(29 days)
Not Found
No
The summary describes an image-guided surgical system that uses patient data for planning and navigation, but it does not mention any AI or ML components or capabilities. The "intelligent" tool holder refers to software-defined spatial boundaries, not AI/ML.
No
The device is intended for use in presurgical planning and providing intra-operative guidance, not for directly treating a disease or condition.
No
The device is described as an "image guided surgical device" intended for "presurgical planning" and "intra-operative procedures," which uses diagnostic images but does not itself produce a diagnosis.
No
The device description explicitly lists multiple hardware components including an optical detector, computer, dedicated instrumentation, operating room cart, and an electromechanical arm (TGS).
Based on the provided information, the Voyager Linux is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Voyager Linux Function: The Voyager Linux uses diagnostic images of the patient's anatomy and provides guidance during surgical procedures. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is for "presurgical planning and to provide orientation and reference information during intra-operative procedures," using diagnostic images.
- Device Description: The description focuses on components related to image-guided surgery, optical tracking, and mechanical guidance (TGS). There is no mention of analyzing biological samples.
Therefore, the Voyager Linux falls under the category of a surgical navigation or image-guided surgery system, not an IVD.
N/A
Intended Use / Indications for Use
The Voyager Linux 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 Linux 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 o soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of O spinal neoplasms
- ENT Procedures O
- Orthopedic surgical procedures O
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Voyager Linux is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. Voyager Linux uses patient data to assist the physician with presurgical planning and interpretive navigation. The TGS, which is an add-on to the Voyager Linux, 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 300 party drill systems.
Summary of Technological Characteristics - The Voyager Linux 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 tools and accessories instrumented with reflective markers. .
- TGS connected to the Voyager Linux 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
Diagnostic images of the patient acquired specifically
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): 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.
Voyager Linux; Z-KAT, Inc., K023975
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
Image /page/0/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. To the left of the logo is the text "K050973" with a line drawn underneath it.
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IMPORTANT
INSTRUCTIONS
- READ the entire label carefully.
- FOLLOW all directions and precautions.
- USE only as directed.
- STORE in original container.
- DISPOSE of empty container properly.
ATTACHMENT 17 - 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 April 15, 2005 Voyager Linux Voyager Linux with the Tactile Guidance System (TGS) Stereotaxic Instrument Class II 21 CFR 882.4560
Substantial Equivalence Claimed To: Voyager Linux; Z-KAT, Inc., K023975 The modification to the Voyager Linux to include the TGS is shown to be substantially equivalent to the cleared system in the previous 510k. As required by risk analysis, all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence.
Description: The Voyager Linux is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. Voyager Linux uses patient data to assist the physician with presurgical planning and interpretive navigation. The TGS, which is an add-on to the Voyager Linux, 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 300 party drill systems.
Summary of Technological Characteristics - The Voyager Linux 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 tools and accessories instrumented with reflective markers. .
- TGS connected to the Voyager Linux 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 Linux 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 Linux is indicated for any medical condition in which the use of stereofactic 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 o soft tissue, vascular and osseous)
- 0 Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
1
Image /page/1/Picture/0 description: The image shows the MAKO Surgical Corp. logo. 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, stylized graphic. The image also contains the number K050973 written in cursive.
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- o ENT Procedures
- Orthopedic surgical procedure o
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2005
Mr. William F. Tapia Director of Regulatory Affairs MAKO Surgical Corporation 2901 Simms Street Hollywood, Florida 33020
Re: K050973
Trade/Device Name: Voyager Linux Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 29, 2005 Received: May 4, 2005
Dear Mr. Tapia:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the energe, 1976, the enactment date of the Medical Device Amendments, or to coninered pror to that 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (110-) that the device, subject to the general controls provisions of the Act. The r our may, therefore, market are as 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 your device is easonned divinal controls. Existing major regulations affecting your device n may be subject to cash of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA our be found in the 'announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised hite i Drivision that your device complies with other requirements of the Act that I Drivias Intactions and regulations administered by other Federal agencies. You must or any I oderal station and sequirements, including, but not limited to: registration and listing (21 comply with an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set CI N Fart 807); and img (21 (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.
3
Page 2 – Mr. William F. Tapia
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin manxoning of substantial equivalence of your device to a legally premarket notification: "The PDs 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 If you uesn't specific davice 10. Jour as 10.1) 276-0115 . Also, please note the regulation entitled, comaci the Office of Complanes as (2 + t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Roh
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/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 shark fin or a curved blade. The graphic is black and appears to be slightly textured.
| 2018 Sinces | |
|---|---|
| ATTACHMENT 15 | |
| 1- 1 - 7 | INDICATIONS FOR USE |
510(k) Number (if known):
Device Name: Voyager Linux
Indications for Use:
The Voyager Linux 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 Linux 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 o soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of O spinal neoplasms
- ENT Procedures 0
- 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)
Signature
icrative
ological Devices
Attachment 15 - 1