(196 days)
K940660/S1
Not Found
No
The description focuses on a physical device (diode, cable, connector) for dose measurement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for dose verification and quality assurance in radiation therapy, not for treating a disease or condition itself.
No
Explanation: The device is described as providing dose verification and quality assurance for radiation therapy, which is a treatment process. While it measures aspects related to the patient's treatment, it is for quality assurance of the therapy itself (dose verification) and not for diagnosing a condition or disease in the patient.
No
The device description explicitly states it consists of physical components like a molded plastic hemisphere, a radiation-sensitive diode, a coaxial cable, and a BNC connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dose verification and quality assurance for patients undergoing radiation therapy." This is a direct measurement of radiation dose delivered to a patient's skin, which is an in vivo measurement (within a living organism).
- Device Description: The device is placed on the patient's skin to measure radiation.
- 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. This device does not analyze such samples.
The device is used for monitoring and quality control during a medical procedure performed on a patient, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
The VeriDose solid state detectors are used to make relative measurements of radiation in therapeutic oncology. Silicon diode detectors have been in use for many years for the measurement of both photons and electrons used in radiation. The VeriDose is intended for the detection of ionizing radiation, it should only be used by persons who have the proper interpretation of its readings and the appropriate safety procedures to be followed in the presence of radiation. The diodes are taped or otherwise attached to a patient's skin during a therapeutic oncology session where the patient is being exposed to radiation. The diodes produce a current directly proportional to the ionizing radiation to which they are exposed. The diodes are more rugged and more sensitive than ionization chambers and are waterproof. They must be connected to an appropriate display device. The purpose of the diode is to measure ionizing radiation independently at various points of interest. The responsible operator should verify the characteristics of each specific detector if the exact parameter is critical to any given clinical application.
These diodes are used to provide dose verification and quality assurance for paţients undergoing radiation therapy.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
The product consists of a waterproof color coded molded plastic hemisphere containing the appropriate buildup material and a radiation sensitive diode attached to a coaxial cable. A BNC connector is supplied for connection to a readout device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
persons who have the proper interpretation of its readings and the appropriate safety procedures to be followed in the presence of radiation.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K940660/S1
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
: Exhibit "C"
K96.4785-
Premarket Notification [510(k)] Summary as required by section 807.92(c)
Date Summary was prepared:
November 21, 1996
Submitter's Name:
JUN 1 3 1997
Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395
Contact Person:
Linda S. Morin Director of Regulatory Affairs and Quality Assurance Phone: 216-248-9300 Fax: 216-248-9301
Device Name:
Veridose Diodes
Classification Name:
Medical Charged-Particle Radiation Therapy System
Predicate Device:
ISORAD Photon Detectors that are part of the Dual Dosimetry System, Model number 37-720, 510(k) number K940660/S1
Intended Use:
(Function): The VeriDose solid state detectors are used to make relative measurements of radiation in therapeutic oncology. Silicon diode detectors have been in use for many years for the measurement of both photons and electrons used in radiation. The VeriDose is intended for the detection of ionizing radiation, it should only be used by persons who have the proper interpretation of its readings and the appropriate safety procedures to be followed in the presence of radiation. The diodes are taped or otherwise attached to a
1
patient's skin during a therapeutic oncology session where the patient is being exposed to radiation. The diodes produce a current directly proportional to the ionizing radiation to which they are exposed. The diodes are more rugged and more sensitive than ionization chambers and are waterproof. They must be connected to an appropriate display device. The purpose of the diode is to measure ionizing radiation independently at various points of interest. The responsible operator should verify the characteristics of each specific detector if the exact parameter is critical to any given clinical application.
Product Description:
The product consists of a waterproof color coded molded plastic hemisphere containing the appropriate buildup material and a radiation sensitive diode attached to a coaxial cable. A BNC connector is supplied for connection to a readout device.
| Model # | Description | Color Code |
|---|---|---|
| 30-471 | VeriDose Diode, 1-4 MV Photon, (positive polarity) | Blue |
| 30-471-8000 | VeriDose Diode, 1-4 MV Photon, (negative polarity) | Blue |
| 30-472 | VeriDose Diode, 6-12 MV Photon, (positive polarity) | Yellow |
| 30-472-8000 | VeriDose Diode, 6-12 MV Photon, (negative polarity) | Yellow |
| 30-473 | VeriDose Diode, 12-18 MV Photon, (positive polarity) | Red |
| 30-473-8000 | VeriDose Diode, 12-18 MV Photon, (negative polarity) | Red |
| 30-474 | VeriDose Diode, 18-25 MV Photon, (positive polarity) | Green |
| 30-474-8000 | VeriDose Diode, 18-25 MV Photon, (negative polarity) | Green |
| 30-475 | VeriDose Diode, 6-25 MeV Electron, (positive polarity) | Silver |
| 30-475-8000 | VeriDose Diode, 6-25 MeV Electron, (negative polarity) | Silver |
| 30-476 | VeriDose Diode, Energy Compensated Photon, (positive polarity) | Black |
| 30-476-8000 | VeriDose Diode, Energy Compensated, (negative polarity) | Black |
Model no. table
GENERAL SPECIFICATIONS:
-
- Range:
2.0 cGy / minute to 1000 cGy / minute. 2 mm²
- Range:
-
- Effective Detection Area:
-
- Output, all models: 1.0 nC/R nominal
-
- Cable length:
-
2 meters
- 2
2
| Range | Particle | Optimal Build-up | mg/cm2 | Same as Isorad
Build-up | Color Dot |
|-------------|----------|--------------------|--------|----------------------------|-----------|
| 1-4 MV | Photon | 5 mm H2O equiv. | 826 | Yes | Blue |
| 6-12 MV | Photon | 15 mm H2O equiv. | 1500 | Yes | Yellow |
| 12-18 MV | Photon | 28 mm H2O equiv. | 2800 | No | Red |
| 18-25 MV | Photon | 36 mm H2O equiv. | 3600 | No | Green |
| 6-25 MeV | Electron | 1 mm Al equiv. | 275 | Yes | Silver |
| 100-662 keV | Photons | Energy Compensated | | No | Black |
- The sensitive area buildup material is hemispherical in shape. 6.
- The angular dependence is less than 5% over the 2 pi hemisphere from 7. perpendicular incidence to 75 degrees and less than 10% from 75 to 90 degrees.
- Linearity is better than 0.3% over the range of 2 cGy / min to 1000 cGy/min 8. provided that dose-per-pulse remains constant.
- There are both positive and negative polarity versions of each. 9.
- The temperature sensitivity is less than 0.3% per degree C. 10.
- The detectors are waterproof and are washable in cold disinfectant. They are 11. molded in plastic that is non-hygroscopic.
-
- The device has a BNC coaxial connector.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Linda S. Morin Corporate Director of Regulatory Affairs and Quality Assurance Victoreen, inc. 6000 Cochran Road Cleveland, Ohio 44139-3395
Re: K964785
VeriDose Diodes Medical Charged-Particle Radiation Therapy System Dated: April 18, 1997 Received: April 25, 1995 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Morin:
We have reviewed your Section SIOR) 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, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 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 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 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 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 disgnostic 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 contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entiled, "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,
William Y
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
4
K964785 510(k) Number:
Veridose Diodes Device Name:
Indications for Use:
These diodes are used to provide dose verification and quality assurance for paţients undergoing radiation therapy.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harild A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use _
1794 ประเทศ
or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________