(88 days)
Not Found
No
The summary describes a robotic system for surgical assistance based on pre-operative planning and optical tracking, without mentioning any AI or ML components for image analysis, decision support, or robotic control.
No.
The device is a robotic system intended to assist surgeons in total knee replacement surgery by providing guidance for accurate placement of knee implant components, not to directly treat a disease or condition itself.
No
Explanation: The device is a robotic surgical system designed to assist surgeons during total knee replacement surgery by providing guidance for accurate implant placement. It uses preoperative CT scans for planning but does not diagnose conditions or diseases. Instead, it aids in the surgical treatment.
No
The device description explicitly states that the system includes a handheld robotic device, an optical sensor navigation system and accessories, and surgical instruments and accessories, in addition to the software system. This indicates it is a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TMINI™ Miniature Robotic System is a stereotaxic instrumentation system for total knee replacement surgery. Its purpose is to assist the surgeon in the surgical procedure itself by providing guidance and spatial boundaries for implant placement.
- Device Description: The description details a robotic system, navigation console, planning workstation, and surgical instruments. These are all tools used during a surgical procedure.
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis on biological specimens. It interacts directly with the patient's bone during surgery.
The device is a surgical robotic system designed to aid in the execution of a surgical procedure, not to perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
Intended Use: TMINI 1.1 like the predicate, the 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: 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. It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
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.
It includes a handheld robotic device, an optical sensor navigation system and accessories, surgical instruments and accessories.
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 Klassic® Knee System
- United® U2™ Knee Total Knee System
Product codes
OLO
Device Description
The TMINI 1.1 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.
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 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 quides 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based surgical planning tools.
CT images used to create a 3D model of the bone for surgical planning
Anatomical Site
Knee for total knee replacement (TKA) surgery. Specific mentions of femur and tibia.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Orthopedic procedures
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 cutting accuracy 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 TMINI™ Miniature Robotic System (TMINI 1.1) met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
Key results:
- Full System Run Through Testing: Passed
- Cutting Accuracy - Pin & Block Placement Accuracy - Cadaver Lab Validation Testing: Passed
- System Gap Balance Accuracy: Passed qualitative surgeon assessment testing; Passed quantitative measurement accuracy testing
- User Needs Validation Testing: Passed
- Usability Testing: Passed
- Software Testing: Passed
- Biocompatibility Testing: Cytotoxicity - Passed; Sensitization - Passed; Intracutaneous Reactivity - Passed; Acute Systemic Toxicity - Passed; Pyrogenicity - Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Performance is reported as "Passed" for various tests.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2024
Think Surgical, Inc. Meliha Mulalic Vice President. OA/RA 47201 Lakeview Blvd Fremont, California 94538
Re: K241031
Trade/Device Name: TMINI Miniature Robotic System (TMINI 1.1) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 10, 2024 Received: May 13, 2024
Dear Meliha Mulalic:
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 Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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 QS 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).
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 (OS) 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.
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 by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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
2
Indications for Use
510(k) Number (if known) K241031
Device Name TMINI™ Miniature Robotic System (TMINI 1.1)
Indications for Use (Describe)
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. It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.
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.
It includes a handheld robotic device, an optical sensor navigation system and accessories, surgical instruments and accessories.
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 Klassic® Knee System
- · United® U2™ Knee Total Knee System
| 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
Image /page/3/Picture/0 description: The image shows the logo for Think Surgical. The logo features a blue sphere with a white reflection at the top, resembling a stylized "T". Below the sphere, the word "THINK" is written in bold, black capital letters, with the "I" replaced by a blue, downward-pointing triangle. Underneath "THINK", the word "SURGICAL" is written in smaller, gray capital letters.
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: | Meliha Mulalic |
| Date Prepared: | 15 April 2024 |
| Device Information: |
| Device Classification: | Class II |
|---|---|
| Trade Name: | TMINITM 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 (TMINI 1.1) 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 K232802.
Device Modification:
The purpose of this submission is to introduce a series of incremental modifications to the TMINI™ Miniature Robotic System to enhance efficiency, consistency and ease of use.
Device Description:
The TMINI 1.1 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.
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
4
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 teardrop shape. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The trademark symbol is located in the upper right corner of the teardrop shape, and the registered trademark symbol is located in the upper right corner of the word "THINK".
model to optimally place the implant. The surgeon reviews and approves the case plan 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 quides 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 1.1 like the predicate, the 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 (TMINI 1.1) 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 system 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 or testing, 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 (TMINI 1.1) to the predicate, TMINI™ Miniature Robotic System cleared via K232802.
5
Image /page/5/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 surgical instrument. Below the 'T', the word 'THINK' is written in bold, sans-serif font, with the 'I' replaced by a blue, needle-like shape. Underneath 'THINK', the word 'SURGICAL' is written in smaller, sans-serif font.
| | TMINI™ Miniature Robotic
| TMINI™ Miniature Robotic
| |
|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Product | System (TMINI 1.1) | System | Conclusion |
| 510(k) number | Subject Device | K232802 | SAME |
| Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | SAME |
| 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.
It includes a handheld robotic
device, an optical sensor
navigation system and
accessories, software system,
surgical instruments and
accessories.
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 | 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.
It includes a handheld robotic
device, an optical sensor
navigation system and
accessories, software system,
surgical instruments and
accessories.
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 | SAME |
| Product | TMINI™ Miniature Robotic System (TMINI 1.1) | TMINI™ Miniature Robotic System | Conclusion |
| | indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System | indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System | |
| Product | TMINI™ Miniature
Robotic System (TMIN
1.1) | TMINI™ Miniature
Robotic System | Substantial
Equivalence
Conclusion |
| 510(k) number
Manufacturer | Subject Device
THINK Surgical Inc. | K232802
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 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 | SAME |
| -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 |
| -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
patient bone registration | Preoperatively determined
landmarks are compared to
intraoperatively identified
landmarks to complete
patient bone registration | SAME |
| -Camera Tracking
Technology | Six camera overhead
tracking with a wide-angle
field of view | Six camera overhead
tracking with a wide-angle
field of view | SAME |
| -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
adjusted along bone axis
only, preserving the
intended implant positioning
philosophy | Substantially
Equivalent |
| Product | TMINI™ Miniature
Robotic System (TMIN
1.1) | TMINI™ Miniature
Robotic System | Substantial
Equivalence
Conclusion |
| 510(k) number | Subject Device | K232802 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| -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
achievable angle between
the medial and lateral
compartments in degrees
with the knee in extension
and in flexion allowing the
surgeon to perform gap
balancing, if desired. | Substantially
Equivalent |
| -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 |
| -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 | - Enovis™ EMPOWR Knee
System®
-Ortho Development®
BKS® and BKS TriMax®
Knee System
-Total Joint Orthopedics
Klassic® Knee System
-United® U2™ Knee
System | SAME |
| Performance Testing
-Full System Run
Through Testing | Passed | Passed | SAME |
| Cutting Accuracy
-Pin & Block Placement
Accuracy
-Cadaver Lab Validation
Testing | Passed | Passed | Substantially
Equivalent |
| -System Gap Balance
Accuracy | Passed qualitative
surgeon assessment
testing
Passed quantitative
measurement accuracy
testing | Passed qualitative
surgeon assessment
testing | |
| -User Needs Validation
Testing | Passed | Passed | SAME |
| -Usability Testing | Passed | Passed | SAME |
| -Software Testing | Passed | Passed | SAME |
| Product | TMINI™ Miniature
Robotic System (TMIN
1.1) | TMINI™ Miniature
Robotic System | Substantial
Equivalence
Conclusion |
| 510(k) number | Subject Device | K232802 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| *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 |
Table 1: Comparison of Intended Use and Indications for Use
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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" in blue, with a sphere behind it. Below the "T" is the word "THINK" in black, with the "I" replaced by a thin blue line extending from the "T" above. Underneath "THINK" is the word "SURGICAL" in a smaller font, also in black.
Substantial Equivalence:
Both the TMINI™ Miniature Robotic System (TMIN 1.1), 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 that 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 TMINI™ 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 (TMINI 1.1) 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 system to enhance system efficiency, consistency and ease of use.
Performance testing to verify the cutting accuracy 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 TMINI™ Miniature Robotic System (TMINI 1.1) met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
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 TMINI 1.1 modifications included in this submission; therefore, no additional biocompatibility testing was required.
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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue circle behind it, forming the top part of the 'T'. Below the 'T', the word 'THINK' is written in bold, sans-serif font, and below that, the word 'SURGICAL' is written in a smaller, sans-serif font.
TMINI™ Miniature Robotic System (TMINI 1.1) Traditional 510(k) Submission
Substantial equivalence in technological characteristic and performance of the TMINI™ Miniature Robotic System to the predicate device is outlined in Table-2 below:
Table-2: Substantial Equivalence
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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 circular shape at the top, resembling a head. Below the 'T', the word 'THINK' is written in bold, sans-serif font. Underneath 'THINK', the word 'SURGICAL' is written in a smaller, sans-serif font.
TMINI™ Miniature Robotic System (TMINI 1.1) Traditional 510(k) Submission
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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, block letters below it. The "I" in "THINK" is stylized to look like a surgical instrument. Below "THINK" is the word "SURGICAL" in smaller, gray letters.
- There are no material changes to any of the direct patient contact components of the TMINI™ Miniature Robotic System as a result of TMINI 1.1 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 evaluate the impact of the change. Risk analysis resulted in the identification of new instance of risks; 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 K232802.
Conclusion
The TMINI™ Miniature Robotic System (TMINI 1.1) is substantially equivalent to the predicate, TMINI™ Miniature Robotic System (K232802), 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 (TMINI 1.1) 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 TMINI™ Miniature Robotic System (TMINI 1.1) to the legally marketed TMINI™ Miniature Robotic System cleared via K232802.