(87 days)
Not Found
No
The description focuses on optical tracking and fiducial markers for localization, with no mention of AI or ML techniques.
No
The device is used for patient positioning and localization during stereotactic radiosurgery or radiotherapy, which are therapeutic procedures, but the device itself does not directly provide therapy. It assists in delivering the therapy accurately.
No
The device is used for precise localization of the treatment isocenter relative to the LINAC isocenter for stereotactic radiosurgery or radiotherapy, which is a treatment delivery function, not a diagnostic one. It aids in placing patients for treatment, not in identifying a disease or condition.
No
The device description explicitly lists hardware components such as a camera array, computer workstation, biteblock optical positioner, and optical calibration jig, indicating it is not a software-only device.
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 RadioCameras™ Biteblock Positioning and Localization System is used to position a patient for radiation therapy. It uses imaging data (CT or MR) and optical tracking to align the patient's cranial lesion with the linear accelerator's isocenter.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on physical positioning and localization based on external markers and imaging data.
Therefore, the device falls under the category of a medical device used for treatment planning and delivery, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The RadioCameras™ Biteblock Positioning and Localization System is indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The RadioCameras™ System provides precise localization and positioning of the cranial lesions relative to the LINAC isocenter.
Product codes
90 IYE
Device Description
This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy on cranial lesions. The RadioCameras™ System uses fiducial markers on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the treatment isocenter relative to the LINAC isocenter. The RadioCameras™ System uses an infrared camera and array, computer workstation, a biteblock optical positioner, and an optical calibration jig.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR scans
Anatomical Site
cranial lesions
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows a handwritten text string that appears to be "K181346". The text is written in a bold, somewhat stylized font, with thick strokes. The numbers and letters are connected, giving the impression of a continuous, flowing script.
JUL 10 1998
510(k) Summary
RadioCameras™ Biteblock Localization and Positioning System
Company: I.
Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
RadioCameras™ Biteblock Localization and Positioning System Product Name: II.
This submission describes a system that is intended to be used to place patients at III. The isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy the isocines on cranial lesions. The RadioCameras™ System uses fiducial markers procedures on cramal lessons. "The ent site on CT or MR scans and optical tracking
on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the of mirators manors on the LINAC isocenter. The RadioCameras™ System treatinent isocontor relative is as and a array, computer workstation, a biteblock optical positioner, and an optical calibration jig.
- The RadioCameras™ System was shown to be substantially equivalent to the IV. The RadioCalificas - Bystem was class on and positioning systems for use in conjunction with linear accelerator-based stereotactic radiosurgery and radiotherapy.
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Image /page/1/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the right and text on the left. The text is arranged in a circular fashion, and it appears to be the words "DEPARTMENT OF HEALTH & HUMAN SERVICES". The bird symbol is composed of three curved lines that suggest the shape of a bird in flight.
JUL 10 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Roger White Group Director Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020
Re:
K981346 RadioCameras™ Biteblock Localization and Positioning System Dated: April 13, 1998 Received: April 14, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. White:
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 morked in invested commerce prior to May 28, 1976, the ensetment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the povisions of the Poderal Food, Drog, and Connectic Act (Act. You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actionished requirements for annual registration, listing of devices, good manufacturing proctice, libeling, and problems against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematice Approval), it may be subject Title 21 Parts 800 to 806 A minimalians affecting you device can be found in the Code of Federal Regulations Title 21, Parts 800 to 895. A substantially equivalent desement on a compliance with the Curred Cool Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR) Part 820) and that, the periodic QS inspections, the Food and Drug Administration (FDA). Will verify such assemptions. Failure to comply with the GMP regulation may result in regulatory and in addition, FDA may publish further wheninger does not offer your device in the Echnal Register. Please note: this response to your premarket notification submission docs not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial quivalence of your device to a legally marketed production 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 yitry disgnotic devices), please contact the Office of Campione at (30 l Art of 1 and manufactions on the promotions on the promotion and advertising of your device, please contact the Office of Complises of Concellent, the prounding the explation catitled, "Misbranding by reference to premarket assisted (2) CFR 807.97). Other general information on your responsibilities under the Art may be obtained from the Division of Small Manufacturers Assistance at its toll-for muniter (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odr/dismaddsmanain.html"
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K18/346
RadioCameras™ Biteblock Positioning and Localization System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The RadioCameras™ Biteblock Positioning and Localization System is indicated
Stated The RadioCameras™ Bitcolock I ostudions in Derform Sterescactic Radiosurgery or
for use with a Linear Accelerator to perform Suctem provides r for use with a Linear Accelerator to perolin Siccessons over on ovides precise
Radiotherapy on cranial lesions. The RadioCameras™ System provides precise Radiotherapy on cranial lessons. The Ratherations of the arrants isocenter.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Lhard le. Seym
on of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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