← Product Code [KXK](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK) · K190296 # GammaTile (K190296) _Gt Medical Technologies · KXK · Mar 13, 2019 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K190296 ## Device Facts - **Applicant:** Gt Medical Technologies - **Product Code:** [KXK](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK.md) - **Decision Date:** Mar 13, 2019 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.5730 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use GammaTile is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms ## Device Story GammaTile is a brachytherapy device consisting of cesium-131 radioactive sources embedded in a collagen matrix. It is used by neurosurgeons in an operating room setting. Following the surgical resection of a recurrent intracranial neoplasm, the device is placed directly into the resection cavity. The collagen matrix serves as a carrier for the radioactive sources, allowing for the immediate, localized delivery of adjuvant radiation therapy to any remaining neoplastic cells in the cavity proximity. This targeted approach aims to eliminate residual tumor cells, potentially improving local control of the recurrent disease. ## Clinical Evidence No clinical data provided. Substantial equivalence is supported by non-clinical performance data, including risk/change analysis and validation testing confirming that modifications do not raise new safety or effectiveness concerns. ## Technological Characteristics Radionuclide brachytherapy source; cesium-131 radioactive sources embedded in a collagen matrix; intended for surgical implantation in intracranial resection cavities. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - GammaTile ([K180515](/device/K180515.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration" below it. March 13, 2019 GT Medical Technologies % Ms. Jessica Newhard Regulatory Affairs Specialist 1809 S Holbrook Lane, Suite 107 TEMPE AZ 85281 Re: K190296 Trade/Device Name: GammaTile™ Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: KXK Dated: February 8, 2019 Received: February 11, 2019 Dear Ms. Newhard: 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 {1}------------------------------------------------ https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120 | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------| | Indications for Use | | | Expiration Date: 06/30/2020 | | 510(k) Number (if known) | | | See PRA Statement below. | | K190296 | | | | | Device Name | | | | | GammaTile | | | | | Indications for Use (Describe) | | | | | | GammaTile is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [X] Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. | | | | | "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | | | | | The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to: | | | | | | Department of Health and Human Services | | | | Food and Drug Administration
Office of Chief Information Officer | | | | | Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov | | | | Type of Use (Select one or both, as applicable) | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number." | | | {3}------------------------------------------------ ## I. 510(k) Summary K190296 | Submitter | GT Medical Technologies | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 1809 S Holbrook Lane
Suite 107
Tempe, AZ 85281 | | Telephone Number | 480-276-8609 | | Contact Person | Jessica Newhard
Regulatory Affairs Specialist
jnewhard@gtmedtech.com | | Date of Preparation | February 12, 2019 | | Device Trade Name | GammaTile™ | | Device Common Name | Radionuclide Brachytherapy Seeds | | Device Classification Name | Radionuclide Brachytherapy Source (per
21CFR §892.5730) | | Predicate Device(s) | Primary Predicate: GammaTile that is the
subject of this submission is substantially
equivalent to GammaTile as described in
510(k) 180515 | | Product Description | GammaTile is a device intended for
the treatment of recurrent intracranial
neoplasms which uses cesium-131
radioactive sources embedded in a
collagen matrix. GammaTile™ is
designed to provide “adjuvant" radiation
therapy – therapy to eliminate any
remaining neoplastic cells – to patients
who require surgical resection of recurrent
brain neoplasms.
GammaTile is positioned within the
resection cavity immediately after surgical
excision of the brain neoplasm to deliver
radiation therapy to any neoplastic cells
that remain in proximity of the resection
cavity. | | Statement of Intended Use compared to
currently marketed predicate device | There is no change to the intended use or
indications for use compared to the
currently marketed predicate.

The intended use of the proposed device
is identical to the legally marketed device: | | | GammaTile is intended to deliver radiation
therapy (brachytherapy). | | | The indication for use is identical to the
legally marketed device: | | | GammaTile is intended to deliver radiation
therapy (brachytherapy) in patients with
recurrent intracranial neoplasms. | | Patient Population | Patients requiring radiation therapy after
excision for recurrent intracranial
neoplasms. | | Statement of Technological
Characteristics | The technological characteristics of the
proposed device, GammaTile, are
identical to those of the predicate,
GammaTile as described in 510(k)
K180515 | | Assessment of Non-clinical Performance
Data | No significant changes have been made to
the technological characteristics of the
proposed device since clearance of the
primary predicate device (K180515). In
addition, the intended use and indication
for use remains the same between the
proposed device and the predicate device
(K180515). A risk/change analysis has
been completed to assess whether the
changes proposed had any impact on
safety or effectiveness of the device. The
risk/change analysis resulted in a
determination of no new risk and validation
testing confirmed these changes did not
raise new safety concerns. | | Conclusion Drawn from Testing | Test results confirmed that the changes
made have no impact to product safety or
efficacy and introduce no new risks. | | Safety and Effectiveness | To ensure that the devices are safe and
effective, all finished products must meet
all acceptance criteria required by the
product specification before distribution.
The required testing is defined in
documented procedures that conform to
the product design specifications. | Table 1. Tabular Summary of 510 (k) {4}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K190296](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K190296) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com