PID-1 PRECISION INTELLIGENT DOSIMETER

K954564 · Gammex, Inc. · IYE · Apr 22, 1996 · Radiology

Device Facts

• Record ID: K954564
• Device Name: PID-1 PRECISION INTELLIGENT DOSIMETER
• Applicant: Gammex, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

This device is intended to be used for precision measurement of ionizing radiation beams.

Device Story

Battery-powered, stand-alone electrometer/dosimeter; measures charge, charge rate (current), dose, and dose rate of ionizing radiation beams. Inputs: ionization chambers and solid-state detectors. Features: automatic time/date logging; manual temperature/pressure entry for measurement correction; data transfer to host computer. Used by medical physicists/technicians for radiation beam calibration. Output: numerical radiation measurements; data logs. Benefit: ensures accurate radiation therapy equipment calibration.

Clinical Evidence

Bench testing only. Device performance verified against calibrated equipment to confirm adherence to product literature specifications.

Technological Characteristics

Battery-powered electrometer; compatible with ionization chambers and solid-state detectors. Includes data logging and host computer interface. Stand-alone form factor.

Indications for Use

Indicated for precision measurement of ionizing radiation beams in clinical or laboratory settings for calibration of medical radiation equipment. Not for direct use on patients.

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

• Victoreen Model 530 Electrometer/Dosemeter (K931927)

Submission Summary (Full Text)

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K954564

Gammex

GAMMEX RMI®

# SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h).

## 1) SUBMITTER

Contact: Thomas A. Demke, D.D.S.
Company: Gammex, Inc.
2500 W. Beltline Highway at University Ave.
Middleton, WI 53562-0327
Telephone: [phone]
Date Summary Prepared: August 15, 1995

## 2) PRODUCT IDENTIFICATION

Brand Name: PID-1 Precision Intelligent Dosimeter
Common Name: Electrometer/Dosimeter
Classification Name: Radiation Therapy Calibration Device

## 3) MARKETED DEVICES

Predicate Device: Victoreen Model 530 Electrometer/Dosemeter (K931927)

## 4) DEVICE DESCRIPTION

The PID-1 Precision Intelligent Dosimeter is a battery-powered, stand-alone, precision electrometer for the calibration of medical radiation beams. It is designed to accommodate different types of ionization chambers and solid state detectors. The PID-1 also incorporates features for logging and transferring measured data to a host computer for analysis.

The PID-1 measures charge, charge rate (current), dose and dose rate. Time and date of measurement are automatically stored with the data. Temperature and pressure data can be entered for automatic correction of measurements.

## 5) INDICATIONS FOR USE

This device is intended to be used for precision measurement of ionizing radiation beams.

Gammex, Inc.
2500 West Beltline Hwy. at University Avenue
P.O. Box 620327
Middleton, WI 53562-0327 U.S.A.
1-608-828-7000
1-800-GAMMEX 1 (426-6391)
FAX [phone]

Milwaukee, WI • Middleton, WI • Benicia, CA • Bad Münstereifel, Germany • Nottingham, England

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Summary Of Safety And Effectiveness
PID-1
Page 2

6) COMPARISON WITH PREDICATE

The PID-1 has the same intended use as the Victoreen Model 530 Electrometer/Dosemeter. Both devices allow the operator to measure the charge, charge rate (current), dose (exposure) and dose rate from ionizing radiation beams. These devices are compatible with similar types of radiation probes. The devices are of similar size and weight. Neither device is intended for direct use on patients.

7) SUMMARY OF STUDIES

Tests conducted on calibrated equipment indicate that the PID-1 will measure to the specifications stated in the product literature.

8) CONCLUSIONS

Gammex considers the PID-1 to be substantially equivalent to the Victoreen Model 530 Electrometer/Dosemeter. Comparison of the features indicates that the intended use and effectiveness of the PID-1 do not significantly differ from the predicate device. The PID-1 does not raise any new potential safety risks.

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