(29 days)
K1414B
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as having the "same principles of operation, same basic functionality, and same detector technology as the predicate device". The primary difference noted is the user interface.
No
The device is a dose calibrator used for measuring radioactive materials for diagnostic and therapeutic applications, but it does not directly apply therapy to a patient.
Yes
The device is explicitly stated to measure radiopharmaceuticals and radioactive materials for "diagnostic and therapeutic applications." While it measures the materials, the context is for their use in diagnosis and therapy, making the device a component in the diagnostic process.
No
The device description explicitly states it is a "dose calibrator" and mentions "detector technology," indicating it includes hardware components for measuring radioactive materials. The software component replaces the user interface but is not the sole component of the 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 radioactive materials and radiopharmaceuticals within a clinical setting for diagnostic and therapeutic applications. This is related to nuclear medicine procedures performed on patients, not the analysis of samples outside the body (in vitro).
- Device Description: The device is described as a "dose calibrator" used for measuring radioactive materials. This aligns with the equipment used in nuclear medicine departments to prepare and administer radioactive doses to patients.
- 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 PC Smart Chamber series is a medical device used in nuclear medicine for measuring radioactivity, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CRC PC Smart Chamber series is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy befa and gamma emitters for diagnostic and therapeutic applications. It is also designed for use by trained medical physicists for diagnostic and therapeutic applications including measurement of the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. This device is also used in numerous research applications for measurement of radioactive materials.
Product codes
KPT
Device Description
Capintec's CRC PC Smart Chamber series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, and research applications. The CRC PC series has the same principles of operation, same basic functionality, and same detector technology as the predicate device, CRC 55t series. The basic detection, measurement process, design concepts, calculations, and response remain the same as the predicate device. The CPC PC Smart Chamber replaces the touchscreen user interface of the predicate device with a laptop or network PC.
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
trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists / nuclear medicine, therapy, and research applications
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)
The CRC PC family of dose calibrators have been tested and approved to the following EMC and electrical safety standards for medical equipment:
IEC 60601-1-2 (2007): 30 Edition: Medical Electrical Equipment – Part 1 General Requirements for Safety - Section 1.2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1 Issued: 2005 Ed:3: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 2010 314 Edition: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
AAMI ES60601-1 Issued: 2005: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
CAN.CSA-C22.2 No. 60601-1:08: Issued: 2008: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K1414B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 2 7 2014
K141*413
page 1 of 2
Appendix # 3
510(k) Summary/Statement Certification
Re: K141413
CHECK ONE ONLY:
21.510(k) Summary. Attached is a summary of safety and effectiveness information
upon which an equivalence determination could be based.
2.510(k) Statement. I certify that, in my capacity as
Vice President, Manufacturing of Capintec, Inc.
I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR20.61.
Mary Anne Yusko
[ Signature*]
Mary Anne Yusko
[Typed or Printed Name]
April 2, 2014 [Date]
- Must be signed by a responsible person or the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter).
1
K1414B
page 2 of 2
Image /page/1/Picture/1 description: The image shows the logo for CAPINTEC, INC. The logo consists of the letters "CII" stacked vertically inside of a square. Below the square is the text "CAPINTEC, INC."
April 3. 2014
RE: Summary of Safety and Effectiveness Information for the Capintec CRC PC series.
Capintec's CRC PC Smart Chamber series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, and research applications. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists for diagnostic and therapeutic applications.
The CRC PC series has the same principles of operation, same basic functionality, and same detector technology as the predicate device, CRC 55t series. The basic detection, measurement process, design concepts, calculations, and response remain the same as the predicate device. There are no differences in intended use or effectiveness. The CPC PC Smart Chamber replaces the touchscreen user interface of the predicate device with a laptop or network PC.
The predicate devices, Capintec dose calibrator lines, upon which the CRC PC is based, have a long history of over 30 years of safe, reliable, and effective use in the field. The addition of a larger PC interface enhances safety and effectiveness by providing improved visibility and easier alphanumeric data input. The CRC PC family of dose calibrators have been tested and approved to the following EMC and electrical safety standards for medical equipment:
IEC 60601-1-2 (2007): 30 Edition: Medical Electrical Equipment – Part 1 General Requirements for Safety - Section 1.2 Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1 Issued: 2005 Ed:3: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6 2010 314 Edition: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
AAMI ES60601-1 Issued: 2005: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
CAN.CSA-C22.2 No. 60601-1:08: Issued: 2008: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The seal is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2014
Capintec. Inc. % Ms. Mary Anne Yusko VP, Development and Regulatory Affairs 620 Alpha Drive PITTSBURGH PA 15241
Re: K141413
Trade/Device Name: Capintec CRC PC with Smart Chamber Series Regulation Number: 21 CFR 892,1360 Regulation Name: Radionuclide does calibrator Regulatory Class: II Product Code: KPT Dated: May 21, 2014 Received: May 29, 2014
Dcar 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: CDRFI 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.
3
Page 2-Ms. Yusko
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/ResourcesforYou/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,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K141413
Device Name; CRC PC with Smart Chamber
Indications for Use: The CRC PC Smart Chamber series is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy befa and gamma emitters for diagnostic and therapeutic applications. It is also designed for use by trained medical physicists for diagnostic and therapeutic applications including measurement of the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. This device is also used in numerous research applications for measurement of radioactive materials.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
$m_{h,f}$
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) 141413
Page 1 of 1