(211 days)
The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.
The CNMC Model 206 is a dosimetry electrometer intended for measuring the output charge of an Ionization chamber or dosimetry diode that is used in a radiotherapy beam.
The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CNMC Model 206 Electrometer/Dosimeter:
General Note: The provided document is a 510(k) Premarket Notification Summary from the FDA. This document primarily focuses on establishing "substantial equivalence" to a predicate device, rather than providing a detailed report of a new clinical study with specific acceptance criteria and performance data for a novel device. Therefore, many of the requested items (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) are not typically found in this type of regulatory submission because the device is not a complex AI/ML system requiring extensive clinical validation. Instead, the focus is on demonstrating that the new device performs comparably to an already approved device.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The CNMC Model 206 Electrometer/Dosimeter is primarily evaluated for "substantial equivalence" to a predicate device (Sun Nuclear Model 1010/206 – K002444). The acceptance criteria are implicitly defined by the specifications of the predicate device and the new device's ability to meet those specifications. The "study" demonstrating this involves comparing the technical specifications and intended use of the CNMC Model 206 to the predicate device.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are the performance specifications of the predicate device, and the "reported device performance" is how the CNMC Model 206 matches or is equivalent to those specifications.
| Parameter | Acceptance Criteria (Predicate Device: Model 1010/206 K002444) | Reported Device Performance (CNMC Model 206) |
|---|---|---|
| Charge: | ||
| Range | 0.0001 pC to 1999.9 nC | 0.0001 pC to 1999.9 nC |
| Resolution | 10 fC | 10 fC |
| Current: | ||
| Range | 0.001 pA to 1999.9 uA | 0.001 pA to 1999.9 uA |
| Resolution | 1 fA | 1 fA |
| Bias voltage | -300/-150 to +300/+150 | -300/-150 to +300/+150 |
| Leakage Current | < 5 fA | < 5 fA |
| Power Supply | Six "D" Cell batteries | Six "D" Cell batteries |
| Battery Operation | Yes | Yes |
| RS 232 Interface | No | No |
| Chamber Library | No | No |
| Air Density Correction | No | No |
| Measuring Units | R, Gy, C, A, h, min, s | R, Gy, C, A, h, min, s |
| Display | Multifunction LCD | Multifunction LCD |
| Long Term Stability | ± 0.1% per year | ± 0.1% per year |
| Connector Type | Triaxial TNC, BNC | Triaxial TNC, BNC |
| How the device is used | Dosimetry electrometer for measuring output charge of an ion chamber in a radiotherapy beam, and for measurements with ion chamber or diode detectors for periodic QA testing. | Dosimetry electrometer for measuring output charge of an ion chamber in a radiotherapy beam, and for measurements with ion chamber or diode detectors for periodic QA testing. |
| Intended use | Radiation dosimetry | Radiation dosimetry |
| Detectors | ion chambers, diodes | ion chambers, diodes |
| Microprocessor controlled | No | No |
| External computer | Not required | Not required |
| Units of design | Identical design | Identical design |
| Testing to specifications | Tested to the same specifications | Tested to the same specifications |
Conclusion from document: The Model 206 is substantially equivalent to the predicate device because:
- The indication for use of the Model 206 is exactly the same as the predicate device.
- The units are of identical design.
- The Model 206 and the predicate device are tested to the same specifications.
- The Model 206 and the predicate device use the same vendors for purchasing of material for manufacturing.
- CNMC considers the Model 206 equivalent in all areas to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a substantial equivalence claim for a comparatively simple electrometer, detailed "test set" data in the context of clinical populations or image datasets is typically not required. The "test" here refers to whether the device's technical specifications match those of the predicate. Data provenance, if any, would be from internal engineering testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided in the document as there isn't a "ground truth" established by experts in the context of diagnostic interpretation (like in AI/ML products). The "ground truth" for an electrometer is its physical measurement accuracy, which is verified against calibrated standards, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for subjective assessments, particularly in medical imaging or clinical diagnosis. This device measures physical quantities and its performance is assessed against known standards, not through human adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is an electrometer/dosimeter, not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are entirely outside the scope of this device and its 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided. This device is a measurement instrument, not an algorithm. Its performance is always "standalone" in that it produces a measurement. The "human-in-the-loop" is the qualified personnel (medical physicists) who interpret and utilize the measurements for calibration and quality control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an electrometer's performance is typically established by traceable physical standards and calibrated reference instruments. The document doesn't explicitly state the methodology for this, but it implies that the device is "tested to the same specifications" as the predicate, which would involve comparison to these physical standards.
8. The sample size for the training set
This information is not applicable/provided. This device is a hardware measurement instrument and does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as item 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 3, 2015
CNMC Company Incorporated % Mr. Thomas Kraus Vice President R&D 865 Easthagen Drive NASHVILLE TN 37217
Re: K150265
Trade/Device Name: Model 206 Electrometer/Dosimeter Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: August 14, 2015 Received: August 17, 2015
Dear Mr. Kraus:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150265
Device Name Model 206 Electrometer/ Dosimeter
Indications for Use (Describe)
The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected. These instruments are used exclusively by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Premarket Notification Summary
CNMC Model 206 Dosimeter/Electrometer
| Submitter: | CNMC Company Incorporated865 Easthagen DriveNashville, Tennessee 37217 |
|---|---|
| Contact: | Thomas KrausVice President R&D615-391-3076tkraus@cnmcco.com |
| Date: | August 24, 2015 |
| Trade Names: | Model 206 Electrometer/ Dosimeter |
| Common Name: | Medical dosimeter, electrometer |
| Classification Name: | Medical charged-particle radiation therapy system (21 CFR 892.5050) |
| Classification: | Class II |
| Product Code: | IYE |
| Substantial Equivalence: | The CNMC Model 206 is substantially equivalent to the Sun Nuclear Model1010/206 – K002444. |
| Description and Use: | The CNMC Model 206 is a medical dosimeter, or medical electrometer that iscapable of performing measurements of diagnostic and therapeutic amountsof ionizing radiation when an appropriate ionization chamber or diodedosimeter is connected. These instruments are used exclusively by qualifiedpersonnel, typically medical physicists, for the calibration and quality control omedical equipment that produces ionizing radiation. |
| Intended Use: | The CNMC Model 206 is a dosimetry electrometer intended for measuring theoutput charge of an lonization chamber or dosimetry diode that is used in aradiotherapy beam. |
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865 Easthagan Drive, Nashville, TN 37217 phone 615 391 3076 800 635 2662 fax 615 885 0285 www.cnmcco.com www.teambest.com
healthcare for everyone
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Similarities/Differences of the CNMC Model 206 electrometer to their predicate device:
| Similarities/Differences of the CNMC Model 206 electrometer to their predicate device: | ||
|---|---|---|
| Model 206 | Model 1010/206K002444 | |
| How the device is used. | Dosimetry electrometer is used formeasuring the output charge of an ionchamber in a radiotherapy beam. Inaddition device is intended formeasurements with ion chamber ordiode detectors as recommendedduring periodic QA testing. | Dosimetry electrometer is used formeasuring the output charge of an ionchamber in a radiotherapy beam. Inaddition device is intended formeasurements with ion chamber ordiode detectors as recommendedduring periodic QA testing |
| Intended use | Radiation dosimetry | Radiation dosimetry |
| Detectors | ion chambers, diodes | ion chambers, diodes |
| Microprocessor controlled | no | no |
| External computer | Not required | Not required |
| Charge: | ||
| Range | 0.0001 pC to 1999.9 nC | 0.0001 pC to 1999.9 nC |
| Resolution | 10 fC | 10 fC |
| Current: | ||
| Range | 0.001 pA to 1999.9 uA | 0.001 pA to 1999.9 uA |
| Resolution | 1 fA | 1 fA |
| Bias voltage | -300/-150 to +300/+150 | -300/-150 to +300/+150 |
| Leakage Current | < 5 fA | < 5 fA |
| Power Supply | Six "D" Cell batteries | Six "D" Cell batteries |
| Battery Operation | Yes | Yes |
| RS 232 Interface | No | No |
| Chamber Library | No | No |
| Air Density Correction | No | No |
| Measuring Units | R, Gy, C, A, h, min, s | R, Gy, C, A, h, min, s |
| Display | Multifunction LCD | Multifunction LCD |
| Long Term Stability | ± 0.1% per year | ± 0.1% per years |
| Connector Type | Triaxial TNC, BNC | Triaxial TNC, BNC |
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865 Easthagan Drive, Nashville, TN 37217 phone 615 391 3076 800 635 2662 fax 615 885 0285 www.cnmcco.com www.teambest.com
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| Conclusion: | The model 206 is substantially equivalent to the predicatedevice for the following reasons: |
|---|---|
| 1. The indication for use of the Model 206 is exactly thesame as the predicate device. | |
| 2. The units are of identical design. | |
| 3. The Model 206 and the predicate device are tested to | |
| the same specifications. | |
| The Model 206 and the predicate device uses the |
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- The Model 206 and the predicate device uses the বা same vendors are for purchasing of the material for manufacturing
-
- CNMC considers the Model 206 equivalent in all areas to the predicate device.
865 Easthagan Drive, Nashville, TN 37217 phone 615 391 3076 800 635 2662 fax 615 885 0285 www.cnmcco.com www.teambest.com
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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.