(21 days)
DRF, DRFs
K/DEN number: Not Found
No
The summary describes a passive optical tracking system for surgical navigation, focusing on hardware (headband, light array) and graphical planning tools. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
No
The device is described as a "graphical planning tool" that assists in surgical procedures by allowing pre-operative and operative planning. It helps in visualization and registration during surgery, but it does not directly treat or cure a disease or condition.
No
Explanation: The device is described as a graphical planning tool for surgical procedures, aiding in visualization and registration during surgery. It does not perform a diagnostic function such as identifying a disease or condition.
No
The device description explicitly mentions a "headband that secures a light array to the patient," indicating a hardware component is part of the system.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Optical Tracking System (OTS) is a graphical planning tool used for pre-operative and operative planning of surgical procedures. It uses a headband with a light array secured to the patient to aid in surgical navigation.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is based on tracking the position of the light array relative to the patient's anatomy during surgery.
Therefore, based on the provided information, the Optical Tracking System is a surgical navigation or planning tool, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to:
Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures
Product codes
HAW
Device Description
The above device consists of a headband that secures a light array to the patient. When coupled with the OTS workstation, the device allows for preoperative and operative planning of surgical procedures through workstation images. The device allows a light array to be secured to a patient non-invasively. Like its Cranial DRF and Spinal DRF predicates it is intended to maintain registration of the system during surgical procedures.
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 Cranial and Spinal DRFs for 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
6.0 510(k) Summary:
510(k) Summary
This summary of the 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: 1
Kevin J. 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 November 25, 1998.
- The name of the device is the Radionics Non-Invasive Dynamic Reference Frame 2 (DRF) for use with Radionics Optical Tracking System (OTS). The common name is an Intraoperative Guidance Device, and its classification name is a stereotaxic instrument (accessory).
- 3 The above device is substantially equivalent to the Radionics Cranial and Spinal DRFs for OTS.
- The above device consists of a headband that secures a light array to the patient. 4 When coupled with the OTS workstation, the device allows for preoperative and operative planning of surgical procedures through workstation images.
- The device allows a light array to be secured to a patient non-invasively. Like its 5 Cranial DRF and Spinal DRF predicates it is intended to maintain registration of the system during surgical procedures.
- The technological characteristics are the same or similar to those found with the 6 predicate device.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of three human profiles facing right, with a stylized design above them that could represent wings or flowing hair.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Mr. Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
K984245 Re:
Trade Name: Radionics Non-Invasive Dynamic Reference Frame Regulatory Class: II Product Code: HAW Dated: November 25, 1998 Received: November 27, 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.
2
Page 2 - Mr. Kevin J. O'Connell
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,
fo coles
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
510(k) Number (if known):
Device Name: Optical Tracking System (OTS) Non-Inyasive Dynamic Reference Frame
Indications for use:
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of cranial and spinal surgical procedures. The OTS is indicated for use in cranial and spinal surgical procedures in which anatomical structures are not clearly visible or where a desired target is close to critical regions. Examples of such procedures using OTS with the Non-Invasive DRF include, but are not limited to:
Catheter shunt placement Craniotomies Tumor resections Skull lesioning Vascular malformations Various ENT procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Dolledz
Division Sian-Off كما Division of General Restorative Devices كمك 510(k) Number
PRESCRIPTION USE
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)