(29 days)
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.
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.
The document provided describes the Veenstra Instruments VDC-506 Dose Calibrator, a radionuclide dose calibrator designed to measure radioactive material. The information focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting in terms of diagnostic accuracy.
The acceptance criteria provided are primarily related to technical specifications and compliance with electrical safety, electromagnetic compatibility (EMC), and software standards, rather than performance metrics like sensitivity, specificity, or reader improvement in a clinical diagnostic context. The document confirms that the device meets these technical criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that the document is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are predominantly technical specifications and regulatory compliance. The "reported device performance" refers to the device meeting these specifications and complying with relevant standards.
| Acceptance Criterion (Technical Specification / Standard Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| Overall Accuracy | ± 3% dependant of specific calibration source and geometric variations |
| Electrometer Accuracy | ± 1% |
| Temperature Coefficient | 0.1 % / °C between 10°C and 40°C at 5 MBq and up |
| Reproducibility | ± 1% over 24 hours, stable conditions |
| Linearity | ± 1% between 1 MBq and 200 GBq (Tc-99m) |
| Electrical Safety (IEC 60601-1: 2005) | Complies with the Standards. |
| Electromagnetic Compatibility (IEC 60601-1-2: 2007) | Complies with the Standards. |
| Software Development (FDA guidance, IEC 62304: 2006) | Complies with its predetermined specification and the Standards and guidance documents. |
| Performance (IEC 61145: 1992, IEC 61303: 1994, IEC 62366: 2007) | Complies with predetermined specification and with the applicable Standards. |
| Readout Range | 0.001 MBq – 200 GBq; 0.01 µCi – 6000 mCi |
| Ionization Chamber Model | Veenstra Instruments VIK-202 |
| Chamber Type | Argon-filled, pressurized, well chamber |
| Ionization Voltage | 150 V lithium battery |
| Geometry of Sensitive Volume (Well Size) | Height: 250 mm (~9.84 in), Diameter: 60 mm (~2.36 in) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the traditional sense of a diagnostic device evaluating patient data. The performance testing conducted was against technical specifications and international standards for radionuclide dose calibrators. Therefore, there is no patient-specific sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set for diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is a dose calibrator, not a diagnostic imaging device that requires interpretation by medical experts (like radiologists). Therefore, no experts were used to establish ground truth for a test set in a diagnostic context. The "ground truth" for the device's accuracy would be established by reference standards or highly accurate measurement techniques in a physics or engineering lab setting.
4. Adjudication Method for the Test Set
As there is no clinical "test set" requiring expert interpretation, no adjudication method was employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices to assess the impact of AI on human reader performance. The Veenstra Instruments VDC-506 Dose Calibrator is a measurement device for radioactive materials, not a diagnostic interpretation tool, and it does not involve human-in-the-loop diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone system for measuring radionuclide activity. The "performance testing" described in the document (electrical safety, EMC, software, and general performance testing against standards) is essentially standalone performance evaluation of the device's technical specifications. It's not an "algorithm only" performance in the context of AI diagnostic applications, but rather the performance of the integrated hardware and software system as a whole.
7. The Type of Ground Truth Used
The ground truth used for performance verification would be:
- Reference standards/Calibrated sources: For evaluating the accuracy, linearity, and reproducibility of the dose measurements.
- International standards: For assessing compliance with electrical safety, EMC, and specific performance characteristics for radionuclide calibrators (e.g., IEC 60601-1, IEC 60601-1-2, IEC 61145, IEC 61303).
- Predetermined specifications: Internal specifications set by the manufacturer against which the device's performance is verified.
8. The Sample Size for the Training Set
The document describes a physical device with software, not a machine learning or AI model that requires a "training set" of data in the common sense. The software development and testing follow standard engineering practices. Therefore, there is no "training set sample size" as would be applicable to an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI algorithm, this question is not applicable to the VDC-506 Dose Calibrator. The "ground truth" for software robustness and functionality is established through verification and validation activities based on software requirements and design specifications.
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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 (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
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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.Madam Curieweg 1Joure, Fryslan 8501 XCThe Netherlands | ||
| Submitter Contact: | Mr. Gert Jan KlokPhone: +011 031-513-416964Fax: +011 031-513-416919Email: gklok@comecer.com | ||
| ApplicationCorrespondent: | Speed To Market, Inc.PO Box 3018Nederland, CO 80466 USAMr. Thomas KroenkePhone: +1 (303) 956-4232Fax: +1 (303) 642-3141Email: tkroenke@speedtomarket.net | ||
| Manufacturing Site: | Comecer Netherlands b.v.Madam Curieweg 1Joure, Fryslan 8501 XCThe Netherlands | ||
| Trade Name: | Veenstra Instruments VDC-506 Dose Calibrator | ||
| Common Name: | Radionuclide dose calibrator | ||
| Classification Name: | Radionuclide dose calibrator | ||
| ClassificationRegulation: | 21 CFR §892.1360 | ||
| Product Code: | KPT | ||
| SubstantiallyEquivalent Devices: | New Model | Predicate510(k) Number | PredicateManufacturer / Model |
| Veenstra InstrumentsVDC-506 DoseCalibrator | K030066 | Nuclear AssociatesCal/Rad Mark VI/VDC505 Dose Calibrator,Model 34-165 |
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| Device Description: | The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is asoftware application installed on a personal computer (PC) runningWindows XP, and is used in conjunction with the Veenstra InstrumentsVIK-202 ionization chamber (VIK-202) to measure the radioactivestrength of radioactive material in vials, syringes and ampoules placedinside the ionization chamber.The VDC-506 software, in conjunction with the PC, serves as thecontrol mechanism and display for the VIK-202 ionization chamber.The PC on which the VDC-506 software is installed is connected to theVIK-202 ionization chamber using a RS-232 cable.It is recommended that the PC includes a touchscreen display forconvenient navigation within the software; however, a touchscreen isnot necessary. |
|---|---|
| Intended Use: | The Veenstra Instruments VDC-506 Dose Calibrator is designed tomeasure the amount of radioactive material in vials, syringes andcapsules. It is used to measure the amount of activity used to prepareradiopharmaceutical kits, measure the activity in syringes ofradiopharmaceuticals prior to injection and to quantify the activityremaining in the syringe following injection. It is indicated for use inthe preparation of radiopharmaceuticals and verification of the activityprior 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/Display Unit | Control Unit which contains asingle board computer. | Personal computer (PC) |
| Controller/Display UnitOperating System | Microsoft® Windows XPEmbedded | Microsoft® Windows XP forPC or higher |
| VDC-506Readout | 0.001 MBq – 200 GBq0.01 µCi – 6000 mCi | Same |
| VDC-506SoftwareFeatures | Future Dose CalculatorQA Protocols for Daily andQuarterly ChecksMo-99 Breakthrough Protocol | Same |
| IonizationChamber Model | Veenstra Instruments VIK-202 | Same |
| Chamber Type | Argon-filled, pressurized, wellchamber | Same |
| IonizationVoltage | 150 V lithium battery | Same |
| Overall Accuracy | ± 3 % dependant of specificcalibration source andgeometric variations | Same |
| ElectrometerAccuracy | ±1% | Same |
| TemperatureCoefficient | 0.1 % / ° C between 10° C and40° C at 5 MBq and up | Same |
| Reproducibility | ± 1% over 24 hours, stableconditions | Same |
| Reproducibility | ± 1% over 24 hours, stableconditions | Same |
| Geometry of theSensitive Volume(Well Size) | Height: 250 mm (~9.84 in)Diameter: 60 mm (~2.36 in) | Same |
| Linearity | ± 1 % between 1 MBq and200 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:• 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. | |
| ElectromagneticCompatibility (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.
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| Performance Testing | The VDC-506 system and VIK-202 ionization chamber were verifiedfor performance in accordance with internal documentation and thefollowing 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.
§ 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.