TCAT TKA Instrument Tray Set

K200632 · THINK Surgical, Inc. · KCT · Apr 8, 2020 · General Hospital

Device Facts

• Record ID: K200632
• Device Name: TCAT TKA Instrument Tray Set
• Applicant: THINK Surgical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Apr 8, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The THINK Surgical TCAT® TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT® tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.

Device Story

TCAT® TKA Instrument Tray Set consists of rectangular anodized aluminum trays with latchable lids; designed to hold specific TSolution One® TKA instruments, tools, and accessories. Trays feature perforated surfaces to facilitate steam penetration, evacuation, and drying during pre-vacuum autoclave sterilization (132°C, 4-minute exposure, 45-minute dry time). Trays are wrapped in FDA-cleared sterilization wrap to maintain sterility. Used in clinical settings; operated by surgical staff. Stanchions inside trays organize instruments for effective sterilant exposure and ease of retrieval. Device ensures instruments are delivered to the surgical field in a sterile, organized state, facilitating efficient surgical workflows.

Clinical Evidence

No clinical or animal testing was performed. Substantial equivalence is supported by bench testing, including sterilization efficacy (BI overkill method, 6-log reduction), packaging validation (ASTM D4169-16), cleaning/reprocessing validation, and biocompatibility (ISO 10993-5 MEM Elution).

Technological Characteristics

Materials: Anodized aluminum (base/lid/tray), silicone, stainless steel, nylon. Design: Rectangular base with latchable lid, perforated surfaces (19-22% open area). Sterilization: Pre-vacuum steam (132°C, 4 min exposure, 45 min dry). Connectivity: None. Software: None. Dimensions: 20" x 9.8" x 4.5".

Indications for Use

Indicated for the protection, organization, and delivery of TCAT® tools, instruments, and accessories to the surgical field for use with the TSolution One® Surgical System during total knee arthroplasty (TKA) procedures.

Regulatory Classification

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.

Predicate Devices

• TCAT® THA Instrument Tray Set (K180127)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 8, 2020

THINK Surgical, Inc. George Prendergast Manager, Regulatory Affairs 47201 Lakeview Blvd Fremont, California 94538

Re: K200632

Trade/Device Name: TCAT® TKA Instrument Tray Set Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 9, 2020 Received: March 10, 2020

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Christopher K. Dugard, MS Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200632 Device Name TCAT® TKA Instrument Tray Set

#### Indications for Use (Describe)

The THINK Surgical TCAT® TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT® tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.

[See the following page for the THINK Surgical compatible devices, sterilization parameters and description of the TCAT® TKA Instrument Tray Set.]

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)

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FORM FDA 3881 (7/17)

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# FORM FDA 3881 (CONTINUED)

## The following is the continuation of FORM FDA 3881 for the TCAT® TKA Instrument Tray Indications for Use

Table 1 lists the lists the THINK Surgical compatible devices:

| Intended instrument tray set contents | Description |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| TCAT General Instruments, Tools and Accessories | Instruments, tools and accessories intended<br>for general use with the TSolution One®<br>Surgical System (TCAT®) |
| TCAT TKA Instruments, Tools, and Accessories | Instruments, tools and accessories intended<br>for TKA use with the TSolution One®<br>Surgical System (TCAT®) |

Table 2 lists the sterilization parameters under which the TCAT® TKA Instrument Tray Set was validated:

| Cycle | Cycle Temperature | Exposure Time | Dry Time |
|------------|-------------------|---------------|------------|
| Pre-vacuum | 132°C (270°F) | 4 minutes | 45 minutes |

Table 3 provides a description of the TCAT® TKA Instrument Tray Set (109154):

| Table 3: Dimensions and weights | | | |
|-----------------------------------------|-------------------------------|------------------------|-----------|
| Tray Name | Dimensions (inches) L x W x H | Weight (lbs) Unloaded: | Loaded |
| TCAT® TKA Base Tray<br>PN 107735 | 20 x 9.8 x 4.5 | 14.21lbs. | 17.33lbs. |
| TCAT® TKA Application Tray<br>PN 107737 | 20 x 9.8 x 4.5 | 7.5lbs. | 18.0lbs. |

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Image /page/4/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue triangle replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.

# SECTION 6

# K200632 510(k) SUMMARY

This 510(k) summary is submitted in accordance with 21CFR 807.92

# Applicant Information:

| Owner Name: | THINK Surgical, Inc. |
|------------------------------------|-------------------------------------------|
| Address: | 47201 Lakeview Blvd.<br>Fremont, CA 94538 |
| Phone: | 510-249-2337 |
| Fax | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | George J. Prendergast |
| Date Prepared: | March 09, 2020 |
| Device Information: | |
| Classification: | Class II |
| Trade Name: | TCAT® TKA Instrument Tray Set |
| Common name: | Sterilization Wrap |
| Classification name: | Sterilization Wrap |
| Regulation number: | 21 CFR 880.6850 |
| Classification Code: | KCT |

## Predicate Device:

TCAT® THA Instrument Tray Set cleared via K180127.

## Device Modification:

The changes to the predicated device allow tools, instruments and accessories to be utilized during a total knee arthroplasty (TKA) procedure. The only modification to this device is one tray set (the Application Tray Set) contains new tools, instruments and accessories for a total knee arthroplasty replace those tools instruments and accessories which were included in the TCAT®THA Instrument Tray Set (the predicate device).

## Device Description:

The TCAT® TKA Instrument Tray Set is intended only for use with TSolution One® Total Knee Application instruments, tools and accessories. These trays are used to enclose and hold the instruments tools and accessories in an organized manner during the

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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue, triangular shape replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.

# TCAT®TKA Instrument Tray Set Special 510(k) Submission

sterilization process and subsequent storage and transportation to and from the surgical suite. The trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and are compatible with repeated steam sterilizations. The trays have perforations to facilitate sterilant penetration, evacuation and drying. Since the trays are perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of the contents.

The trays have the same size and same basic configuration of the predicate device: a rectangular base with a latchable lid. The trays have perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom surface and interior shelves of the trays contain stanchions designed to separately hold each individual instrument, tool and accessory for effective sterilant exposure, evacuation and drying during the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removal from the tray.

The sterilization trays have 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 45 minute dry time. While reuseable, these trays will not be serviced or repaired. The type and maximum number of instruments, tools and accessories for each of the trays follow:

| TCAT® TKA Base Tray (Tray 1 Top) | | |
|----------------------------------|-------------------------------------|----------|
| Part Number | Description | Quantity |
| 103426 | Cutter Motor | 1 |
| 106298-04 | Digitizer Ball Probe | 1 |
| 106382 | Digitizer Probe Hub | 1 |
| 103593 | Recovery Marker Installation Tool | 1 |
| 102940 | Cutter Verification Gauge | 1 |
| 103636 | Cutter Wrench Set | 1 |
| 105716 | Wrench, Hex, 2.5mm | 1 |
| 103279 | Wrench, Hex, 8mm | 1 |
| 101884 | Wrench, T-Handle, Square, 8mm | 1 |
| 104948 | BMM Probe Assembly | 1 |
| Hospital Supplied | Fixation Clamp, Ø4-5mm pin/Ø8mm rod | 2 |
| Hospital Supplied | Fixation Clamp, Ø8mm rod/Ø8mm rod | 1 |
| Hospital Supplied | Fixation Clamp, Ø3-4mm pin/Ø5mm rod | 1 |

| TCAT ® TKA Base Tray (Tray 1 Bottom) | | |
|--------------------------------------|------------------------------------------|----------|
| Part Number | Description | Quantity |
| 103205 | Fixation Arm, Straight | 1 |
| 106219 | Fixation Adapter Rod, Right-Angle 4 inch | 1 |
| 103414 | Swivel Block | 1 |
| 100086 | Wrench, Open End, 1-1/8 inch | 1 |
| 103384 | Cutter Motor Cable | 1 |

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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with a blue vertical line replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue line adds a touch of color and visual interest.

| TCAT® TKA Application Tray (Tray 2 top) | | |
|-----------------------------------------|----------------------------------------|----------|
| Part Number | Description | Quantity |
| 106219 | Fixation Adapter Rod, Right Angle | 1 |
| 104948 | BMM Probe Assembly | 1 |
| 106825 | Spiked Disk, Femoral Epicondylar Clamp | 2 |
| 102613 | Recovery Marker, Tack, Ø1.5x11mm | 2 |
| 106413 | Cutter Bearing Sleeve, 120mm | 1 |
| 106298-03 | Digitizer Percutaneous Probe | 1 |
| 107720 | Recovery Marker, Groove, Ø4x125mm | 2 |
| Hospital Supplied | Fixation Pin, Self-Drilling, Ø3x125mm | 1 |
| Hospital Supplied | Fixation Pin, Self-Drilling, Ø4x125mm | 2 |
| 103454-NS | Cutter, Ø2.0x159mm | 1 |
| 103455 | Cutter, Ball Probe, 151mm | 1 |
| 106428 | Cutter, Flat, Ø6.2x144mm | 1 |
| 103450 | Fixation Adapter Rod, Straight | 2 |

| TCAT® TKA Application Tray (Tray 2 Bottom) | | |
|--------------------------------------------|----------------------------|----------|
| Part Number | Description | Quantity |
| 107714 | Cutter Drive Assembly, TKA | 1 |
| 103206 | Fixation Arm, Straight | 1 |
| 103414 | Swivel Block | 1 |
| Hospital Supplied | Wrench, Nut Driver, 5mm | 1 |
| 106824 | Clamp, Femoral Epicondylar | 1 |

## Indications for Use:

The THINK Surgical TCAT®TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.

## Technological Characteristics Comparison Table

Three fundamental characteristics are the same between the two devices:

- 1. Basic design: Both the TCAT®TKA Instrument Tray Set and the predicate device 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 the same.
- 2. Role in sterile barrier system: The TCAT® TKA Instrument Tray Set and the predicate device must be wrapped with an FDA-cleared sterilization wrap to maintain sterility. Neither the subject device or the predicate contains gaskets, valves nor filters.
- 3. Fundamental technology: The TCAT®TKA Instrument Tray Set and the predicate device allow the sterilant (steam) to penetrate and render its contents sterile by relying on surface perforations.

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Image /page/7/Picture/1 description: The image shows the logo for "THINK Surgical". The word "THINK" is written in large, bold, sans-serif letters, with the "I" in "THINK" being a blue, elongated triangle. Below the word "THINK" is the word "SURGICAL" in smaller, sans-serif letters. The logo is simple and modern, and the blue "I" adds a touch of color and visual interest.

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 Set<br>(Subject Device) | TCAT® THA Instrument<br>Tray Set (Predicate<br>Device) | Comparison |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K200632 | K180127 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Intended Use | The THINK Surgical<br>TCAT® TKA Instrument<br>Tray Set is intended to<br>protect, organize and<br>deliver to the surgical field<br>TCAT® tools, instruments<br>and accessories. The<br>trays allow sterilization of<br>tools, 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<br>TCAT® THA Instrument<br>Tray Set is intended to<br>protect, organize and<br>deliver to the surgical field<br>TCAT® tools, instruments<br>and 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>Contents | TCAT® General<br>Instrument, Tools and<br>Accessories:<br>Instruments, tools and<br>accessories intended for<br>general use with the<br>TCAT® TSolution One®<br>Total Knee Application.<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® Surgical System.<br>TCAT® THA Instruments,<br>Tools and Accessories:<br>Instruments, tools and<br>accessories intended for<br>use with the TCAT®<br>Surgical System. | Identical |
| Intended<br>Instrument Tray<br>Set Contents<br>Maximum Load | Medical devices/<br>instruments weighing no<br>less than 7.5lbs-18.0lbs.<br>total including the weight<br>of the trays. | Medical devices/<br>instruments weighing no<br>less than 14.21lbs-<br>14.39lbs. total including<br>the weight of the trays. | Similar |
| Design Characteristics | | | |
| Device<br>Composition | Base, lift out tray, lid | Base, lift out tray, lid | Same |
| Inserts | Yes | Yes | Same |
| Characteristic | TCAT® TKA Instrument<br>Tray Set<br>(Subject Device) | TCAT® THA Instrument<br>Tray Set (Predicate<br>Device) | Comparison |
| 510(k) number | TBD | K180127 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Handles | Yes | Yes | Same |
| Latches | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Materials | | | |
| Lid/base/Lift out<br>tray, not including<br>inserts | Aluminum | Aluminum | Same |
| Inserts | Silicone, aluminum,<br>stainless steel, nylon | Silicone, aluminum,<br>stainless steel, nylon | Same |
| Latch | Stainless steel | Stainless steel | Same |
| Assembled<br>Dimensions | 20" x 9.8" x 4.5" | 20" x 9.8" x 4.5" | Same |
| Weight containing<br>max load | 18.0lbs. | 19.5lbs. | Similar |
| Sterilization | | | |
| Percent of surface perforations | | | |
| -lid | 21% | 21% | Same |
| -base | 19% | 19% | Same |
| -lift out tray | 22% | 22% | Same |
| Sterilization<br>Method | Pre-Vacuum (Steam) | Pre-Vacuum (Steam) | Same |
| Cycle | 132°C (270°F) | 132°C (270°F) | Same |
| Temperature | | | |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Drying Time | 45 minutes | 45 minutes | Same |

## Table 4: Comparison of Technological Characteristics Between the Subject Device and the Predicate Device

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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" in "THINK" being a blue triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.

# Non-Clinical Performance Testing

Table 5 summarizes the non-clinical performance testing of the TCAT® TKA Instrument Tray Set:

- Sterilization Efficacy
- . Packaging
- . Cleaning
- Biocompatibility .
- Use and Sterile Processing Guide .

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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" represented by a blue, elongated triangle. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.

# TCAT®TKA Instrument Tray Set Special 510(k) Submission

| Table 5: Summary of Non-Clinical Performance Testing | |
|------------------------------------------------------|--|
|------------------------------------------------------|--|

| Non-Clinical<br>Performance Testing | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sterilization Efficacy<br>(ANSI/AAMI/ISO<br>14937:2013 -<br>Sterilization of<br>Healthcare Product -<br>General Requirements<br>for Characterization of a<br>Sterilizing Agent and<br>the Development,<br>Validation and Routine<br>Control of a Sterilization<br>Process for Medical<br>Devices) | To verify the TCAT® TKA<br>Instrument Tray Sets containing<br>the maximum load were inoculated<br>with biological indicators placed in<br>areas of the trays deemed to be<br>most difficult for sterilant (steam) to<br>penetrate. Following inoculation,<br>the trays were wrapped in FDA-<br>cleared sterilization wraps. The<br>trays indicated that the BI Overkill<br>method provided a six-log<br>reduction of the indicator organism. | -All biological indicators<br>(BIs) must be incubated<br>for a minimum of 7 days<br>at 55°C-60°C<br>-The positive control for<br>the SAL testing must<br>show characteristic<br>growth of the indicator<br>organism<br>-Valid temperature data<br>must be collected for<br>each product probe<br>location<br>-Temperature probes<br>used during profiling of<br>the test article must be<br>within ±0.5°C of at least<br>one post calibration<br>reference temperature<br>that is representative of<br>the profiling cycles<br>-All directly-inoculated<br>test article components<br>must demonstrate to<br>contain no bacteriostatic<br>properties by showing<br>growth of G.<br>stearothermophilus<br>during method suitability<br>testing |
| Packaging (ASTM<br>D4169-16 - Standard<br>Practice for<br>Performance Testing of<br>Shipping Containers<br>and Systems) | To verify the TCAT® TKA<br>Instrument Tray Sets were<br>evaluated with maximum load,<br>wrapped according to use<br>instructions and in the shipping<br>configuration<br>according to a shipping<br>validation test. The results<br>indicate packaging<br>requirements were met. | -Is the packaging or parts<br>of the Application Tray<br>damaged<br>-Is the Packaging or parts<br>of the Base Tray<br>damaged<br>-Are the labels and<br>packing list still affixed<br>and legible | PASS |
| Reprocessing | To verify the TCAT® TKA<br>Instrument Tray Sets were<br>evaluated for cleanability<br>according to the user<br>instructions. The results<br>indicated cleanability<br>requirements were met. | -Observer shall provide<br>each participant with an<br>IFU<br>-Observer shall ask each<br>participant to read the IFU<br>carefully<br>-Observer shall ask each<br>user to simulate the<br>reprocessing steps<br>according to the IFU<br>-Observer shall fill out the<br>data collection sheet | PASS |
| | | indicates all reprocessing<br>steps PASS | |
| Biocompatibility<br>(ANSI/AAMI/ISO 10993-<br>5:2009 - Biological<br>Evaluation of Medical<br>Devices - Part 5: Tests<br>for In Vitro Cytotoxicity) | To verify the TCAT® TKA Instrument<br>Tray Sets were<br>evaluated for biocompatibility<br>according to ISO 10993-<br>1. The results indicated<br>biocompatibility requirements<br>were met. | MEM Elution Study<br>-Test article meets a<br>passing score of 2 or<br>below; test article is not<br>considered to have a<br>cytotoxic potential | PASS |
| Use and Sterile<br>Processing Guide | To verify the TCAT® TKA Instrument<br>Tray Sets were evaluated in<br>accordance with the appropriate<br>guidances. The results<br>indicated use and Sterile<br>Processing Guide<br>requirements were met. | -Participant is able to load<br>components in the tray<br>-Participant is able to load<br>components in the tray<br>with the aid of visual<br>indications showing<br>storage location of each<br>instrument<br>-Participant is able to<br>carry one Instrument Tray<br>-Participant is able to load<br>all components in the tray<br>without requiring an<br>additional tool<br>Participant is able to<br>remove all components in<br>the tray without requiring<br>an additional tool | PASS |

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Image /page/10/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.

## TCAT®TKA Instrument Tray Set Special 510(k) Submission

## Clinical and Animal Testing

No clinical or animal testing were required.

## Conclusion

The conclusions drawn from the nonclinical and clinical tests demonstrate that the TCAT® TKA Instrument Tray Set is as safe, as effective, and performs as well as or better than the legally marketed device.