TCAT TKA Instrument Tray

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". December 20, 2021 THINK Surgical, Inc. George Prendergast Manager, Regulatory Affairs 47201 Lakeview Boulevard Fremont, California 94538 Re: K203468 Trade/Device Name: TCAT® TKA Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 12, 2021 Received: November 15, 2021 Dear George Prendergast: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203468 Device Name TCAT® TKA Instrument Tray #### Indications for Use (Describe) The THINK Surgical TCAT® TKA Instrument Tray is intended to protect, organize and deliver to the surgical field TCAT® tools, instruments and accessories. The tray allows sterilization of TCAT® tools, instruments and maintains sterility of the enclosed devices until used. The tray is wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process. [See the following page for THINK Surgical compatible devices, sterilization parameters and description of the TCAT® TKA Instrument Tray]. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # FORM FDA 3881 (CONTINUED) T # The following is the continuation of FORM FDA 3881 for the TCAT® TKA Instrument Tray Indications for Use | Table 1: Intended Instrument Tray Contents | | | | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------|------------| | Intended instrument Tray Contents | Description | | | | TCAT General Instruments, Tools and<br>Accessories | Instruments, tools and accessories intended for<br>general use with the TSolution One® Total Knee<br>Application (TCAT® component) | | | | TCAT TKA Instruments, Tools, and<br>Accessories | Instruments, tools and accessories intended for<br>TKA use with the TSolution One® Total Knee<br>Application (TCAT® component) | | | | Table 2: Sterilization Parameters | | | | | Cycle | Cycle Temperature | Exposure Time | Dry Time | | Pre-vacuum | 132°C (270°F) | 4 minutes | 60 minutes | | Table 3: Dimensions and Weights | | | | | Tray Name | Dimensions (inches)<br>L x W x H | Weight (lbs.) | | | | | Unloaded: | Loaded | | TCAT® TKA Instrument Tray | 21.2" x 10.0" x 4.9" | 11.0lbs. | 24.0lbs. | {4}------------------------------------------------ # 510(k) SUMMARY This summary of 510(k) is submitted in accordance with the requirements of 21CFR 807.92 | Applicant Information: | | |------------------------------------|-------------------------------------------| | Owner Name: | THINK Surgical, Inc. | | Address: | 47201 Lakeview Blvd.<br>Fremont, CA 94538 | | Phone: | 510-376-3834 | | Fax | 510-249-2396 | | Establishment Registration Number: | 3000719653 | | Contact Person: | George J. Prendergast | | Date Prepared: | December 20, 2021 | | Device Information: | | | Classification: | Class II | | Trade Name: | TCAT® TKA Instrument Tray | | Common Name: | Sterilization Wrap | | Classification Name: | Sterilization Wrap | | Regulation Number: | 21 CFR 880.6850 | | Classification Code: | KCT | # Predicate Device: TCAT® TKA Instrument Tray Set cleared via K200632. ### Device Modifications: The changes to the predicate device allow tools, instruments and accessories to be utilized during a total knee arthroplasty (TKA) procedure. The modifications to this device are there is one tray with a lift out tray which contains tools, instruments and accessories for a total knee arthroplasty, the addition of a silicone mat ('utility area'), and the addition of a 13mm Recovery Marker holder. ### Device Description: The TCAT® TKA Instrument Tray is intended only for use with TSolution One® Total Knee Application instruments, tools and accessories. This tray is used to enclose and hold the instruments, tools and accessories in an organized manner during the sterilization process and subsequent storage and transportation to and from the surgical suite. The tray is designed to fit any standard autoclave and is constructed primarily of anodized aluminum. The tray is compatible with repeated steam sterilizations. The tray has perforations to facilitate sterilant penetration, evacuation and drying. Since the tray is perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of the contents. {5}------------------------------------------------ The trav has the basic same size and a minor configuration change to the predicate device: a rectanqular base with a latchable lid and a lift out tray. The tray has perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom tray surface and lift out tray surface contain stanchions designed to separately hold each individual instrument, tool and accessory for effective sterilant exposure, sterilant evacuation and drying the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removal from the tray. The lift out tray contains a silicone mat which may used to sterilize additional THINK Surgical part. The instrument tray has been tested only with THINK Surgical instruments, tools and accessories for a 4 minute sterilization cycle of pre-vacuum steam sterilization at 132°C, with a 60 minute dry time. While reuseable, these trays will not be serviced or repaired. The type and maximum number of instruments, tools and accessories included in the tray follow: | TCAT® TKA Instrument Tray (Top Tray) | | | |--------------------------------------|---------------------------------------|----------| | Part Number | Description | Quantity | | 109150 | Cutter, Flat, Ø6.2x134mm | 1 | | 107937 | Cutter, Ø2.0x148mm | 1 | | 107974 | Cutter Ball Probe, 139mm | 1 | | 104948 | BMM Probe Assembly | 2 | | 106382 | Digitizer Probe Hub | 1 | | 109189 | Fixation Pin, Self-Drilling, Ø4x150mm | 2 | | 107720 | Recovery Marker, Groove, Ø4x125mm | 2 | | 106298-03 | Digitizer Percutaneous Probe | 1 | | 106298-04 | Digitizer Ball Probe | 1 | | 103593 | Recovery Marker Installation Tool | 1 | | 103297 | Wrench, Hex, 8mm | 1 | | 101888 | Wrench, T-Handle, Square, 8mm | 1 | | 109195 | Recovery Marker, Tack, Ø2.0x13mm | 2 | | TCAT® TKA Instrument Tray (Lift Out Tray) | | | |-------------------------------------------|-------------------------------------|----------| | Part Number | Description | Quantity | | 109066 | Swivel Clamp | 2 | | 103450 | Fixation Adapter Rod, Straight | 2 | | 109190 | Fixation Clamp, Ø4mm Pin / Ø8mm Rod | 2 | | 109142 | Cutter Motor | 1 | | 105745 | Cutter Motor Assembly | 1 | | 107642 | Arm Tool Coupler | 1 | | 108181 | Goniometer | 1 | | 103205 | Fixation Arm, Straight | 2 | | 103384 | Cutter Motor Cable | 1 | | 107720 | Recovery Marker, Groove, Ø4x125mm | 2 | {6}------------------------------------------------ # Indications for Use: The THINK Surgical TCAT®TKA Instrument Tray is intended to protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories. The tray allows sterilization of TCAT® tools, instruments and accessories and maintains sterility of the enclosed devices until used. The tray is wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process. Table 1 lists the lists the THINK Surgical compatible devices: | Table 1: Intended Instrument Tray Contents | | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Intended instrument Tray Contents | Description | | TCAT General Instruments, Tools<br>and Accessories | Instruments, tools and accessories intended<br>for general use with the TSolution One® Total<br>Knee Application (TCAT® component) | | TCAT TKA Instruments, Tools,<br>and Accessories | Instruments, tools and accessories intended<br>for TKA use with the TSolution One® Total<br>Knee Application (TCAT® component) | # Table 1: Intended Instrument Trav Contents Table 2 lists the sterilization parameters under which the TCAT® TKA Instrument Tray was validated: ### Table 2: Sterilization Parameters | Cycle | Cycle Temperature | Exposure Time | Dry Time | |------------|-------------------|---------------|------------| | Pre-vacuum | 132°C (270°F) | 4 minutes | 60 minutes | Table 3 provides a description of the TCAT® TKA Instrument Tray (109200): ### Table 3: Dimensions and Weights | Tray<br>Name | Dimensions (inches)<br>L x W x H | Weight (lbs.) | | |---------------------------|----------------------------------|---------------|----------| | TCAT® TKA Instrument Tray | 21.2" x 10.0" x 4.9" | 11.0lbs. | 24.0lbs. | ### Technological Characteristics: The modified device, the THINK Surgical TCAT® TKA Instrument Tray is the same as the predicate device which was previously cleared under K200632 in that it: - . incorporates the same basic design and has similar design features such as inserts, handles and latches - incorporates the same materials such as aluminum, nylon, silicone and . stainless steel - is packaged the same as the predicate device ● - has the same sterilization parameters as the predicate device ● {7}------------------------------------------------ # Comparison of Technological and Performance Characteristics Three fundamental characteristics are the same between the subject device and predicate devices: - 1. Basic design: Both the TCAT® TKA Instrument Tray and the predicate device have a basic lid/trav design with latches, handles, perforations, and contoured inserts or sections for containing items for sterilization, storage and transport. General size, shape, and weight of both the subject device and predicate device are similar. The materials of the subject device and the materials of the predicate device are the same. - 2. Role in sterile barrier system: The TCAT® TKA Instrument Tray and the predicate device must be wrapped with an FDA-cleared sterilization wrap to maintain sterility. Neither the subject device nor the predicate contains gaskets, valves or filters. - 3. Fundamental technology: The TCAT® TKA Instrument Tray and the predicate device allow the sterilant (steam) to penetrate and render its contents sterile by relving on surface perforations. The following tables provide a comparison of technological characteristics between the subject device and the predicate device (Table 4) and a summary of non-clinical performance testing (Table 5). | Characteristic | TCAT® TKA Instrument<br>Tray<br>(Subject Device) | TCAT® TKA Instrument<br>Tray Set (Predicate<br>Device) | Comparison | |--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) number | K203468 | K200632 | | | Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | | | Intended Use | The THINK Surgical TCAT®<br>TKA Instrument Tray Set is<br>intended to protect,<br>organize and deliver to the<br>surgical field TCAT® tools,<br>instruments and<br>accessories. The trays<br>allow sterilization of tools,<br>instruments and<br>accessories, and maintain<br>sterility of the enclosed<br>devices until used. The<br>trays are wrapped with an<br>FDA-cleared sterilization<br>wrap during the pre-<br>vacuum autoclave<br>sterilization process. | The THINK Surgical TCAT®<br>THA Instrument Tray Set is<br>intended to protect,<br>organize and deliver to the<br>surgical field TCAT® tools,<br>instruments and<br>accessories. The trays<br>allow sterilization of tools,<br>instruments and<br>accessories, and maintain<br>sterility of the enclosed<br>devices until used. The<br>trays are wrapped with an<br>FDA-cleared sterilization<br>wrap during the pre-<br>vacuum autoclave<br>sterilization process. | Same | | Intended<br>Instrument Tray<br>Set Contents<br>Maximum Load | Medical devices/<br>instruments weighing no<br>less than 11.0lbs-24.0lbs.<br>total including the weight of<br>the trays. | Medical devices/<br>instruments weighing no<br>less than 14.21lbs-14.39lbs.<br>total including the weight of<br>the trays. | Similar | | Characteristic | TCAT® TKA Instrument<br>(Subject Device) | TCAT® TKA Instrument<br>Tray Set (Predicate Device) | Comparison | | 510(k) number | K203468 | K200632 | | | Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | | | Intended<br>Instrument Tray<br>Contents | TCAT® General<br>Instrument, Tools and<br>Accessories:<br>Instruments, tools and<br>accessories intended for<br>general use with the<br>TCAT® Total Knee<br>Application.<br><br>TCAT® TKA Instruments,<br>Tools and Accessories:<br>Instruments, tools and<br>accessories intended for<br>use with the TCAT®<br>TSolution One® Total<br>Knee Application. | TCAT® General<br>Instrument, Tools and<br>Accessories:<br>Instruments, tools and<br>accessories intended for<br>general use with the<br>TCAT® Total Knee<br>Application.<br><br>TCAT® TKA Instruments,<br>Tools and Accessories:<br>Instruments, tools and<br>accessories intended for<br>use with the TCAT®<br>TSolution One® Total Knee<br>Application. | Similar | | Design Characteristics | | | | | Device<br>Composition | Single tray with a lift out<br>tray, lid | Base tray, Accessories tray,<br>each with a lift out tray, lid | Similar | | Inserts | Yes | Yes | Same | | Handles | Yes | Yes | Same | | Latches | Yes | Yes | Same | | Reusable | Yes | Yes | Same | | Materials | | | | | Single tray with a<br>lift out tray, lid, not<br>including inserts | Aluminum | Aluminum | Same | | Inserts | Silicone, aluminum,<br>stainless steel, nylon | Silicone, aluminum,<br>stainless steel, nylon | Same | | Latch | Stainless steel | Stainless steel | Same | | 13mm Recovery<br>Marker Holder | Polymer<br>Polyphenylsulfone,<br>Polypropylene<br>Homopolymer or<br>Polypropylene Polymer | Not contained in the<br>predicate device | Different | | Silicone Mat | Silicone | Not contained in the<br>predicate device | Different | | Assembled Dimensions | | | | | Assembled<br>Dimensions | 21.2" x 10.0" x 4.9" | 20" x 9.8" x 4.5" | Similar | | Max Load Weight | | | | | Weight containing<br>max load | 24.0lbs | 19.5lbs | Similar | | Characteristic | TCAT® TKA Instrument<br>Tray<br>(Subject Device) | TCAT® TKA Instrument<br>Tray Set (Predicate<br>Device) | Comparison | | 510(k) number | K203468 | K200632 | | | Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | | | Sterilization | | | | | Percent of surface perforations | | | | | -lid | 21% | 21% | Similar | | -bottom tray | 13% | 19% | | | -lift out tray | 19% | 22% | | | Sterilization<br>Method | Pre-Vacuum (Steam) | Pre-Vacuum (Steam) | Same | | Cycle<br>Temperature | 132°C (270°F) | 132°C (270°F) | Same | | Cycle Time | 4 minutes | 4 minutes | Same | | Drying Time | 60 minutes | 45 minutes | Different | ## Table 4: Comparison of Technological Characteristics Between the Subject Device and the Predicate Device {8}------------------------------------------------ {9}------------------------------------------------ # Non-Clinical Performance Testing Table 5 summarizes the non-clinical performance testing of the TCAT® TKA Instrument Tray Set: - Sterilization Efficacy . - Shipping/Packaging . - . Handle Strength Testing - Verification of Instrument Tray Product Requirements by Inspection and Analysis . - . Verification of Instrument Tray Product Requirements by Lab Test # Table 5: Summary of Non-Clinical Performance Testing | Non-Clinical | Purpose | Results | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Performance Testing | | | | Sterilization Efficacy | To verify the sterilization efficacy, the TCAT® TKA<br>Instrument Tray contained the maximum load and was<br>inoculated with biological indicators placed in areas of<br>the tray deemed to be most difficult for sterilant<br>(steam) to penetrate. Following inoculation, the tray<br>was wrapped in an FDA-cleared sterilization wrap. The<br>results indicated that the BI Overkill method provided a<br>six-log reduction of the indicator organism.<br><br>Standard Followed: ANSI/AAMI/ISO 14937:2013 –<br>Sterilization of Healthcare Product – General<br>Requirements for Characterization of a Sterilizing<br>Agent and the Development, Validation and Routine<br>Control of a Sterilization Process for Medical Devices | PASS | | Shipping/Packaging | The TCAT® TKA Instrument Tray was evaluated with<br>maximum load and configured in the shipping<br>configuration according to a shipping validation test.<br>The results indicate packaging requirements were met.<br><br>Standard Followed: ASTM D4169-16, Standard<br>Practice for Performance Testing of Shipping<br>Containers and Systems | PASS | {10}------------------------------------------------ | Non-Clinical<br>Performance Testing | Purpose | Results | |---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Handle Strength<br>Testing | The TCAT® TKA Instrument Tray handle strength was<br>evaluated.<br><br>Standard Followed: ASTM ST77:2013, Containment<br>Devices for Reusable Medical Device Sterilization | PASS | | Verification of<br>Instrument Tray<br>Product Requirements<br>by Inspection and<br>Analysis | The method of verification was to visually inspect<br>the instrument tray per specifications and inspect and<br>analyze documents listed in the protocol to identify the<br>design outputs. The design outputs were then verified<br>against corresponding product requirements.<br><br>Standard Followed:<br>THINK Surgical developed specification | PASS | | Verification of<br>Instrument Tray<br>Product Requirements<br>by Lab Test | The method of verification was physical, non-<br>destructive testing of the instrument tray to verify<br>design outputs against corresponding product<br>requirements.<br><br>Standard Followed:<br>THINK Surgical developed specification | PASS | ## Clinical and Animal Testing No clinical or animal testing were required. # Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K203468, the TCAT® TKA Instrument Tray, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared in K200632.