(113 days)
No
The summary describes a robotic surgical system that uses CT data for planning and navigation, and a robotic arm for passive constraint. While it uses the term "intelligent" tool holder, the description focuses on software-defined spatial boundaries and stereotactic guidance based on pre-operative CT data, which are characteristic of traditional computer-assisted surgery systems, not AI/ML. There is no mention of AI, ML, deep learning, or training/test sets for such algorithms.
No.
The Robotic Arm Interactive Orthopedic System (RIO) is a surgical assistance system designed to help surgeons with precision during orthopedic procedures, not to directly treat or cure a disease.
No
Explanation: The device is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries and navigation, and serving as a tool holder/guide during surgery. Its function is to aid in the surgical procedure, not to diagnose a condition.
No
The device description explicitly lists multiple hardware components including an optical detector, computer, dedicated instrumentation, drill system, and a robotic arm.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Robotic Arm Interactive Orthopedic System (RIO) is a surgical guidance system. It assists surgeons during orthopedic procedures by providing spatial boundaries and reference information based on CT scans of the patient's anatomy. It is used during surgery, not for testing samples outside the body.
- Intended Use: The intended use clearly states it is for assisting surgeons during orthopedic procedures (knee and hip replacement).
- Device Description: The description details a robotic arm, optical detector, computer, and software used for surgical guidance and tool holding/guiding. There is no mention of analyzing biological samples.
Therefore, the RIO system falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 RIO is indicated for use in surgical knee and hip 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 o
- Total hip arthroplasty (THA) o
Product codes
OLO
Device Description
The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: knee procedures (per the predicate device K081867) and THA procedures (per RIO-THA described in this 510(k) submission). 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 (knee or hip), 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, Hip
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)
System level verification testing was performed in the laboratory with RIO-THA using sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting THA. Further testing was performed with RIO-THA using cadaveric material where post-operative x-rays were obtained and evaluated in order to validate the system's intended use. The results of these tests satisfied all required acceptance criteria and were found to support substantial equivalence of the RIO-THA to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091998, K081867, K010602, K040368, K052213, K072716, K022364, K050615, K022365
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
FEB 2 4 2010
Image /page/0/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles an abstract shape. At the top of the image, the text "K093425" is written in handwriting.
Page 1 of 2
2555 davie road fort lauderdale, florida 33317 tel 954.927.2044
fax 954.927.044
EXHIBIT 2 510(K) SUMMARY
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| Phone number: |
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| Date Prepared: |
| Device Trade Name: |
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MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL. 33317 954-927-2044 x 605 954-927-0446 William F. Tapia November 1, 2009 Robotic Arm Interactive Orthopedic System - THA (RIO - THA) 21 CFR 882.4560 Stereotaxic Instrument Class II OLO
Substantial Equivalence Claimed To: RIO - THA is substantially equivalent to MAKO Surgical's RIO -Hip (K091998), Tactile Guidance System v2.0 (a.k.a. RIO, K081867), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716), Orthosoft's Navitrack System – Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K050615) and Stryker's Navigation System-Hip Module (K022365).
Description: The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: knee procedures (per the predicate device K081867) and THA procedures (per RIO-THA described in this 510(k) submission). 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 (knee or hip), 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 RIO-THA compared to the predicate devices are listed below:
| Technological
Characteristics | RIO-THA | RIO (K081867), RIO-Hip
(K091998) | Brainlab Vectorvision (VV)
(K010602, K040368,
K052213, K072716) | Orthosoft Navitrack System –
Total Hip Replacement
(K022364) | Stryker Navigation
System-Hip Module
(K050615, K022365) |
|----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------|
| Major
Components | Guidance Module,
robotic arm, camera
stand, drill system | Guidance Module, robotic
arm, camera stand, drill
system | Available in several different
configurations (VV-Compact,
VV-Sky, VV-2) | Computer cart, camera stand | Computer cart,
camera stand |
| Tools/accessories | Various probes, arrays
tracked by optical
camera | Various probes, arrays
tracked by optical camera | Various probes, arrays tracked
by optical camera | Various probes, arrays tracked
by optical camera | Various probes, arrays
tracked by optical
camera |
| Images Use | CT | CT | CT, CT-free | CT | CT |
Performance Data:
System level verification testing was performed in the laboratory with RIO-THA using sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting THA. Further testing was performed with RIO-THA using cadaveric material where post-operative x-rays were obtained and evaluated in order to validate the system's intended use. The results of these tests satisfied all required acceptance criteria and were found to support substantial equivalence of the RIO-THA to the predicate devices.
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Image /page/1/Picture/0 description: This image contains the logo for MAKO Surgical Corp, along with the text 'K093425' and 'Page 2 of 2'. The image also contains the address '2555 davie road fort lauderdale, florida 33317' and the phone and fax numbers 'tel 954.927.2044' and 'fax 954.927.0446' respectively. The logo is a stylized 'MAKO' with the words 'SURGICAL CORP.' underneath.
Intended Use/Indications for Use:
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 RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic r no no 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 o
- Total hip arthroplasty (THA) o
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around the perimeter. In the center is a stylized image of a bird-like figure, possibly representing an eagle, with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB 2 4 2010
Mako Surgical Corp. % Mr. William F. Tapia Director, Regulatory Affairs 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K093425
Trade/Device Name: Robotic Arm Interactive System - THA Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2010 Received: January 25, 2010
Dear Mr. Tapia:
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
3
Page 2 - Mr. William F. Tapia
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word MAKO is a stylized arrow pointing upwards. At the top of the image is the text "Co 93425".
2555 davie road fort lauderdale, florida 33317 tel 954.927.2044
fax 954 927 0446
EXHIBIT 1
INDICATIONS FOR USE
510(k) Number (if known): K093425
Device Name: RIO-THA
Indications for Use:
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 RIO is indicated for use in surgical knee and hip 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 0
- Total hip arthroplasty (THA) 0
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × OR
Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter Thoms
(Division Sign-Off) Division of Survical, Orthopedic, and Restorative Devices
510(k) Number /093428