(90 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and software for surgical planning based on workstation images, which is typical for image-guided surgery systems without explicit AI/ML components.
No
Explanation: The device is described as a system that aids in preoperative and operative planning of surgical procedures, acting as an accessory to an OTS workstation. It does not directly treat or alleviate a medical condition but rather provides information and guidance for surgical procedures.
No
Explanation: The device is described as allowing for "preoperative and operative planning of surgical procedures" and is coupled with an "OTS workstation" for this purpose. This functionality suggests it is a surgical planning and navigation tool, not a diagnostic device which primarily focuses on identifying the nature or cause of a disease or condition. Its intended use is to aid in surgical procedures where a target is close to critical structures, which is an operational aid rather than a diagnostic one.
No
The device description explicitly states it includes "LED array hardware" and a "registration device," indicating it is not solely software.
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 Function: The description clearly states the device is a "registration device, LED array hardware, and operational software" used for "preoperative and operative planning of surgical procedures through workstation images." It assists in surgical navigation and planning based on imaging data.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is centered around image-guided surgical planning and navigation.
Therefore, the device falls under the category of a surgical navigation system or similar surgical planning tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The system accessories are indicated for all cranial and spinal surgical procedures covered by the OTS where anatomical Spinal Surgicur procedures is is where a desired target is close to critical structures.
Product codes
HAW
Device Description
The above modular product groups consist of a registration device, LED array hardware, and operational software. When coupled with the OTS workstation, the devices allow for preoperative and operative planning of surgical procedures through workstation images. The accessories are intended as a visualization aid to surgery. When fitted to a surgical instrument, the LED array hardware allows the surgeon to correlate the instrument location to the patient scan data. Likewise, when attached to a microscope, the LED array hardware allows the surgeon to correlate the focused viewing area to patient scan data, and to guide the microscope to a desired target 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
surgeon
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)
Zeiss Surgical Microscope Navigator (SMN) and Surgical Tool Navigator (STN)
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
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, MA01803 Tel: (781) 272 - 1233 Fax: (781) 272 - 2428
This summary was prepared on April 1, 1998.
-
The names of these devices are the Radionics Universal Instrument Registration and Microscope Module I accessories for use with Radionics Optical Tracking System (OTS). The common name is Intraoperative Guidance Device, and its classification name is Stereotaxic instrument (accessory)
-
The above modular product groups are substantially equivalent to the Zeiss Surgical Microscope Navigator (SMN) and Surgical Tool Navigator (STN) modular product groups manufactured by Carl Zeiss, Inc
-
The above modular product groups consist of a registration device, LED array hardware, and operational software. When coupled with the OTS workstation, the devices allow for preoperative and operative planning of surgical procedures through workstation images.
-
The accessories are intended as a visualization aid to surgery. When fitted to a surgical instrument, the LED array hardware allows the surgeon to correlate the instrument location to the patient scan data. Likewise, when attached to a microscope, the LED array hardware allows the surgeon to correlate the focused viewing area to patient scan data, and to guide the microscope to a desired target using workstation images.
-
The technological characteristics are the same or similar to those found with the predicate device where LED systems are used to provide tracking information as an aid to surgery.
1
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an abstract emblem that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 JUL
Ms. Lisa M. Benati · Senior Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803
Re: K981213 Trade Name: Universal Instrument Registration (UIS) Microscope Module I Regulatory Class: II Product Code: HAW Dated: April 1, 1998 Received: April 2, 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 M. Benati
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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) 594-4648. Additionally, for questions on the promotion and advertising of your devices, 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
3
510(k) Number (if known):___98 |2 |3
Device Name: UNIVERSAL INSTRUMENT REGISTRATION AND MICROSCOPE MODULE I ACCESSORIES TO RADIONICS' OPTICAL TRACKING SYSTEM (OTS). Indications For Use:
The system accessories are indicated for all cranial and spinal surgical procedures covered by the OTS where anatomical Spinal Surgicur procedures is is 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)
(Division Sign-Off)
Division of General Restoratio:
510(k) Number K981213
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Option: Formst 1-7-95)