(27 days)
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.
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.
The provided text is a 510(k) summary for a modification to the Radionics Optical Tracking System (OTS). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it include specifics about sample sizes, expert qualifications, or ground truth establishment relevant to performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and device performance from the provided text.
The document primarily focuses on the regulatory submission process, stating that the modification involves using a NDI Polaris Camera and incorporating reflective spheres, and that these accessories function in the same way as their wired counterparts. It confirms substantial equivalence but does not detail performance data, clinical trials, or validation studies in the way you've outlined.
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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.
- 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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
collef
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983603
§ 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).