(194 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is of a standard dose calibrator.
No
The device is a dose calibrator used to measure high activity radiopharmaceuticals and radioactive materials, not to deliver therapeutic treatment.
No
The device is a dose calibrator used to measure the activity of radiopharmaceuticals and radioactive materials, not to diagnose medical conditions in patients.
No
The device description explicitly states it uses a "sealed reentrant well chamber as the detector," which is a hardware component. The summary also mentions electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, the CRC-77tHR is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure the activity of radiopharmaceuticals and radioactive materials. This is a measurement of the radioactive source itself, not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health.
- Device Description: It's described as a "dose calibrator" used in isotope production and radiopharmaceutical production environments. This aligns with measuring the strength of radioactive materials, not analyzing biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CRC-77tHR's function is to measure the activity of radioactive materials, which is a different purpose.
N/A
Intended Use / Indications for Use
The CRC-77tHR is intended to be used by qualified radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.
Product codes (comma separated list FDA assigned to the subject device)
KPT
Device Description
The Capintec CRC-77tHR is dose calibrator which uses a touch screen user interface and sealed reentrant well chamber as the detector. The gas fill pressure has been lowered in order to extend the maximum activity range for isotope manufacturing and radiopharmaceutical production environments.
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
Qualified radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites.
The CRC-77tHR is used in a laboratory bench top setting.
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, electromagnetic compatibility (EMC) and Usability Compliance to IEC 60601-1-2 (2014):Ed. 4, IEC 60601-1: Issued: 2005/12/15 Ed. 3, IEC 60601-1-6: Issue:2010/01/27 Ed:3, AAMI ES60601-1: Issued: 2012/08/20, CSA C22.2#60601-1: Issued: 2014/03/01 Ed: 3, IEC 62304: Issue:2006/05/09 Ed:1.
Software verification and validation testing were conducted.
The CRC-77tHR was also evaluated at an isotope production site.
Key results: The CRC-77tHR was found to have a safety and effectiveness profile that is similar to the predicate device. The data demonstrate that the CRC-77tHR device performs comparably to the predicate device at a higher activity range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Range: Maximum activity for Tc-99m is approximately 400 Curies, Maximum activity for F-18 is approximately 130 Curies
Resolution: .01 mCi (10 µCi)
Minimum activity range > 100 µCi
Energy Range: 15 keV to 3 MeV
Electrometer Accuracy: + 2%
Electrometer Linearity:
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Capintec, Inc. % Ms. Mary Yusko VP, Product Development and Regulatory Affairs 7 Vreeland Road FLORHAM PARK NJ 07932
Re: K162394
Trade/Device Name: CRC-77tHR Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide Dose Calibrator Regulatory Class: II Product Code: KPT Dated: December 19, 2016 Received: December 21, 2016
Dear Ms. Yusko:
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 O'Hara
For
Robert Ochs, Ph.D. 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) K162394
Device Name
CRC-77tHR
Indications for Use (Describe)
The CRC-77tHR is intended to be used by qualified radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for CAPINTEC, INC. The logo consists of the letters "CII" stacked on top of each other inside of a square. Below the square is the text "CAPINTEC, INC."
RE: Summary of Safety and Effectiveness Information for the Capintec CRC-77tHR
I. SUBMITTER
Capintec, Inc. 7 Vreeland Road Florham Park, NJ 07932 Phone 201-825-9500 201-825-1336 FAX
Contact Person: Mary Anne Yusko Date Prepared: February 12, 2017
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II. DEVICE Name of Device: CRC-77tHR
Common or Usual Name: Radionuclide Dose Calibrator Regulatory Class II, Product Code: KPT (90) 21 CFR 892.1360 -
III. PREDICATE DEVICE CRC -55t Dose Calibrator series, which received FDA clearance under 510(k) number K101452. This predicate device has not been subject to a design related recall. The predicate devices, Capintec dose calibrator lines, upon which the CRC-77tHR is based, have a long history of over 30 years of safe, reliable, and effective use in the field.
IV. DEVICE DESCRIPTION
The Capintec CRC-77tHR is dose calibrator which uses a touch screen user interface and sealed reentrant well chamber as the detector. The gas fill pressure has been lowered in order to extend the maximum activity range for isotope manufacturing and radiopharmaceutical production environments. A diagram of the system is shown below.
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Image /page/4/Figure/0 description: The image shows a diagram of a CRC-77t Readout system. The system includes a CRC-77t Readout device, a dipper, a liner, an ionization chamber, a line cord, and an optional printer. The CRC-77t Readout device is connected to the ionization chamber and the optional printer via cables. The dipper and liner are separate components of the system.
V. INDICATIONS FOR USE
The CRC-77tHR is intended to be used by qualified radiopharmacists, radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
DEVICE The CRC -77tHR series is identical to the predicate device, the CRC-55t series, in terms of scientific technology, principles of operations, radiation detectors, measurement processes, calibration, algorithms, calculations, user interface, and basic circuitry design. There are two basic differences between models. The first difference is that CRC-77tHR has a lower fill gas pressure, which reduces the sensitivity of the chamber in order to extend maximum activity which the device can measure. This change allows the 77tHR to be used in isotope and radiopharmaceutical production facilities which need to measure higher activity levels. The second difference is that the electrometer board, which is located in the base of the ionization chamber for the 55t models, has been relocated to the readout of the 77tHR. This was done to protect the electronics from radiation damage by removing them from the radiation field. Otherwise, the technical characteristics of the models are the same.
The predicate device includes brachytherapy measurements as an intended use. The CRC-77tHR, with lower fill pressure and reduced sensitivity, has not been validated for LDR measurements at this time. Therefore, brachytherapy source measurements were not included in the listed intended use. The removal of this intended use does not affect safety or effectiveness of the CRC-77tHR for its listed applications.
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- VII. PERFORMANCE DATA The CRC-77tHR The following performance data were provided in support of the substantial equivalence determination
- Electrical safety, electromagnetic compatibility (EMC) and Usability Compliance IEC 60601-1-2 (2014):Ed. 4. Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
IEC 60601-1: Issued: 2005/12/15 Ed. 3 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety & Essential Performance; Corr. 1: 2006, Corr. 2: 2007. Amd. 1: 2012
IEC 60601-1-6: Issue:2010/01/27 Ed:3 Medical electrical equipment – Part 1-6: General requirements for safety - Collateral Standard: Usability Review of usability per 60601-1 3rd Edition
AAMI ES60601-1: Issued: 2012/08/20 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, Amendment 1. Product safety evaluation to AAMI 60601-1 3rd Edition, Amendment 1
CSA C22.2#60601-1: Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 62304: Issue:2006/05/09 Ed:1 Medical Device Software - Software Life Cycle Processes
Technical Specifications:
Measurement Range: Maximum activity for Tc-99m is approximately 400 Curies Maximum activity for F-18 is approximately 130 Curies Resolution: .01 mCi (10 µCi) Minimum activity range > 100 µCi This model should not be used for activity measurements less than 100 µCi Energy Range: 15 keV to 3 MeV Electrometer Accuracy: + 2% NOTE: Overall accuracy is determined by the specific nuclide and sample configuration, geometry difference between the reference source and sample, and accuracies of the reference sources used for calibration. Electrometer Linearity: