(23 days)
Not Found
No
The description focuses on image-guided navigation using optical tracking of instruments relative to fluoroscopic images. There is no mention of AI/ML techniques for image analysis, decision support, or other functions.
No
The device is a surgical navigation system that assists in positioning instruments during surgical procedures. It does not directly treat a disease or condition.
No
This device provides navigational guidance during surgical procedures to assist in positioning instruments. It does not diagnose diseases or conditions.
No
The device description explicitly lists multiple hardware components (registration phantom, calibration grid, C-arm, computer workstation, ergonomic cart, optical camera, tools and accessories) that are part of the FluoroLab Plus system, indicating it is not a software-only device.
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.
- FluoroLab Plus Function: The FluoroLab Plus system is described as a navigational guidance system used during surgical procedures to assist surgeons in positioning instruments. It uses fluoroscopic images and optical tracking of instruments.
- Lack of Specimen Analysis: The description does not mention the collection, preparation, or analysis of any biological specimens from the patient. Its function is entirely focused on providing real-time guidance based on imaging and instrument tracking within the surgical field.
Therefore, FluoroLab Plus falls under the category of a surgical navigation system or image-guided surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images.
Surgeon with intraoperative navigational guidance based on pre-acquired fluorosco Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.
Product codes
HAW
Device Description
FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic images, standard C-arm fluoroscope
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical 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)
K984298, K954276, K990214, K000310, K962939
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
K0/3025
Image /page/0/Picture/1 description: The image shows the logo for "z-kat, inc.". The logo features a stylized letter "z" on the left side of the text. The text is in a simple, sans-serif font and is horizontally aligned.
OCT - 3 2001
2905 simms street hollywood florida 33020 tel 954.927.2044
fax 954 927 0446
zkatīzz-kat.com www.z.kat.com
510(K) SUMMARY
SUBMITTER: Z-KAT, Inc.
ADDRESS: 2903 Simms Street
Hollywood, FL 33020
PHONE NUMBER: 954-927-2044
FAX NUMBER: 954-927-0446
CONTACT PERSON: William F. Tapia
DATE PREPARED: August 23, 2001
TRADE NAME: FluoroLab Plus
COMMON NAME: Stereotaxic Instrument
CLASSIFICATION NAME: Class II
SUBSTANTIAL EQUIVALENCE CLAIMED TO:
- The Fluorotactic Guidance System, Mk I, Z-KAT, Inc., K984298 1.
-
- StealthStation, Sofamor Danek, K954276
-
- FluoroNav, Sofamor Danek, K990214
-
- The Voyager; Marconi Medical Systems, K000310
-
- VectorVision2, BrainLab, K962939
DESCRIPTION:
FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
FluoroLab Plus will consist of following basic components:
-
- Registration phantom
1
-
- Calibration grid
-
- Fluoroscopic image intensifier system (C-arm)
-
- Computer workstation with monitor and video acquisition box
-
- Ergonomic cart
- FluoroLab Plus software application 6)
- Optical camera with Tool Interface Unit (TIU) 7)
- Tools and accessories surgical tools and accessories instrumented with LEDs or reflective 8) markers
INTENDED USE:
FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2001
William F. Tapia Z-KAT, Inc. 2903 Simms Street Hollywood, Florida 33020
Re: K013025
Trade/Device Name: FluoroLab Plus Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 23, 2001 Received: September 10, 2001
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.
3
Page 2 - Mr. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,
Susan Walker, MS
- J 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
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Image /page/4/Picture/0 description: The image shows the logo for "z-kat, inc.". The logo features a stylized letter "z" on the left side of the text. The text is in a simple, sans-serif font and is black.
2903 simms street hollywood florida 33020 tel 954.927.2044 fax 954 927 0446
INDICATIONS FOR USE
| 510(k) Number (if known): | K013025 |
|---|---|
| --------------------------- | --------- |
Device Name: FluoroLab Plus
Indications for Use:
FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images.
Surgeon with intraoperative navigational guidance based on pre-acquired fluorosco Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.
(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)
Su Wor
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K013025