(38 days)
No
The summary describes an image-guided surgical system with an electromechanical arm for tactile guidance. It mentions using CT data for planning and navigation and software-defined spatial boundaries. There is no mention of AI, ML, deep learning, or any related concepts in the device description, intended use, or the specific sections for AI/ML information. The description of the TGS as "intelligent" appears to refer to its software-controlled constraints rather than AI/ML capabilities.
No
The device is an image-guided surgical device intended for presurgical planning and intraoperative guidance, assisting the physician in performing surgical procedures but not directly providing therapy itself.
Yes
The device uses diagnostic images (CT scans) to assist with presurgical planning and intra-operative navigation, which are activities directly related to diagnosis and treatment guidance.
No
The device description explicitly states that the system includes hardware components such as an optical detector, computer, dedicated instrumentation, tools and accessories, and an electromechanical arm (TGS).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Voyager/Tactile Guidance System - CT is an image-guided surgical device. Its primary function is to assist physicians with presurgical planning and provide intra-operative guidance using patient CT data. It helps the surgeon navigate and prepare anatomical sites during surgery.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the patient. It works directly with imaging data and provides physical guidance during a surgical procedure.
Therefore, the device's intended use and description clearly place it outside the scope of In Vitro Diagnostics. It is a surgical guidance system.
N/A
Intended Use / Indications for Use
The Voyager/Tactile Guidance System - CT is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Voyager/Tactile Guidance System - CT is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
- ENT Procedures
- Orthopedic surgical procedure
Product codes
HAW
Device Description
The VoyagerTactile Guidance System - CT is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. VoyagerTactile Guidance System - CT uses patient CT data to assist the physician with presurgical planning and interpretive/intraoperative navigation. The TGS, which is an add-on to the Voyager platform, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the TGS and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 3ª party drill systems.
The Voyager/Tactile Guidance System - CT consists of the following basic components:
- High Resolution color liquid crystal display (LCD) touch screen monitor .
- . Uninterruptible Power Supply (UPS)
- . Central Processing Unit (CPU)
- Isolation Transformer ●
- Keyboard and Mouse .
- Optical Detector
- . Operating Room Cart
- Tool and accessories -- surgical and TGS tools and accessories including instrumentation with reflective . markers
- . TGS - connected to the Voyager platform to enable stereotactic guidance of standard surgical tools.
- Software application specific software provided as part of system or via standard media (e.g., CD-ROM) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Intra-cranial, Spinal, ENT, Orthopedic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 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 black graphic design. Above the graphic design is the text "K05-2851/".
Page 1 of 1
25.11 Samme Gueer
hollywood. Borida 33020
151954 927 2011
(2) 354.927 04:5
ATTACHMENT 12 510(K) SUMMARY
Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Cleared Device Trade Name: Modified Device Trade Name: Common Name: Classification Name: Classification #:
MAKO Surgical Corp. 2901 Simms Street, Hollywood, FL, 33020 954-927-2044 954-927-0446 William F. Tapia October 7, 2005 Voyager Linux with the Tactile Guidance System (TGS) Voyager/Tactile Guidance System - CT Stereotaxic Instrument Class II 21 CFR 882.4560
Substantial Equivalence Claimed To: Voyager Linux with the Tactile Guidance System (TGS) as described in MAKO Surgical Corp.'s K050973. The modification to add CT capability is shown to be substantially equivalent to the previously cleared system. As required by risk analysis, all verification activities performed to date by designated individuals and the results demonstrated substantial equivalence.
Description: The VoyagerTactile Guidance System - CT is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. VoyagerTactile Guidance System - CT uses patient CT data to assist the physician with presurgical planning and interpretive/intraoperative navigation. The TGS, which is an add-on to the Voyager platform, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the TGS and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 3ª party drill systems.
Summary of Technological Characteristics: The Voyager/Tactile Guidance System - CT consists of the following basic components:
- High Resolution color liquid crystal display (LCD) touch screen monitor .
- . Uninterruptible Power Supply (UPS)
- . Central Processing Unit (CPU)
- Isolation Transformer ●
- Keyboard and Mouse .
- Optical Detector �
- . Operating Room Cart
- Tool and accessories -- surgical and TGS tools and accessories including instrumentation with reflective . markers
- . TGS - connected to the Voyager platform to enable stereotactic guidance of standard surgical tools.
- Software application specific software provided as part of system or via standard media (e.g., CD-ROM) .
Intended Use: The Voyager/Tactile Guidance System - CT is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide oriedtion and reference information during intra-operative procedures.
The Voyager/Tactile Guidance System - CT is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anal mical stucture may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, o vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal o neoplasms
- ENT Procedures 0
- ಂ Orthopedic surgical procedure
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.
NOV 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
William F. Tapia Mako Surgical Corp. 2901 Simms Street Hollywood, Florida 33020
Re: K052851
Trade/Device Name: Voyager/Tactile Guidance System - CT Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 1, 2005 Received: November 14, 2005
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 such 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); 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.
2
Page 2- William F. Tapia
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark N Wilkerson
Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic that resembles a mountain peak or an abstract letter "A". There is also a handwritten annotation "K052851" above the logo.
2901_simmy street ==
101954.327.2044
for 354 927 0446
ATTACHMENT 10
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Voyager/Tactile Guidance System - CT
' Arwood, florida 'n car
Indications for Use:
The Voyager/Tactile Guidance System - CT is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Voyager/Tactile Guidance System - CT is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
- Intra-cranial surgical procedures involving space occupying lesions or matformations (including o soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of O spinal neoplasms
- ENT Procedures ಂ
- Orthopedic surgical procedures O
Prescription Use
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)
Mark A. Wilkerson
and Neu
510(k) Number K0528
Attachment 10 - 1