CRC-15BT by CAPINTEC, INC. | FDA 510(k) Summary

The CRC 15BT dose calibrator is intended to be used by trained medical physicists, or qualified technologists to measure the activity or output of radioactive brachytherapy sources, including HDR, LDR and IVBT sources.

Device Description

The CRC 15BT dose calibrator is a well type ionization chamber specifically designed to accurately and rapidly measure all types of brachytherapy sources with appropriate calibration and source positioning device. The ionization chamber is connected to a readout, which converts measured current into a displayed value in units of either Ci (activity) or U (air kerma strength). The unit is sealed and pressurized with UPC Argon. which improves sensitivity and eliminates the need for temperature and pressure corrections.

AI/ML Overview

Based on the provided text, the device in question is the Capintec CRC 15BT calibrator, a radionuclide dose calibrator. The document is a 510(k) submission review with an acceptance letter from the FDA. This type of document typically focuses on establishing "substantial equivalence" to a predicate device rather than detailing specific acceptance criteria and performance studies in the way a clinical trial might for a new drug or an AI-powered diagnostic device.

Therefore, much of the requested information (related to AI algorithms, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this device and this type of regulatory submission. The CRC 15BT is a physical medical device for measuring radioactive sources, not a software-based diagnostic tool with AI components.

However, I can extract the relevant information regarding the device's validation and "acceptance criteria" as described in the document, framed within the context of a 510(k) submission for a physical device.

Here's the breakdown of what can be synthesized from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as implied by text)	Reported Device Performance (as stated in text)
Intended Use Suitability	Suitable for all clinically available gamma and high-energy beta brachytherapy sources, including HDR, LDR, and IVBT in any number of configurations (seeds, ribbons, source trains).	"evaluated by the University of Wisconsin ADCL, and found to be a suitable instrument for all clinically available gamma and high-energy beta brachytherapy sources, including HDR, LDR, and IVBT in any number of configurations including, seeds, ribbons, and source trains with appropriate source holders."
Accuracy/Measurement	Accurately and rapidly measure activity or output of radioactive brachytherapy sources.	Converts measured current into a displayed value in units of Ci (activity) or U (air kerma strength). The core design is a minor modification of the CRC 15R, which has an "excellent reputation for long term stability, reliability, safety and effectiveness." The 15BT is expected to "maintain the same excellent quality as the CRC 15R."
Activity Range	Accommodate higher activity range required for HDR sources.	Modifications to the 15BT include "reduced fill gas pressure and an increased bias voltage to accommodate a higher activity range required for HDR sources."
Stability, Reliability, Safety, Effectiveness	Maintain high standards comparable to the predicate device (CRC 15R).	Expected to maintain "excellent quality... same level of safety and effectiveness and long term reliability" as the CRC 15R, which has been commercially available for over 10 years with an "excellent reputation."
Compliance with Safety Standards	Adherence to relevant medical electrical equipment safety standards.	"tested and approved to the following safety standards for medical equipment: EN60601-1:1990+A1+A2, IEC60601-1:1998+A1+A2, EN60601-1-2, IEC60601-1-4:1996, Can/CSA C22.2 No.606101-M90, IEC 606601-1-1:1993+A1."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of a specific number of brachytherapy sources tested. The evaluation was done by the University of Wisconsin ADCL, implying a testing protocol was followed, but the "sample size" of sources is not quantified.
Data Provenance: The testing was carried out by the University of Wisconsin ADCL (Accredited Dosimetry Calibration Laboratory), an independent, accredited laboratory. This indicates an objective, third-party evaluation. The data would be prospective testing data, specifically for the CRC 15BT.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable in the AI/Diagnostic Sense. For a dose calibrator, "ground truth" is typically established by physical standards and reference measurements, often against primary standards maintained by national metrology institutes or through cross-calibration with other precisely calibrated instruments. The University of Wisconsin ADCL is accredited for dosimetry calibration, indicating they possess the expertise and equipment to establish accurate reference measurements for brachytherapy sources. The text doesn't mention "experts" in the context of subjective interpretation like radiologists, but rather a specialized laboratory performing objective measurements.

4. Adjudication method for the test set

Not Applicable. This concept is for subjective interpretations/diagnoses (e.g., by human readers in an AI study). For a physical measurement device like a dose calibrator, the "adjudication" is the verification of the calibration and measurement accuracy against established physical standards by the ADCL.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical device, not an AI software requiring human reader interaction or augmentation.

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

Not Applicable / Interpreted Differently. The device is standalone in its operation of measuring radiation. It's a sensor system that performs its function without human interpretation of its core measurement (though humans operate it and use its output). There is no "algorithm" in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the CRC 15BT, the "ground truth" for its performance would be physical measurement standards and reference sources with known activities or air kerma strengths, established and traceable to national or international primary standards. The University of Wisconsin ADCL's role is to ensure the calibrator accurately measures these known quantities.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for this type of device, this question is irrelevant.

Summary

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AUG 0 2 2002

Image /page/0/Picture/1 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 company name, CAPINTEC, INC. To the left of the logo is the number 2002.

January 10, 2001

RE: Summary of Safety and Effectiveness Information for the Capintec CRC 15BT calibrator.

The CRC 15BT has been evaluated by the University of Wisconsin ADCL, and found to be a suitable instrument for all clinically available gamma and high-energy beta brachytherapy sources, including HDR, LDR, and IVBT in any number of configurations including, seeds, ribbons, and source trains with appropriate source holders.

The CRC 15BT design is a minor modification to the Capintec CRC 15R dose calibrator to increase the activity range to accommodate HDR sources. The CRC 15R has been commercially available for over 10 years and has an excellent reputation for long term stability, reliability, safety and effectiveness. The modifications to the 15BT are limited to reduced fill gas pressure and in increase bias voltage to accommodate a higher activity range required for HDR sources. The basic chamber design and readout are the same as the CRC 15R. Consequently, the CRC 15BT is expected to maintain the same excellent quality as the CRC 15R. with the same level of safety and effectiveness and long term reliability.

The CRC 15BT has also been tested and approved to the following safety standards for medical equipment:

Medical Electrical Equipment, Part 1 General Requirements - EN60601-1: 1990+A1+A2 Medical Electrical Equipment, Part 1 General Reguirements - IEC60601-1: 1998+A1+A2 Medical Electrical Equipment, Part 1 General Requirements Section 1.2 Collateral standard: Electromagnetic Compatibility-EN60601-1-2 Medical Electrical Equipment, Part 1 General Requirements for Safety Section 1.4 Collateral Standard: Programmable Electrical Medical Systems-IEC60601-1-4:1996 Medical Electrical Equipment, Part 1 General Requirements-Can/CSA C22.2 No.606101-M90 Medical Electrical Systems-IEC 606601-1-1:1993+A1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2002

Ms. Mary Anne Dell CAPINTEC, Inc. 540 Alpha Drive PITTSBURGH PA 15238 USA Re: K020150

Trade/Device Name: CRC 15BT Calibrator Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide dose calibrator Regulatory Class: II Product Code: 90 KPT Dated: May 13, 2002 Received: May 14, 2002

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. Drue, 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.

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Page 2

This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-459
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-461
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-461
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-465
Other	(301) 594-469

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" (21 CFR Part 807.97). 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 yours,

Henry C. Snogdon

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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Appendix 2

Indications for Use Form

Page

510(k) Number (if known):

Device Name: CRC 15BT

Indications For Use: The CRC 15BT dose calibrator is intended to be used by trained medical physicists, or qualified technologists to measure the activity or output of radioactive brachytherapy sources, including HDR, LDR and IVBT sources.

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020150

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.