(62 days)
Not Found
No
The summary describes a graphical planning and navigation tool with no mention of AI, ML, or related concepts. The predicate devices are also older navigation systems.
No
The device is described as a graphical planning tool for preoperative planning and intraoperative navigation during surgical procedures, not for actively treating a condition.
No
The device is described as a "graphical planning tool" for preoperative planning and intraoperative navigation during surgical procedures, including biopsies. It does not extract or process medical information to identify a disease, condition, or provide a diagnosis. Its function is to guide surgical procedures.
No
The description refers to "intraoperative navigation" and "Optical Tracking System," which strongly implies the use of hardware components for tracking and navigation during surgery, not just software for planning. The predicate devices also include "Optical Tracking System" and "Stereotactic System," further suggesting hardware involvement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "graphical planning tool" for "preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures." This describes a tool used during a surgical procedure to guide the surgeon, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reiterates the intended use, focusing on planning and navigation during surgery.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly a surgical navigation system, which falls under a different regulatory category than IVDs. The predicate devices listed also support this conclusion, as they are also surgical navigation systems.
N/A
Intended 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.
Product codes
HAW
Device Description
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.
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)
K964801, K974602, K954276, K971247
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
4/29/99
5.0 510(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 CFR § 807.92.
-
- The submitter of this premarket notification is:
Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: (781) 272-1233 Fax: (781) 272-2428 Contact Name: Lisa Misterka Benati
- The submitter of this premarket notification is:
This summary was prepared on February 25, 1999.
-
- The name of this device is:
| Classification Name: | Stereotaxic instrument |
|---|---|
| Common/Usual Name: | Intraoperative Guidance Device |
| Proprietary Name: | Radionics Optical Tracking System (OTS) |
Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247].
-
- The submission describes a revised indications for the Optical Tracking System to provide for use in frameless cranial biopsy procedures.
-
- 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.
-
- The technological characteristics are the same or similar to those found in the predicate devices.
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 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.
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 vour 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 of of /
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)
Daouf
neral Restorative De
Image /page/3/Picture/8 description: The image shows the words "Prescription Use" followed by a line and a check mark. Below that, the text "(Per 21 CFR 801.109)" is visible. The check mark indicates that the prescription use is confirmed.
Over the Counter Use ન્ભર
(Optional Format 1-2-96)
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