(203 days)
Not Found
No
The description focuses on image processing, coordinate calculations based on fiducial markers, and robotic arm control, without mentioning any AI or ML techniques for image analysis, planning, or guidance. The surgeon directly manipulates a virtual guidewire, indicating a rule-based or algorithmic approach rather than a learned model.
No.
The device assists in surgical guidance and accurate placement of instruments, but it does not directly treat a disease or condition.
No
The device is described as a guidance system that assists in the "accurate placement of a guiding device for surgery" by providing "intra-operative planning of the precise insertion point and angle." It calculates coordinates for a robot arm to position a drill guide. This is an assistive tool for surgical procedures, not a device used to diagnose a medical condition or disease.
No
The device description explicitly lists four hardware components: Robot arm, Registration/drill guide artifact, Fluoroscopic image intensifier system (C-arm), and a Personal computer (PC) with specific hardware. While software is a critical part of the system, it is not the only component.
Based on the provided information, the Fluorotactic Guidance System Mk. I is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Fluorotactic Guidance System Mk. I Function: This system is used to assist a surgeon in the placement of surgical instruments within the patient's body during a procedure. It uses imaging and robotic guidance to achieve this.
- Lack of Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its function is entirely focused on guiding surgical tools based on real-time imaging.
Therefore, the Fluorotactic Guidance System Mk. I falls under the category of a surgical guidance system or surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.
The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.
Product codes
HAW
Device Description
The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area.
The Fluorotactic Guidance System Mk. I system will consist of four components:
- Robot arm
- Registration/drill guide artifact
- Fluoroscopic image intensifier system (C-arm)
- Personal computer (PC) with a Data Translation image acquisition card and two monitors
The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view.
The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
K954276, K961844, K970604, K861692
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
JUN 2 3 1999
11645 Biscayne Blvd. Suite 308 Miami, FL 33181-3139 Tel 305.895.9022 Fax 305.895.8286 zkat@z-kat.com
510(k) Summary
Submitter: Z-KAT, Inc.
Address: 11645 Biscayne Blvd. Suite 304 Miami, FL 33181
Phone number: (305) 895-9022
Fax number: (305) 895-9023
Contact person: Rony Abovitz
Date prepared: November 18, 1998
Trade name: Z-KAT Fluorotactic ™ Guidance System
Common name: Stereotaxic Instrument
Classification name: Class II
Substantial equivalence claimed to:
-
- StealthStation, Surgical Navigation Technologies, Inc., K954276
-
- Radionics Operating Arm & OTS System/StereoPlan, K961844
-
- Picker International Viewpoint System, K970604
-
- Fischer Imaging AutoGuide (Part of Mammotest Mammography System), K861692
Description:
The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area.
1
Summary of technological characteristics:
The Fluorotactic Guidance System Mk. I system will consist of four components:
-
- Robot arm
-
- Registration/drill guide artifact
-
- Fluoroscopic image intensifier system (C-arm)
-
- Personal computer (PC) with a Data Translation image acquisition card and two monitors
The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view.
The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 1999
Mr. Rony Abovitz Mr. Rony Aboviz
Vice President, Biomedical Research and Development Z-KAT, Inc. 11645 Biscayne Boulevard, Suite 304 Miami, Florida 33181
K984298 Re: K984298
Trade Name: Z-KAT Fluorotactic™ Guidance System Regulatory Class: II Product Code: HAW Dated: March 30, 1999 Received: March 31, 1999
Dear Mr. Abovitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced
in the indication in the best in the increases tiglizent (for the indications for We have reviewed your Securit is tu(K) notified to wivalent (for the indications for
above and we have determined the device is substantially equivalent (for the indications above and we have determined the devices marketed in interstate commerce prior to the use stated in the enclosure) to devices marketed be simments, or to devices that
May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that May 28, 1976, the enactment date of the Messions of the Federal Food, Drug, and
have been reclassified in accordance with the provisions of the Federal Food, Drug, and have been reclassified in accordance with the provisions of the general controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therelore, inaractions of the Act include requirements for provisions of the Act. The general connolo provincial in the more of actice, labeling, and annual 10gistrations against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
nd in the same of the collection of the diditional controls. Existing major If your device is classified (see above) into such additions controls. Existing major (Premarket Approval), it may be subject to such addition of Federal Regulations, Title 21,
regulations affecting your device can be found in the commencembiance with the regulations aftecting your device can be tound in the occase assumes compliance with the Parts 800 to 895. A substantially equivalia as set forth in the Quality System
current Good Manufacturing Practice requirement, as set forth in the Part 870) and the current Good Manufacturing Fractice requiation (21 CFR Part 820) and that,
Regulation (QS) for Medical Devices: General Instituction (EDA) will verif Regulation (QS) for Medical Devices. General IDBut Administration (FDA) will verify
through periodic (QS) inspections, the AM samation may result in regulatory through periodic (QS) Inspections, the I ook and Drag Presult in regulation may result in regulatory such assumptions. Failure to comply with in Girli regencents concerning your device in the action. In addition, FDA may publish nuture announcemarket notification submission does
Federal Register. Please note: this response to your premarket notification in the A Federal Register. Please note: tills response to Jour pros. 53 through 542 of the Act for not affect any obligation you might have under socked by on other Federal laws or regulations.
3
Page 2 -- Mr. Rony Abovitz
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to begin mainer 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 809.10 for in vitro diagnostic devices), please contact the Office of and additionally 6097794-4595. Additionally, for questions on the promotion and Compliance at (201) 591 1595. Financially , 1997. Inchience at (301) 594-4639 Also, please note the regulation entitled, "Misbranding by reference to premarket Also, prease note the regulation only see are al information on your responsibilities under the notification (21 CFTC 007.97). Only getting of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K984298 510(k) Number (if known):_
Device Name: Z-KAT Fluorotactic ™ Guidance System Mk. I
Indications for Use:
The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.
The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K984298 |
| Prescription Use | |
| (Per 21 CFR 801.109) | X |
| OR | |
| Over-the-Counter Use |