(88 days)
Not Found
No
The summary describes a robotic arm for surgical guidance based on CT data and software-defined boundaries, but does not mention AI or ML. The term "intelligent" is used in a general sense to describe the robotic arm's function as a tool holder/guide within defined constraints, not necessarily implying AI/ML capabilities.
No.
The Robotic Arm Interactive Orthopedic System (RIO) is described as assisting the surgeon during orthopedic procedures by providing spatial boundaries for orientation and reference information and stereotactic guidance. It serves as an "intelligent" tool holder or guide, passively constraining the preparation of an anatomical site. This indicates it is a surgical tool and navigation system, not a device directly applying therapy to a patient.
No
Explanation: The device is described as an assistive tool for surgeons during orthopedic procedures, providing guidance and spatial boundaries, rather than diagnosing conditions. Its primary function is therapeutic/interventional support rather than diagnostic imaging or analysis.
No
The device description explicitly lists multiple hardware components including an optical detector, computer, dedicated instrumentation, drill system, and a robotic arm, in addition to the operating software.
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 used during orthopedic procedures (knee and hip replacement). It assists the surgeon with planning and navigation based on patient CT data and provides physical guidance through a robotic arm.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The system relies on imaging data (CT) and physical interaction with the patient's anatomy during surgery.
Therefore, the RIO system falls under the category of a surgical guidance or robotic-assisted surgical 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
- Acetabular reaming during total hip arthoplasty (THA)
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The main 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 hip procedures (per RIO-Hip 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. The 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, hospital setting
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-Hip using sawbone models to evaluate setup, reqistration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA. Further testing was performed with RIO-Hip using cadaveric material where postoperative 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-Hip to the predicate devices.
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.
K083644, K081867, K010602, K040368, K052213, K072716, K022364
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/2 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized shark fin above the word "MAKO" in a bold, sans-serif font. Below "MAKO" is the text "SURGICAL CORP." in a smaller, sans-serif font.
Page 1 of 2
lori lauderdale, flonda 33317 2555 davie road tel 954 927 2044 fax 954.927.0446_
510(K) SUMMARY
Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Device Trade Name: Regulation Number: Regulation Name: Requiatory Class: Product Code:
MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL, 33317 954-927-2044 x 605 954-927-0446 William F. Tapia June 30, 2009 Robotic Arm Interactive Orthopedic System - Hip (RIO - Hip) 21 CFR 882.4560 Stereotaxic Instrument Class II OLO
Substantial Equivalence Claimed To: RIO – Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081867), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364).
Description: The main 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 hip procedures (per RIO-Hip 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. The 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-Hip compared to the predicate devices are listed below:
| Technological
Characteristics | RIO-Hip | Tactile Guidance System
(K083644, K081867) | Brainlab Vectorvision
(VV)
(K010602, K040368,
K052213, K072716) | Orthosoft Navitrack
System - Total Hip
Replacement
(K022364) |
|----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| 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 |
| 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 |
| Images Use | CT | CT | CT, CT-free | CT |
Performance Data:
System level verification testing was performed in the laboratory with RIO-Hip using sawbone models to evaluate setup, reqistration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA. Further testing was performed with RIO-Hip using cadaveric material where postoperative 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-Hip to the predicate devices.
1
Image /page/1/Picture/0 description: The image contains the text "K091998" underlined at the top left, and the text "Page 2 of 2" underlined at the top right. In the center of the image is the MAKO Surgical Corp. logo. The logo is a stylized arrow pointing upwards above the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters below.
| 2555 Davie Road | Fort Lauderdale, Florida 33317 | tel: 954.587.2044 | fax: 954.587.3475 |
|---|---|---|---|
| ----------------- | -------------------------------- | ------------------- | ------------------- |
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
- Acetabular reaming during total hip arthoplasty (THA) o
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.
SEP 28 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MAKO Surgical Corporation % Mr. William F. Tapia Director, Regulatory Affairs 2555 Davie Road Ft. Lauderdale, Florida 33317
Re: K091998
Trade/Device Name: RIO-Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: September 2, 2009 Received: September 3, 2009
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 Eederal Regulations Title 21 Barts 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
3
Page 2 - Mr. William F. Tapia
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/ucm111800 html 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 Port 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/cdrl/mdr/ 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 tolling the (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millhiser
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kc. 9 1998
2555 davie road fort lauderdale, florida 33317 lel 954.927.2044 fax 954 927.0446
EXHIBIT 1
INDICATIONS FOR USE
510(k) Number (if known): K091998
Device Name: RIO-Hip
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 an probedures can be identified relative to a CT based model of the anatomy. These procedures include:
- Unicondylar knee replacement and/or patellofemoral knee replacement o
- 0 Acetabular reaming during total hip arthoplasty (THA)
Prescription Use _ X
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)
Neil R. Graham
(Division Sign Off)
ion of Surgical, Orthopedic, Restorative Device
510(k) Number K091998