SUN 125C IONIZATION CHAMBER

K112981 · Sun Nuclear Corp. · LHN · Jan 25, 2012 · Radiology

Device Facts

• Record ID: K112981
• Device Name: SUN 125C IONIZATION CHAMBER
• Applicant: Sun Nuclear Corp.
• Product Code: LHN · Radiology
• Decision Date: Jan 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Ionization Chamber model 1041 is intended for the purpose of calibrating and measuring the ionizing radiation output from medical radiation therapy machines. This includes beam scanning as well as absolute dose calibration.

Device Story

The Sun 125c (model 1041) is a waterproof, cylindrical thimble-type ionization chamber used for radiation therapy quality assurance. It functions by applying an external voltage across an internal 0.125 cc ionization volume; ionizing radiation creates a current collected on a central electrode. The device is connected via a high-impedance triaxial cable to an external electrometer. It is vented to the atmosphere to allow for air density corrections. Used by medical physicists or technicians in clinical radiation therapy settings, the device provides raw current data to an electrometer, which the clinician uses to verify radiation beam profiles and perform absolute dose calibration. This ensures the accuracy of radiation delivery to patients, supporting safe and effective cancer treatment.

Clinical Evidence

No clinical data. The device relies on bench testing and comparison of physical principles to the predicate device to demonstrate substantial equivalence.

Technological Characteristics

Cylindrical thimble-type ionization chamber; 0.125 cc active volume; ABS plastic construction; triaxial cable with BNC or TNC connector; waterproof; vented to atmosphere for density correction; passive sensing principle.

Indications for Use

Indicated for use by medical professionals for the calibration and measurement of ionizing radiation output from medical radiation therapy machines, including beam scanning and absolute dose calibration.

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

• PTW 31006 1.015cc Pinpoint Ionization Chamber (K972212)

Submission Summary (Full Text)

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K112981

JAN 2 5 2012

# 510k Premarket Notification Summary

Date: September 30, 2011

#### Submitted by:

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

Classification Name: System, Radiation Therapy, Charged-Particle, Medical

Common Name: Ionization Chamber

Proprietary Name: Sun 125c Ionization Chamber

Establishment Registration Number: 1038814

Classification: Class II, Classification LHN

To our knowledge, none have been established Performance Standards:

Substantial Equivalence: This instrument is similar in function to PTW 31006 ~ 1.015cc Pinpoint Ionization Chamber, K972212.

#### Description and Use:

The Sun Nuclear model 1041 "SUN125c" is a waterproof, fully-guarded, cylindrical "thimble" type ionization chamber constructed primarily of ABS plastic. The chamber is mounted to a lownoise, high impedance triaxial cable which is terminated with either a bayonet (BNC) or threaded triaxial (TNC) connector. The ionization volume of the chamber is 0.125 cc, which is appropriate for beam scanning and absolute dose measurements. This active volume is vented to the atmosphere through the cable sheath, allowing for conventional air density corrections.

#### Intended Use:

The Ionization Chamber model 1041 is intended for the purpose of calibrating and measuring the ionizing radiation output from medical radiation therapy machines. This includes beam scanning as well as absolute dose calibration.

Similarities and Differences between SNC Sun 125c lonization Chamber and PTW 31006:

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### Similarities with Marketed Devices:

Both devices work on the same principles of:

- Application of an externally generated voltage across the ionization volume. .
- Collection of ion current on a central electrode, connected through a high impedance . cable to the measurement electrometer.
- Achieve a dosimetric response close to that of water .
- Atmospheric communication that allows air density correction t
- Waterproof ionization chamber .

### Differences with Marketed Devices

The Sun125c has a larger active measurement volume than the predicate device.

# Safety and Effectiveness

The indications for use, design, materials, manufacturing, and specifications of the Sun125c ionization chamber does not raise any issues with regards to safety and effectiveness.

## Comparison to Predicate device:

Sun Nuclear Corporation considers the Sun125c ionization chamber equivalent in all respects to the predicate devices for radiation therapy beam data acquisition.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. 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

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

JAN 2 5 2012

Re: K112981

Trade/Device Name: 1041-Scanning Ionization Chamber Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: September 30, 2011 Received: October 6, 2011

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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<11298 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

# Indications for Use:

The Ionization Chamber model 1041 is intended for the purpose of calibrating and measuring the ionizing radiation output from medical radiation therapy machines. This includes beam scanning as well as absolute dose calibration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use_

Mary Pastel

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K112981

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