(44 days)
Not Found
No
The summary describes a standard image-guided surgical system using optical tracking and image superposition, with no mention of AI or ML capabilities.
No.
The device assists with surgical planning and navigation, it does not directly treat or cure a disease or condition.
No
The device uses "diagnostic images of the patient" but is described as an "image guided surgical device" intended for "presurgical planning" and "interpretive/interoperative navigation." Its purpose is to assist the physician during surgery, not to generate a diagnosis itself.
No
The device description explicitly lists multiple hardware components, including an optical detector, computer, monitor, UPS, CPU, isolation transformer, keyboard, mouse, and surgical tools.
Based on the provided information, the Z-Box device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- Z-Box uses diagnostic images: The Z-Box system utilizes diagnostic images of the patient (like CT or MRI scans) to assist with surgical planning and navigation. It does not analyze biological samples.
- Intended Use is surgical guidance: The stated intended use is for presurgical planning and intra-operative guidance based on imaging data, not for diagnosing conditions by analyzing biological samples.
Therefore, the Z-Box falls under the category of an image-guided surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Z-Box 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 Z-Box 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 Z-Box System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Z-Box uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
Z-Box will consist of 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 (on wheeled-base pedestal)
- Operating Room Cart
- Tool and accessories surgical tools and accessories instrumented with LEDs or reflective markers
- dMIS kit surgical instrument kit containing IGS tools and accessories and dMIS key
- dMIS key electronic storage media containing disposable software application
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic images
Anatomical Site
- Intra-cranial
- Spinal
- Not Found (for ENT Procedures)
- Not Found (for Orthopedic surgical procedure)
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 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/0 description: The image shows the logo for "z-kat, inc.". The logo features a stylized, abstract graphic to the left of the text. The text "z-kat, inc." is written in a simple, sans-serif font and is positioned to the right of the graphic.
Ko30'764
2003 simms street www.z kat.com
510(K) SUMMARY
SUBMITTER: 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: March 10, 2003
TRADE NAME: Z-Box
COMMON NAME: Stereotaxic Instrument
CLASSIFICATION NAME: Class II
CLASSIFICATION #: 21CFR 882.4560
SUBSTANTIAL EQUIVALENCE CLAIMED TO:
-
- Voyager Linux; Z-KAT, Inc., K023975
DESCRIPTION:
The Z-Box System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Z-Box uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
Z-Box will consist of following basic components:
- High Resolution color liquid crystal display (LCD) touch screen monitor 1)
-
- Uninterruptible Power Supply (UPS)
- Central Processing Unit (CPU) 3)
-
- Isolation Transformer
-
- Keyboard and Mouse
1
-
Optical Detector (on wheeled-base pedestal) 6)
K030764 -
- Operating Room Cart
-
Tool and accessories surgical tools and accessories instrumented with LEDs or reflective 8) markers
-
- dMIS kit surgical instrument kit containing IGS tools and accessories and dMIS key
-
- dMIS key electronic storage media containing disposable software application
INTENDED USE:
The Z-Box 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 Z-Box 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
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
APR 2 4 2003
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christina Vance Regulatory Affairs Representative Z-KAT, Inc. 2901 Simms Street Hollywood, Florida 33020
Re: K030764
Trade/Device Name: Z-Box Regulation Number: 21 CFR 882.4560 Regulation Names: Stereotaxic instrument Regulatory Class: II Product Codes: HAW Dated: April 11, 2003 Received: April 14, 2003
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.
3
Page 2 - Ms. Christina Vance
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 (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) you may obtain. 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. Purrst
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
fax 954.927.0446
INTENDED USE
Z-Box 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.
Z-Box 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 ●
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030764