LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201

• K Number: K984398
• Device Name: LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
• Manufacturer: BIO-RAD
• Date Cleared: 1998-12-18 ( 9 days)
• Product Code: DHN HAW
• Regulation Number: 866.5100

Intended 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.

Device Description

The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to The Fluorotactic Guidance System Mik. I is all mice states, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to instruments using two captured indoroscopic mages. The capacity of the 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 The plan consists of specifying the misulate the necessary coordinates for the robot arm, which will position the drill guide over the surgical area. The Fluorotactic Guidance System Mk. I system will consist of four components: 1) Robot arm 2) Registration/drill guide artifact 3) Fluoroscopic image intensifier system (C-arm) 3) Pludical 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 entibediced 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 suidewire 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.

Predicate Devices

K954276, K961844, K970604, K861692

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image processing, geometric calculations based on fiducial markers, and surgeon manipulation of a virtual guidewire to determine coordinates for a robot arm. There is no mention of AI or ML algorithms being used for image analysis, planning, or guidance.

Therapeutic

No
The device is described as assisting in the accurate placement of a guiding device for surgery, such as positioning a drill guide for precise placement of screws, nails, or needles. It is a guidance system, not a device that directly treats or prevents a disease or condition.

Diagnostic

No

This device is designed to assist in the accurate placement of surgical instruments by providing guidance and positioning assistance. It does not diagnose diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists four components, including a robot arm, registration/drill guide artifact, fluoroscopic image intensifier system (C-arm), and a medical computer (PC) with hardware. This indicates it is a system with significant hardware components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
• Device Function: The Fluorotactic Guidance System Mk. I is used to assist a surgeon in the placement of a surgical guiding device directly on or within the patient's body during surgery. It uses imaging and a robotic arm to guide the surgeon's actions.
• No Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its function is entirely focused on guiding a surgical procedure based on real-time imaging and spatial calculations.

Therefore, the Fluorotactic Guidance System Mk. I falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

HAW

Device Description

The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to accurately navigate a drill, endoscope, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to position the drill guide over the surgical area. The capacity of the 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 angles. The software will then calculate the necessary coordinates for the robot arm, which will position the drill guide over the surgical area.

The Fluorotactic Guidance System Mk. I system will consist of four components:

• 1. Robot arm
• 2. Registration/drill guide artifact
• 3. Fluoroscopic image intensifier system (C-arm)
• 4. Medical 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 entibediced 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 suidewire 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

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopic images

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): 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.

K954276, K961844, K970604, K861692

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

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).

Summary

0

JUN 2 3 1999

K984298

Fax [phone] Miami. FL 33181-3139 Tel [phone]

510(k) Summary

Submitter: Z-KAT, Inc.

Address: 11645 Biscayne Blvd. Suite 304 Miami, FL 33181

Phone number: [phone]

Fax number: [phone]

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:

• 1. StealthStation, Surgical Navigation Technologies, Inc., K954276
• 1. StealdhStation, Burglear Navig-TS System/StereoPlan, K961844

2. Radionics Operating Arm & OTS System/StereoPlan, K961844

• 2. Radiomes Operamal Viewpoint System, K970604
• 3. Picker International Viewpoint System, R77000-4

4. 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 The Fluorotactic Guidance System Mik. I is all mice states, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to instruments using two captured indoroscopic mages. The capacity of the 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 The plan consists of specifying the misulate the necessary coordinates for the robot arm, 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:

• 1. Robot arm
• 2. Registration/drill guide artifact
• 3. Fluoroscopic image intensifier system (C-arm)
• 3. Pludical 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 entibediced 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 suidewire 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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three parallel lines that curve and flow together, resembling a stylized human form or a wave-like design. The text is arranged around the circle's perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Mr. Rony Abovitz Mr. Rohy Abovitz
Vice President, Biomedical Research and Development Z-KAT, Inc. 11645 Biscayne Boulevard, Suite 304 Miami, Florida 33181

K984298 Re: 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 We have reviewed your Section 510(x) notenouslially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to use stated in the enclosure) to devices marketed in antice Amendments, or to devices that May 28, 1976, the enaciment date of the Modion Do no of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (XCt). " Fournay, incretore, manaving of the Act include requirements for provisions of the Act. The generales, 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 If your device is classified (see above) into such additional controls. Existing major (Premarket Approval), it thay be subject to satis the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Paris 800 to 895. A substaintially oquirement, as set forth in the Quality System current Good Manufacturing Practices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulation such assumptions. Tanare to compy within announcements concerning your device in the action. In addition, I Dri may passes to your premarket notification submission does rederal Register. Treaso noter singly have under sections 531 through 542 of the Act for not allect ally obligation you might have and and 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 $10(k) This letter will allow you to begill marketing your antial equivalence of your device and thus, and premarket notification. The PDA iniding of Baboutines virtor 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 If you desire specific advice for your devices), please contact the Office of and additionally 809.10 for in Vitto diagnolice for questions on the promotion and Compliance at [phone]. Additionally, 201 compliance at [phone].
advertising of your device, please contact the Office of Compliance at promories Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please hote the regulation childer, "Wholesandion on your responsibilities under the notification" (21 CFK 807.97). Other general Manufacturers Assistance at its toll-free Act may oc obtained 41 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia 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	K984298
510(k) Number

Prescription Use	X	OR	Over-the-Counter Use
(Per 21 CFR 801.109)