OPTICAL TRACKING SYSTEM (OTS)

• K Number: K990632
• Device Name: OPTICAL TRACKING SYSTEM (OTS)
• Manufacturer: RADIONICS, INC.
• Date Cleared: 1999-04-29 ( 62 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: K964801 , K974602 , K954276 , K971247
• Predicate For: N/A

Intended Use

The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

Device Description

The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Radionics Optical Tracking System - OTS) and its FDA clearance letter. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document discusses:

• The device name and its classification.
• Its substantial equivalence to predicate devices.
• Revised indications for use (specifically for frameless cranial biopsy).
• General information about its function as a graphical planning and intraoperative navigation tool for cranial and spinal surgical procedures.
• The FDA's confirmation of market clearance.

Therefore, I cannot provide the requested table and study details based on the given information. The information needed to answer the prompt (acceptance criteria, study design, performance results, ground truth, sample sizes, expert qualifications, etc.) is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.

Summary

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4/29/99

5.0 510(k) Summary

K990632

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 CFR § 807.92.

• 1. The submitter of this premarket notification is:
     Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: [phone] Fax: [phone] Contact Name: Lisa Misterka Benati

This summary was prepared on February 25, 1999.

• 2. The name of this device is:

Classification Name:	Stereotaxic instrument
Common/Usual Name:	Intraoperative Guidance Device
Proprietary Name:	Radionics Optical Tracking System (OTS)

• 3. This device is substantially equivalent to:
     Radionics Optical Tracking System [K964801, K974602]

Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247].

• 4. The submission describes a revised indications for the Optical Tracking System to provide for use in frameless cranial biopsy procedures.
• 5. The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. Example procedures include, but are not limited to:

Catheter shunt placement Vascular malformations Frameless cranial biopsy Various ENT procedures Craniotomies Tumor resections

Spinal implant procedures Spinal biopsy Laminectomy Diskectomy Decompression for spinal tumor.

• 6. The technological characteristics are the same or similar to those found in the predicate devices.

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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 circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Ms. Lisa Misterka Benati Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516

Re: K990632 Trade Name: Optical Tracking System (Modification) Regulatory Class: II Product Code: HAW Dated: February 25, 1999 Received: February 26, 1999

Dear Ms. Benati:

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.

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Page 2 - Ms. Lisa Misterka Benati

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.

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 [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Optical Tracking System (OTS) - Revised Indications for Use

Indications for Use:

The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

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

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neral Restorative De

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Over the Counter Use ન્ભર

(Optional Format 1-2-96)

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Regulation Number and Section

§ 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).