(59 days)
Yes
The document explicitly states that the TPLAN® Planning Station component has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model.
No.
The device is a surgical assistance system that helps surgeons accurately place knee implant components, but it does not directly treat a disease or condition itself.
No
The TMINI® Miniature Robotic System is described as a stereotaxic instrumentation system that assists surgeons in total knee replacement (TKR) surgery by providing guidance and preparing bone for implant components. While it uses preoperative CT scans for planning and referencing anatomical structures, its primary function is surgical assistance and guidance (therapy/surgical planning), not diagnosing a medical condition.
No
The device description explicitly states that the system consists of three primary components: a Preoperative Planning Workstation (software), an Optical Tracking Navigation Console (likely hardware and software), and a robotically controlled hand-held tool (hardware and software). This indicates the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TMINI® Miniature Robotic System is a surgical guidance system used during total knee replacement surgery. It assists the surgeon in planning and executing bone preparation and implant placement based on pre-operative imaging and intraoperative tracking.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely focused on surgical planning and execution within the body.
- Input: The primary input is CT scans, which are imaging data, not biological specimens for in vitro analysis.
- Output: The output is guidance and assistance for the surgeon during the surgical procedure, not diagnostic information derived from specimen analysis.
While the device uses pre-operative imaging and incorporates a machine learning algorithm for image segmentation, these are tools used to facilitate the surgical procedure, not to perform in vitro diagnostic testing on biological samples.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
TMIN® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMNI® Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications:
- · Enovis™ EMPOWR Knee System®
- · Ortho Development® BKS® and BKS TriMax® Knee System
- · Total Joint Orthopedics Klassic® Knee System
- · United® U2™ Total Knee System
- · Medacta® GMK® Sphere / SpheriKA Knee Systems
- · Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- · Maxx Orthopedics Freedom® Total & Titan Knee
- · LINK® LinkSymphoKnee System
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The TMINI® Miniature Robotic System like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical. Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. In addition, this submission will add a web-based method for surgeons to review, approve and download approved surgical plans generated on the TPLAN Planning Station.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.
Mentions image processing
Yes
Mentions AI, DNN, or ML
The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity.
Input Imaging Modality
CT based surgical planning tools, CT scans
Anatomical Site
Knee, femoral bone, tibial bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, 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)
Performance testing to verify the function of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TMIN® Miniature Robotic System (TPLAN Planning Station and TCM) met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted and all test criteria were met.
Full System Run Through Testing: Passed
Cutting Accuracy Pin & Block Placement Accuracy Cadaver Lab Validation Testing System Gap Balance Accuracy: Passed
User Needs Validation Testing: Passed
Usability Testing: Passed
Software Testing: Passed
Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity): Passed
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.
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.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
January 6, 2025
THINK Surgical, Inc. Denise Duchene Director, Regulatory Affairs 47201 Lakeview Blvd Fremont, California 94538
Re: K243481
Trade/Device Name: TMINI Miniature Robotic System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 7, 2024 Received: November 8, 2024
Dear Denise Duchene:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243481
Device Name TMINI® Miniature Robotic System
Indications for Use (Describe)
TMIN® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMNI® Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications:
- · Enovis™ EMPOWR Knee System®
- · Ortho Development® BKS® and BKS TriMax® Knee System
- · Total Joint Orthopedics Klassic® Knee System
- · United® U2™ Total Knee System
- · Medacta® GMK® Sphere / SpheriKA Knee Systems
- · Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- · Maxx Orthopedics Freedom® Total & Titan Knee
- · LINK® LinkSymphoKnee System
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| 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 logo features the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, three-dimensional sphere with a white "T" shape on it. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
510(k) SUMMARY
Applicant Information:
| Owner Name: | THINK Surgical, Inc. |
|---|---|
| Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Phone number: | 408-921-5648 |
| Fax number: | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | Denise Duchene |
| Date Prepared: | 15 November 2024 |
| Device Information: |
| Device Classification: | Class II |
|---|---|
| Trade Name: | TMINI® Miniature Robotic System |
| Common name: | Orthopedic Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Regulation number: | 882.4560 |
| Product Code: | OLO |
Predicate Device:
The TMINI® Miniature Robotic System (TPLAN® Planning Station and THINK Case Manager (TCM)) is substantially equivalent in intended use. Indications for Use, design. materials, technology, operational principles and performance to the predicate, TMINI® Miniature Robotic System, cleared via K243285.
Device Modification:
The purpose of this submission is to introduce modifications to the TPLAN Planning station used with the TMIN® Miniature Robotic System to enhance efficiency and consistency. The TPLAN® Planning Station component of the TMINI® Miniature Robotic System has been modified to improve the segmentation algorithm using a pre-trained and closed machine learning model during the development, enhance DICOM data importing, update the implant display and selection tools, and improve cybersecurity. In addition, we have added the THINK Case Manager (TCM) as a remote method for surgeon review, approval and downloading of approved surgical plans.
Device Description:
The TMINI® Miniature Robotic System like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical. Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that
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Image /page/5/Picture/1 description: The image is a logo for Think Surgical. The logo features a blue circle with a white "T" inside of it. The word "THINK" is written in bold, black letters below the circle. The word "SURGICAL" is written in smaller, black letters below the word "THINK".
assists the surgeon in preparing the bone for implantation of TKA components. In addition, this submission will add a web-based method for surgeons to review, approve and download approved surgical plans generated on the TPLAN Planning Station.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively.
Intended Use:
The TMINI System (TPLAN Planning Station and TCM) like the predicate TMINI Miniature Robotic System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use:
The Indications for Use of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) and the predicate are the same (See Table 1), Both describe the use of a system that uses diagnostic imaging of the patient to allow a surgeon to plan and execute orthopedic total knee procedures. The only difference is that the device, that is the subject of this 510(k) submission, implements a series of incremental modifications to the TPLAN Planning Station and introduces a web-based method for surgeon review, approval and download of surqical plans to enhance system efficiency, consistency and ease of use.
None of the changes made to the predicate, nor the aggregate of all changes, have altered the indications for use, nor have they raised new type of safety or effectiveness questions.
Tables 1 and 2, below identify the substantial equivalence of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) to the predicate, TMINI® Miniature Robotic System cleared via K243285.
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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue sphere at the top and a blue triangle extending downwards. Below the 'T', the word 'THINK' is written in a bold, sans-serif font, and below that, the word 'SURGICAL' is written in a smaller, sans-serif font.
| Product | TMINI® Miniature Robotic
System (TPLAN Planning
Station and TCM) | TMINI® Miniature Robotic
System | Conclusion |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) number | K243481 | K243285 | |
| Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | |
| Product Code | OLO | OLO | SAME |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | SAME |
| Intended Use | Intended to assist the surgeon
in providing software defined
spatial boundaries for
orientation and reference
information to anatomical
structures during orthopedic
procedures. | Intended to assist the surgeon
in providing software defined
spatial boundaries for
orientation and reference
information to anatomical
structures during orthopedic
procedures. | SAME |
| Indications for Use | The TMINI® Miniature Robotic
System is indicated as a
stereotaxic instrumentation
system for total knee
replacement (TKA) surgery. It is
to assist the surgeon by
providing software-defined
spatial boundaries for
orientation and reference
information to identifiable
anatomical structures for the
accurate placement of knee
implant components.
The robotic device placement is
performed relative to
anatomical landmarks as
recorded using the system
intraoperatively and based on a
surgical plan-determined
preoperatively using CT based
surgical planning tools.
The targeted population has the
same characteristics as the
population that is suitable for
the implant(s) compatible with
the TMINI® Miniature Robotic
System.
The TMINI® Miniature Robotic
System is to be used with the
following knee replacement
system(s) in accordance with
the indications and
contraindications:
- Enovis™ EMPOWR Knee
System® - Ortho Development BKS®
and BKS TriMax® Knee
System
Total Joint Orthopedics | The TMINI® Miniature Robotic
System is indicated as a
stereotaxic instrumentation
system for total knee
replacement (TKA) surgery. It is
to assist the surgeon by
providing software-defined
spatial boundaries for
orientation and reference
information to identifiable
anatomical structures for the
accurate placement of knee
implant components.
The robotic device placement is
performed relative to
anatomical landmarks as
recorded using the system
intraoperatively and based on a
surgical plan-determined
preoperatively using CT based
surgical planning tools.
The targeted population has the
same characteristics as the
population that is suitable for
the implant(s) compatible with
the TMINI® Miniature Robotic
System.
The TMINI® Miniature Robotic
System is to be used with the
following knee replacement
system(s) in accordance with
the indications and
contraindications: - Enovis™ EMPOWR Knee
System® - Ortho Development BKS®
and BKS TriMax® Knee
System - Total Joint Orthopedics | SAME |
| Product | TMINI® Miniature Robotic
System (TPLAN Planning
Station and TCM) | TMINI® Miniature Robotic
System | Conclusion |
| | - United U2™ Knee Total
Knee System - Medacta® GMK® Sphere /
SpheriKA Knee Systems - Zimmer Biomet Anterior &
Posterior Referencing - Persona® Knee
- b-ONE MOBIO® Total
Knee System - Maxx Orthopedics
- Freedom® Total & Titan
Knee - LINK® LinkSymphoKnee
System | - United U2™ Knee Total
Knee System - Medacta® GMK® Sphere /
SpheriKA Knee Systems - Zimmer Biomet Anterior &
Posterior Referencing - Persona® Knee
- b-ONE MOBIO® Total
Knee System - Maxx Orthopedics
- Freedom® Total & Titan
Knee - LINK® LinkSymphoKnee
System | |
Table 1: Comparison of Intended Use and Indications for Use
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Image /page/7/Picture/0 description: The image is a logo for "Think Surgical". The logo features a stylized letter "T" with a blue sphere at the top, resembling a head. The word "THINK" is written in bold, dark gray letters below the "T", and the word "SURGICAL" is written in smaller letters below "THINK".
Substantial Equivalence:
Both the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM), the subject of this submission, and the predicate device have the same intended use. Both are indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components during orthopedic procedures.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The difference between the new device and the predicate is that the new device incorporates a series of incremental changes to the TPLAN Planning Station component and adds a web-based tool for review of surgical plans to enhance system efficiency, consistency and ease of use. None of these changes either individually or in the aggregate alter the intended use, Indications for Use, design, materials, technology, or operational principles of the TMIN® Miniature Robotic System and no new questions of safety or effectiveness resulted from the changes.
The Indications for Use of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) and the predicate are the same (See Table 1). Both describe the use of a system that uses diagnostic imaging of the patient to allow a surgeon to plan and execute orthopedic total knee procedures. The only difference is that the device, that is the subject of the 510(k) submission, implements a series of incremental modifications to the TPLAN Planning Station and add a web-based application for review, approval and download of approved surgical plans to enhance system efficiency, consistency and ease of use.
Performance testing to verify the function of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TMIN® Miniature Robotic System (TPLAN Planning Station and TCM) met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted and all test criteria were met.
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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue sphere at the top, resembling a head. Below the 'T', the word 'THINK' is written in bold, sans-serif font, with the 'I' replaced by a blue, elongated triangle pointing downwards. Underneath 'THINK', the word 'SURGICAL' is written in a smaller, sans-serif font.
Biocompatibility information for patient contacting materials and testing for the TMINI® Miniature Robotic System were presented in predicate device submission K232802. There are no material changes to any of the direct patient contact components of the TMINI® Miniature Robotic System as a result of TPLAN Planning Station and TCM modifications included in this submission; therefore, no additional biocompatibility testing was required.
Substantial equivalence in technological characteristic and performance of the TMINI® Miniature Robotic System to the predicate device is outlined in Table-2 below:
| Product | TMINI® Miniature Robotic
System (TPLAN Planning
Station and TCM) | TMINI® Miniature Robotic
System | Conclusion |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510(k) number | K243481 | K243285 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Materials | | | |
| Materials Used | Uses materials with a long
history of use in orthopedic
procedures or provided
biocompatibility data
consistent with ISO 10993
requirements | Uses materials with a long
history of use in orthopedic
procedures or provided
biocompatibility data
consistent with ISO 10993
requirements | SAME |
| Technological
Characteristics | | | |
| Major System Components | Planning, web-based plan
review, and robot control
software, robotic positioning
device, navigation system,
reusable and disposable
instrumentation | Planning and robot control
software, robotic positioning
device, navigation system,
reusable and disposable
instrumentation | Substantially
equivalent |
| Patient Imaging | CT images used to create a
3D model of the bone for
surgical planning | CT images used to create a
3D model of the bone for
surgical planning | SAME |
| Preoperative planning workstation | TPLAN three-dimensional
preoperative planning
workstation | TPLAN three-dimensional
preoperative planning
workstation | SAME |
| Surgical planning system | Technician guided surgical
planning with surgeon
review and approval on a
desktop planning station | Technician guided surgical
planning with surgeon
review and approval on a
desktop planning station | SAME |
| Surgical planning review, approval, and approved plan export or download | Performed by surgeon on
either the TPLAN Planning
Station or the THINK Case
Manager (TCM) | Performed by the surgeon
on the TPLAN Planning
Station | Substantially
equivalent |
| Bone Marker Arrays for bone registration and tracking | Active markers on femur
and tibia mounted onto the
bones via an attachment
assembly | Active markers on femur
and tibia mounted onto the
bones via an attachment
assembly | SAME |
| Surgical Exposure | Similar to traditional surgical
exposure | Similar to traditional surgical
exposure | SAME |
| Patient/Robot Registration | Preoperatively determined
landmarks are compared to
intraoperatively identified
landmarks to complete | Preoperatively determined
landmarks are compared to
intraoperatively identified
landmarks to complete | SAME |
Table-2: Substantial Equivalence
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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The logo features a blue circle with a white "T" inside, and the word "THINK" in black, sans-serif font below the circle. The word "SURGICAL" is in smaller, gray, sans-serif font below the word "THINK".
| | Product | TMINI® Miniature Robotic
System (TPLAN Planning
Station and TCM) | TMINI® Miniature Robotic
System | Conclusion |
|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | 510(k) number | K243481 | K243285 | |
| | Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| ● | Camera Tracking | Six camera overhead | Six camera overhead | SAME |
| | Technology | tracking with a wide-angle
field of view | tracking with a wide-angle
field of view | |
| ● | Cut guide
positioning | Robotic device places bone
pins in the correct plane,
then cutguide or drill block is
attached to the pins and
bone | Robotic device places bone
pins in the correct plane,
then cutguide or drill block is
attached to the pins and
bone | SAME |
| ● | Intraoperative
planning changes | Implant position can be fully
adjusted, allowing deviation
from the intended implant
positioning philosophy and
implant size | Implant position can be fully
adjusted, allowing deviation
from the intended implant
positioning philosophy and
implant size | SAME |
| ● | Bone Preparation
Technique | A surgical saw is used to cut
the bone through a cut
guide | A surgical saw is used to cut
the bone through a cut
guide | SAME |
| ● | Intraoperative
Anatomic
Measurements | The tracked bone arrays
and bone registration data
are used to determine the
knee flexion angle and
varus/valgus laxity | The tracked bone arrays
and bone registration data
are used to determine the
knee flexion angle and
varus/valgus laxity | SAME |
| ● | Gap Balancing | Displays the maximum
space in the medial and
lateral compartments in
millimeters with the knee in
extension and in flexion
allowing the surgeon to
perform gap balancing, if
desired | Displays the maximum
space in the medial and
lateral compartments in
millimeters with the knee in
extension and in flexion
allowing the surgeon to
perform gap balancing, if
desired | SAME |
| ● | TKA Component
Implantation
Technique | Implants are secured to the
bone, either with or without
cement using standard
surgical technique provided
by the implant manufacturer | Implants are secured to the
bone, either with or without
cement using standard
surgical technique provided
by the implant manufacturer | SAME |
| Product | TMINI® Miniature Robotic
System (TPLAN Planning
Station and TCM) | TMINI® Miniature Robotic
System | Conclusion | |
| 510(k) number | K243481 | K243285 | | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | SAME | |
| Compatible Knee
Implant Systems | - Enovis™ EMPOWR
Knee System®
- Ortho Development®
BKS® and BKS TriMax®
Knee System - Total Joint Orthopedics
Klassic® Knee System - United® U2™ Knee
System - Medacta® GMK®
Sphere / SpheriKA
Knee Systems - Zimmer Biomet Anterior
& Posterior Referencing - Persona® Knee
- b-ONE MOBIO® Total
Knee System - Maxx Orthopedics
Freedom® Total &
Titan Knee - LINK®
- LinkSymphoKnee
System | - Enovis™ EMPOWR
Knee System® - Ortho Development®
BKS® and BKS TriMax®
Knee System - Total Joint Orthopedics
Klassic® Knee System - United® U2™ Knee
System - Medacta® GMK®
Sphere / SpheriKA
Knee Systems - Zimmer Biomet Anterior
& Posterior Referencing - Persona® Knee
- b-ONE MOBIO® Total
Knee System - Maxx Orthopedics
Freedom® Total &
Titan Knee - LINK®
- LinkSymphoKnee
System | SAME | |
| Performance Testing | | | | |
| Full System Run
Through Testing | Passed | Passed | SAME | |
| Cutting Accuracy
Pin & Block
Placement
Accuracy
Cadaver Lab
Validation Testing
System Gap
Balance Accuracy | Passed | Passed | SAME | |
| User Needs Validation
Testing | Passed | Passed | SAME | |
| Usability Testing | Passed | Passed | SAME | |
| Software Testing | Passed | Passed | SAME | |
| *Biocompatibility
Testing | | | | |
| Cytotoxicity | *Passed | Passed | SAME | |
| Sensitization | *Passed | Passed | SAME | |
| Intracutaneous
Reactivity | *Passed | Passed | SAME | |
| Acute Systemic
Toxicity | *Passed | Passed | SAME | |
| Pyrogenicity | *Passed | Passed | SAME | |
10
Image /page/10/Picture/0 description: The image shows the logo for Think Surgical. The logo features a blue sphere with a white reflection on top, resembling a stylized "T". Below the sphere, the word "THINK" is written in a bold, sans-serif font, with the "I" replaced by a thin, vertical line that extends upwards to touch the sphere. Below the word "THINK", the word "SURGICAL" is written in a smaller, sans-serif font.
- There are no material changes to any of the direct patient contact components of the TMIN® Miniature Robotic System as a result of TPLAN Planning Station and TCM modifications included in this submission; therefore, no additional biocompatibility testing was required.
Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. Each change was assessed separately and in the aggregate through risk analysis and appropriate performance testing to
11
Image /page/11/Picture/0 description: The image shows the logo for Think Surgical. The logo features the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, downward-pointing triangle. Above the word "THINK" is a blue circle with a white highlight, and the letters "TM" are to the right of the circle.
evaluate the impact of the change. Risk analysis resulted in the identification of new instances of risk; however, no new clinical hazards were identified, and no new questions of safety or effectiveness were identified as a result of these changes. The risks identified have been mitigated to acceptable levels and there is no change in the overall risk profile of the device compared to the predicate cleared in K243285.
Conclusion
The TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) is substantially equivalent to the predicate, TMIN® Miniature Robotic System (K243285), in the following ways:
- it has the same intended use,
- . it has the same Indication for Use,
- it has the same technological characteristics and operating principles and . incorporates the same design and materials.
Performance testing and risk analysis has demonstrated that the performance and risk profile of the TMINI® Miniature Robotic System (TPLAN Planning Station and TCM) is substantially equivalent to that of the predicate device and does not raise any new question of safety and effectiveness.
THINK Surgical Inc. respectfully submits that this filing contains adequate information and data to demonstrate the substantial equivalence of the TMIN® Miniature Robotic System (TPLAN Planning Station and TCM) to the legally marketed TMINI® Miniature Robotic System cleared via K243285.