shipped empty | Shipped loaded with instrumentation | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside on the left. To the right of the square is the company name, "CONMED," in bold, black letters. Below the name is the word "CORPORATION" in smaller, gray letters. #### VII. PERFORMANCE DATA # Non-Clinical Performance ConMed conducted verification and validation testing including performance testing in accordance with ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization as well as: handle strength verification, cleaning, biocompatibility, packaging and transportation and a non-clinical user validation. Based on this testing, it has been determined that the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device cleared under (K090560). # Clinical Performance This submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence. #### VIII. CONCLUSION The Enhance Allograft Wedge Instrument Tray is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate device. #### IX. SUBSTANTIAL EQUIVALENCE STATEMENT The performance testing data for the subject device Enhance Allograft Wedge Instrument Tray (T903) demonstrates the subject device is as safe, as effective, and performs as well as the predicate device (K090560).