(234 days)
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No
The description focuses on standard dose calibration techniques using stored calibration factors and ion chamber current processing, with no mention of AI or ML.
No.
The device measures radioactive material for radiopharmaceutical preparation and verification, but it does not directly treat or diagnose a disease or condition in a patient.
No
Explanation: The device, the Mark VI Dose Calibrator, measures the amount of radioactive material in radiopharmaceuticals for preparation and verification prior to administration. It does not diagnose medical conditions.
No
The device description explicitly mentions an "ion chamber" and a "control/readout unit," which are hardware components used to measure and process radioactive material.
Based on the provided information, the Mark VI Dose Calibrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use of the Mark VI Dose Calibrator is to measure radioactive material in vials, syringes, and capsules, and to verify the activity of radiopharmaceuticals prior to patient administration. It does not involve testing or analyzing biological samples from a patient.
- The device description focuses on measuring radioactive material. It describes an ion chamber and processing of electrical current based on isotopic calibration factors. This is a physical measurement of radioactivity, not a diagnostic test performed on a biological sample.
Therefore, the Mark VI Dose Calibrator falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Mark VI 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
90 KPT
Device Description
Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the control/readout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.
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
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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): 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.
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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.
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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).
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§ 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 U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a bird-like figure with three lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2003
Ms. Christine Castleberry RA & OA Manager Nuclear Associates 120 Andrews Road HICKSVILLE NY 11801 Re: K030066 Trade/Device Name: Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator Regulatory Class: II Product Code: 90 KPT Dated: May 29, 2003 Received: June 3, 2003
Dear Ms. Castleberry:
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.
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); 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
510(k) Number (if known): K030066
Device Name: Cal/Rad Mark VI / VDC-505 Dose Calibrator
Indications For Use:
The Mark VI 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.
Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the control/readout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
David R. Legmann
(Division Sign-Off) Division of Reproductive. and Radiological Devices 510(k) Number