(81 days)
THE CAPINTEC 292 ELECTROMETER IS INTENDED TO BE USED BY TRAINED MEDICAL PHYSICISTS OR QUALIFIED RADIATION THERAPY TECHNOLOGISTS TO PERFORM QUALITY ASSURANCE CHECKS AND MEASUREMENTS ON THE OUTPUT FROM THERAPEUTIC X-RAY MACHINES OR TELETHERAPY UNITS. WITH THE ADDITION OF AN OPTIONAL CAPINTEC CRC DOSE CALIBRATOR CHAMBER, THE 292 MAY ALSO BE USED BY TRAINED MEDICAL PAYSICISTS OR QUALIFIED TECHNOLOGISTS TO MEASURE RADIOACTIVE SOURCES USED FOR THERAPEUTIC OR DIAGNOSTIC TREATMENT.
The 292 is a precise and accurate software controlled low impedance electrometer with four measurement ranges, adjustable + bias voltage which can act as a dose or dose rate meter.
Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:
Acceptance Criteria and Device Performance Study for Capintec Model 292 Electrometer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 100% success in function and intended use | Excellent agreement between 292 and 192 electrometers when measuring x-ray machines (to the limits of reproducibility of individual x-ray machines). |
| 100% agreement between software algorithms and manual calculations. | |
| Agreed to within 1% between 292 (with CRC dose calibrator chamber) and CRC 15R dose calibrator when measuring NIST radioactive sources. | |
| Evaluation of suggestions for improvement in software/hardware from "beta test sites" | Suggestions were received and would be evaluated, tested, and incorporated if appropriate. |
| Correction of any problems discovered during beta testing | Problems would be corrected prior to release to production. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical "sample size" in terms of number of devices or number of measurements for the primary comparison. Instead, it describes:
- Test Set Description: "The same NIST calibrated ionization chamber was used with both the 192 and 292 electrometers, and measurements were made under a variety of accelerator and orthovoltage machine settings."
- Data Provenance: The measurements were likely conducted internally by Capintec or in collaboration with a National Institute of Standards and Technology (NIST) certified facility, given the use of "NIST calibrated ionization chamber" and "NIST radioactive sources." The "beta test sites," which contributed to identifying issues and suggestions, were described as "selected radiation oncology facilities." The data is likely prospective as it involves new testing of the 292 electrometer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify a distinct set of "experts" to establish a ground truth for the test set. Instead, the ground truth is established by:
- Reference Devices: The predicate devices (Capintec Model 192 electrometer and CRC 15R dose calibrator) served as the de-facto "ground truth" for comparison. These are established, pre-amendment devices or existing devices with proven performance.
- NIST Calibration: The use of "NIST calibrated ionization chamber" and "NIST radioactive sources" implies that the accuracy of the measurements and the reference values are traceable to national standards, which can be considered the highest form of metrological "ground truth."
- Implicit Expertise: While not explicitly stated as "experts," the "trained medical physicists or qualified radiation therapy technologists" who performed the measurements using the 192, 292, and CRC 15R would have the necessary qualifications to conduct these tests and interpret the results.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is described. The comparison relies on:
- Direct Measurement Comparison: Results from the 292 were directly compared to those from the predicate 192 electrometer and the CRC 15R dose calibrator.
- Software Verification: Software algorithms were verified against "manual calculations," suggesting a direct comparison without a complex multi-person adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where different human readers interpret cases with and without AI assistance. The Capintec Model 292 Electrometer is a measurement device, not an interpretive diagnostic tool, so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance evaluation of the algorithm (software) was explicitly done: "In addition, the software algorithms were verified against manual calculations and agreement was 100%." This verifies the internal logic and calculations performed by the device's software without direct human interpretation being part of the performance metric.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Reference Device Performance: The established, pre-amendment Capintec Model 192 electrometer and the CRC 15R dose calibrator served as the primary reference for performance comparison.
- NIST Traceability: The use of "NIST calibrated ionization chamber" and "NIST radioactive sources" indicates that the ground truth for the physical measurements is traceable to national metrological standards.
- Manual Calculation Verification: For the software, "manual calculations" served as the ground truth.
8. The Sample Size for the Training Set
The document does not specify a sample size for a "training set." The 292 electrometer is a microprocessor-based measurement device, not an AI/machine learning model that typically requires a distinct training set. The development process would involve traditional engineering, calibration, and testing, rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not directly applicable. The device's functionality is based on established physics principles and precision measurement, with performance verified against existing, validated devices and NIST standards.
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APR 2 4 1998
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CAPIN
510(k) SUMMARY
Submission Date: January 30, 1998
Pursuant to the requirements of Section 510(k) of the Food, Drug, and Cosmetic Act, notification is made of the intention of Capintec, Inc. to manufacture and market an electrometer used for output measurements of therapeutic x-ray machines, teletherapy units, or radioactive sources.
Capintec is divided into two physical locations as follows:
Corporate Headquarters Capintec. Inc. 6 Arrow Road Ramsey, New Jersey 07446 Phone 201-825-9500 201-825-1336 FAX
Manufacturing Facility Capintec, Inc. 540 Alpha Drive Pittsburgh, PA 15238 Phone 412-963-1988 FAX 412-963-0610
Contact Person: Mary Anne Dell Contact Site: Manufacturing Facility
Classification Name: Electrometer IYE (892.5050) (accessory item to linear accelerator) Classification Number: Common or Usual Name: Electrometer Capintec Model 292 Electrometer Proprietary Name: Establishment Registration Number: 2518843 Regulatory Class: II
Description: The 292 is a precise and accurate software controlled low impedance electrometer with four measurement ranges, adjustable + bias voltage which can act as a dose or dose rate meter.
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Substantial equivalence: The model 292 is a microprocessor based upgrade of the model 192 electrometer. Both units perform exactly the same function, measure current with high precision over a select range of interest, and convert the measured current to radiological units with appropriate conversion factors. Both units were developed for use with the same ionization chambers, and same application. The model 192 uses analog circuitry for measurement and calibration, while the 292 has replaced the analog circuitry with microprocessor based technology to provide enhanced performance specifications and better data manipulation. The 192 is a preamendment device which was first manufactured and distributed in 1973, and is still sold today.
Intended Use: The Capintec 292 electrometer is intended to be used by trained medical physicists or qualified radiation therapy technologists to perform quality assurance checks and measurements on the output from therapeutic linear accelerators or teletherapy units. With the addition of a Capintec CRC dose calibrator chamber, the 292 may also be used by trained medical physicists or qualified technologists to measure radioactive sources used for therapeutic or diagnostic treatment.
Test Results: The same NIST calibrated ionization chamber was used with both the 192 and 292 electrometers, and measurements were made under a variety of accelerator and orthovoltage machine settings. Test results from both electrometers show excellent agreement to the limits of the reproducibility of the individual x-ray machines. In addition, the software algorithms were verified against manual calculations and agreement was 100%.
After the addition of a CRC dose calibrator chamber to the 292, the same NIST radioactive sources were measured on the 292 and a CRC 15R dose calibrator. Results agreed to within 1%.
Capintec has released several 292 units to selected radiation oncology facilitates for clinical testing and evaluation and provided testing procedures to each site. Acceptance criteria is 100% success in function and intended use. Suggestions received for improvement in the software or hardware from these "beta test sites" will be evaluated, tested, and incorporated when appropriate. Any problems discovered during this process will be corrected prior to release to production for commercial shipment.
Conclusion: The 292 functions as intended and is substantially equivalent in performance and intended use to the 192 electrometer for measurement of output from therapy x-ray machines and equivalent to the CRC15R dose calibrator in performance and intended use for the measurement of radioactive sources used in therapy or diagnostic applications. The 292 provides significantly improved performance specifications and better data manipulation compared to its predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 1998
Mary Anne Dell, M.S. General Manager and Radiation Physicist Capintec, Inc. 540 Alpha Drive Pittsburgh, PA 15238
Re:
K980402 Capintec Model 292 Electrometer Dated: January 30, 1998 Received: February 2, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Dell:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
K980402 10(1) Number (if known):
Device Name: CAPINTEC MODEL 292 ELECTROMETER
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ﻟﻤﺖ. ﻋ
indic: tions l'or Use:
THE CAPINTEC 292 ELECTROMETER IS INTENDED TO BE USED BY TRAINED MEDICAL PHYSICISTS OR QUALIFIED RADIATION THERAPY TECHNOLOGISTS TO PERFORM QUALITY ASSURANCE CHECKS AND MEASUREMENTS ON THE OUTPUT FROM THERAPEUTIC X-RAY MACHINES OR TELETHERAPY UNITS.
WITH THE ADDITION OF AN OPTIONAL CAPINTEC CRC DOSE CALIBRATOR CHAMBER, THE 292 MAY ALSO BE USED BY:TRAINED MEDICAL PAYSICISTS OR QUALIFIED TECHNOLOGISTS TO MEASURE RADIOACTIVE SOURCES USED FOR THERAPEUTIC OR DIAGNOSTIC TREATMENT.
(F LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980402
Prescription Use
('er 2. CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.