Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the product as a physical instrument tray set for sterilization and organization, with no mention of software, data processing, or AI/ML capabilities. The performance studies focus on sterilization efficacy, packaging, cleaning, and biocompatibility, which are typical for physical medical devices and do not involve AI/ML evaluation.

Therapeutic

No
This device is an instrument tray set designed to organize, protect, and sterilize surgical tools. It does not directly provide therapy or treatment to a patient.

Diagnostic

No.
The device is described as an instrument tray set intended to protect, organize, and deliver surgical tools and instruments, and to facilitate their sterilization. Its primary function is to hold and transport other devices, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states it is constructed primarily of anodized aluminum and is a physical tray set for organizing and sterilizing surgical instruments. It does not mention any software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories." It also facilitates sterilization and maintains sterility. This is a function related to surgical instruments and their handling, not to testing samples from the human body.
Device Description: The description focuses on the physical characteristics of the trays for holding and sterilizing surgical instruments. There is no mention of reagents, assays, or any components used for analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Using reagents or assays

The device is clearly designed to support surgical procedures by managing the instruments used in those procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.

Product codes (comma separated list FDA assigned to the subject device)

KCT

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,
4 min cycle with 45-min dry time

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Testing:

Sterilization Efficacy:
- Purpose: Demonstrate sterilization efficacy of the TCAT THA Instrument Tray Sets containing the maximum inoculated load.
- Results: The test resulted in no growth and six-log reduction at the half-cycle for both devices of the indicator organism.
Packaging:
- Purpose: Demonstrate that the THINK Surgical TCAT® THA Instrument Tray Set was evaluated with maximum load, wrapped according to use instructions and in the shipping configurations according to a shipping validation test.
- Results: The results for both trays indicate packaging endpoints were met.
Cleaning:
- Purpose: Demonstrate that that the cleaning instructions for the TCAT THA Instrument Tray Set are valid.
- Results: The results for both tray indicated cleaning endpoints were met.
Biocompatibility:
- Purpose: Demonstrate that the TCAT THA Instrument Tray Set is biocompatible.
- Results: Under the conditions of the test, the device extract was not cytotoxic.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072211

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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
general use with the TSolution One® Surgical
System (TCAT)
TCAT THA Instruments, Tools, and Accessories	Instruments, tools and accessories intended for THA
use with the TSolution One® Surgical System
(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
Tray Set Contents | Dimensions, L x W x H
(inches) | Weight |
|--------------------------------------------|----------------------------------------------------------|-----------------------------------|------------------------------------------|
| TCAT® Base
Instrument Tray
PN 107735 | TCAT general use
instruments, tool and
accessories | 20 x 9.8 x 4.5 | Unloaded: 14.21lbs.
Loaded: 17.33lbs. |
| TCAT® THA
Instrument Tray
PN107736 | Instruments, tools and
accessories for THA
only | 20 x 9.8 x 4.5 | Unloaded: 14.39lbs.
Loaded: 19.50lbs. |

3

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:	(510) 249-2323
Fax Number:	(510) 249-2396
Date Prepared:	March8, 2019
Device Trade Name:	TCAT ®THA Instrument Tray Set
Device Common Name:	Sterilization Cassettes, Instrument Tray, Sterilization Tray.
Instrument Delivery System
Classification Name:	Sterilization wrap,
Product Code	KCT
Regulation Number:	21 CFR 880.6850
Predicate Device:	Intuitive Surgical® Instrument and Accessory Sterilization
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,

5

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
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

Contents	Description
TCAT General Instruments, Tools
and Accessories	Instruments, tools and
accessories intended for general
use with the TSolution One®
Surgical System (TCAT)
TCAT THA Instruments, Tools,
and Accessories	Instruments, tools and
accessories intended for THA use
with the TSolution One®
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
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
Instrument Tray
Set Contents | Dimensions,
L x W x H
(inches) | Weight |
|--------------------------------------------|-------------------------------------------------------------|--------------------------------------|------------------------------------------------|
| TCAT® Base
Instrument Tray
PN 107735 | TCAT general
use instruments,
tool and
accessories | 20x9.8x4.5 | Unloaded:
14.21lbs.
Loaded:
17.33lbs. |
| TCAT® THA
Instrument Tray
PN107736 | Instruments,
tools and
accessories for
THA only | 20x9.8x4.5 | Unloaded:
14.39lbs.
Loaded:
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
Instrument Tray Set
(Subject Device) | Intuitive Surgical®
Instrument Accessory
Trays, K072211 | Comparison |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | A sterilization tray 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. | A sterilization tray 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. | Same |
| Load
Contents | TCAT General
Instrument, Tools and
Accessories:
Instruments, tools and
accessories intended for
general use with the
TCAT Surgical System

TCAT THA,
Instruments Tools
and Accessories:
Instruments, tools and
accessories intended for
THA use with the
TCAT Surgical System | Intuitive Surgical
EndoWrist Instruments:
DaVinci and DaVinci S
families of 8mm and
45mm Endo Wrist
Instruments

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:

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.
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
Performance
Testing	Purpose	Results
Sterilization Efficacy
(ISO 17665-1: 2006
Sterilization of health
care products-Moist Heat
Part 1 Requirements for
the development,
validation and routine
control of sterilization
process for medical
devices.)	Demonstrate sterilization efficacy of
the TCAT THA Instrument Tray
Sets containing the maximum
inoculated load.	The test
resulted in no
growth and
six-log
reduction at
the half-cycle
for both
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
(ASTM D4169-16
Standard Practice for
Performance Testing in
Shipping Containers and
Systems)	Demonstrate that the THINK
Surgical TCAT® THA Instrument
Tray Set was evaluated with
maximum load, wrapped according
to use instructions and in the
shipping configurations according
to a shipping validation test.	The results
for both
trays
indicate
packaging
endpoints
were met.
Cleaning
(FDA. 2015.Guidance for
Industry and FDA Staff-
Processing/Reprocessing
Medical Devices in Health
Care Settings: Validation
and Labeling)	Demonstrate that that the cleaning
instructions for the TCAT THA
Instrument Tray Set are valid.	The results
for both
tray
indicated
cleaning
endpoints
were met.
Biocompatibility
(ISO 10993-5:2009
Cytotoxicity Test)	Demonstrate that the TCAT
THA Instrument Tray Set is
biocompatible.	Under the
conditions
of the test,
the device
extract was
not
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).