(9 days)
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.
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:
- Robot arm
- Registration/drill guide artifact
- Fluoroscopic image intensifier system (C-arm)
- 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.
This 510(k) summary (K984298) describes the Z-KAT Fluorotactic™ Guidance System Mk. I, a stereotaxic instrument intended to assist in the accurate placement of a guiding device for surgery using coordinated fluoroscopy. However, it does not provide details about specific acceptance criteria or a study proving the device meets accepted performance standards.
Here's an analysis based on the provided text, highlighting what is missing or explicitly not stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|
| Precision of calculated coordinates | Not provided |
| Accuracy of robot arm positioning | Not provided |
| Time taken for system setup and planning | Not provided |
| User interface usability | Not provided |
| Safety validation | Not provided |
Comments: The submission describes the functionality of the device (enabling a surgeon to guide instruments using two captured fluoroscopic images, calculating coordinates for a robot arm), but does not specify quantifiable acceptance criteria (e.g., "positioning accuracy within X mm") nor does it present data showing the device achieved such criteria. The purpose of this 510(k) is to demonstrate substantial equivalence to previously cleared devices, not necessarily to prove specific performance metrics against pre-defined acceptance criteria with a new, standalone study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: Not specified.
- Data Provenance: Not specified. (The document mentions using a standard C-arm to capture images but doesn't detail any clinical or simulated test data used for performance evaluation in this summary.)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No, this document does not describe an MRMC comparative effectiveness study.
- Effect Size of AI vs. Without AI: Not applicable, as no such study is presented. The device is a guidance system, not an AI for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Not explicitly described. The summary focuses on the integrated system where the surgeon manipulates a virtual guidewire and the system outputs coordinates for the robot arm. While the software performs calculations independently, a "standalone study" in the context of device performance usually implies direct quantitative measurement of the algorithm's output against a gold standard without human input as part of the measured performance metric. This is not detailed.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified. For a guidance system, ground truth would typically involve precise measurements (e.g., from a phantom or cadaver with known fiducial locations) to assess accuracy between the intended and actual positions. This is not mentioned.
8. Sample Size for the Training Set
- Training Set Size: Not applicable/Not specified. This device is described as a guidance system that performs calculations based on image input and surgeon interaction. It's not presented as a machine learning or AI model that requires a "training set" in the conventional sense to learn patterns from data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable/Not specified, as it's not described as an AI/ML model needing a training set.
In summary, this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain the detailed performance study information, acceptance criteria, or ground truth methodology that would typically be found in a more comprehensive premarket approval (PMA) application or a 510(k) for a novel AI/ML-driven device requiring extensive clinical validation. The FDA's clearance (K984298) acknowledges the device's substantial equivalence for the stated indications for use, implying that the safety and effectiveness are comparable to existing, legally marketed predicate devices without necessarily requiring new, extensive performance data against predefined acceptance criteria for this specific submission type.
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JUN 2 3 1999
Fax 305.895.8286 Miami. FL 33181-3139 Tel 305.895.9022
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
-
- StealdhStation, Burglear Navig-TS System/StereoPlan, K961844
- Radionics Operating Arm & OTS System/StereoPlan, K961844
-
- Radiomes Operamal Viewpoint System, K970604
-
- Picker International Viewpoint System, R77000-4
- 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.
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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)
-
- 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.
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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.
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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 (501) 594-4395. Additionally, 201 compliance at (301) 594-4639.
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 (301) 443-6597 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
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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.
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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) |
§ 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).