MODEL 1014 PC ELECTROMETER

K092019 · Sun Nuclear Corp. · IYE · Sep 15, 2009 · Radiology

Device Facts

• Record ID: K092019
• Device Name: MODEL 1014 PC ELECTROMETER
• Applicant: Sun Nuclear Corp.
• Product Code: IYE · Radiology
• Decision Date: Sep 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The PC Electrometer Model 1014 is a dosimetry electrometer intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. . In addition the PC Electrometer Model 1014 is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40.

Device Story

PC Electrometer Model 1014 is a dosimetry tool for radiation oncology; measures ion current from ion chambers or diode dosimeters. Inputs: electrical signals from detectors; ambient temperature/pressure via internal/external sensors. Operation: high-impedance operational amplifiers with capacitors measure charge; adjustable ion chamber voltage bias (bipolar). Output: data transmitted via USB to PC for display/recording. Used in clinical settings by medical physicists for machine calibration (e.g., AAPM TG-51) and QA protocols (e.g., TG-40, TG-142). Benefits: enables precise radiation output verification and compliance with dosimetry standards.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Conductive enclosure (4cm x 10.5cm x 14cm) for EMI shielding; two triaxial BNC inputs; USB interface for power and data; internal temperature and pressure sensors; high-impedance operational amplifiers; LED status indicators.

Indications for Use

Indicated for use by medical physicists in radiation oncology to measure ion current from ion chambers or diode dosimeters for radiotherapy beam calibration and periodic quality assurance testing.

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

• Sun Nuclear Model 1010 Dosimetry Electrometer (K002444)

Submission Summary (Full Text)

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SEP 1 5 2009

# 510k Premarket Notification Summary

1692019

#### Submitted by:

Sun Nuclear Corporation 425-A Pineda Court Melbourne, FL 32940 Ph: 321-259-6862 Fax: [phone]

Classification Name: Unknown

Common Name: Electrometer

Proprietary Name: PC Electrometer - Model 1014

Establishment Registration Number: 1038814

Classification: Class II, Classification 901YE

To our knowledge, none have been established Performance Standards:

Substantial Equivalence: This instrument is similar in function to Sun Nuclear Model 1010 Dosimetry Electrometer #K002444

#### Description and Use:

The PC Electrometer Model 1014 has two triaxial BNC inputs for connection to ion chambers for dosimetric measurements. The ion chamber voltage bias can be adjusted to various levels at either polarity. For air density correction, there are internal temperature and pressure sensors that measure ambient conditions and an input for an external remote temperature sensor. A USB port provides power and data communication with a Personal Computer (PC) which runs the application software to display and record data; an auxiliary power jack is also provided in case USB power is not available. The conductive enclosure (4cm x 10.5cm x 14cm) provides EMI shielding and LED status indicators. The PC Electrometer Model 1014 is a Radiation Oncology Medical Physics tool used to measure ion current from either ion chambers or diode dosimeter. These applications include periodic or annual calibration of the radiation output of the delivery machine when a calibrated ion chamber is connected such as AAPM Report 67 (TG-51) as well as periodic QA applications that do not require calibrated radiation detectors, such as described in AAPM Report 13 (TG-22, 24), AAPM Report 46 (TG-40) TG-40 and soon to be published TG-142, an update to TG-40.

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### Intended Use:

The PC Electrometer Model 1014 is a dosimetry electrometer intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. . In addition the PC Electrometer Model 1014 is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40.

## Similarities and Differences between SNC Model 1010 and SNC Model 1014:

Similarities:

- 1. Both designed and manufactured by Sun Nuclear.
- 2. Both have similar Intended Uses
- 3. Both use high impedance operational amplifiers with capacitors to measure charge
- 4. Both measure bi-polar charge (current) from ion chambers and diode radiation detectors
- 5. Both have ion chamber voltage bias that can be adjusted to various levels at either polarity.

Differences:

- 1. 1014 has 2 detector inputs, 1010 has one
- 2. 1014 has (internal and external) temperature sensors and an internal pressure sensor, 1010 has none unless it was connected to the SNC Data Bridge.
- 3. 1014 has data logging ability to the PC; the 1010 required a SNC Data Bridge for data logging.
- 4. 1014 power comes from USB connection. 1010 uses internal batteries for power.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SEP 1 5 2009

Ms. Noel Downey Project Manager Sun Nuclear Corporation 425-A Pineda Court MELBOURNE FL 32940

Re: K092019

Trade/Device Name: 1014 - PC Electrometer Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 24, 2009 Received: July 6, 2009

#### Dear Ms. Downey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical )

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K092019

Device Name: 1014-PC Electrometer

Indications for Use:

The PC Electrometer Model 1014 is a dosimetry electrometer intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. . In addition the PC Electrometer Model 1014 is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perseription Use

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Over-The-Counter Use

Norri hothang

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

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