(30 days)
Not Found
No
The summary describes a system that tracks the position and trajectory of a microscope using LEDs and a camera array, which is a standard optical tracking method, not AI/ML. There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No
The device is used for localizing targets in surgical procedures. It is a surgical navigation system, which assists the surgeon but does not directly treat the condition.
No
The device's intended use is to localize targets in surgical procedures, specifically for guidance during cranial and spinal surgeries, not to diagnose a disease or condition. The device description also focuses on tracking the microscope's focal point for surgical navigation.
No
The device description explicitly states it includes hardware components (LEDs attached to the microscope, camera array) in addition to the software module.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Interactive, image-guided means of localizing targets in surgical procedures." This describes a device used during a surgical procedure to guide the surgeon, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a system that tracks the position and trajectory of a microscope's focal point using LEDs and cameras. This is a surgical navigation system, not a device that analyzes biological samples.
- Anatomical Site: The device is used in "cranial and spinal" surgical procedures, which are performed directly on the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to assist in surgical procedures by providing guidance based on imaging and tracking.
N/A
Intended Use / Indications for Use
Interactive, image-guided means of localizing targets in surgical procedures. OTS 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
The above device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point is tracked using light emitting diodes (LEDs) attached to the microscope and viewed by a camera array in conjunction with digital communications with the microscope.
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)
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
3/4/99
7.0 510(k) Summary:
/C990326
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.
1.0 The submitter of this premarket notification is:
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 January 29, 1999.
- 2.0 The name of the device is the Radionics OTS Microscope Module II 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).
- 3.0 The above device is substantial equivalent to the Radionics Microscope Module I cleared via 510(k) K981213 and Zeiss Surgical Microscope Navigator System cleared via 510(k) K965139.
- 4.0 The above device consists of a software module that allows a variable focused microscope to be used with OTS. The position and trajectory of the microscope's focal point is tracked using light emitting diodes (LEDs) attached to the microscope and viewed by a camera array in conjunction with digital communications with the microscope.
- 5.0 The device like its predicates is intended for cranial and spinal surgical procedures.
- 6.0 The technological characteristics are the same or similar to those found with the predicate device.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Mr. Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
Re: K990326
Trade Name: Optional Tracking System (OTS) Microscope Module II Regulatory Class: II Product Code: HAW Dated: February 1, 1999 Received: February 2, 1999
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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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,
Stpt Rhodes
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 1 of 1
11:48
:
510(k) Number (if known):
K990326
Device Name: Optical Tracking System (OTS) Microscope Module II
Indications for use:
Interactive, image-guided means of localizing targets in surgical procedures. OTS 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)
Hok Elurch
15990326
PRESCRIPTION USE _X
OR
Over-The-Counter Use
(Per 21 CFR 801.109
(Optional Format 1-2-96)