Veenstra Instruments VDC-506 Dose Calibrator

K142325 · Comecer Netherlands B.V. · KPT · Sep 18, 2014 · Radiology

Device Facts

• Record ID: K142325
• Device Name: Veenstra Instruments VDC-506 Dose Calibrator
• Applicant: Comecer Netherlands B.V.
• Product Code: KPT · Radiology
• Decision Date: Sep 18, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1360
• Device Class: Class 2

Intended Use

The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.

Device Story

VDC-506 Dose Calibrator measures radioactive material in vials, syringes, and capsules; utilizes VIK-202 ionization chamber (argon-filled, pressurized well chamber) to detect radiation; PC-based software (Windows XP or higher) acts as control and display unit; connected via RS-232 cable. Used by clinicians to prepare radiopharmaceutical kits, verify activity before injection, and quantify residual activity post-injection. Provides quantitative activity readouts; assists in ensuring accurate dosing for patient safety. System includes QA protocols for daily/quarterly checks and Mo-99 breakthrough protocol.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 61145 (calibration/usage), IEC 61303 (radionuclide calibrator performance), and IEC 62366 (usability). Software verified and validated per IEC 62304 and FDA guidance.

Technological Characteristics

Argon-filled, pressurized well ionization chamber (VIK-202); 150V lithium battery ionization voltage; PC-based control/display via RS-232; Windows XP or higher OS; measurement range 0.001 MBq–200 GBq; accuracy ±3%; linearity ±1%. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61145, IEC 61303, IEC 62304, IEC 62366.

Indications for Use

Indicated for use in the preparation of radiopharmaceuticals and verification of radioactive activity prior to patient administration in clinical settings.

Regulatory Classification

Identification

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

Predicate Devices

• Nuclear Associates Cal/Rad Mark VI/VDC 505 Dose Calibrator, Model 34-165 (K030066)

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 18, 2014

Comecer Netherlands b.v. % Mr. Thomas Kroenke Principal Correspondent Speed To Market, Inc. P.O. Box 3018 NEDERLAND CO 80466

Re: K142325

Trade/Device Name: Veenstra Instruments Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator Regulatory Class: II Product Code: KPT Dated: August 22, 2014 Received: August 25, 2014

Dear Mr. Kroenke:

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 device-related 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/Resourcesfor You/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. O'Hara for

Janine M. Morris 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

510(k) Number (if known) K142325

Device Name

Veenstra Instruments VDC-506 Dose Calibrator

#### Indications for Use (Describe)

The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| Submission Date: | 14 August 2014 | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------------------------|
| Submitter: | Comecer Netherlands b.v.<br>Madam Curieweg 1<br>Joure, Fryslan 8501 XC<br>The Netherlands | | |
| Submitter Contact: | Mr. Gert Jan Klok<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Application<br>Correspondent: | Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>Mr. Thomas Kroenke<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Manufacturing Site: | Comecer Netherlands b.v.<br>Madam Curieweg 1<br>Joure, Fryslan 8501 XC<br>The Netherlands | | |
| Trade Name: | Veenstra Instruments VDC-506 Dose Calibrator | | |
| Common Name: | Radionuclide dose calibrator | | |
| Classification Name: | Radionuclide dose calibrator | | |
| Classification<br>Regulation: | 21 CFR §892.1360 | | |
| Product Code: | KPT | | |
| Substantially<br>Equivalent Devices: | New Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Veenstra Instruments<br>VDC-506 Dose<br>Calibrator | K030066 | Nuclear Associates<br>Cal/Rad Mark VI/VDC<br>505 Dose Calibrator,<br>Model 34-165 |

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| Device Description: | The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is a<br>software application installed on a personal computer (PC) running<br>Windows XP, and is used in conjunction with the Veenstra Instruments<br>VIK-202 ionization chamber (VIK-202) to measure the radioactive<br>strength of radioactive material in vials, syringes and ampoules placed<br>inside the ionization chamber.<br><br>The VDC-506 software, in conjunction with the PC, serves as the<br>control mechanism and display for the VIK-202 ionization chamber.<br>The PC on which the VDC-506 software is installed is connected to the<br>VIK-202 ionization chamber using a RS-232 cable.<br><br>It is recommended that the PC includes a touchscreen display for<br>convenient navigation within the software; however, a touchscreen is<br>not necessary. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Veenstra Instruments VDC-506 Dose Calibrator is designed to<br>measure the amount of radioactive material in vials, syringes and<br>capsules. It is used to measure the amount of activity used to prepare<br>radiopharmaceutical kits, measure the activity in syringes of<br>radiopharmaceuticals prior to injection and to quantify the activity<br>remaining in the syringe following injection. It is indicated for use in<br>the preparation of radiopharmaceuticals and verification of the activity<br>prior to patient administration. |

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### Technology Comparison:

The VDC-506 employs the same technological characteristics as the predicate device.

| Characteristic | Predicate Device | Proposed Device |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Controller/<br>Display Unit | Control Unit which contains a<br>single board computer. | Personal computer (PC) |
| Controller/<br>Display Unit<br>Operating System | Microsoft® Windows XP<br>Embedded | Microsoft® Windows XP for<br>PC or higher |
| VDC-506<br>Readout | 0.001 MBq – 200 GBq<br>0.01 µCi – 6000 mCi | Same |
| VDC-506<br>Software<br>Features | Future Dose Calculator<br>QA Protocols for Daily and<br>Quarterly Checks<br>Mo-99 Breakthrough Protocol | Same |
| Ionization<br>Chamber Model | Veenstra Instruments VIK-202 | Same |
| Chamber Type | Argon-filled, pressurized, well<br>chamber | Same |
| Ionization<br>Voltage | 150 V lithium battery | Same |
| Overall Accuracy | ± 3 % dependant of specific<br>calibration source and<br>geometric variations | Same |
| Electrometer<br>Accuracy | ±1% | Same |
| Temperature<br>Coefficient | 0.1 % / ° C between 10° C and<br>40° C at 5 MBq and up | Same |
| Reproducibility | ± 1% over 24 hours, stable<br>conditions | Same |
| Reproducibility | ± 1% over 24 hours, stable<br>conditions | Same |
| Geometry of the<br>Sensitive Volume<br>(Well Size) | Height: 250 mm (~9.84 in)<br>Diameter: 60 mm (~2.36 in) | Same |
| Linearity | ± 1 % between 1 MBq and<br>200 GBq (Tc-99m) | Same |

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### Summary of Performance Testing:

| Electrical Safety | The VIK-202 ionization chamber was tested for performance in accordance with the following Standards:<br>• IEC 60601-1: 2005, Medical electrical equipment – Part 1. General requirements for basic safety and essential performance |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test results indicated that the VIK-202 complies with the Standards. |
| Electromagnetic<br>Compatibility (EMC)<br>Testing | The VIK-202 ionization chamber was tested for performance in accordance with the following Standard:<br>• IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. |
| | Test results indicated that the VIK-202 complies with the Standards. |
| Software Testing | Software device modifications made to the VDC-506 system were designed and developed according to a robust software development process, and were rigorously verified and validated.<br>Software information is provided in accordance with internal documentation and the following Standards and guidance documents:<br>• FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;<br>• FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; and<br>• IEC 62304: 2006, Medical device software – Software life cycle processes. |

Test results indicate that the VDC-506 complies with its predetermined
specification and the Standards and guidance documents.

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| <b>Performance Testing</b> | The VDC-506 system and VIK-202 ionization chamber were verified<br>for performance in accordance with internal documentation and the<br>following Standards: |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|

- o IEC 61145: 1992, Calibration and usage of ionization chamber systems for assay of radionuclides;
- o IEC 61303: 1994, Medical electrical equipment – Radionuclide calibrators – Particular methods for describing performance; and
- IEC 62366: 2007, Medical devices Application of usability o engineering to medical devices.

Test results indicated that the VDC-506 system and VIK-202 comply with predetermined specification and with the applicable Standards.

### Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the VDC-506 system. The results of these activities demonstrate that the VDC-506 system is safe and effective when used in accordance with its intended use and labeling.

Therefore, the VDC-506 system is considered substantially equivalent to the predicate device.