CRC PC Smart Chamber K1

K192199 · Capintec, Inc. · KPT · Sep 12, 2019 · Radiology

Device Facts

• Record ID: K192199
• Device Name: CRC PC Smart Chamber K1
• Applicant: Capintec, Inc.
• Product Code: KPT · Radiology
• Decision Date: Sep 12, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1360
• Device Class: Class 2

Intended Use

The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.

Device Story

Device is a sealed, pressurized reentrant well-style ionization chamber; functions as a radioisotope dose calibrator. Input: radiopharmaceutical samples in a 3 ml Karl 100 sample cartridge. Operation: measures radiation activity via ionization; uses networked PC as user interface. Output: activity measurement of radiopharmaceuticals. Used in clinical settings by nuclear medicine professionals. Device is a shortened version of the predicate (12.5 inches vs 18.1 inches) to fit the TEMA Karl 100 system. Fixed geometry ensures reproducibility. Benefits: enables precise measurement of diagnostic radiopharmaceuticals within an automated administration system.

Clinical Evidence

No clinical data. Bench testing and risk assessment performed to verify that the device meets specifications and functions as expected following physical modification and software deactivation.

Technological Characteristics

Pressurized reentrant well-style ionization chamber. Dimensions: 12.5 inches height. Connectivity: Networked PC interface. Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 62366 (Usability engineering).

Indications for Use

Indicated for qualified nuclear medicine technologists, physicians, and radiopharmacists to measure radiopharmaceuticals (beta/gamma emitters) for diagnostic applications using the TEMA Karl 100 system.

Regulatory Classification

Identification

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

Predicate Devices

• CRC-PC Smart Chamber series (K141413)

Submission Summary (Full Text)

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September 12, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Capintec, Inc. % Ms. Mary Anne Yusko VP Regulatory Affairs 7 Vreeland Road FLORHAM PARK NJ 07932

Re: K192199

Trade/Device Name: CRC PC Smart Chamber K1 Regulation Number: 21 CFR 892.1360 Regulation Name: Radionuclide Dose Calibrator Regulatory Class: Class II Product Code: KPT Dated: August 14, 2019 Received: August 15, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192199

Device Name

CRC PC with Smart Chamber K1

## Indications for Use (Describe)

The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
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| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 vertically inside of a square. Below the square is the text "CAPINTEC, INC." in a simple sans-serif font. The logo is black and white.

August 9, 2019

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| Device Trade Name: | CRC PC Smart Chamber K1 |
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| Common or Usual Name: | Radioisotope Dose Calibrator |
| Classification Name: | Radioisotope dose calibrator (21 CFR 982.1360) |
| Regulatory Class: | II |
| Product Code: | KPT |
| Predicate Device: | The CRC-PC Smart Chamber K1 dose calibrator is a modification of the<br>predicate device, CRC-PC Smart Chamber series, which received FDA<br>clearance under 510(k) number K141413 |

Manufacturer: Capintec, Inc. 7 Vreeland Road Florham Park, New Jersey 07932 USA Phone: [phone] FAX [phone]

Product Description: The Capintec CRC PC Smart Family of dose calibrators are sealed, pressurized reentrant well style ionization chambers which use a networked PC as the user interface. The CRC PC Smart Chamber K1 is modified CRC PC Smart Chamber, which has been shortened in height to fit into the Karl 100 Dose Administration System, which is manufactured by TEMA.

Indications for Use: The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be only with the TEMA Karl 100 radiopharmaceutical dose administration system.

Comparison to Predicate Device: The CRC-PC Smart Chamber K1 is identical to the predicate device, the CRC-PC Smart Chamber, in terms of scientific technology, method of operation, radiation detector design, calibration, measurement processes, and basic electronic circuitry. There are two design main differences between the two devices: vertical dimension change and deactivation of some software found in the CRC-PC Smart Chamber, The CRC-PC Smart Chamber K1 height is reduced from the standard chamber height of 18,1 inches to 12.5 inches. The reduced height allows it to fit without any other modification into the Karl 100 dose administration system. It will be used in only one geometric configuration, 3 ml of solution in the Karl 100 sample cartridge. This assures reproducible geometry. Since there is only one geometry. Moly Assay has been removed from the software.

Safety and Effectiveness: Risk assessment confirms that all identified risks were either mitigated or are within acceptable limits. Verification and validation testing confirmed the CRC-PC Smart Chamber K1 meets all stated specifications and functions as expected.

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CRC PC Smart Chamber K1, is one of many Capintec dose calibrators which utilize the same ionization chamber design. These dose calibrators have a long history of over 40 years of safe, reliable, and effective use in the field. The CRC PC family of dose calibrators, including the CRC PC Smart Chamber K1, is approved to the following EMC and electrical safety standards for medical equipment:

IEC 60601-1-2 (2007) Ed 3: 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 30 Edition: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability

IEC 62366:2007 (Ed 1). Medical device application of usability engineering to medical devices

Conclusion: Based on the above summary, Capintec concludes that the CRC PC Smart Chamber K1 is substantially equivalent to its predicate device.