(89 days)
Not Found
No
The device description focuses on mechanical and electrical components, radiation delivery mechanisms, and safety features. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is described as a "teletherapy device intended to be used for the stereotactic irradiation of intracranial structures," which is a therapeutic application.
No
The device is a teletherapy device intended for the stereotactic irradiation of intracranial structures, which is a treatment function, not a diagnostic one.
No
The device description clearly details physical components like a source carrier, shield, collimator, motors, limit switches, and a treatment unit, indicating it is a hardware-based medical device with a treatment planning system component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the stereotactic irradiation of intracranial structures." This describes a therapeutic procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a teletherapy device that delivers radiation for treatment. It involves a source of radiation, collimators, and a system for positioning and delivering the radiation to a specific area within the patient's head. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The OUR Rotafing Gamma System is a therapeutic device used for radiation therapy.
N/A
Intended Use / Indications for Use
The OUR Rotating Gamma System is a teletherapy device intended to be used for the stereotactic irradiation of intracranial structures.
Product codes
90 IWB
Device Description
The OUR Rotating Gamma System is a teletherapy device which contains 30 Co60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built-in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter. Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the 600 y-ray beams during treatment, 30 nonoverlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The y-ray treatment unit, b) the stereotactic localization system, and c) the treatment planning system.
To ensure mechanical safety, the system uses redundant limit switches to detect the positions of the doors, and the couch. Low torque motors are used such that all motions can be stopped by one hand. Electrical safety is ensured by use 24VDC power in the entire treatment unit with multiple current limiting breakers. Redundant timing devices are used for treatment timing accuracy. The novel radiation shutter reduces transient radiation exposure to patient's normal structures and adds radiation safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial structures
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)
Leksell Gamma Unit Model 23004
Reference Device(s)
Philips SRS-200
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5750 Radionuclide radiation therapy system.
(a)
Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.(b)
Classification. Class II.
0
MAY 20 1997
EXHIBIT #1 Page 1 of 5
V. SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY
This summary of (510k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : ____________________________________
| : | ﺎ ﺗﺮ |
|---|---|
| 4 10 |
,
| Submtter's Ientification | OUR Scientific International, Inc. 1 World Trade Center, Suite 7871 New York, NY 10048 | ||||||
|---|---|---|---|---|---|---|---|
| Date Summary Prepared | February 18, 1997 | ||||||
| Contact Person: | Vivian Guo, President (212) 524-9739 | ||||||
| Name of Device: | |||||||
| Proprietary:OUR Rotating Gamma SystemClassification:Radionuclide Radiation Therapy SystemCommon:Gamma System | Proprietary: | OUR Rotating Gamma System | Classification: | Radionuclide Radiation Therapy System | Common: | Gamma System | |
| Proprietary: | OUR Rotating Gamma System | ||||||
| Classification: | Radionuclide Radiation Therapy System | ||||||
| Common: | Gamma System | ||||||
| Predicate Device Information: | The OUR Rotating Gamma System is substantially equivalent to the Leksell Gamma Unit Model 23004, Type B, manufactured and marketed by Elekta Instruments. The predicate device has previously obtained FDA 510(k) clearance for marketing in the United States for the treatment of selected intracranial abnormalities. The equivalence is established based on the intended use, performance specifications, materials and technical characteristics. In one technical aspect, the OUR Rotating Gamma System is equivalent to the SRS-200 system by Philips Medical Systems, Inc. | ||||||
| Device Description: | The OUR Rotating Gamma System is a teletherapy device which contains 30 60 Co sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built-in" secondary collimator, which |
has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
1
EXHIBIT #1 Page 2 of 5
as a radiation shutter. Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the 600 y-ray beams during treatment, 30 nonoverlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The y-ray treatment unit, b) the stereotactic localization system, and c) the treatment planning system.
To ensure mechanical safety, the system uses redundant limit switches to detect the positions of the doors, and the couch. Low torque motors are used such that all motions can be stopped by one hand. Electrical safety is ensured by use 24VDC power in the entire treatment unit with multiple current limiting breakers. Redundant timing devices are used for treatment timing accuracy. The novel radiation shutter reduces transient radiation exposure to patient's normal structures and adds radiation safety.
The OUR Rotating Gamma System is intended to be used in the treatment of selected intracranial abnormalities, previously cleared by FDA for the Leksell Gamma Knife and for the Philips SRS-200 Radiosurgery System.
Patient-contacting materials include the screws employed in the stereotactic localization frame. Material composition of these screws consist of titanium. Specification TC 4/T-A6V/AMS 4928H which is not subject to biocompatibility testing.
Intended Use:
Biocompatibility Assessment:
2
Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The image is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OUR Scientific International, Inc. c/o Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 410 Great Neck, NY 11021
20 1997 MAY
Re: K970647 OUR Rotating Gamma System Stereotactic Radiosurgery Unit Dated: February 18, 1997 Received: February 20, 1997 Regulatory Class: II ... 21 CFR 892.5750/Procode: 90 IWB
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510k) notification of intent to market the device referenced above and we have decemined 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, ind Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrancing and adulteration.
If your device is classified (see above) into either class III (Premated Approval), it may be subject to such additional controls. Existing major regulations affecting your device in be Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. This response to your premarket notification does not affect any obligation you might have under sections 51 through 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 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please of 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 water 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,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
EXHÍBIT B
Page 1 of I
510(k) Number (if known): __
Device Name: OUR Scientific International, Inc. OUR Rotating Gamma System
Indications For Use:
.)
The OUR Rotafing Gamma System is a teletherapy device intended to be used for the stereotactic irradiation of intracranial structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Shmid a. Segmon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970647