(29 days)
Not Found
No
The description focuses on standard dose calibration technology and software control, with no mention of AI or ML terms or concepts.
No
The device measures radioactive material and its activity, but it does not directly apply therapy to a patient. Its function is for preparation and verification, not treatment.
No
The device measures the amount of radioactive material in radiopharmaceuticals for preparation and administration, not a physiological state or medical condition of a patient.
No
The device description explicitly states that the software is used "in conjunction with the Veenstra Instruments VIK-202 ionization chamber" and that the PC running the software is "connected to the VIK-202 ionization chamber using a RS-232 cable." This indicates a necessary hardware component (the ionization chamber) that is integral to the device's function. Furthermore, performance studies include testing of the VIK-202 ionization chamber for electrical safety and EMC.
Based on the provided information, the Veenstra Instruments VDC-506 Dose Calibrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure the amount of radioactive material in vials, syringes, and capsules for the preparation and administration of radiopharmaceuticals to patients. This is a measurement of a substance outside the human body, but it's not being used to diagnose a condition or disease based on analysis of biological specimens.
- Device Description: The device measures radioactivity using an ionization chamber. This is a physical measurement of a radioactive source, not an analysis of a biological sample.
- Lack of Biological Specimen Analysis: The description does not mention the analysis of any biological specimens (like blood, urine, tissue, etc.) for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The VDC-506 measures the activity of radioactive materials before they are administered to a patient, which is a quality control and preparation step, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KPT
Device Description
The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is a software application installed on a personal computer (PC) running Windows XP, and is used in conjunction with the Veenstra Instruments VIK-202 ionization chamber (VIK-202) to measure the radioactive strength of radioactive material in vials, syringes and ampoules placed inside the ionization chamber.
The VDC-506 software, in conjunction with the PC, serves as the control mechanism and display for the VIK-202 ionization chamber. The PC on which the VDC-506 software is installed is connected to the VIK-202 ionization chamber using a RS-232 cable.
It is recommended that the PC includes a touchscreen display for convenient navigation within the software; however, a touchscreen is not necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety: The VIK-202 ionization chamber was tested for performance in accordance with the following Standards: 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 Compatibility (EMC) Testing: The VIK-202 ionization chamber was tested for performance in accordance with the following Standard: 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. Software information is provided in accordance with internal documentation and the following Standards and guidance documents:
- FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;
- FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; and
- 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.
Performance Testing: The VDC-506 system and VIK-202 ionization chamber were verified for performance in accordance with internal documentation and the following Standards:
- IEC 61145: 1992, Calibration and usage of ionization chamber systems for assay of radionuclides;
- IEC 61303: 1994, Medical electrical equipment – Radionuclide calibrators – Particular methods for describing performance; and
- IEC 62366: 2007, Medical devices Application of usability 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1360 Radionuclide dose calibrator.
(a)
Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three abstract human profiles facing right, stacked on top of each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
1
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/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 (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. 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
2
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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3
| Submission Date: | 14 August 2014 | ||
|---|---|---|---|
| Submitter: | Comecer Netherlands b.v. | ||
| Madam Curieweg 1 | |||
| Joure, Fryslan 8501 XC | |||
| The Netherlands | |||
| Submitter Contact: | Mr. Gert Jan Klok | ||
| Phone: +011 031-513-416964 | |||
| Fax: +011 031-513-416919 | |||
| Email: gklok@comecer.com | |||
| Application | |||
| Correspondent: | Speed To Market, Inc. | ||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| Mr. Thomas Kroenke | |||
| Phone: +1 (303) 956-4232 | |||
| Fax: +1 (303) 642-3141 | |||
| Email: tkroenke@speedtomarket.net | |||
| Manufacturing Site: | Comecer Netherlands b.v. | ||
| Madam Curieweg 1 | |||
| Joure, Fryslan 8501 XC | |||
| The Netherlands | |||
| Trade Name: | Veenstra Instruments VDC-506 Dose Calibrator | ||
| Common Name: | Radionuclide dose calibrator | ||
| Classification Name: | Radionuclide dose calibrator | ||
| Classification | |||
| Regulation: | 21 CFR §892.1360 | ||
| Product Code: | KPT | ||
| Substantially | |||
| Equivalent Devices: | New Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Veenstra Instruments | |||
| VDC-506 Dose | |||
| Calibrator | K030066 | Nuclear Associates | |
| Cal/Rad Mark VI/VDC | |||
| 505 Dose Calibrator, | |||
| Model 34-165 |
4
| Device Description: | The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is a
software application installed on a personal computer (PC) running
Windows XP, and is used in conjunction with the Veenstra Instruments
VIK-202 ionization chamber (VIK-202) to measure the radioactive
strength of radioactive material in vials, syringes and ampoules placed
inside the ionization chamber.
The VDC-506 software, in conjunction with the PC, serves as the
control mechanism and display for the VIK-202 ionization chamber.
The PC on which the VDC-506 software is installed is connected to the
VIK-202 ionization chamber using a RS-232 cable.
It is recommended that the PC includes a touchscreen display for
convenient navigation within the software; however, a touchscreen is
not necessary. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
5
Technology Comparison:
The VDC-506 employs the same technological characteristics as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Controller/ | ||
| Display Unit | Control Unit which contains a | |
| single board computer. | Personal computer (PC) | |
| Controller/ | ||
| Display Unit | ||
| Operating System | Microsoft® Windows XP | |
| Embedded | Microsoft® Windows XP for | |
| PC or higher | ||
| VDC-506 | ||
| Readout | 0.001 MBq – 200 GBq | |
| 0.01 µCi – 6000 mCi | Same | |
| VDC-506 | ||
| Software | ||
| Features | Future Dose Calculator | |
| QA Protocols for Daily and | ||
| Quarterly Checks | ||
| Mo-99 Breakthrough Protocol | Same | |
| Ionization | ||
| Chamber Model | Veenstra Instruments VIK-202 | Same |
| Chamber Type | Argon-filled, pressurized, well | |
| chamber | Same | |
| Ionization | ||
| Voltage | 150 V lithium battery | Same |
| Overall Accuracy | ± 3 % dependant of specific | |
| calibration source and | ||
| geometric variations | Same | |
| Electrometer | ||
| Accuracy | ±1% | Same |
| Temperature | ||
| Coefficient | 0.1 % / ° C between 10° C and | |
| 40° C at 5 MBq and up | Same | |
| Reproducibility | ± 1% over 24 hours, stable | |
| conditions | Same | |
| Reproducibility | ± 1% over 24 hours, stable | |
| conditions | Same | |
| Geometry of the | ||
| Sensitive Volume | ||
| (Well Size) | Height: 250 mm (~9.84 in) | |
| Diameter: 60 mm (~2.36 in) | Same | |
| Linearity | ± 1 % between 1 MBq and | |
| 200 GBq (Tc-99m) | Same |
6
Summary of Performance Testing:
| Electrical Safety | The VIK-202 ionization chamber was tested for performance in accordance with the following Standards:
• 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
Compatibility (EMC)
Testing | The VIK-202 ionization chamber was tested for performance in accordance with the following Standard:
• 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.
Software information is provided in accordance with internal documentation and the following Standards and guidance documents:
• FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;
• FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; and
• 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.
7
| Performance Testing | The VDC-506 system and VIK-202 ionization chamber were verified
for performance in accordance with internal documentation and the
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.