(127 days)
Not Found
No
The summary describes a brachytherapy source and its physical properties, with no mention of AI or ML in its function or intended use.
Yes
The device is described as treating "selected localized tumors" and delivering radiation for "surface brachytherapy procedures," which are therapeutic medical interventions.
No
The device, CivaDerm™ Pd103, is described as a brachytherapy source intended for treating localized tumors by delivering x-ray radiation. Its purpose is therapeutic (treatment), not diagnostic (identifying or characterizing disease).
No
The device description clearly states it utilizes biocompatible materials, bioabsorbable polymers, and a radionuclide (Pd-103) encapsulated within a planar unidirectional source with gold backing. This describes a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of localized tumors using radiation. IVDs are used for the diagnosis or monitoring of diseases or conditions by examining samples from the human body (like blood, urine, or tissue).
- Device Description: The device description clearly states it's a "brachytherapy source" that delivers radiation for treatment. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the CivaDerm™ Pd103 is a therapeutic medical device, specifically a brachytherapy source, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CivaDermPd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors.
This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
Product codes
ONL, KXK
Device Description
The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures.
By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All required non-clinical testing has been successfully performed according to published industry standards. CivaDerm finished devices are tested and meet acceptance criteria determined by product design specifications to verify each device is safe and effective. Products released from manufacturing meet requirements for product integrity, apparent activity, external contamination, among others. The device, as designed, is as safe and will be as effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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September 20, 2019
CivaTech Oncology, Inc. % Blix Winston, MPA, MS Director Regulatory Affairs TAMM Net. Inc. 2600 Mullinix Mill Road MT. AIRY MD 21771
Re: K191324
Trade/Device Name: CivaDerm™ Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: ONL, KXK Dated: September 4, 2019 Received: September 4, 2019
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. 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/cfpmn/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
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K191324
Device Name CivaDerm™
Indications for Use (Describe)
CivaDermPd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors.
This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
1. 510(k) Submitter:
Mrs. Suzanne Babcock CivaTech Oncology, Inc. 2810 Meridian Parkway, #152 Durham, NC 27713
Phone: (919) 314-5515 Email: sbabcock@civatechoncology.com
2. Submission Correspondent:
Blix Winston, MPA, MS TAMM Net, Inc., Director Regulatory Affairs 2600 Mullinix Mill Road Mt. Airy, MD 21771
Ph: 301-607-9185 Email: blix@tammnet.com
3. Date Prepared: May 14, 2019
| 4. Name of Device: | CivaDerm™ |
|---|---|
| Common Name: | Radionuclide Brachytherapy Source |
| Classification Name: | Radionuclide Brachytherapy Source |
| 21 CFR 892.5730, Product Code ONL, KXK | |
| Classification: | Class II |
| Product Code: | ONL, KXK |
| 510k number: | K191324 |
ട്. Identification of devices to which the submitted claims equivalence:
Device Name: RIC Conformal Source Model 100 Brachytherapy Source 510K Number: K090321 Classification: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: ONL, KXK Concurrence Date: 05/27/2009
6. Device Description:
The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a
4
planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures.
By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.
7. Indications for Use
CivaDermPa103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.
This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
8. Characteristics of the device in comparison to those of the predicate device(s)
The function of the CivaDerm for temporary surface applications is the same as the predicate device. CivaDermPd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.
This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
9. Safety and Performance:
All required non-clinical testing has been successfully performed according to published industry standards. CivaDerm finished devices are tested and meet acceptance criteria determined by product design specifications to verify each device is safe and effective. Products released from manufacturing meet requirements for product integrity, apparent activity, external contamination, among others. The device, as designed, is as safe and will be as effective as its predicate device.
10. Conclusion
Based on the design, material, function and intended use discussed herein. CivaTech Oncology®, Inc. believes the CivaDerm is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.