Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization tray for surgical instruments and does not perform any computational or analytical functions.

Therapeutic

No.

This device is an instrument tray designed for organizing, protecting, and sterilizing surgical tools, not for providing therapy directly to a patient.

Diagnostic

No

The device is an instrument tray designed to protect, organize, and sterilize surgical tools. It does not perform any diagnostic functions like detecting, monitoring, or predicting medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical instrument tray made of anodized aluminum, designed to hold and sterilize surgical instruments. It is not software.

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 surgical instruments and accessories to the surgical field, and to facilitate their sterilization. This is a function related to surgical procedures and instrument management, not diagnostic testing performed on samples from the human body.
Device Description: The description details a tray designed to hold and sterilize surgical instruments. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies focus on sterilization efficacy, packaging, handle strength, and verification of product requirements related to the tray's physical properties and function in the sterilization process. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as reagents, calibrators, controls, or the analysis of biological specimens (blood, urine, tissue, etc.).

In summary, the THINK Surgical TCAT® TKA Instrument Tray is a surgical accessory designed for the management and sterilization of surgical instruments, not for performing in vitro diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

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

KCT

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.

The tray has the basic same size and a minor configuration change to the predicate device: a rectangular 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.

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

surgical field

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: The TCAT® TKA Instrument Tray contained the maximum load and was inoculated with biological indicators placed in areas of the tray deemed to be most difficult for sterilant (steam) to penetrate. Following inoculation, the tray was wrapped in an FDA-cleared sterilization wrap. The results indicated that the BI Overkill method provided a six-log reduction of the indicator organism. Standard Followed: ANSI/AAMI/ISO 14937:2013. Results: PASS.
Shipping/Packaging: The TCAT® TKA Instrument Tray was evaluated with maximum load and configured in the shipping configuration according to a shipping validation test. The results indicate packaging requirements were met. Standard Followed: ASTM D4169-16. Results: PASS.
Handle Strength Testing: The TCAT® TKA Instrument Tray handle strength was evaluated. Standard Followed: ASTM ST77:2013. Results: PASS.
Verification of Instrument Tray Product Requirements by Inspection and Analysis: The method of verification was to visually inspect the instrument tray per specifications and inspect and analyze documents listed in the protocol to identify the design outputs. The design outputs were then verified against corresponding product requirements. Standard Followed: THINK Surgical developed specification. Results: PASS.
Verification of Instrument Tray Product Requirements by Lab Test: The method of verification was physical, non-destructive testing of the instrument tray to verify design outputs against corresponding product requirements. Standard Followed: THINK Surgical developed specification. Results: PASS.

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.

K200632

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 logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

December 20, 2021

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

Re: K203468

Trade/Device Name: TCAT® TKA Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: November 12, 2021 Received: November 15, 2021

Dear George Prendergast:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K203468

Device Name

TCAT® TKA Instrument Tray

Indications for Use (Describe)

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

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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3

FORM FDA 3881 (CONTINUED)

T

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

Table 1: Intended Instrument Tray Contents
Intended instrument Tray Contents	Description
TCAT General Instruments, Tools and
Accessories	Instruments, tools and accessories intended for
general use with the TSolution One® Total Knee
Application (TCAT® component)
TCAT TKA Instruments, Tools, and
Accessories	Instruments, tools and accessories intended for
TKA use with the TSolution One® Total Knee
Application (TCAT® component)
Table 2: Sterilization Parameters
Cycle	Cycle Temperature	Exposure Time	Dry Time
Pre-vacuum	132°C (270°F)	4 minutes	60 minutes
Table 3: Dimensions and Weights
Tray Name	Dimensions (inches)
L x W x H	Weight (lbs.)
		Unloaded:	Loaded
TCAT® TKA Instrument Tray	21.2" x 10.0" x 4.9"	11.0lbs.	24.0lbs.

4

510(k) SUMMARY

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

Applicant Information:
Owner Name:	THINK Surgical, Inc.
Address:	47201 Lakeview Blvd.
Fremont, CA 94538
Phone:	510-376-3834
Fax	510-249-2396
Establishment Registration Number:	3000719653
Contact Person:	George J. Prendergast
Date Prepared:	December 20, 2021
Device Information:
Classification:	Class II
Trade Name:	TCAT® TKA Instrument Tray
Common Name:	Sterilization Wrap
Classification Name:	Sterilization Wrap
Regulation Number:	21 CFR 880.6850
Classification Code:	KCT

Predicate Device:

TCAT® TKA Instrument Tray Set cleared via K200632.

Device Modifications:

The changes to the predicate device allow tools, instruments and accessories to be utilized during a total knee arthroplasty (TKA) procedure. The modifications to this device are there is one tray with a lift out tray which contains tools, instruments and accessories for a total knee arthroplasty, the addition of a silicone mat ('utility area'), and the addition of a 13mm Recovery Marker holder.

Device Description:

The TCAT® TKA Instrument Tray is intended only for use with TSolution One® Total Knee Application instruments, tools and accessories. This tray is used to enclose and hold the instruments, tools and accessories in an organized manner during the sterilization process and subsequent storage and transportation to and from the surgical suite. The tray is designed to fit any standard autoclave and is constructed primarily of anodized aluminum. The tray is compatible with repeated steam sterilizations. The tray has perforations to facilitate sterilant penetration, evacuation and drying. Since the tray is perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of the contents.

5

The trav has the basic same size and a minor configuration change to the predicate device: a rectanqular base with a latchable lid and a lift out tray. The tray has perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom tray surface and lift out tray surface contain stanchions designed to separately hold each individual instrument, tool and accessory for effective sterilant exposure, sterilant evacuation and drying the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removal from the tray. The lift out tray contains a silicone mat which may used to sterilize additional THINK Surgical part.

The instrument tray has been tested only with THINK Surgical instruments, tools and accessories for a 4 minute sterilization cycle of pre-vacuum steam sterilization at 132°C, with a 60 minute dry time. While reuseable, these trays will not be serviced or repaired. The type and maximum number of instruments, tools and accessories included in the tray follow:

TCAT® TKA Instrument Tray (Top Tray)
Part Number	Description	Quantity
109150	Cutter, Flat, Ø6.2x134mm	1
107937	Cutter, Ø2.0x148mm	1
107974	Cutter Ball Probe, 139mm	1
104948	BMM Probe Assembly	2
106382	Digitizer Probe Hub	1
109189	Fixation Pin, Self-Drilling, Ø4x150mm	2
107720	Recovery Marker, Groove, Ø4x125mm	2
106298-03	Digitizer Percutaneous Probe	1
106298-04	Digitizer Ball Probe	1
103593	Recovery Marker Installation Tool	1
103297	Wrench, Hex, 8mm	1
101888	Wrench, T-Handle, Square, 8mm	1
109195	Recovery Marker, Tack, Ø2.0x13mm	2

TCAT® TKA Instrument Tray (Lift Out Tray)
Part Number	Description	Quantity
109066	Swivel Clamp	2
103450	Fixation Adapter Rod, Straight	2
109190	Fixation Clamp, Ø4mm Pin / Ø8mm Rod	2
109142	Cutter Motor	1
105745	Cutter Motor Assembly	1
107642	Arm Tool Coupler	1
108181	Goniometer	1
103205	Fixation Arm, Straight	2
103384	Cutter Motor Cable	1
107720	Recovery Marker, Groove, Ø4x125mm	2

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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, Tools
and Accessories	Instruments, tools and accessories intended
for general use with the TSolution One® Total
Knee Application (TCAT® component)
TCAT TKA Instruments, Tools,
and Accessories	Instruments, tools and accessories intended
for TKA use with the TSolution One® Total
Knee Application (TCAT® component)

Table 1: Intended Instrument Trav Contents

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

Table 2: Sterilization Parameters

Cycle	Cycle Temperature	Exposure Time	Dry Time
Pre-vacuum	132°C (270°F)	4 minutes	60 minutes

Table 3 provides a description of the TCAT® TKA Instrument Tray (109200):

Table 3: Dimensions and Weights

| Tray
Name | 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:

1. Basic design: Both the TCAT® TKA Instrument Tray and the predicate device have a basic lid/trav design with latches, handles, perforations, and contoured inserts or sections for containing items for sterilization, storage and transport. General size, shape, and weight of both the subject device and predicate device are similar. The materials of the subject device and the materials of the predicate device are the same.
1. 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.
1. Fundamental technology: The TCAT® TKA Instrument Tray and the predicate device allow the sterilant (steam) to penetrate and render its contents sterile by relving on surface perforations.

The following tables provide a comparison of technological characteristics between the subject device and the predicate device (Table 4) and a summary of non-clinical performance testing (Table 5).

| Characteristic | TCAT® TKA Instrument
Tray
(Subject Device) | TCAT® TKA Instrument
Tray Set (Predicate
Device) | Comparison |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K203468 | K200632 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| 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. | 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. | Same |
| Intended
Instrument Tray
Set Contents
Maximum Load | Medical devices/
instruments weighing no
less than 11.0lbs-24.0lbs.
total including the weight of
the trays. | Medical devices/
instruments weighing no
less than 14.21lbs-14.39lbs.
total including the weight of
the trays. | Similar |
| Characteristic | TCAT® TKA Instrument
(Subject Device) | TCAT® TKA Instrument
Tray Set (Predicate Device) | Comparison |
| 510(k) number | K203468 | K200632 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Intended
Instrument Tray
Contents | TCAT® General
Instrument, Tools and
Accessories:
Instruments, tools and
accessories intended for
general use with the
TCAT® Total Knee
Application.

TCAT® TKA Instruments,
Tools and Accessories:
Instruments, tools and
accessories intended for
use with the TCAT®
TSolution One® Total
Knee Application. | TCAT® General
Instrument, Tools and
Accessories:
Instruments, tools and
accessories intended for
general use with the
TCAT® Total Knee
Application.

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

8

9

Non-Clinical Performance Testing

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

Sterilization Efficacy .
Shipping/Packaging .
. Handle Strength Testing
Verification of Instrument Tray Product Requirements by Inspection and Analysis .
. Verification of Instrument Tray Product Requirements by Lab Test

Table 5: Summary of Non-Clinical Performance Testing

Non-Clinical	Purpose	Results
Performance Testing
Sterilization Efficacy	To verify the sterilization efficacy, the TCAT® TKA
Instrument Tray contained the maximum load and was
inoculated with biological indicators placed in areas of
the tray deemed to be most difficult for sterilant
(steam) to penetrate. Following inoculation, the tray
was wrapped in an FDA-cleared sterilization wrap. The
results indicated that the BI Overkill method provided a
six-log reduction of the indicator organism.

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 | The TCAT® TKA Instrument Tray was evaluated with
maximum load and configured in the shipping
configuration according to a shipping validation test.
The results indicate packaging requirements were met.

Standard Followed: ASTM D4169-16, Standard
Practice for Performance Testing of Shipping
Containers and Systems | PASS |

10

| Non-Clinical

Performance Testing	Purpose	Results
Handle Strength
Testing	The TCAT® TKA Instrument Tray handle strength was
evaluated.

Standard Followed: ASTM ST77:2013, Containment
Devices for Reusable Medical Device Sterilization | PASS |
| Verification of
Instrument Tray
Product Requirements
by Inspection and
Analysis | The method of verification was to visually inspect
the instrument tray per specifications and inspect and
analyze documents listed in the protocol to identify the
design outputs. The design outputs were then verified
against corresponding product requirements.

Standard Followed:
THINK Surgical developed specification | PASS |
| Verification of
Instrument Tray
Product Requirements
by Lab Test | The method of verification was physical, non-
destructive testing of the instrument tray to verify
design outputs against corresponding product
requirements.

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.