Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a robotic surgical system for hip arthroplasty that uses diagnostic images for planning and execution. It mentions software for planning and a robotic arm for implementation. There is no mention of AI, ML, deep learning, or any related terms in the intended use, device description, or performance studies. The focus is on precise implementation of a pre-surgical plan, which is characteristic of traditional robotic systems, not necessarily AI/ML-driven ones.

Therapeutic

Yes
The device is described as a surgical system, including a robotic surgical tool used for bone preparation in total hip arthroplasty, indicating it is directly involved in treatment.

Diagnostic

No

Explanation: The device is described as a surgical system for presurgical planning and intraoperative procedures, explicitly stating it "uses diagnostic images" but does not perform the diagnostic function itself. It's an implementation tool, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of both the TPLAN™ Preoperative Planning Workstation (software) and TCAT™, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories. This indicates it is a hardware and software system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The TCAT™/TPLAN™ Surgical System is a surgical planning and implementation tool. It uses diagnostic images (like CT scans) of the patient's anatomy in situ to plan and execute a surgical procedure (total hip arthroplasty). It does not analyze biological specimens.
Intended Use: The intended use is for presurgical planning and intraoperative guidance during a surgical procedure, not for analyzing samples outside the body.

Therefore, the TCAT™/TPLAN™ Surgical System falls under the category of a surgical device or system, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The TCAT™/TPLAN™ Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presuraical software plan,

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The TCAT™/TPLAN™ Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Product codes

OJP, HAW

Device Description

The TCAT™ TPLAN™ Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, and reaming techniques for the preparation of bone for patients requiring a THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™ , a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision bone preparation possible before and during THA surgical procedures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT Scan

Anatomical Site

femoral canal (for primary total hip arthroplasty (THA))

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician / 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)

Bench and simulated use tests included functional software testing for the TPLAN™ Surgical Planning Workstation hardware, software, and user interface, and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument /tools for the TCAT™/TPLAN™ Surgical System.

The TCAT™ Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements:

TPLAN™/TCAT™ host computer and operating system .
TPLAN™/TCAT™ Graphical User Interface .
TPLAN™/TCAT™ Software Architecture .
. TPLAN™ addition of CT file complete/size check
TPLAN™ CT Slice Region of Interest .
TCAT™ Electromechanical Arm .
TCAT™ Base Hardware .
TCAT™ Bearing Sleeve .
. TPLAN™/TCAT™ elimination of pin patient/robot registration
. TCAT™ Two-Pin Registration Recovery
TCAT™ Percutaneous Probe .
. Change of TCAT™ Irrigation Set Length and Manufacturer
TCAT™ Monitor Drape .

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

Not Found

Predicate Device(s)

K072629

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2014

Curexo Technology Corporation % Mr. Glen Emelock 32 Harrison Street Melrose, Massachusetts 02176

Re: K140585

Trade/Device Name: TCAT™/TPLANTM Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OJP, HAW Dated: July 17, 2014 Received: July 21, 2014

Dear Mr. Emelock:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

K140585 510(k) Number:

Device Name: TCAT™/TPLAN™ Surgical System

Indications For Use:

The TCAT™/TPLAN™ Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The TCAT™/TPLANTMSurgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

AND/OR

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-C
(21 CFR §

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

TCAT™/TPLANTM

Page 1 of 1

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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter Name: Submitter Address : Contact Person: Phone Number: Fax Number: Date Prepared: Device Trade Name: Device Common Name: Classification Name: Requlation Number: Predicate device: Reason for submission:
Curexo Technology Corp. 47320 Mission Falls Court Fremont. CA 94539 Glen Emelock (510) 249-2300 (510) 249-2396 March, 2014 TCAT™/TPLAN™ Surgical System Stereotaxic Instrument Orthopedic Computer Controlled Surgical System, OJP, HAW 21 CFR 882.4560 DigiMatch™ ROBODOC® Surgical System, K072629 Not previously marketed in the USA

Device Description:

The TCAT™ TPLAN™ Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, and reaming techniques for the preparation of bone for patients requiring a THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™ , a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision bone preparation possible before and during THA surgical procedures..

Intended Use:

The TCAT™/TPLAN™ Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presuraical software plan,

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

The TCAT™/TPLAN™ Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.

Predicate Device:

The TCAT™/TPLAN™ Surgical System is substantially equivalent to the DigiMatch™ ROBODOC® Surgical System, K072629.

Comparison of Technological Characteristics and Principles of Operation:

The TCAT™/TPLAN™ Surgical System is similar to the legally marketed device listed previously in that they share the same intended use and indications, technological characteristics, principles of operation and performance data as the predicate device.

Table 1 provides a comparison of technological characteristics and principles of operation between the TCAT™/TPLAN™ Surgical System and its predicate device.

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	Table 1: Comparison of Technological Characteristics and Principles of Operation

| Device | Patient Image Data | Presurgical
Plan | Surgical
Plan Data | Machine
Instructions | Patient/Robot
Registration
Requirement | Robot
Electromechanical
Arm |
|-------------------------------------------|--------------------|---------------------|-----------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| DigiMatch™
ROBODOC®
Surgical System | Yes, CT Scan | Yes,
Presurgery | Yes, high
level
operative
plan | Yes, Robotic
Arm driven
by validated
control
software and
hardware | Yes, point to
surface
registration | Yes, robot with
single
electromechanical
arm and end
effector implement
control file
instructions |
| TCAT™/TPLAN™
Surgical System | Yes, CT Scan | Yes,
Presurgery | Yes, high
level
operative
plan | Yes, Robotic
Arm driven
by validated
control
software and
hardware | Yes, point to
surface
registration | Yes, robot with
single
electromechanical
arm and end
effector implement
control file
instructions |

Any minor differences between the TCAT™/TPLAN™Surgical System and its predicate device raise no new questions of safety or effectiveness nor change the device's intended therapeutic effect in comparison to its predicate.

Performance Data:

The TCAT™ Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements:

TPLAN™/TCAT™ host computer and operating system .
TPLAN™/TCAT™ Graphical User Interface .
TPLAN™/TCAT™ Software Architecture .
. TPLAN™ addition of CT file complete/size check
TPLAN™ CT Slice Region of Interest .
TCAT™ Electromechanical Arm .
TCAT™ Base Hardware .
TCAT™ Bearing Sleeve .
. TPLAN™/TCAT™ elimination of pin patient/robot registration
. TCAT™ Two-Pin Registration Recovery
TCAT™ Percutaneous Probe .
. Change of TCAT™ Irrigation Set Length and Manufacturer
TCAT™ Monitor Drape .

Bench and simulated use tests included functional software testing for the TPLAN™ Surgical Planning Workstation hardware, software, and user interface, and hardware, functional software, user interface, instrument/tool and sterile disposable accessory testing and simulated clinical use of new and changed instrument /tools for the TCAT™/TPLAN™ Surgical System.

Conclusions

In conclusion, based on the intended use, indications for use, technological characteristics and performance data the TCAT™TPLAN™ Surgical is substantially equivalent (SE) to the DigiMatch™ ROBODOC® Surgical System, K072629 predicate device.