(18 days)
Not Found
No
The document describes image processing and navigation capabilities but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is used for pre-surgical planning and intra-operative navigation, assisting the physician but not directly treating the patient or restoring a function.
No
The device is an image-guided surgical device that uses diagnostic images for presurgical planning and intra-operative navigation, but it does not perform the diagnosis itself. Its intended use is to assist the physician during surgery, not to make a diagnosis.
No
The device description explicitly states that the Voyager System includes an optical detector (infrared sensor), computer, and dedicated instrumentation, in addition to operating software. This indicates it is a hardware and software system, not software-only.
Based on the provided information, the Voyager 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.
- Voyager's Function: The Voyager device uses diagnostic images (like CT or MRI scans) of the patient's anatomy to assist with surgical planning and navigation during surgery. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states its purpose is for presurgical planning and intra-operative guidance based on imaging data.
- Device Description: The description focuses on the hardware (optical detector, computer, instrumentation) and software used for image-guided surgery.
- Anatomical Site: The anatomical sites listed are areas of the body where surgery is performed, not where biological samples are collected for testing.
In summary, the Voyager is a surgical navigation system that utilizes medical imaging, not a device that performs diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Voyager 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 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 procedures .
Product codes
HAW
Device Description
The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic images
Anatomical Site
Intra-cranial, Spinal, ENT, Orthopedic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Intra-operative procedures
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 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
DEC 2 0 2002
K0239rs
2901 simms street tel 954 927 2044
510(K) SUMMARY
SUBMITTER: Z-KAT, Inc.
z-kat, inc.
ADDRESS: 2901 Simms Street
Hollywood, FL 33020
PHONE NUMBER: 954-927-2044
FAX NUMBER: 954-927-0446
CONTACT PERSON: Christina Vance
DATE PREPARED: November 27, 2002
TRADE NAME: Voyager Linux
COMMON NAME: Stereotaxic Instrument
CLASSIFICATION NAME: Class II
SUBSTANTIAL EQUIVALENCE CLAIMED TO:
- Voyager 6.0 Software Option; Marconi Medical Systems, K000310 1.
DEVICE DESCRIPTION:
The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
Voyager will consist of following basic components:
-
- High Resolution color liquid crystal display (LCD) Touch Screen Monitor
-
- Breakout Box
- Tool Interface Unit (TIU) 3)
- Uninterruptable Power Supply (UPS) 4)
- Central Processing Unit (CPU) 5)
1
- Isolation Transformer 6)
- 12023975
-
- Keyboard and Mouse
-
- Optical Detector (on wheeled-base pedestal)
- Operating Room Cart 9)
-
- Tools and accessories surgical tools and accessories instrumented with LEDs or reflective markers
INTENDED USE:
The Voyager 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 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 procedures .
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.
Ms. Christina Vance Regulatory Affairs Representative Z-Kat. Inc. 2901 Simms Street Hollywood, Florida 33020
Re: K023975
Trade/Device Name: Voyager Linux Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 27, 2002 Received: December 2, 2002
Dear Ms. Vance:
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. 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.
3
Page 2 - Ms. Christina Vance
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Miriam C. Provost
{61 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
z-kat, inc.
2901 simms street hollywood, florida 33020 tol 954.927.2044 fax 954.927.0446 zkat@z-kat.com www.z-kat.com
INDICATIONS FOR USE
| 510(k) Number (if known): | K023975 |
|---|---|
| --------------------------- | --------- |
Device Name: Voyages
Indications for Use:
The Voyager 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 oxientation and reference information during intra-operative procedures.
The Voyager 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 tigid anatomical structure may be made, such as:
- . Intra-crania surgical procedures involving space occupying lessons or malformations (including soft tissue, vascular and osseous)
- Spinal surgical procedures involving spinal stabilization, neutal decompression, or ● resection of spinal neoplasms
- ENT Procedures .
- Orthopedic surgical procedures ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | OR | Over-the-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
| Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| 510(k) Number | K023975 |