(390 days)
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.
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. 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.
This document describes the TCAT® TKA Instrument Tray, a Class II medical device intended to protect, organize, and facilitate the sterilization of surgical tools and instruments for total knee arthroplasty (TKA) procedures.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TCAT® TKA Instrument Tray are based on non-clinical performance testing. The "Results" column in the table below effectively serves as the reported device performance.
| Non-Clinical Performance Testing | Acceptance Criteria & Purpose | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Purpose: To verify the sterilization efficacy. The instrument tray, with maximum load and inoculated biological indicators (BIs) in difficult-to-penetrate areas, was wrapped in an FDA-cleared sterilization wrap. Acceptance Criteria: The results should indicate a six-log reduction of the indicator organism (BI Overkill method). Standard Followed: ANSI/AAMI/ISO 14937:2013 – Sterilization of Healthcare Product – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. | PASS |
| Shipping/Packaging | Purpose: To evaluate the TCAT® TKA Instrument Tray with maximum load in its shipping configuration. Acceptance Criteria: Packaging requirements must be met. Standard Followed: ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. | PASS |
| Handle Strength Testing | Purpose: To evaluate the handle strength of the TCAT® TKA Instrument Tray. Acceptance Criteria: The handle strength should meet the requirements specified by the standard. Standard Followed: ASTM ST77:2013, Containment Devices for Reusable Medical Device Sterilization. | PASS |
| Verification of Instrument Tray Product Requirements by Inspection and Analysis | Purpose: To visually inspect the instrument tray per specifications and inspect and analyze documents to identify design outputs. These design outputs are then verified against corresponding product requirements. Acceptance Criteria: Design outputs must be verified against corresponding product requirements. Standard Followed: THINK Surgical developed specification. | PASS |
| Verification of Instrument Tray Product Requirements by Lab Test | Purpose: To perform physical, non-destructive testing of the instrument tray to verify design outputs against corresponding product requirements. Acceptance Criteria: Design outputs must be verified against corresponding product requirements through physical testing. Standard Followed: THINK Surgical developed specification. | PASS |
Study Proving Device Meets Acceptance Criteria:
The device's compliance with the acceptance criteria is demonstrated through a series of non-clinical performance testing summarized in Table 5 of the provided document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for each test. For tests like Sterilization Efficacy, it mentions "the TCAT® TKA Instrument Tray contained the maximum load," implying at least one tray was tested under specified conditions. For Shipping/Packaging, it states "The TCAT® TKA Instrument Tray was evaluated," suggesting at least one or a small number of trays were subjected to the tests.
- Data Provenance: The data is based on non-clinical testing performed in a laboratory setting by THINK Surgical, Inc., or a qualified testing facility. The document does not specify a country of origin for the data beyond the manufacturer's location in Fremont, CA, USA. The data is prospective as it was generated specifically for the 510(k) submission to demonstrate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and testing. The tests conducted are non-clinical (e.g., sterilization efficacy, mechanical strength) and rely on established scientific protocols, standards (e.g., ANSI/AAMI/ISO, ASTM), and laboratory measurements, not expert human interpretation of medical data. Therefore, there is no "ground truth" derived from medical experts for these specific tests.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the tests are objective, standardized non-clinical evaluations rather than subjective interpretations requiring adjudication among experts. The results are typically "Pass" or "Fail" against predefined criteria within the respective standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an instrument tray for surgical tools and sterilization. It is not an AI-powered diagnostic or assistive tool that would involve human readers or image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical instrument tray, not an algorithm or AI system.
7. The type of ground truth used
As explained in point 3, the concept of "ground truth" established by human experts or pathology is not applicable here. Instead, the "ground truth" for the non-clinical tests is based on:
- Standardized protocols and scientific principles: For sterilization, the "ground truth" is a 6-log reduction of biological indicators, a universally accepted benchmark for sterility assurance.
- Engineering specifications and test methods: For mechanical properties (e.g., handle strength, shipping integrity), the "ground truth" is adherence to established industry standards (ASTM) and internal THINK Surgical specifications.
- Measurable physical parameters: For dimensional verification and material composition, the "ground truth" is direct measurement and material analysis.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical instrument tray, not software or an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 andAccessories | Instruments, tools and accessories intended forgeneral use with the TSolution One® Total KneeApplication (TCAT® component) | ||
| TCAT TKA Instruments, Tools, andAccessories | Instruments, tools and accessories intended forTKA use with the TSolution One® Total KneeApplication (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)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. |
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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.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.
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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 |
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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, Toolsand Accessories | Instruments, tools and accessories intendedfor general use with the TSolution One® TotalKnee Application (TCAT® component) |
| TCAT TKA Instruments, Tools,and Accessories | Instruments, tools and accessories intendedfor TKA use with the TSolution One® TotalKnee 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
| TrayName | Dimensions (inches)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 ●
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Comparison of Technological and Performance Characteristics
Three fundamental characteristics are the same between the subject device and predicate devices:
-
- 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.
-
- 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.
-
- 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 InstrumentTray(Subject Device) | TCAT® TKA InstrumentTray Set (PredicateDevice) | Comparison |
|---|---|---|---|
| 510(k) number | K203468 | K200632 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Intended Use | The THINK Surgical TCAT®TKA Instrument Tray Set isintended to protect,organize and deliver to thesurgical field TCAT® tools,instruments andaccessories. The traysallow sterilization of tools,instruments andaccessories, and maintainsterility of the encloseddevices until used. Thetrays are wrapped with anFDA-cleared sterilizationwrap during the pre-vacuum autoclavesterilization process. | The THINK Surgical TCAT®THA Instrument Tray Set isintended to protect,organize and deliver to thesurgical field TCAT® tools,instruments andaccessories. The traysallow sterilization of tools,instruments andaccessories, and maintainsterility of the encloseddevices until used. Thetrays are wrapped with anFDA-cleared sterilizationwrap during the pre-vacuum autoclavesterilization process. | Same |
| IntendedInstrument TraySet ContentsMaximum Load | Medical devices/instruments weighing noless than 11.0lbs-24.0lbs.total including the weight ofthe trays. | Medical devices/instruments weighing noless than 14.21lbs-14.39lbs.total including the weight ofthe trays. | Similar |
| Characteristic | TCAT® TKA Instrument(Subject Device) | TCAT® TKA InstrumentTray Set (Predicate Device) | Comparison |
| 510(k) number | K203468 | K200632 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| IntendedInstrument TrayContents | TCAT® GeneralInstrument, Tools andAccessories:Instruments, tools andaccessories intended forgeneral use with theTCAT® Total KneeApplication.TCAT® TKA Instruments,Tools and Accessories:Instruments, tools andaccessories intended foruse with the TCAT®TSolution One® TotalKnee Application. | TCAT® GeneralInstrument, Tools andAccessories:Instruments, tools andaccessories intended forgeneral use with theTCAT® Total KneeApplication.TCAT® TKA Instruments,Tools and Accessories:Instruments, tools andaccessories intended foruse with the TCAT®TSolution One® Total KneeApplication. | Similar |
| Design Characteristics | |||
| DeviceComposition | Single tray with a lift outtray, lid | Base tray, Accessories tray,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 alift out tray, lid, notincluding inserts | Aluminum | Aluminum | Same |
| Inserts | Silicone, aluminum,stainless steel, nylon | Silicone, aluminum,stainless steel, nylon | Same |
| Latch | Stainless steel | Stainless steel | Same |
| 13mm RecoveryMarker Holder | PolymerPolyphenylsulfone,PolypropyleneHomopolymer orPolypropylene Polymer | Not contained in thepredicate device | Different |
| Silicone Mat | Silicone | Not contained in thepredicate device | Different |
| Assembled Dimensions | |||
| AssembledDimensions | 21.2" x 10.0" x 4.9" | 20" x 9.8" x 4.5" | Similar |
| Max Load Weight | |||
| Weight containingmax load | 24.0lbs | 19.5lbs | Similar |
| Characteristic | TCAT® TKA InstrumentTray(Subject Device) | TCAT® TKA InstrumentTray Set (PredicateDevice) | 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% | |
| SterilizationMethod | Pre-Vacuum (Steam) | Pre-Vacuum (Steam) | Same |
| CycleTemperature | 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
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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® TKAInstrument Tray contained the maximum load and wasinoculated with biological indicators placed in areas ofthe tray deemed to be most difficult for sterilant(steam) to penetrate. Following inoculation, the traywas wrapped in an FDA-cleared sterilization wrap. Theresults indicated that the BI Overkill method provided asix-log reduction of the indicator organism.Standard Followed: ANSI/AAMI/ISO 14937:2013 –Sterilization of Healthcare Product – GeneralRequirements for Characterization of a SterilizingAgent and the Development, Validation and RoutineControl of a Sterilization Process for Medical Devices | PASS |
| Shipping/Packaging | The TCAT® TKA Instrument Tray was evaluated withmaximum load and configured in the shippingconfiguration according to a shipping validation test.The results indicate packaging requirements were met.Standard Followed: ASTM D4169-16, StandardPractice for Performance Testing of ShippingContainers and Systems | PASS |
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| Non-ClinicalPerformance Testing | Purpose | Results |
|---|---|---|
| Handle StrengthTesting | The TCAT® TKA Instrument Tray handle strength wasevaluated.Standard Followed: ASTM ST77:2013, ContainmentDevices for Reusable Medical Device Sterilization | PASS |
| Verification ofInstrument TrayProduct Requirementsby Inspection andAnalysis | The method of verification was to visually inspectthe instrument tray per specifications and inspect andanalyze documents listed in the protocol to identify thedesign outputs. The design outputs were then verifiedagainst corresponding product requirements.Standard Followed:THINK Surgical developed specification | PASS |
| Verification ofInstrument TrayProduct Requirementsby Lab Test | The method of verification was physical, non-destructive testing of the instrument tray to verifydesign outputs against corresponding productrequirements.Standard Followed: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.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).