CivaSheet is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaSheet may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

Device Description

The CivaSheet is a planar brachytherapy device designed to be implanted in the body to treat selected localized tumors. The CivaSheet utilizes biocompatible materials to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaSheet will be offered in two configurations: a shielded unidirectional version, and an unshielded version. Both versions are intended as permanent implants and are partially bio-absorbable.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification decision letter from the FDA regarding a device called CivaSheet PD-103.

It primarily discusses:

The FDA's review and determination of substantial equivalence for the CivaSheet device.
Regulatory information, including the device's classification, applicable regulations, and responsibilities of the manufacturer.
The intended use and indications for use of the CivaSheet.
A comparison of the CivaSheet with a predicate device (CivaString), focusing on design, materials, function, and intended use, and concluding that the differences do not raise new questions regarding safety and effectiveness.

There is no mention of a study involving test sets, ground truth establishment, expert readers, or performance metrics against acceptance criteria. The approval is based on substantial equivalence to a legally marketed predicate device, rather than a clinical performance study with specific acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2014

CivaTech Oncology, Inc. % Mr. Blix Winston Submission Correspondent Tammnet, Inc. 2600 Mullinix Mill Road MT AIRY MD 21771

Re: K140490

Trade/Device Name: CivaSheet PD-103 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 21, 2014 Received: August 22, 2014

Dear Mr. Winston:

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.

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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

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140490

Device Name CivaSheet

Indications for Use (Describe)

CivaSheet is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized tumors. The device may be used either as the primary treatment of residual disease after excision of the primary tumor. CivaSheet may be indicated for use concurrently with other treatment modalities, such as external beam radiation therapy or chemotherapy.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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1. 510(k) Submitter:

Mrs. Suzanne Babcock CivaTech Oncology, Inc. PO Box 14310 Research Triangle Park North Carolina, 27709

Ph: 919-314-5515 Email: sbabcock@civatechoncology.com

2. Submission Correspondent:

Blix Winston Tammnet Inc. 2600 Mullinix Mill Road Mt. Airy, MD 21771 Phone: 301-607-9185 Email: Blix@tammnet.com

1. Date Prepared: February 26, 2014
1. Name of Device: CivaSheet Common Name: Radionuclide Brachytherapy Source Classification Name: Brachytherapy Radionuclide Regulation 21 CFR 892.5730, Product Code KXK
1. Identification of device(s) to which the submitted device claims equivalence:
- . CivaString by CivaTech Oncology Inc., K082159

6. Device Description:

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7. Intended Use of the Device:

CivaSheet is intended for medical purposes to be placed into a body cavity or tissue as a source of nuclear radiation for therapy.

8. Indications for Use

Characteristics of the device in comparison to those of the predicate 9. device

When compared with the Intended Use and Indications for Use of the predicate, the Intended Use and Indications for Use do not change.

The design of the predicate and CivaSheet is a sealed source from which a therapeutic dosage of radioactive energy is delivered. The predicate device uses a sealed source in a linear configuration. CivaSheet uses a sealed source in a sheet configuration.

The energy emitted from CivaSheet is exactly the same as current Pd 103 sources: 20-23 keV x-rays.

10. Safety and Performance:

The difference between the CivaSheet and the above mentioned predicate devices does not raise any new questions reqarding the safety and effectiveness of the device. The device, as designed, is as safe and effective as its predicate device.

11. Conclusion

Based on the design, material, function and intended use discussed herein, CivaTech Oncology, Inc. believes the CivaSheet is substantially equivalent to predicate device currently marketed under the Federal Food, Drug and Cosmetic Act.

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.