(30 days)
Not Found
No
The summary describes a modification to an existing optical tracking system, focusing on the incorporation of wireless accessories that function equivalently to their wired counterparts. There is no mention of AI, ML, or related concepts, and the description of the technology is purely based on optical tracking and workstation image processing.
No
The device is an intraoperative guidance system used for planning surgical procedures, not for treatment.
No
Explanation: The device is described as an "Intraoperative Guidance Device" used for planning surgical procedures and tracking instruments, not for diagnosing medical conditions.
No
The device description explicitly mentions "battery-powered Wireless Standard Probe and DRF accessories" which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Radionics Optical Tracking System (OTS) is an "Intraoperative Guidance Device" used in "cranial and spinal surgical procedures." It functions by allowing "preoperative and operative planning... using workstation images."
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples from the patient. Its function is to provide guidance during surgery based on anatomical landmarks and images.
Therefore, the device's purpose and mechanism of action fall outside the scope of in vitro diagnostics. It is a surgical guidance system.
N/A
Intended Use / Indications for Use
The Radionics Optical Tracking System (OTS) Wireless System 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 modification involves the incorporation of battery-powered Wireless Standard Probe and DRF accessories. These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS. When coupled with the OTS workstation, the above wireless 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.
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)
Radionics OTS
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
AUG 5 1898
K98236
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:
Lisa Misterka Benati Senior 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 July 1, 1998.
-
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 incorporation of battery-powered Wireless Standard Probe and DRF accessories . These accessories are substantially equivalent to their wired counterparts in the predicate Radionics OTS.
-
When coupled with the OTS workstation, the above wireless 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 wireless Standard Probe and DRF are intended to facilitate the preoperative and operative planning of cranial and spinal surgical procedures. There are no operational differences between the wired and wireless accessories. All phases of preoperative and operative planning remain unchanged.
-
Apart from the power source, the technological characteristics are the same as or similar to, those of the predicate wired device where LED-based systems and 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 features a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community and collaboration. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 1998
Ms. Lisa Misterka Benati Senior Regulatory Engineer Radionics, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
Re: K982364 Trade Name: Radionics Optical Tracking System, (OTS) Wireless System Regulatory Class: II Product Code: HAW Dated: July 2, 1998 Received: July 6, 1998
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.
2
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 (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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Montodrason
112
K982364 510(k) Number (if known): __
1-1-1-5-1 11-1
Friendry Lis
Device Name: Radionics Optical Tracking System (OTS) Wireless System
Indications for Use:
The Radionics Optical Tracking System (OTS) Wireless System 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)
picocella
(Division) Sign-Off)
Division of General Restorative Devices K982364
510(k) Number.
Prescription Use (Per 21 CFR 801.199)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)