VERIDOSE DIODES

K964785 · Victoreen, Inc. · IYE · Jun 13, 1997 · Radiology

Device Facts

• Record ID: K964785
• Device Name: VERIDOSE DIODES
• Applicant: Victoreen, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended 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.

Device Story

VeriDose Diodes are solid-state silicon radiation detectors used for relative measurement of ionizing radiation in therapeutic oncology. The device consists of a waterproof, color-coded molded plastic hemisphere containing buildup material and a radiation-sensitive diode connected to a coaxial cable with a BNC connector. During radiation therapy, the diode is attached to the patient's skin; it generates an electrical current directly proportional to the incident ionizing radiation. The device is operated by qualified clinical personnel who connect the diode to an external display device to read the output. The measurements provide independent verification of radiation dose at specific points of interest, assisting in quality assurance and clinical decision-making regarding patient treatment delivery. The device is designed to be more rugged and sensitive than traditional ionization chambers.

Clinical Evidence

Bench testing only. Performance specifications provided include linearity (better than 0.3% over 2-1000 cGy/min), angular dependence (less than 5% from 0-75 degrees, less than 10% from 75-90 degrees), and temperature sensitivity (less than 0.3% per degree C).

Technological Characteristics

Silicon diode radiation detector; waterproof, non-hygroscopic molded plastic housing; hemispherical buildup material (H2O equivalent or Al equivalent); BNC coaxial connector; 2.0 cGy/min to 1000 cGy/min range; 2 mm² effective detection area; 1.0 nC/R nominal output; 2-meter cable length; passive sensing (current generation proportional to radiation).

Indications for Use

Indicated for dose verification and quality assurance for patients undergoing radiation therapy.

Regulatory Classification

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.

Predicate Devices

• ISORAD Photon Detectors that are part of the Dual Dosimetry System, Model number 37-720 (K940660/S1)

Submission Summary (Full Text)

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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 13 1997

Victoreen, Inc.
6000 Cochran Road
Cleveland, Ohio 44139-3395

**Contact Person:**

Linda S. Morin
Director of Regulatory Affairs
and Quality Assurance
Phone: [phone]
Fax: [phone]

**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

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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 no. table

| 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 |

## GENERAL SPECIFICATIONS:

1. Range: 2.0 cGy / minute to 1000 cGy / minute.
2. Effective Detection Area: 2 mm²
3. Output, all models: 1.0 nC/R nominal
4. Cable length: 2 meters

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| 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 |

6. The sensitive area buildup material is hemispherical in shape.

7. The angular dependence is less than 5% over the 2 pi hemisphere from perpendicular incidence to 75 degrees and less than 10% from 75 to 90 degrees.

8. Linearity is better than 0.3% over the range of 2 cGy / min to 1000 cGy/min provided that dose-per-pulse remains constant.

9. There are both positive and negative polarity versions of each.

10. The temperature sensitivity is less than 0.3% per degree C.

11. The detectors are waterproof and are washable in cold disinfectant. They are molded in plastic that is non-hygroscopic.

12. The device has a BNC coaxial connector.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 13 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 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 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 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.

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 [phone] 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 [phone]. 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 [phone] or [phone] 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

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510(k) Number: K964785

Device Name: Veridose Diodes

Indications for Use:

These diodes are used to provide dose verification and quality assurance for patients undergoing radiation therapy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K964785

Prescription Use ☑ or Over-The-Counter Use ☐