CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS

K071396 · Capintec, Inc. · KPT · Jun 28, 2007 · Radiology

Device Facts

• Record ID: K071396
• Device Name: CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
• Applicant: Capintec, Inc.
• Product Code: KPT · Radiology
• Decision Date: Jun 28, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1360
• Device Class: Class 2

Intended 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.

Device Story

CRC 25 series dose calibrator; reduced-feature version of CRC 15Ultra. Measures radioactivity of radiopharmaceuticals and brachytherapy sources; utilizes detectors to quantify radiation output. Operated by nuclear medicine technologists, physicians, or medical physicists in clinical or research environments. Provides quantitative measurements of radioactive materials; assists clinicians in verifying dose accuracy for patient administration. Benefits include cost-effective, reliable measurement of radioactive sources for diagnostic and therapeutic applications.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, hardware, and algorithmic similarity to the predicate device, supported by bench testing to safety standards including IEC 61010-1, IEC 61010-2-101, IEC 61326, UL 61010A-1, and CAN/CSA-C22.2 standards.

Technological Characteristics

Radionuclide dose calibrator; utilizes radiation detectors for measurement. Complies with IEC 61010-1, IEC 61010-2-101, IEC 61326, UL 61010A-1, and CAN/CSA-C22.2 safety standards for electrical laboratory equipment. Features include optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET).

Indications for Use

Indicated for use by qualified nuclear medicine technologists and medical physicists to measure radiopharmaceuticals (including high energy beta/gamma emitters) and radioactive brachytherapy sources (HDR, LDR, IVBT). Well counter indicated for low activity radioactive sources/solutions and laboratory test applications. Used in clinical and research settings.

Regulatory Classification

Identification

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

Predicate Devices

• Capintec CRC 15Ultra

Submission Summary (Full Text)

{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}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of three stylized human profiles facing right, with flowing lines suggesting movement or progress.

## 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 [phone] or [phone]

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