(72 days)
Not Found
No
The summary describes a stereotactic surgical system that uses CT data for pre-surgical planning and intraoperative navigation with a robotic arm. While it mentions the robotic arm as an "intelligent" tool holder, the description focuses on software-defined spatial boundaries and stereotactic guidance based on a CT model, not on learning or adaptive algorithms characteristic of AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No.
The device is intended to assist the surgeon during orthopedic procedures by providing spatial boundaries and stereotactic guidance, and aiding with pre-surgical planning and implant placement, rather than directly treating a disease or condition.
No
Explanation: The device is indicated for use in surgical knee procedures to assist the surgeon, not to diagnose a condition. It provides guidance and planning based on CT data, but its primary function is surgical assistance, not diagnosis.
No
The device description explicitly states that the Mako System with the Partial Knee Application includes hardware components such as a robotic arm, an integrated cutting system, an optical detector, a 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:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mako System with the Partial Knee Application is a surgical guidance system. It assists surgeons during orthopedic procedures by providing stereotactic guidance based on patient CT data. It is used during surgery to help with planning, implant placement, and navigation of anatomical structures.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. Its function is to provide spatial information and guidance during a surgical procedure.
Therefore, the device's intended use and function clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Partial Knee Application (PKA), for use with the Mako System, is intended to assist the surgeon in providing software defined spatial boundaries for orientation to anatomical structures during orthopedic procedures.
The Partial Knee Application (PKA), for use with the Mako System, 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Mako System with the Partial Knee 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Product Specification Verification: Verify that PKA fields and values implemented into the eRequest application must match the THA Product Specifications. Result: Pass
eRequest - Full System Run Through for PKA Application: Verify the integration of the eRequest Lifecycle into the Mako System provides adequate functionality to successfully complete the pre-operative planning workflow. Result: Pass
eRequest LifeCycle PKA 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. Result: Pass
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
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
May 11, 2017
Re: K170584
Trade/Device Name: Mako Partial Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 27, 2017 Received: February 28, 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
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
Partial Knee Application
Indications for Use (Describe)
The Partial Knee Application (PKA), for use with the Mako System, is intended to assist the surgeon in providing software defined spatial boundaries for orientation to anatomical structures during orthopedic procedures.
The Partial Knee Application (PKA), for use with the Mako System, 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.
| 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)
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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 an arc.
55 Davie Road · Ft. Lauderdale, FL 3 2044 · Fax 954.927.0 ww.makosuraical.com
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 Partial Knee Application
Common Name: Partial Knee Application (PKA)
Regulation Name: Stereotaxic Instrument
Regulation Number: 21 CFR 882.4560
Device Classification: Class II
Product Code: OLO
Substantial Equivalence Claimed To:
The Mako Partial Knee Application is substantially equivalent to Mako Surgical's Partial Knee Application cleared via K112507.
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 Partial Knee Application.
Description:
The Mako System with the Partial Knee 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 Partial Knee Application compared to the predicate device are listed below:
| Technological
Characteristics | Mako Partial Knee Application | Mako Partial Knee Application
(K112507) |
|----------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 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 Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Mako System, 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.
Performance Data:
| Validation / Verification
Method | Purpose | Validation / Verification
Results |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Specification
Verification | Verify that PKA fields and
values implemented into
the eRequest application
must match the THA
Product Specifications. | Pass |
| eRequest - Full System | Verify the integration of | Pass |
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| Run Through for PKA
Application | the eRequest Lifecycle
into the Mako System
provides adequate
functionality to
successfully complete the
pre-operative planning
workflow | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| eRequest LifeCycle PKA
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 Partial Knee 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.
Image /page/5/Picture/3 description: The image shows a light blue, abstract shape against a white background. The shape is curved and tapers at both ends, resembling a stylized wing or a swooping arc. The color is a soft, pastel blue, and the overall impression is minimalist and clean.