CivaStringPd103 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. CivaString 4103 may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

Device Description

CivaString" d103 is a linear LDR (low dose rate) brachytherapy source comprised of polymeric materials. CivaString 1103 contains Pd-103 isotope that is distributed into "wells" along the length of the device. Wells may be filled or left empty (to provide gaps in regions where no radiation is desired) based on the overall therapy plan prescription.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "CivaStringPd103," a radionuclide brachytherapy source. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria and performance metrics for the device itself.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points from your request cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not present. The submission focuses on comparing the CivaStringPd103's characteristics to predicate devices.
Sample sized used for the test set and the data provenance: Not present. No test set data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
Adjudication method: Not present.
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 present. This device is a brachytherapy source, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

The 510(k) submission for CivaStringPd103 focuses on demonstrating "substantial equivalence" based on:

Intended Use and Indications for Use: Stated to be the same as predicate devices.
Design: A sealed source delivering therapeutic radioactive energy, with the key difference being a linear "string" configuration versus point "seeds."
Energy Emitted: "Exactly the same as current Pd 103 sources: 20-23 keV x-rays."
Safety and Performance: The submission claims that the differences do not raise questions regarding safety and effectiveness, and the device is "as safe and effective as its predicate devices."

This type of submission relies on the established safety and effectiveness of the legally marketed predicate devices rather than new clinical trials with defined acceptance criteria for the new device's performance.

Summary

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Section 5 - 510(k) Summary

SEP 3 0 2008

1. Applicant Contact:

Lois V. Smart Regulatory Consultant Smart Consulting Services, Inc. 1317 Buchanan Drive Mebane, NC 27302 Phone: (919) 563-0869 Fax: (888) 622-4075 Email: loissmart@yahoo.com

Date Prepared: July 30, 2008

CivaStringPd103 2. Name of Device: Common Name: Radionuclide Brachytherapy Source Classification Name: Brachytherapy Radionuclide Regulation 21 CFR 892.5730, Product Code KXK

Identification of device(s) to which the submitted claims equivalence: 3.

The CivaString 1103 is substantially equivalent to the following predicate devices:

RadioMed™ Source by RadioMed Corporation, 510(k) K001070 �
OptiSource103 by International Brachytherapy, Inc., 510(k) K040766 ●
Readi-Strand Model PSStrand by Worldwide Medical Technologies, Inc., � 510(k) K023179

4. Device Description:

5. Intended Use of the Device:

CivaString"d103 is intended for medical purposes to be placed into a body cavity or tissue as a source of nuclear radiation for therapy.

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Indications for Use 6.

CivaStringPd103 is indicated for use as a permanent interstitial brachytherapy source for the treatment of selected localized turnors. The device may be used either as the primary treatment or for treatment of residual disease after excision of the primary tumor. CivaString 9103 may be indicated for use concurrently with or sequentially with other treatment modalities, such as external beam radiation therapy or chemotherapy.

7. Characteristics of the device in comparison to those of the predicate device(s)

When compared with the Intended Use and Indications for Use of the three (3) predicates, the Intended Use and Indications for Use does not change.

The design of each of the predicates and CivaString 8103 is a sealed source from which a therapeutic dosage of radioactive energy is delivered. The predicate devices use a sealed source in a "seed" configuration. CivaString"d103 is a sealed source in the form of a string and is linear versus current point sources.

The energy emitted from CivaStringPd103 is exactly the same as current Pd 103 sources: 20-23 keV x-rays.

8. Safety and Performance:

The difference between the CivaString" and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the device. The device, as designed, is as safe and effective as its predicate devices.

9. Conclusion

Based on the design, material, function and intended use discussed herein. CivaTech Oncology, Inc. believes the CivaString 8103 is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/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 depiction of an eagle, represented by three curved lines that suggest the bird's wings and body.

SEP 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CivaTech Oncology, Inc. % Ms. Lois Smart Regulatory Consultant Smart Consulting Services, Inc. 1317 Buchanan Drive MEBANE NC 27302

Rc: K082159

Trade/Device Name: CivaStringPd103 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class; II Product Code: KXK Dated: July 30, 2008 Received: July 31, 2008

Dear Ms. Smart:

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 (PMA), 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.

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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 (OS) 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jaque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

K082159

510k number if known:

Device Name:

CivaStringPd103

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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.