Model 206 Electrometer/Dosimeter

K150265 · Cnmc Company Incorporated · IYE · Sep 3, 2015 · Radiology

Device Facts

• Record ID: K150265
• Device Name: Model 206 Electrometer/Dosimeter
• Applicant: Cnmc Company Incorporated
• Product Code: IYE · Radiology
• Decision Date: Sep 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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.

Device Story

Medical dosimeter/electrometer; measures ionizing radiation output charge; inputs from connected ionization chambers or diode dosimeters; used by medical physicists in clinical settings for calibration and quality control of radiotherapy equipment; battery-operated (six D-cells); features multifunction LCD display; provides charge and current measurements; no microprocessor control; no external computer required; aids in ensuring accurate radiation delivery for patient treatment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Medical electrometer; non-microprocessor controlled; battery-powered (six D-cell batteries); analog-style operation; inputs via Triaxial TNC or BNC connectors; output via multifunction LCD; measures charge (0.0001 pC to 1999.9 nC) and current (0.001 pA to 1999.9 uA); leakage current < 5 fA; bias voltage -300/-150 to +300/+150; long-term stability ± 0.1% per year.

Indications for Use

Indicated for use by qualified personnel, typically medical physicists, for the calibration and quality control of medical equipment that produces ionizing radiation, specifically for measuring output charge of ionization chambers or dosimetry diodes in radiotherapy beams.

Regulatory Classification

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.

Predicate Devices

• Sun Nuclear Model 1010/206 (K002444)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [e-mail]

"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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Image /page/3/Picture/0 description: The image shows the logo for a company called "CNMC". The letters are in a stylized font, with the top half of the letters in blue and the bottom half in green. Below the logo is the text "a Best Medical International company" in a smaller font. The logo is simple and modern, and the colors are eye-catching.

## 510(k) Premarket Notification Summary

## CNMC Model 206 Dosimeter/Electrometer

| Submitter: | CNMC Company Incorporated<br>865 Easthagen Drive<br>Nashville, Tennessee 37217 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Thomas Kraus<br>Vice President R&D<br>615-391-3076<br>[e-mail] |
| 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<br>1010/206 – K002444. |
| Description and Use: | The CNMC Model 206 is a medical dosimeter, or medical electrometer that is<br>capable of performing measurements of diagnostic and therapeutic amounts<br>of ionizing radiation when an appropriate ionization chamber or diode<br>dosimeter is connected. These instruments are used exclusively by qualified<br>personnel, typically medical physicists, for the calibration and quality control o<br>medical equipment that produces ionizing radiation. |
| Intended Use: | The CNMC Model 206 is a dosimetry electrometer intended for measuring the<br>output charge of an lonization chamber or dosimetry diode that is used in a<br>radiotherapy beam. |

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865 Easthagan Drive, Nashville, TN 37217 phone [phone] 635 2662 fax [phone] www.cnmcco.com www.teambest.com

healthcare for everyone

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Image /page/4/Picture/0 description: The image shows the CNMC logo, with the letters in blue and green. The top half of the letters are blue, and the bottom half are green. The text "a Best Medical International company" is below the logo.

#### 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<br>K002444 |
| How the device is used. | Dosimetry electrometer is used for<br>measuring the output charge of an ion<br>chamber in a radiotherapy beam. In<br>addition device is intended for<br>measurements with ion chamber or<br>diode detectors as recommended<br>during periodic QA testing. | Dosimetry electrometer is used for<br>measuring the output charge of an ion<br>chamber in a radiotherapy beam. In<br>addition device is intended for<br>measurements with ion chamber or<br>diode detectors as recommended<br>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 | < 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 [phone] 635 2662 fax [phone] www.cnmcco.com www.teambest.com

Image /page/4/Picture/5 description: The image features a logo for "Best healthcare for everyone." The logo is set against a blue background. Above the word "Best" is a circle of green figures holding hands, and below the word "Best" is the tagline "healthcare for everyone."

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Image /page/5/Picture/0 description: The image shows the logo for a company called "CNMC". The letters are split into two colors, with the top half of the letters in blue and the bottom half in green. To the right of the letters is a green plus sign. Below the letters is the text "a Best Medical International company".

| Conclusion: | The model 206 is substantially equivalent to the predicate<br>device for the following reasons: |
|-------------|-------------------------------------------------------------------------------------------------|
| | 1. The indication for use of the Model 206 is exactly the<br>same 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
- 5. CNMC considers the Model 206 equivalent in all areas to the predicate device.

865 Easthagan Drive, Nashville, TN 37217 phone [phone] 635 2662 fax [phone] www.cnmcco.com www.teambest.com

Image /page/5/Picture/5 description: The image features the word "Best" in a stylized font, with the tagline "healthcare for everyone" underneath. Above the word "Best" is a graphic of several green figures holding hands in a circle. The background is a gradient of blue, with a lighter shade at the top and a darker shade at the bottom.