(192 days)
Not Found
No
The description mentions "software-defined spatial boundaries" and an "intelligent" tool holder, but these terms, in this context, likely refer to programmed constraints and automated functions based on pre-defined rules and CT data, not adaptive learning or pattern recognition characteristic of AI/ML. There is no mention of AI, ML, or related concepts like training or test sets for model development.
No.
This device is described as a surgical guidance system intended to assist surgeons with orientation and reference information during hip procedures, not to provide therapy itself. It facilitates the surgeon's work and precision during a therapeutic procedure (total hip arthroplasty), but it does not directly apply a therapeutic effect to the patient.
No
The device is described as a stereotaxic instrument and a robotic arm intended to assist surgeons with "software defined spatial boundaries for orientation and reference information to anatomical structures" and "stereotactic guidance during minimally invasive orthopedic surgical procedures." It uses patient CT data for "presurgical planning and interpretive navigation." This indicates it is a surgical guidance or navigation system, not a device that diagnoses a disease or condition.
No
The device description explicitly states that the TGS - Hip includes hardware components such as an optical detector, computer, dedicated instrumentation, tools and accessories, and a robotic arm. It is not solely 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 Tactile Guidance System - Hip is a surgical navigation and guidance system used during orthopedic procedures. It assists the surgeon with spatial orientation and reference information based on pre-operative CT data. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for assisting the surgeon during surgical hip procedures.
- Device Description: The description details a stereotaxic instrument with an optical detector, computer, robotic arm, etc., all used for surgical guidance, not laboratory testing of samples.
Therefore, the device 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 Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System - Hip is indicated for use in surgical 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: Acetabular reaming during total hip arthoplasty (THA)
Product codes
HAW, OLO
Device Description
The TGS - Hip is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. The TGS – Hip is enabled for use in conjunction with a 30 party drill system (e.g., Stryker drill system) in order to support the surgeon's preparation of the acetabulum during total hip arthroplasty. The TGS – Hip uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS - Hip robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS - Hip robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as burrs and reamers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Hip (acetabulum, anatomical bony structures)
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)
System level verification testing was performed in the laboratory with TGS-Hip using sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA. Further testing was performed with TGS-Hip using cadaveric material where postoperative x-rays/CT scans 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 TGS-Hip to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072806, K010602, K040368, K052213, K072716, K022364
Reference Device(s)
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
083644
JUN 19 2009
fort lauderdale_florida 33317 fəx 954.927 0446 tel 954,927 2044 2555 davie road
EXHIBIT 9 510(K) SUMMARY
Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Device Trade Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:
MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL, 33317 954-927-2044 x 605 954-927-0446 William F. Tapia December 5, 2008 Tactile Guidance System - Hip (TGS - Hip) 21 CFR 882.4560 Stereotaxic Instrument Class II HAW
Substantial Equivalence Claimed To: The TGS – Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364).
Description: The TGS - Hip is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. The TGS – Hip is enabled for use in conjunction with a 30 party drill system (e.g., Stryker drill system) in order to support the surgeon's preparation of the acetabulum during total hip arthroplasty. The TGS – Hip uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS - Hip robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS - Hip robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as burrs and reamers.
Summary of Technological Characteristics Compared to Predicate Devices:
The technological characteristics of the TGS-Hip compared to the predicate devices is listed below.
| Technological Characteristics | TGS-Hip | Brainlab Vectorvision (VV)
Hip | Orthosoft Navitrack
System - Total Hip
Replacement |
|-------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------|
| Major Components | Guidance Module, robotic
arm, camera stand | 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 |
| Images Use | CT | CT, CT-free | CT |
Performance Data:
System level verification testing was performed in the laboratory with TGS-Hip using sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA. Further testing was performed with TGS-Hip using cadaveric material where postoperative x-rays/CT scans 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 TGS-Hip to the predicate devices.
Intended Use/Indications for Use: The Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical
1
K0Y3644
Image /page/1/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, 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 a wave or a fin, adding a visual element to the logo.
255 davie road
2555 davie road
fax 954 927 4
structures during orthopedic procedures. The Tactile Guidance System - Hip is indicated for use in Stravaros dailing of thopours procedures. In the reserv 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:
Acetabular reaming during total hip arthoplasty (THA) ்
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.
Public Health Service
JUN 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mako Surgical Corporation % Mr. William F. Tapia Director, Regulatory Affairs 2555 Davie Road Davie, Florida 33317
Re: K083644
Trade/Device Name: Tactile Guidance System - Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: May 28, 2009 Received: June 2, 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, listing 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 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-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/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/cdrh/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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address 1 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Per
Per
Per D.N
Per
Mark N. Melkersony Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
683644
Image /page/4/Picture/1 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 graphic that resembles a shark fin or a mountain peak. The logo is simple and modern, and it conveys a sense of strength and precision.
fort lauderdale, florida 33317 tel 954.927.2044 fax 954.927.0446 2555 davie road
INDICATIONS FOR USE
510(k) Number (if known): K083644
Device Name: Tactile Guidance System - Hip
Indications for Use:
The Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Tactile Guidance System - Hip is indicated for use in surgical 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: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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)
Nil keogh for mxm
(Division Sign Off)
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083644