(211 days)
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No
The document describes a standard medical dosimeter/electrometer for measuring radiation, with no mention of AI or ML capabilities in its function, intended use, or description.
No
The device is a medical dosimeter used for calibrating and quality control of medical equipment that produces ionizing radiation, not for directly treating patients.
No
The device is described as a medical dosimeter/electrometer used for measuring amounts of ionizing radiation and for the calibration and quality control of medical equipment that produces ionizing radiation. It is not used for diagnosing medical conditions in patients.
No
The device description explicitly states it is a "medical dosimeter, or medical electrometer" and is capable of performing measurements when an "appropriate ionization chamber or diode dosimeter is connected," indicating it is a hardware device that interacts with other hardware components.
Based on the provided text, the CNMC Model 206 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a medical dosimeter/electrometer used for measuring ionizing radiation output from medical equipment. This is an in vivo measurement (measuring radiation delivered to a patient or phantom), not an in vitro measurement (measuring substances in samples taken from the body).
- Device Description: The description reinforces its function in measuring radiation from medical equipment.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or diagnosing diseases based on sample analysis.
Therefore, the CNMC Model 206 falls under the category of a medical device used for quality control and calibration of radiation-producing equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYE
Device Description
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.
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
qualified personnel, typically medical physicists
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)
Sun Nuclear Model 1010/206 – K002444
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Premarket Notification Summary
CNMC Model 206 Dosimeter/Electrometer
| Submitter: | CNMC Company Incorporated
865 Easthagen Drive
Nashville, Tennessee 37217 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Thomas Kraus
Vice President R&D
615-391-3076
tkraus@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 Model
1010/206 – K002444. |
| Description and Use: | 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 o
medical equipment that produces ionizing radiation. |
| Intended Use: | The CNMC Model 206 is a dosimetry electrometer intended for measuring the
output charge of an lonization chamber or dosimetry diode that is used in a
radiotherapy 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 1010/206 | |
| K002444 | ||
| How the device is used. | Dosimetry electrometer is used for | |
| measuring the output charge of an ion | ||
| chamber in a radiotherapy beam. In | ||
| addition device is intended for | ||
| measurements with ion chamber or | ||
| diode detectors as recommended | ||
| during periodic QA testing. | Dosimetry electrometer is used for | |
| measuring the output charge of an ion | ||
| chamber in a radiotherapy beam. In | ||
| addition device is intended for | ||
| measurements with ion chamber or | ||
| diode detectors as recommended | ||
| during 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 |