(111 days)
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No
The description focuses on the physical construction and function of an ionization chamber for radiation measurement, with no mention of AI or ML.
No.
The device is intended for calibrating and measuring radiation output from medical radiation therapy machines, not for direct therapeutic application to patients.
No
The device is used to calibrate and measure the radiation output of medical radiation therapy machines, not to diagnose patients.
No
The device description clearly states it is a physical ionization chamber constructed of ABS plastic with a cable and connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "calibrating and measuring the ionizing radiation output from medical radiation therapy machines." This is a measurement and calibration device used in a clinical setting, but it does not involve testing samples taken from the human body (in vitro).
- Device Description: The description details a physical device for measuring radiation, not a test or reagent for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
The device is used to ensure the accuracy of medical equipment that treats patients, but it does not perform diagnostic testing on the patients themselves.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LHN
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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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: 321-259-7979 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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