(82 days)
Not Found
No
The summary describes a stereotactic surgical system with a robotic arm and software for pre-surgical planning and intraoperative guidance based on CT data. While it uses the term "intelligent" tool holder, the description focuses on software-defined spatial boundaries and haptic guidance, which are characteristic of robotic-assisted surgery systems, not necessarily AI/ML. There is no mention of AI, ML, deep learning, or any related concepts, nor is there a description of training or test sets typically associated with AI/ML model development.
No
The device is a stereotactic instrument that assists the surgeon during orthopedic procedures by providing guidance and information, but it does not directly treat a disease or condition. Its purpose is to aid in the accurate placement of orthopedic implants.
No
The device is intended to assist the surgeon in providing spatial boundaries and navigation during orthopedic procedures, not to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components including a robotic arm, integrated cutting system, optical detector, computer, dedicated instrumentation, planning laptop, and tools and accessories.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Mako System's Function: The Mako System is a surgical robotic system used during orthopedic procedures to assist the surgeon with planning, navigation, and preparing the anatomical site. It works directly on the patient's body, not on specimens taken from the body.
- 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 details a robotic arm, cutting system, optical detector, computer, etc., all components used in a surgical setting.
The Mako System is a surgical assistance device, not a diagnostic device that analyzes samples outside the body.
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 Mako System is indicated for use in a surgical hip procedure 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:
· Total Hip Arthroplasty (THA)
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Mako System with the subject 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/haptic 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.
Once configured for a specific application, the Mako robotic arm 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
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical procedure
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)
Performance Data - The Mako System has been evaluated through the following non-clinical performance testing:
- Software testing
- Instrument performance testing
- Mako Total Hip Application full system run through
- Bone registration accuracy verification
- Implant models and visuals verification
- Full system cadaver validation
- Biocompatibility verification
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application are equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2020
Mako Surgical Corp. Liza Gordillo Senior Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317
Re: K193128
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: November 8, 2019 Received: November 12, 2019
Dear Liza Gordillo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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 Mako System is indicated for use in a surgical hip procedure 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:
· 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)
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Image /page/3/Picture/1 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 stylized wave or mountain range.
555 Davie Road · Ft. Lauderdale, FL 33317 927.2044 • Fax 954.927.0446 ww.makosurgical.com
510(k) SUMMARY
| Sponsor: | Mako Surgical Corp.
2555 Davie Road,
Fort Lauderdale, FL 33317 |
|------------------------|----------------------------------------------------------------------|
| Contact Person: | Liza Gordillo
liza.gordillo@stryker.com
Phone: 954-628-0802 |
| Date Prepared: | November 8, 2019 |
| Proprietary Name: | Mako Total Hip Application |
| Common Name: | Total Hip Application (THA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR Section 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |
Substantial Equivalence Claimed To:
The subject device, the Mako Total Hip Application, is substantially equivalent to the predicate device, the Mako Total Hip Application cleared via K191998.
Device Modification:
The following changes have been made to the Mako Total Hip Application:
For clarity, reference to surgical knee procedures, including the unicondylar knee replacement and/or patellofemoral knee replacement indication, will be removed from the Mako Total Hip Application Indications for Use.
The MAKO Total Hip Application is being modified to integrate the Direct Superior (DS) approach, add compatibility with additional acetabular implants, enhance implant planning and pelvic registration, implement new features to facilitate user experience, update the starting software interface, and add additional instrumentation.
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Description:
The Mako System with the subject 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/haptic 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.
Once configured for a specific application, the Mako robotic arm 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.
| | Technological
Characteristics | Mako Total Hip Application | Mako Total Hip Application
(K191998) |
|--|----------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | 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 |
CT
Summary of Technological Characteristics Compared to Predicate Devices:
The technological characteristics of the Mako Total Hip Application compared to the
Intended Use/Indications for Use:
Image 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.
CT
The Mako System is indicated for use in a surgical hip procedure 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:
• Total Hip Arthroplasty (THA)
Performance Data - The Mako System has been evaluated through the following non-clinical performance testing:
5
- Software testing ●
- Instrument performance testing ●
- Mako Total Hip Application full system run through ●
- Bone registration accuracy verification
- . Implant models and visuals verification
- Full system cadaver validation ●
- Biocompatibility verification .
Conclusions of Performance Testing:
Performance testing has demonstrated that the characteristics of the subject Mako Total Hip Application are equivalent to the predicate device. The device is also as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness. Therefore, the performance testing supports a determination of Substantial Equivalence.