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K Number
K983603
Device Name
REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME
Manufacturer
RADIONICS, INC.
Date Cleared
1998-11-10

(27 days)

Product Code
HAW
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Radionics OTS with Passive-Reflective Tracking Configuration is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.
Device Description
This premarket notification describes a modification to the Radionics Optical Tracking System (OTS). The common name of this device is Intraoperative Guidance Device, and its classification name is Stereotaxic instrument. The modification involves the use of a NDI Polaris Camera and the incorporation of reflective spheres to the Standard Probe, Depth Probe, UIR, Microscope Frame, and DRF accessories. These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS. When coupled with the OTS workstation and using the NDI Polaris Camera, the above reflective accessories function in the same way as the predicate wired versions by allowing preoperative and operative planning of cranial and spinal surgical procedures using workstation images.
More Information

Not Found

Not Found

No
The summary describes a modification to an existing optical tracking system, focusing on hardware changes (camera and reflective spheres) and their function in surgical planning. There is no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.

No
The device is described as an "Intraoperative Guidance Device" and "Stereotaxic instrument" used for surgical procedures to assist in anatomical localization and planning, not to treat or cure a disease or condition.

No
The description indicates the device is an "Intraoperative Guidance Device" used for navigation and planning during surgery, rather than for diagnosing a condition.

No

The device description explicitly mentions hardware components like the NDI Polaris Camera, reflective spheres, and various accessories (Standard Probe, Depth Probe, UIR, Microscope Frame, and DRF). It describes a modification to an existing hardware system (Radionics Optical Tracking System) and the incorporation of new hardware elements.

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

Here's why:

  • Intended Use: The intended use clearly states the device is for use in "cranial and spinal surgical procedures." This indicates a direct application in surgical intervention on a patient's body.
  • Device Description: The description details a "Stereotaxic instrument" used for "preoperative and operative planning of cranial and spinal surgical procedures using workstation images." This further reinforces its role in surgical guidance and planning, not in analyzing biological samples.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Providing information about a patient's health status based on in vitro analysis.
    • Detecting or measuring substances in biological samples.

IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to assist in surgical procedures by providing guidance based on anatomical landmarks and imaging, which is a different category of medical device.

N/A

Intended Use / Indications for Use

The Radionics OTS with Passive-Reflective Tracking Configuration is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

Product codes

HAW

Device Description

This premarket notification describes a modification to the Radionics Optical Tracking System (OTS). The common name of this device is Intraoperative Guidance Device, and its classification name is Stereotaxic instrument.
The modification involves the use of a NDI Polaris Camera and the incorporation of reflective spheres to the Standard Probe, Depth Probe, UIR, Microscope Frame, and DRF accessories. These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS.
When coupled with the OTS workstation and using the NDI Polaris Camera, the above reflective accessories function in the same way as the predicate wired versions by allowing preoperative and operative planning of cranial and spinal surgical procedures using workstation images.
Like their counterparts in the predicate Radionics OTS, the reflective based tools are intended to facilitate the preoperative and operative planning of cranial and spinal surgical procedures. There are no operational differences between the wired and reflective accessories. All phases of preoperative and operative planning remain unchanged.
Apart from the use of passive reflectance with the OTS tools, rather than an AC or DC power source, the technological characteristics are the same as or similar to, those of the predicate wired device where infrared signals are used to provide tracking information as an aid to cranial and spinal surgery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial and spinal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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

5.0 510(k) Summary

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.

  1. The submitter of this premarket notification is:

Kevin O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Tel: (781) 272 - 1233 Fax: (781) 272 - 2428

This summary was prepared on October 8, 1998.

  1. This premarket notification describes a modification to the Radionics Optical Tracking System (OTS). The common name of this device is Intraoperative Guidance Device, and its classification name is Stereotaxic instrument.

  2. The modification involves the use of a NDI Polaris Camera and the incorporation of reflective spheres to the Standard Probe, Depth Probe, UIR, Microscope Frame, and DRF accessories . These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS.

  3. When coupled with the OTS workstation and using the NDI Polaris Camera, the above reflective accessories function in the same way as the predicate wired versions by allowing preoperative and operative planning of cranial and spinal surgical procedures using workstation images.

  4. Like their counterparts in the predicate Radionics OTS, the reflective based tools are intended to facilitate the preoperative and operative planning of cranial and spinal surgical procedures. There are no operational differences between the wired and reflective accessories. All phases of preoperative and operative planning remain unchanged.

  5. Apart from the use of passive reflectance with the OTS tools, rather than an AC or DC power source, the technological characteristics are the same as or similar to, those of the predicate wired device where infrared signals are used to provide tracking information as an aid to cranial and spinal surgery.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with healthcare. The symbol is composed of three figures in profile, representing the department's focus on people and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 10 1998

Mr. Kevin O'Connell Regulatory Engineer Radionics Software Application, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

K983603 Re: Trade Name: Radionics Optical Tracking System (OTS) with Passive-Reflective Tracking Configuration Regulatory Class: II Product Code: HAW Dated: October 13, 1998 Received: October 14, 1998

Dear Mr. O'Connell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

2

Page 2 - Mr. Kevin O'Connell

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 Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Page

510(k) Number (if known): 983603

Device Name: Radionics Optical Tracking System (OTS) with Passive-Reflective Tracking Configuration

Indications for Use:

The Radionics OTS with Passive-Reflective Tracking Configuration is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983603