(38 days)
Capintec dose calibrator lines
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No
The document explicitly states that the device uses the "same basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response" as the predicate device and does not mention any AI or ML capabilities.
No
This device is a dose calibrator used to measure radioactive materials or sources, not to treat patients.
No
The device measures radiopharmaceuticals and radioactive sources, which are used in diagnostic procedures, but the device itself is a measurement tool (calibrator, well counter) rather than a device that makes a diagnosis.
No
The device description explicitly states it uses "the same basic hardware, and same detectors as the CRC 15 Ultra," indicating it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the measurement of radiopharmaceuticals and radioactive brachytherapy sources. These are used in vivo (within the body) for diagnostic imaging or therapeutic treatment.
- Device Description: The device is a dose calibrator and optional well counter, designed to measure the activity of radioactive materials. This is a measurement of the source itself, not a diagnostic test performed on a biological sample in vitro.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes within those samples, which are hallmarks of IVD devices.
Therefore, the CRC 25R dose calibrator is a device used in nuclear medicine and brachytherapy for measuring radioactive sources, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR. LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.
Product codes (comma separated list FDA assigned to the subject device)
KPT
Device Description
The Capintec CRC 25 series is a reduced feature version of the CRC 15Ultra. The CRC 25 series uses the same basic hardware, and same detectors as the CRC 15 Ultra, but does not provide the ability to use multiple chambers, nor does the CRC 25 support the addition of a beta counter.
The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device. The CRC 25 is a far more cost effective solution to a user who does not require the sophisticated multichamber features of the CRC 15 Ultra.
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
The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, or medical phyicists in clinical or research applications.
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.
Capintec dose calibrator lines
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/0 description: The image shows the logo for CAPINTEC, INC. The logo consists of the letters "CII" stacked on top of each other and enclosed in a square. Below the square is the text "CAPINTEC, INC." The text is in a simple, sans-serif font.
May 15, 2007
07/396
JUN 2 8 2007
RE: Summary of Safety and Effectiveness Information for the Capintec CRC 25 series.
The Capintec CRC 25 series is a reduced feature version of the CRC 15Ultra. The CRC 25 series uses the same basic hardware, and same detectors as the CRC 15 Ultra, but does not provide the ability to use multiple chambers, nor does the CRC 25 support the addition of a beta counter.
The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device. The CRC 25 is a far more cost effective solution to a user who does not require the sophisticated multichamber features of the CRC 15 Ultra.
The predicate devices, Capintec dose calibrator lines, upon which the CRC 25 is based, have a long history of safe, reliable, and effective use in the field. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, or medical phyicists in clinical or research applications.
The CRC 25 family of does calibrators has also been tested and approved to the following safety standards for laboratory equipment:
- IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1 General Requirements IEC 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 2 Particular Reguirement for In Vitro Diagnostic Equipment IEC 61326 Electrical equipment for electrical equipment for measurement, control, and laboratory use-EMC requirements UL 61010A-1 Electrical Equipment for Laboratory Use; Part 1: General Requirements CAN/CSA-C22.2 No. 61010-1:2004 Standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements CAN/CSA-C22.2 No. 61010-2-101-04 Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use; Part 2-101: Particular Requirements for In Vitro Diagnostics (IVD) Medical Equipment
1
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 28 2007
Mary Anne Dell, M.S. VP and General Manager CAPINTEC. Inc. 620 Alpha Drive PITTSBURG PA 15238
Re: K071396
Trade/Device Name: CRC 25 Series Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator Regulatory Class: II Product Code: KPT Dated: May 18, 2007 Received: May 29, 2007
Dear Ms. Dell:
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 (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo also contains three stars and the words "Food and Drug Administration". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
cling and Promoting Public Scatth
2
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix # 2
Indications for Use Form-
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: CRC 25 series
Indications For Use: The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR. LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Hulu Reever
(Division Sign-Off) (Division Sign-Om)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number -771396