(203 days)
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No
The description focuses on standard electrometer functions and data logging, with no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is used for the calibration of medical radiation beams, which are therapeutic. However, the device itself is a measurement tool and does not directly provide therapy.
No
The device is used for the precision measurement of ionizing radiation beams for calibration, not for diagnosing a medical condition in a patient.
No
The device description explicitly states it is a "battery-powered, stand-alone, precision electrometer" and mentions accommodating different types of ionization chambers and solid state detectors, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "precision measurement of ionizing radiation beams," specifically for "calibration of medical radiation beams." This is a measurement and calibration function related to medical equipment, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on measuring physical quantities like charge, current, dose, and dose rate, and accommodating different types of radiation detectors. It does not mention analyzing biological samples or providing diagnostic information about a patient's health.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition in a patient.
The device is clearly intended for quality control and calibration of medical radiation equipment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This device is intended to be used for precision measurement of ionizing radiation beams.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Tests conducted on calibrated equipment indicate that the PID-1 will measure to the specifications stated in the product literature.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for GAMMEX RMI. The text is in bold, black font. The RMI has a circled R symbol next to it.
SUMMARY OF SAFETY AND BETTECT MICRTESS
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: Company:
Telephone:
Thomas A. Demke, D.D.S. Gammex. Inc. 2500 W. Beltline Highway at University Ave. Middleton, WI 53562-0327 (608) 828-7260 August 15, 1995
PRODUCT IDENTIFICATION 2)
Date Summary Prepared:
| Brand Name: | PID-1 Precision Intelligent Dosimeter |
|---|---|
| Common Name: | Electrometer/Dosimeter |
| Classification Name: | Radiation Therapy Calibration Device |
MARKETED DEVICES 3)
Predicate Device:
Victoreen Model 530 Electrometer/Dosemeter (K931927)
DEVICE DESCRIPTION 4)
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.
INDICATIONS FOR USE 5)
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, W1 53562-0327 U.S.A.
1-608-828-7000 1-800-GAMMEX 1 (426-6391) FAX 1-608-828-7500
1
Summary Of Safety And Effectiveness PID-1 Page 2
COMPARISON WITH PREDICATE 6)
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.
SUMMARY OF STUDIES 7)
Tests conducted on calibrated equipment indicate that the PID-1 will measure to the specifications stated in the product literature.
CONCLUSIONS 8)
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.