(49 days)
Not Found
No
The summary describes a robotic surgical system for stereotactic guidance based on CT data and pre-surgical planning. While it uses software-defined spatial boundaries and is described as an "intelligent" tool holder, there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on stereotactic guidance and robotic assistance, not on AI-driven analysis or decision-making.
No.
The device assists the surgeon during orthopedic procedures by providing spatial boundaries and navigation, but it does not directly treat a disease or condition itself.
No
The Mako System is described as a surgical assistance system that provides guidance for orthopedic procedures, specifically for assisting surgeons with pre-surgical planning, implant placement, and intraoperative navigation using patient CT data. It does not mention diagnosing medical conditions or diseases.
No
The device description explicitly lists multiple hardware components including a robotic arm, integrated cutting system, optical detector, computer, and dedicated instrumentation, in addition to the software.
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 Mako System is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries, orientation, and reference information to anatomical structures. This is a surgical guidance and assistance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a stereotactic instrument with a robotic arm, cutting system, optical detector, computer, etc., used for surgical procedures. It focuses on assisting with pre-surgical planning, implant placement, and intraoperative navigation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The Mako System is a surgical robotic system designed to aid surgeons in performing orthopedic procedures. It falls under the category of surgical instruments or systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Make System 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 · Total Hip Arthroplasty (THA)
Product codes
OLO
Device Description
The Mako System with the Total Hip Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.
The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.
The Mako 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 and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
| Validation / Verification Method | Purpose | Validation / Verification Results |
|---|---|---|
| Product Specification Verification | Verify that THA fields and values implemented into the eRequest application must match the THA Product Specifications. | Pass |
| eRequest – Full System Run Through for THA Application | Verify the integration of the eRequest Lifecycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow | Pass |
| eRequest LifeCycle THA Validation | Validate in a simulated-use environment, with appropriate user, that the implementation of eRequest LifeCycle into the Mako System provides adequate functionality to successfully complete the pre-operative workflow and satisfies the customer requirements. | Pass |
Conclusions: Performance testing has demonstrated that the characteristics of the Mako Total Hip Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.
Key Metrics
Not Found
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
April 18, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mako Surgical Corp. Shikha Khandelwal Staff Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317
Re: K170593
Trade/Device Name: Mako Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 30, 2017 Received: March 31, 2017
Dear Shikha Khandelwal:
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-
Image /page/0/Picture/10 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
1
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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Mako Total Hip Application
Indications for Use (Describe)
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Make System 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
· Total Hip Arthroplasty (THA)
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized blue arc above the word "MAKO" in bold, black letters. Below "MAKO" is the text "SURGICAL CORP" in smaller, black letters, with a registered trademark symbol to the right.
55 Davie Road • Ft. Lauderdale, FL 3331 7.2044 • Fax 954.927.04 ww.makosuraical.com
K170593 - Page 1 of 3
510(K) SUMMARY
Sponsor:
MAKO Surgical Corp. 2555 Davie Road Fort Lauderdale, FL 33317
Contact Person:
Shikha Khandelwal, PhD Shikha.khandelwal@stryker.com Phone: 201-831-6921 Fax: 201-831-3921
Date Prepared: February 24, 2017
Proprietary Name: Mako Total Hip Application
Common Name: Total Hip Application (THA)
Regulation Name: Stereotaxic Instrument
Regulation Number: 21 CFR 882.4560
Device Classification: Class II
Product Code: OLO
Substantial Equivalence Claimed To:
The Mako Total Hip Application is substantially equivalent to Mako Surgical's Total Hip Application cleared via K141989.
Device Modification: An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning phase of the Mako Total Hip Application.
Description:
The Mako System with the Total Hip Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.
4
The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.
The Mako 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 the Mako Total Hip Application compared to the predicate device are listed below:
| Technological
Characteristics | Mako Total Hip Application | Mako Total Hip Application
(K141989) |
|----------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Major
Components | Guidance Module, robotic arm,
camera stand, cutting system,
preoperative planning laptop. | Guidance Module, robotic arm,
camera stand, cutting system,
preoperative planning laptop. |
| Tools/accessories | Various reusable and disposable
instruments | Various reusable and disposable
instruments |
| Image Use | CT | CT |
Intended Use/Indications for Use:
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical knee and hip procedures in which the use of stereotactic surgery mav 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
- Total Hip Arthroplasty (THA) .
Performance Data:
| Validation / Verification
Method | Purpose | Validation / Verification
Results |
|---------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Specification
Verification | Verify that THA fields and
values implemented into
the eRequest application
must match the THA | Pass |
5
| Product Specifications. | ||
|---|---|---|
| eRequest – Full System | ||
| Run Through for THA | ||
| Application | Verify the integration of | |
| the eRequest Lifecycle | ||
| into the Mako System | ||
| provides adequate | ||
| functionality to | ||
| successfully complete the | ||
| pre-operative planning | ||
| workflow | Pass | |
| eRequest LifeCycle THA | ||
| Validation | Validate in a simulated- | |
| use environment, with | ||
| appropriate user, that the | ||
| implementation of | ||
| eRequest LifeCycle into | ||
| the Mako System provides | ||
| adequate functionality to | ||
| successfully complete the | ||
| pre-operative workflow | ||
| and satisfies the customer | ||
| requirements. | Pass |
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the Mako Total Hip Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.