(111 days)
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.
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.
This 510(k) premarket notification describes the Sun 125c Ionization Chamber (model 1041), a medical device intended for calibrating and measuring ionizing radiation output from medical radiation therapy machines, including beam scanning and absolute dose calibration. It does not contain information about studies with patient data, AI/human reader performance, or ground truth establishment in a medical diagnostic context. The submission focuses on device safety and equivalence to a predicate device based on engineering principles and performance specifications.
Here's an analysis based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in the form of a detailed table or report a study with performance metrics like accuracy, sensitivity, or specificity in a clinical diagnostic context. Instead, the "acceptance criteria" are implied by the comparison to a predicate device and the demonstration of similar functional principles and safety.
The reported "device performance" is primarily characterized by its design specifications and functionalities, as well as its similarity to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Works on principles of externally generated voltage across ionization volume | "Application of an externally generated voltage across the ionization volume." |
| Collects ion current on a central electrode | "Collection of ion current on a central electrode..." |
| Achieves a dosimetric response close to that of water | "Achieve a dosimetric response close to that of water." |
| Atmospheric communication allowing air density corrections | "Atmospheric communication that allows air density correction." |
| Waterproof design | "Waterproof ionization chamber." |
| Appropriate for beam scanning and absolute dose measurements | "The chamber is... appropriate for beam scanning and absolute dose measurements." |
| Does not raise safety and effectiveness issues compared to predicate | "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." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission focuses on the technical specifications and equivalence of the device, not on clinical performance studies involving patient data or a specific "test set" in the context of diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided as the device is not for diagnostic interpretation of medical data where expert radiologists or similar specialists would establish ground truth.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a diagnostic test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed or mentioned in this submission. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, which is not the primary function of this ionization chamber.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not performed or mentioned. This device is a physical instrument for measurement, not an AI algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" in this context is based on established physics principles of radiation dosimetry and metrology. The "truth" is derived from calibrated standards and known physical properties, not from pathology, outcomes data, or expert consensus in a diagnostic sense. The device is validated against the expected physical behavior of an ionization chamber and its ability to measure radiation accurately according to these principles.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical instrument, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
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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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<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
3-1
§ 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.