TCAT (R) THA Instrument Tray Set

K180127 · THINK Surgical, Inc. · KCT · Mar 15, 2019 · General Hospital

Device Facts

• Record ID: K180127
• Device Name: TCAT (R) THA Instrument Tray Set
• Applicant: THINK Surgical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Mar 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The THINK Surgical TCAT® THA Instrument Tray Set is intended to protect, organize, and deliver 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 FDAcleared sterilization wrap during the pre-vacuum autoclave sterilization process.

Device Story

TCAT® THA Instrument Tray Set consists of anodized aluminum trays with perforated lids, bases, and sides; includes internal stanchions/shelves to organize specific TSolution One® Surgical System instruments. Used in clinical settings to hold instruments during pre-vacuum steam autoclave sterilization (132°C, 4-minute exposure, 45-minute dry time); requires FDA-cleared sterilization wrap. Trays maintain sterility of contents during storage and transport to the surgical suite. Benefits include organized delivery of surgical tools and protection of instruments during the sterilization cycle.

Clinical Evidence

Bench testing only. Sterilization efficacy validated per ISO 17665-1:2006, demonstrating six-log reduction of indicator organisms at half-cycle. Packaging validated per ASTM D4169-16. Cleaning validation performed per FDA 2015 guidance. Biocompatibility confirmed via ISO 10993-5:2009 cytotoxicity testing; device extracts were non-cytotoxic.

Technological Characteristics

Materials: Anodized aluminum (base/lid), silicone, stainless steel, nylon (inserts/latches). Design: Rectangular base with latchable lid, perforated (19-22% surface area) for steam penetration. Dimensions: 20" x 9.8" x 4.5". Sterilization: Pre-vacuum steam (132°C). Standards: ISO 17665-1 (sterilization), ASTM D4169-16 (packaging), ISO 10993-5 (biocompatibility).

Indications for Use

Indicated for use by healthcare providers to protect, organize, and deliver TCAT tools, instruments, and accessories for the TSolution One® Surgical System during sterilization, storage, and transport.

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

• Intuitive Surgical® Instrument and Accessory Sterilization Trays (K072211)

Submission Summary (Full Text)

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March 15, 2019

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

Re: K180127

Trade/Device Name: TCAT® THA Instrument Tray Set Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 13, 2019 Received: February 14, 2019

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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

51O(k) Number (if known) K180127

Device Name TCAT® THA Instrument Tray Set

### Indications for Use (Describe)

The THINK Surgical TCAT® THA Instrument Tray Set is intended to protect, organize, and deliver 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 FDAcleared sterilization wrap during the pre-vacuum autoclave sterilization process.

Table 1 lists the THINK Surgical compatible devices:

### Table 1: THINK Surgical Compatible devices

| Intended Instrument Tray Set Contents | Description |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| TCAT General Instruments, Tools and Accessories | Instruments, tools and accessories intended for<br>general use with the TSolution One® Surgical<br>System (TCAT) |
| TCAT THA Instruments, Tools, and Accessories | Instruments, tools and accessories intended for THA<br>use with the TSolution One® Surgical System<br>(TCAT) |

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

### Table 2: Sterilization Parameters

| 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® THA Instrument Tray Set (107985):

### Table 3: Description of the TCAT THA Instrument Tray Set

| Tray Name | Intended Instrument<br>Tray Set Contents | Dimensions, L x W x H<br>(inches) | Weight |
|--------------------------------------------|----------------------------------------------------------|-----------------------------------|------------------------------------------|
| TCAT® Base<br>Instrument Tray<br>PN 107735 | TCAT general use<br>instruments, tool and<br>accessories | 20 x 9.8 x 4.5 | Unloaded: 14.21lbs.<br>Loaded: 17.33lbs. |
| TCAT® THA<br>Instrument Tray<br>PN107736 | Instruments, tools and<br>accessories for THA<br>only | 20 x 9.8 x 4.5 | Unloaded: 14.39lbs.<br>Loaded: 19.50lbs. |

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Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for "THINK Surgical". The word "THINK" is in large, gray, block letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, with a focus on the company name.

## 510(k) Summary of K180127

| Submitter Name: | THINK Surgical, Inc. |
|----------------------|---------------------------------------------------------------------------------------------|
| Submitter Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Contact Person: | George J. Prendergast |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | March8, 2019 |
| Device Trade Name: | TCAT ®THA Instrument Tray Set |
| Device Common Name: | Sterilization Cassettes, Instrument Tray, Sterilization Tray.<br>Instrument Delivery System |
| Classification Name: | Sterilization wrap, |
| Product Code | KCT |
| Regulation Number: | 21 CFR 880.6850 |
| Predicate Device: | Intuitive Surgical® Instrument and Accessory Sterilization<br>Trays (K072211) |

### Device Description:

The TCAT THAT Instrument Tray Set is intended only for use with TSolution One® Surgical System instruments, tools and accessories. These trays are 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 trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and 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: a rectangular base with 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 removing from the tray.

The sterilization trays have been tested for use only with THINK Surgical instruments. tools and accessories for a sterilization cycle of pre-vacuum steam sterilization at 132 °C,

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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. Below the logo, the text "4 min cycle with 45-min dry time" is present. The logo is in gray and blue.

The type and maximum number of instruments, tool and accessories for each of the trays listed above are as follows:

| TCAT® 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 Set | 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 |

| TCAT® 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 |

| TCAT® THA Application Tray (Tray 2) Top | | |
|-----------------------------------------|-----------------------------------------|----------|
| Part Number | Description | Quantity |
| 105653 | Cutter Bearing Sleeve, 244mm | 1 |
| 102613 | Recovery Marker, Tack Ø1.5 x 11mm | 1 |
| 102709 | Cutter Ball Probe, 276mm | 1 |
| 102862-NS | Cutter, Flat, Ø8.25x268mm | 1 |
| 106298-03 | Digitizer Percutaneous Probe | 1 |
| 107720 | Recovery Marker, Groove, Ø4x125mm | 2 |
| 105734 | Cuter, Ball, Ø6x268mm | 1 |
| 107719 | Recovery Marker, Divot, Ø4x70mm | 1 |
| Hospital<br>Supplied | Fixation Screw, Self-Drilling, Ø5x150mm | 3 |

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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters. Above the "I" is a small, blue square. Below the word "THINK" is the word "SURGICAL" in smaller, blue letters.

| TCAT® THA Application Tray (Tray 2) Bottom | | |
|--------------------------------------------|------------------------------------|----------|
| Part Number | Description | Quantity |
| 107645 | Cutter Drive Assembly | 1 |
| 105751 | Impactor Coupler Assembly, | 1 |
| | Magnetic | |
| 107667 | Impactor, Acetabular Cup, 010 | 1 |
| 107666 | Reamer Driver, Acetabular Cup, 001 | 2 |
| 107642 | Arm Tool Coupler | 1 |

### Indications for Use:

The THINK Surgical TCAT® THA 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.

Table 1 lists the THINK Surgical compatible devices:

| Intended Instrument Tray Set<br>Contents | Description |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| TCAT General Instruments, Tools<br>and Accessories | Instruments, tools and<br>accessories intended for general<br>use with the TSolution One®<br>Surgical System (TCAT) |
| TCAT THA Instruments, Tools,<br>and Accessories | Instruments, tools and<br>accessories intended for THA use<br>with the TSolution One®<br>Surgical System (TCAT) |

### Table 1: THINK Surgical Compatible Devices

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

### Table 2: Sterilization Parameters

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

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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in gray block letters, with a small blue square above the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, blue font. The logo is simple and modern, and the use of color is effective in creating a visual hierarchy.

Table 3 provides a description of the TCAT® THA Instrument Tray Set (107985):

| Tray Name | Intended<br>Instrument Tray<br>Set Contents | Dimensions,<br>L x W x H<br>(inches) | Weight |
|--------------------------------------------|-------------------------------------------------------------|--------------------------------------|------------------------------------------------|
| TCAT® Base<br>Instrument Tray<br>PN 107735 | TCAT general<br>use instruments,<br>tool and<br>accessories | 20x9.8x4.5 | Unloaded:<br>14.21lbs.<br>Loaded:<br>17.33lbs. |
| TCAT® THA<br>Instrument Tray<br>PN107736 | Instruments,<br>tools and<br>accessories for<br>THA only | 20x9.8x4.5 | Unloaded:<br>14.39lbs.<br>Loaded:<br>19.50lbs. |

### Table 3: Description of the TCAT® THA Instrument Tray Set

### Predicate Device:

The TCAT® THA Instrument Tray Sets are similar to the Intuitive Surgical® Instrument Accessory Trays, K072211.

### Technological Characteristics Comparison:

Table 4 provides a comparison of technological characteristics and principles of operation between the TCAT THA Instrument Tray Set System and its predicate devices.

| Feature | TCAT® THA<br>Instrument Tray Set<br>(Subject Device) | Intuitive Surgical®<br>Instrument Accessory<br>Trays, K072211 | Comparison |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | A sterilization tray is a<br>device intended to be<br>used to enclose another<br>medical device that is to<br>be sterilized by a health<br>care provider. It is<br>intended to allow<br>sterilization of the<br>enclosed medical device. | A sterilization tray is a<br>device intended to be used to<br>enclose another medical<br>device that is to be sterilized<br>by a health care provider. It<br>is intended to allow<br>sterilization of the enclosed<br>medical device. | Same |
| Load<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 Surgical System<br><br>TCAT THA,<br>Instruments Tools<br>and Accessories:<br>Instruments, tools and<br>accessories intended for<br>THA use with the<br>TCAT Surgical System | Intuitive Surgical<br>EndoWrist Instruments:<br>DaVinci and DaVinci S<br>families of 8mm and<br>45mm Endo Wrist<br>Instruments<br><br>Intuitive Surgical<br>Reusable Accessories:<br>DaVinci and Davinci S<br>families of 8mm and 5mm<br>accessories including<br>canulae, obturators,<br>cannula mounts, sterile<br>adapters, etc. | |
| Contents<br>Maximum<br>Load | Medical<br>devices/instruments<br>weighing a maximum<br>of 17.33lbs for TCAT<br>base instrument tray<br>and<br>weighing a maximum<br>of 19.50lbs for the<br>THA instrument tray. | Medical<br>devices/instruments<br>weighing a maximum of<br>1lbs for Endo Wrist<br>instrument tray<br>and<br>weighing a maximum of<br>7lbs for DaVinci and<br>Davinci S trays. | Similar |
| Design Characteristics | | | |
| Device<br>Composition | Base, lift out tray, lid | Base, lid | Similar |
| Inserts | Yes | Yes | Same |
| Handles | Yes | Yes | Same |
| Latches | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Materials | | | |
| Lid/base/lift<br>out tray, not<br>including<br>inserts | Aluminum | Aluminum | Same |
| Inserts | Silicone, aluminum,<br>stainless steel, nylon | - | - |
| Latch | Stainless steel | - | - |
| Assembled<br>Dimensions | 20" x 9.8" x 4.5" | 24.1" x 9.7" x 5.5" | Similar |
| Max load<br>weight | 17lbs for TCAT base<br>tray<br>19.5lbs for THA<br>instrument tray | 21lbs. | Similar |
| Sterilization | | | |
| Percent of surface perforations for<br>both subject devices: | | Percent of surface perforations for the<br>predicate device: | |
| -lid | 21% | -lid, base | - |
| -base | 19% | - | - |
| -lift out tray | 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 | 45 minutes | 30 minutes | Similar |

Table 4:Technological Characteristics Comparison Table

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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters, with a blue square above the "T". Below "THINK" is the word "SURGICAL" in smaller, blue letters.

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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in a smaller, blue font.

The TCAT® THA Instrument Tray Sets were found to be similar to the predicate. Three fundamental similarities are:

1. Basic design: Both the TCAT THA Instrument Trays and the predicate 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. Fundamental Technology: The TCAT THA Instrument Tray Sets and the predicate allow the sterilant (steam) to penetrate and render its contents sterile by relying on surface perforations.

Primary differences are related to size, shape, intended contents, surface perforations, and appearance.

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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 large, bold, gray letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, and it conveys a sense of innovation and precision.

### Summary of Non-Clinical Testing:

Table 5 summarizes the non-clinical performance testing of the TCAT® THA Instrument Tray Sets:

- Sterilization Efficacy ●
- . Packaging
- Cleaning
- Biocompatibility ●

| Table 5: Summary of Non-Clinical Performance Testing | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Non-Clinical<br>Performance<br>Testing | Purpose | Results |
| Sterilization Efficacy<br>(ISO 17665-1: 2006<br>Sterilization of health<br>care products-Moist Heat<br>Part 1 Requirements for<br>the development,<br>validation and routine<br>control of sterilization<br>process for medical<br>devices.) | Demonstrate sterilization efficacy of<br>the TCAT THA Instrument Tray<br>Sets containing the maximum<br>inoculated load. | The test<br>resulted in no<br>growth and<br>six-log<br>reduction at<br>the half-cycle<br>for both<br>devices |

# Table 5: Summary of Non-Clinical Performance Testing

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Image /page/11/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in gray, block letters, with a small blue square above the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, blue font. The logo is simple and modern, and the colors are clean and professional.

| | of the indicator organism. | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Packaging<br>(ASTM D4169-16<br>Standard Practice for<br>Performance Testing in<br>Shipping Containers and<br>Systems) | Demonstrate that the THINK<br>Surgical TCAT® THA Instrument<br>Tray Set was evaluated with<br>maximum load, wrapped according<br>to use instructions and in the<br>shipping configurations according<br>to a shipping validation test. | The results<br>for both<br>trays<br>indicate<br>packaging<br>endpoints<br>were met. |
| Cleaning<br>(FDA. 2015.Guidance for<br>Industry and FDA Staff-<br>Processing/Reprocessing<br>Medical Devices in Health<br>Care Settings: Validation<br>and Labeling) | Demonstrate that that the cleaning<br>instructions for the TCAT THA<br>Instrument Tray Set are valid. | The results<br>for both<br>tray<br>indicated<br>cleaning<br>endpoints<br>were met. |
| Biocompatibility<br>(ISO 10993-5:2009<br>Cytotoxicity Test) | Demonstrate that the TCAT<br>THA Instrument Tray Set is<br>biocompatible. | Under the<br>conditions<br>of the test,<br>the device<br>extract was<br>not<br>cytotoxic. |

### Conclusions

The conclusions drawn from the nonclinical that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device Intuitive Surgical® Instrument and Accessory Sterilization Trays (K072211).