MIS Spine Frame Instrument Case

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000 October 16, 2015 Thompson Surgical Instruments, Inc. Stephanie Myers, Product Manager 10170 East Cherry Bend Road, Traverse City, MI 49684 Re: K151347 Trade/Device Name: MIS Spine Frame Instrument Case Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 15, 2015 Received: September 18, 2015 Dear Ms. Myers, 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. Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health and 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 are three stylized human profiles facing to the right, stacked on top of each other. {1}------------------------------------------------ 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/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) K151347 Device Name MIS Spine Frame Instrument Case Indications for Use (Describe) Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor frame components, lighting accessories, and blade or frame accessories between used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity. | CYCLE | CYCLE TEMP | EXPOSURE TIME | DRY TIME | |-----------|---------------|---------------|------------| | Prevacuum | 132°C (270°F) | 4 Minutes | 30 Minutes | | Gravity | 121°C (250°F) | 30 Minutes | 30 Minutes | Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@)fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Submitter: Thompson Surgical Instruments, Inc. Product: MIS Spine Frame Instrument Case Image /page/3/Picture/2 description: The image shows the logo for Thompson Surgical Instruments. The logo has the company name in bold, black letters, with the words "SURGICAL INSTRUMENTS" in a smaller font size below the name. To the right of the company name is a blue symbol. Below the logo is the text "K151347". # 510(k) Summary | Submitter Name: | Thompson Surgical Instruments, Inc. | | | | | | | | | | | | | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--| | Submitter Address: | 10170 E Cherry Bend Rd<br>Traverse City, MI 49684 | | | | | | | | | | | | | | Contact Person: | Stephanie Myers, Research & Development /Product Manager | | | | | | | | | | | | | | Phone Number: | 231-922-5170 | | | | | | | | | | | | | | Fax: | 231-922-0174 | | | | | | | | | | | | | | Date Prepared: | September 14, 2015 | | | | | | | | | | | | | | Device Trade Name: | MIS Spine Frame Instrument Case | | | | | | | | | | | | | | Classification Name: | Sterilization Wrap Containers, Cassettes, and Accessories | | | | | | | | | | | | | | Device Class: | Class II | | | | | | | | | | | | | | Classification<br>Regulation: | 21 CFR 880.6850 | | | | | | | | | | | | | | Product Code: | KCT | | | | | | | | | | | | | | Predicate Device: | The instrument case described in this submission was compared and found to be<br>substantially equivalent to the K3131170 Sonicision™ Sterilization Tray<br>manufactured by Covidien. K3131170 was cleared August 28th, 2013. | | | | | | | | | | | | | | Statement of Intended<br>Use: | Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for<br>use in healthcare facilities to store, transport, organize, and sterilize surgical<br>instruments such as retractor blades, retractor frame components, lighting<br>accessories, and blade or frame accessories between uses when used in combination<br>with an FDA cleared sterilization wrap. Validated sterilization parameters include<br>pre-vacuum steam and gravity.<br>CYCLECYCLE TEMPEXPOSURE TIMEDRY TIME Prevacuum132°C (270ºF)4 Minutes30 Minutes Gravity121ºC (250ºF)30 Minutes30 Minutes | | | | | | | | | | | | | | Device Description: | Thompson Surgical Instruments “MIS Spine Frame Instrument Case,” model<br>50000MSF, is intended to hold surgical instruments such as retractor blades,<br>retractor frame components, lighting accessories, and blade or frame accessories<br>during storage, transportation, and sterilization, as indicated. It is composed of<br>materials that can be reused with steam sterilization methods and DCG graphics may<br>be used. It has a distribution of perforations on the outer surfaces and between case<br>levels that allow for optimal steam penetration. Vent to volume is .110. It is reusable | | | | | | | | | | | | | {4}------------------------------------------------ Submitter: Product: Thompson Surgical Instruments, MIS Spine Frame Instrument Case Inc. and provided to the customer in a non-sterile conditions. This case can be described as an accessory for the Thompson Retractor. Technological and The MIS Spine Frame Instrument Case was found to be similar to the predicate. Performance Three fundamental similarities are: Characteristics: Basic design: Both the MIS Spine Frame Instrument Case and the predicate 1. have a basic lid/base design with latches, handles, perforations, and contoured inserts or sections for containing items for sterilization, storage, and transport. General size, shape, weight, and materials are not identical but are similar. 2. Role in sterile barrier system: The MIS Spine Frame Instrument Case and the predicate must be enclosed with a qualified FDA cleared sterilization wrap to maintain sterility. Neither contains gaskets, valves, or filters. 3. Fundamental Technology: The MIS Spine Frame Instrument Case and the predicate allow the sterilant (steam) to penetrate and render its contents sterile by relying on surface perforations. > Primary differences are related to minor variances in size, shape, intended contents, surface perforations, and overall look. However, performance data demonstrate that the differences do not adversely affect safety and effectiveness. Please see further comparison below. | | Proposed: MIS Spine Frame<br>Instrument Case | Predicate: Sonicision™ Sterilization Tray K131170 | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | Thompson Surgical<br>Instruments MIS Spine Frame<br>Instrument Case is intended<br>for use in healthcare facilities<br>to store, transport, organize,<br>and sterilize medical devices<br>and other instrumentation<br>between uses when used in<br>combination with a FDA<br>cleared sterilization wrap. | To encase and protect<br>reusable batteries and<br>generators of the Sonicision<br>system during sterilization<br>and storage. Compatible<br>sterilization systems are<br>indicated as follows:<br>STERRATD® 100s, STERRAD®<br>NX ®, STERRAD® 100NX®,<br>STERIS Amsco® V-PRO® 1,<br>STERIS Amsco® V-PRO® 1<br>Plus, STERIS Amsco® V-PRO®<br>max | | Design<br>Characteristics: | | | | -Composition: | Base, lift out tray, and lid | Base and lid | # Comparison to Predicate Devi {5}------------------------------------------------ Submitter: Inc. Thompson Surgical Instruments, ## Product: MIS Spine Frame Instrument Case Image /page/5/Picture/2 description: The image contains the logo for Thompson Surgical Instruments. The logo features the company name in bold, sans-serif font, with "Thompson" on the top line and "SURGICAL INSTRUMENTS" on the bottom line. To the right of the name is a stylized blue symbol. Below the logo is the alphanumeric code "K151347". | -Intended content<br>(max load): | Medical devices/instruments<br>weighing no less than 25lbs<br>total including the weight of<br>the MIS Spine Frame<br>Instrument Case. | One Sonicision generator and<br>one battery pack | |--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------| | -Inserts: | Yes | Yes | | -Handles: | Yes | Yes | | -Latches: | Yes | Yes | | -Reusable: | Yes | Yes | | Materials: | | | | -Lid/base/lift out<br>tray not including<br>inserts: | Aluminum | Polysulfone | | -Inserts: | Silicone, Aluminum, Stainless<br>Steel, Nylon | Silicone | | -Latch: | Stainless steel | Polysulfone | | Assembled<br>Dimensions: | 11" x 23.5" | 5.9" X 8.1" | | Weight containing<br>max load: | 25 lbs | 1.58 lbs | | Percent of surface<br>perforations on lid,<br>base, lift out tray: | Lid has 15.7%, lift out tray has<br>19.2%, and base has 13.6% | 9.7% | # Non-Clinical Performance Studies: The MIS Spine Frame Instrument Case was evaluated in accordance with applicable clauses/criteria specified in AAMI 5T77:2006. Test evidence supporting sterilization efficacy, cleaning, and biocompatibility are provided in the submission. A brief discussion of tests used to support the conclusion of substantial equivalence with the predicate device is provided below. Sterilization efficacy: The MIS Spine Frame Instrument Case and the predicate containing the maximum load were inoculated with biological indicators placed in areas of the trays deemed to be most difficult for sterilant (steam) to penetrate. Following inoculation, the trays were wrapped in FDA cleared sterilization wraps. {6}------------------------------------------------ | Submitter:<br>Thompson Surgical Instruments, Inc. | Product:<br>MIS Spine Frame Instrument Case | Thompson<br>SURGICAL INSTRUMENTS<br>K151347 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | They trays were then exposed to the sterilization cycles (Steam sterilization for the<br>MIS Spine Frame Instrument Case and STERRAD or STERIS sterilization for the<br>predicate). The results for both trays indicated that half cycles provided a six log<br>reduction of the indicator organism. | | | | Cleaning: The MIS Spine Frame Instrument Case was tested for cleanability. The<br>results indicated a pass. Supporting evidence is included in the submission. | | | | Biocompatibility: The MIS Spine Frame Instrument Case is considered non-cytotoxic<br>as based on MEM elution test results. Supporting evidence is found in the<br>submission. | | | | Clinical Performance<br>Studies: | This premarket notification report does not rely on the assessment of clinical<br>performance data to demonstrate substantial equivalence. | | | Conclusion: | The MIS Spine Frame Instrument Case is substantially equivalent to the Sonicision™<br>Sterilization Tray, K131170. None of the differences between the MIS Spine Frame<br>Instrument Case and the predicate change the intended use or raise new questions<br>of safety or effectiveness. | | {7}------------------------------------------------ Submitter: Thompson Surgical Instruments, Inc. Product: MIS Spine Frame Instrument Case Image /page/7/Picture/2 description: The image shows the logo for Thompson Surgical Instruments. The logo features the word "Thompson" in bold, black letters, with the words "SURGICAL INSTRUMENTS" in smaller, thinner letters underneath. To the right of the word "Thompson" is a blue symbol that appears to be a stylized "T". Below the logo is the alphanumeric code "K151347". 5