(372 days)
Not Found
No
The description focuses on stereotactic guidance, pre-surgical planning, and intraoperative navigation based on CT data, with the robotic arm acting as an "intelligent" tool holder by passively constraining movement within software-defined boundaries. There is no mention of AI or ML algorithms being used for tasks like image analysis, decision support, or adaptive control.
No.
The device is a surgical assistance system that helps surgeons with spatial boundaries and navigation during orthopedic procedures, rather than directly treating a medical condition itself.
No
The device is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries and navigation, and it is indicated for use in surgical knee procedures. It does not diagnose conditions.
No
The device description explicitly states that the Partial Knee Application is used with the RIO system, which includes hardware components such as an optical detector, robotic arm, guidance module, computer, dedicated instrumentation, operating software, tools, accessories, and a cutting system. While the application itself is software, it is an integral part of a larger system that includes significant hardware.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Partial Knee Application (PKA) and the RIO system are used during surgical procedures to assist the surgeon with planning, navigation, and guiding tools based on pre-operative CT data of the patient's anatomy. They are not analyzing biological samples.
- Intended Use: The intended use clearly states it's for assisting the surgeon during orthopedic procedures and providing spatial boundaries and reference information to anatomical structures.
- Device Description: The description focuses on the hardware (robotic arm, optical detector, computer) and software used for surgical guidance and planning, not for analyzing biological specimens.
The device is a surgical guidance and assistance system, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
- Restoris Multicompartmental Knee System .
- Restoris Porous Partial Knee System ●
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.
RIO's robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical knee 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)
The Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:
- MICS Handpiece Functional Test: This verification test is intended to verify the MAKO Integrated Cutting System (MICS) requirements. Results: Pass.
- MICS Attachments Functional Test: This verification test is intended to verify that the straight sagittal saw blades met applicable specifications. Results: Pass.
- RIO Base Array Functional Test: This verification test is intended to verify that the Base Array assemblies when used with the Base Array Connector meet applicable specifications. Results: Pass.
- Bone Arrays and Clamps Functional Test: This verification test is intended to verify that the array movement is equal or less than the assembly requirement to a fixed position after cutting. Results: Pass.
- PKA Application Performance Test: This verification test is intended to verify that the real time performance of the PKA application met applicable specifications. Results: Pass.
- Disposable Cutter Strength Testing: This verification test is intended to verify that the narrow saw blades met applicable specifications. Results: Pass.
- Bone Mineral Density Application Functional Test: This verification test is intended to verify that the Bone Mineral Density function met applicable specifications. Results: Pass.
- Full System Run-through test: This verification test is intended to verify that the Partial Knee Application Software, and supporting instrumentation provides adequate functionality to be able to successfully complete a PKA. Results: Pass.
- System Accuracy Test: The purpose of this test is to determine the overall system accuracy as a result of bone registration and bone resection accuracy. This protocol will use the verification results obtained from bone registration verification test and bone resection test and combine these results using a statistical approach. Results: Pass.
- PKA System Validation with MCK Implant system: Validate in a simulated-use environment that the integration of the Robotic Arm Interactive Orthopedic System (RIO) with the Partial Knee Application Software, MCK implant system and supporting instrumentation provides adequate functionality to successfully complete a Partial Knee Arthroplasty procedure and satisfies the customer requirements. Results: Pass.
- PKA System Validation with Restoris Porous Implant system: Validate in a simulated-use environment that the integration of the Robotic Arm Interactive Orthopedic System (RIO) with the Partial Knee Application Software, Restoris implant system and supporting instrumentation provides adequate functionality to successfully complete a Partial Knee Arthroplasty procedure and satisfies the customer requirements.
Conclusions of Non-clinical Data: The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate device.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
MAKO Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K142530
Trade/Device Name: Partial Knee Application (PKA) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 8, 2015 Received: August 10, 2015
Dear Mr. Reeves:
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
Page 2 - Mr. Jonathan Reeves
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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142530
Device Name Partial Knee Application (PKA)
Indications for Use (Describe)
The Partial Knee Application (PK A), for use with the Robotic Arm Interactive Orthopedic System (RIO), is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
- · Restoris Multicompartmental Knee System
- · Restoris Porous Partial 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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See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below "MAKO" is the text "SURGICAL CORP" in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or a stylized mountain range.
555 Davie Road • Ft. Lauderdale, FL one 954.927.2044 • Fax 954.927.0 ww.makosurgical.com
510(K) SUMMARY
| Submitter: | MAKO Surgical Corp. |
|---|---|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number: | 954-628-0655 |
| Fax number: | 954-927-0446 |
| Contact Person: | Jonathan Reeves |
| Date Prepared: | Aug 29, 2014 |
| Device Trade Name: | Partial Knee Application (PKA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Primary Predicate Device:
Partial Knee Application is substantially equivalent to the following 510(k) cleared device:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RIO – PKA (Partial Knee Application) | MAKO Surgical | K112507 |
Additional Predicate Devices:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RIO - TKA (Total Knee Application) | MAKO Surgical | K143752 |
Device Modifications: The following modifications have been made to RIO Partial Knee Application:
- A power tool to perform the cutting for partial knee arthroplasty (MAKO ● Integrated Cutting System (MICS)) has been added to the system.
- Accessories (drills, burrs, blades and attachments) for the MICS cutting system have been added to the system
- A bone mineral density (BMD) phantom has been added to the system which ● allows the system to display the CT scan on a density scale in standard units. The BMD feature is intended to provide the surgeon with a means to assess bone density.
- . Instrumentation (arrays, bone pins, gap spoons) have been modified or added to the system to improve the usability of the system
- . The ability to implant the Restoris Porous implant system using the RIO system was added to the system.
- . Motorized tool alignment for the RIO setup has been added to the system to improve ease of use.
4
- Range of motion increase on RIO to improve ease of use. ●
Description: Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, cutting system, and a robotic arm. The system's architecture is designed to support partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.
RIO's robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.
| Summary of Technological Characteristics Compared to Predicate Devices: The | |
|---|---|
| technological characteristics of Partial Knee Application compared to the predicate | |
| device are listed below: |
| Technological
Characteristics | Partial Knee
Application | RIO-PKA
(K112507) | RIO-TKA
(K143752) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Major
Components | Guidance
Module, robotic
arm, camera
stand, cutting
system,
preoperative
planning laptop. | Guidance Module,
robotic arm, camera
stand, cutting system,
preoperative planning
laptop. | Guidance Module,
robotic arm, camera
stand, cutting
system,
preoperative
planning laptop. |
| Tools/accessori
es | Various reusable
instruments | Various reusable
instruments | Various reusable
instruments |
| Images Use | CT | CT | CT |
Intended Use/Indications for Use
The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in which the
5
use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
The Implant systems with which the system is compatible:
- Restoris Multicompartmental Knee System .
- Restoris Porous Partial Knee System ●
Performance Data:
The Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:
| Validation / Verification | Acceptance Criteria | Validation / Verification |
|---|---|---|
| Method | Results | |
| MICS Handpiece | ||
| Functional Test | This verification test is | |
| intended to verify the | ||
| MAKO Integrated Cutting | ||
| System (MICS) | ||
| requirements. | Pass | |
| MICS Attachments | ||
| Functional Test | This verification test is | |
| intended to verify that the | ||
| straight sagittal saw blades | ||
| met applicable | ||
| specifications. | Pass | |
| RIO Base Array Functional | ||
| Test | This verification test is | |
| intended to verify that the | ||
| Base Array assemblies | ||
| when used with the Base | ||
| Array Connector meet | ||
| applicable specifications. | Pass | |
| Bone Arrays and Clamps | ||
| Functional Test | This verification test is | |
| intended to verify that the | ||
| array movement is equal or | ||
| less than the assembly | ||
| requirement to a fixed | ||
| position after cutting. | Pass | |
| PKA Application | ||
| Performance Test | This verification test is | |
| intended to verify that the | ||
| real time performance of the | ||
| PKA application met | ||
| applicable specifications. | Pass | |
| Disposable Cutter Strength | ||
| Testing | This verification test is | |
| intended to verify that the | ||
| narrow saw blades met | Pass | |
| applicable specifications. | ||
| Bone Mineral Density | ||
| Application Functional Test | This verification test is | |
| intended to verify that the | ||
| Bone Mineral Density | ||
| function met applicable | ||
| specifications. | Pass | |
| Full System Run-through | ||
| test | This verification test is | |
| intended to verify that the | ||
| Partial Knee Application | ||
| Software, and supporting | ||
| instrumentation provides | ||
| adequate functionality to be | ||
| able to successfully | ||
| complete a PKA | Pass | |
| System Accuracy Test | The purpose of this test is to | |
| determine the overall | ||
| system accuracy as a result | ||
| of bone registration and | ||
| bone resection accuracy. | ||
| This protocol will use the | ||
| verification results obtained | ||
| from bone registration | ||
| verification test and bone | ||
| resection test and combine | ||
| these results using a | ||
| statistical approach. | Pass | |
| PKA System Validation | ||
| with MCK Implant system | Validate in a simulated-use | |
| environment that the | ||
| integration of the Robotic | ||
| Arm Interactive Orthopedic | ||
| System (RIO) with the | ||
| Partial Knee Application | ||
| Software, MCK implant | ||
| system and supporting | ||
| instrumentation provides | ||
| adequate functionality to | ||
| successfully complete a | ||
| Partial Knee Arthroplasty | ||
| procedure and satisfies the | ||
| customer requirements. | Pass | |
| PKA System Validation | ||
| with Restoris Porous | ||
| Implant system | Validate in a simulated-use | |
| environment that the | ||
| integration of the Robotic | ||
| Arm Interactive Orthopedic | ||
| System (RIO) with the | Pass | |
| Partial Knee Application | ||
| Software, Restoris implant | ||
| system and supporting | ||
| instrumentation provides | ||
| adequate functionality to | ||
| successfully complete a | ||
| Partial Knee Arthroplasty | ||
| procedure and satisfies the | ||
| customer requirements. |
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7
Conclusions of Non-clinical Data:
The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate device.
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