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.

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.

AI/ML Overview

The provided document pertains to the FDA 510(k) clearance for the Capintec CRC-77tHR radionuclide dose calibrator. The information details the device's technical specifications and performance data, but it does not describe a study involving AI assistance, human readers, or image-based diagnostics with associated ground truth and expert adjudication methods.

The document outlines a traditional medical device clearance process for a dose calibrator, focusing on:

Substantial equivalence to a predicate device (CRC-55t Dose Calibrator series).
Technical specifications, including measurement range, resolution, energy range, electrometer accuracy, linearity, and reproducibility.
Compliance with electrical safety, electromagnetic compatibility (EMC), and usability standards (e.g., IEC 60601-1, IEC 62304 for software).
Software verification and validation testing, with a "moderate" level of concern.
Evaluation at an isotope production site.

Therefore, many of the requested points regarding AI, human-in-the-loop performance, multi-reader multi-case studies, and specific ground truth methodologies for image-based diagnostics are not applicable to this device's clearance information.

However, I can extract and present the acceptance criteria and reported device performance related to the dose calibrator's technical specifications from the provided text.

Acceptance Criteria and Reported Device Performance (CRC-77tHR Radionuclide Dose Calibrator)

The acceptance criteria for this device are primarily tied to its technical specifications and its performance metrics, which demonstrate substantial equivalence to its predicate device (CRC-55t) while operating at a higher activity range.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Measurement Range	Must be able to measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters.	Maximum activity for Tc-99m: approximately 400 CuriesMaximum activity for F-18: approximately 130 Curies
Resolution	Not explicitly stated as acceptance criteria, but a key performance metric.	0.01 mCi (10 µCi)
Minimum Activity Range	Must be suitable for levels > 100 µCi (implies that less than 100 µCi is not an intended use).	Minimum activity range > 100 µCi
Energy Range	Not explicitly stated as acceptance criteria, but a key performance metric.	15 keV to 3 MeV
Electrometer Accuracy	Not explicitly stated as acceptance criteria, but a key performance metric.	± 2%
Electrometer Linearity	< 2% (implied acceptance limit)	< 2% over a dynamic range of 10-11 A to 10-6 A
Reproducibility	± 1% in 24 hours with unit powered at all times (implied acceptance limit)	± 1% in 24 hours with unit powered at all times
Electrical Safety	Compliance with IEC 60601-1, AAMI ES60601-1, CSA C22.2#60601-1.	Compliance demonstrated through testing (listed standards).
EMC	Compliance with IEC 60601-1-2.	Compliance demonstrated through testing (listed standard).
Usability	Compliance with IEC 60601-1-6.	Compliance demonstrated through review of usability.
Software V&V	Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern: Moderate.	Software verification and validation testing conducted appropriately; documentation provided.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that the CRC-77tHR was also evaluated at an isotope production site. It does not specify the sample size for this evaluation (e.g., number of measurements, number of isotopes tested, duration of testing). The data provenance is implied to be prospective as it's an evaluation of the device being submitted for clearance, and the location is an isotope production site, presumably in the US where Capintec is based. No specific country of origin is stated for the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a measurement instrument (dose calibrator), not an AI-powered diagnostic device requiring expert review of output. Its ground truth for performance metrics (e.g., accuracy, linearity) would be established against traceable standards and reference sources, not human expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As a measurement device, performance is evaluated against physical standards and known values, not through human adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is typically done for diagnostic tools that assist human readers in interpreting medical images or data. The CRC-77tHR is a standalone measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is a standalone device. Its performance metrics (accuracy, linearity, reproducibility) were evaluated intrinsically without a human 'in-the-loop' assisting in its primary measurement function. The performance data presented are for the device itself.

7. The Type of Ground Truth Used:

The ground truth for the performance metrics (e.g., measurement accuracy, linearity, reproducibility) would be based on:

Reference sources/standards: Calibrated radioactive sources with known activity levels are used to verify the device's accuracy and linearity.
Traceable measurements: Comparisons to other calibrated instruments or standards in a laboratory setting.
Engineering specifications: Adherence to designed operational parameters.
Essentially, the ground truth is derived from physics and dosimetry principles, relying on metrological standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a "training set." It's a traditional medical device based on established physics principles and internal calibration.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K162394

Device Name

CRC-77tHR

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

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

{4}------------------------------------------------

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.

{5}------------------------------------------------

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: < 2% over a dynamic range of 10115 A to 106 A Reproducibility: + 1% in 24 hours with unit powered at all times.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The level of concern is moderate because a failure or latent design flaw could directly result in minor injury to the patient or operator. The level of concern is also moderate because a failure or latent flaw could indirectly result in minor injury to the patient through incorrect or delayed information or through the action of a care provider.

{6}------------------------------------------------

The CRC-77tHR was also evaluated at an isotope production site. Animal, clinical and biocompatibility studies are not applicable and were not performed. The CRC-77tHR is used in a laboratory bench top setting and has no direct patient contact.

SUMMARY

Summary Based on documented performance, the CRC-77tHR was found to have a safety and effectiveness profile that is similar to the predicate device.

CONCLUSIONS The data demonstrate that the CRC-77tHR device performs comparably to VIII. the predicate device at a higher activity range.

Regulation Number and Section

§ 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.