GammaTile

K190296 · Gt Medical Technologies · KXK · Mar 13, 2019 · Radiology

Device Facts

• Record ID: K190296
• Device Name: GammaTile
• Applicant: Gt Medical Technologies
• Product Code: KXK · Radiology
• Decision Date: Mar 13, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients with recurrent intracranial neoplasms requiring radiation therapy after surgical excision.

Regulatory Classification

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)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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<br>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<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | | |
| | | Department of Health and Human Services | |
| | Food and Drug Administration<br>Office of Chief Information Officer | | |
| | Paperwork Reduction Act (PRA) Staff<br>[e-mail] | | |
| 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<br>information unless it displays a currently valid OMB number." | | |

{3}------------------------------------------------

## I. 510(k) Summary

K190296

| Submitter | GT Medical Technologies |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 1809 S Holbrook Lane<br>Suite 107<br>Tempe, AZ 85281 |
| Telephone Number | 480-276-8609 |
| Contact Person | Jessica Newhard<br>Regulatory Affairs Specialist<br>[e-mail] |
| Date of Preparation | February 12, 2019 |
| Device Trade Name | GammaTile™ |
| Device Common Name | Radionuclide Brachytherapy Seeds |
| Device Classification Name | Radionuclide Brachytherapy Source (per<br>21CFR §892.5730) |
| Predicate Device(s) | Primary Predicate: GammaTile that is the<br>subject of this submission is substantially<br>equivalent to GammaTile as described in<br>510(k) 180515 |
| Product Description | GammaTile is a device intended for<br>the treatment of recurrent intracranial<br>neoplasms which uses cesium-131<br>radioactive sources embedded in a<br>collagen matrix. GammaTile™ is<br>designed to provide “adjuvant" radiation<br>therapy – therapy to eliminate any<br>remaining neoplastic cells – to patients<br>who require surgical resection of recurrent<br>brain neoplasms.<br>GammaTile is positioned within the<br>resection cavity immediately after surgical<br>excision of the brain neoplasm to deliver<br>radiation therapy to any neoplastic cells<br>that remain in proximity of the resection<br>cavity. |
| Statement of Intended Use compared to<br>currently marketed predicate device | There is no change to the intended use or<br>indications for use compared to the<br>currently marketed predicate.<br><br>The intended use of the proposed device<br>is identical to the legally marketed device: |
| | GammaTile is intended to deliver radiation<br>therapy (brachytherapy). |
| | The indication for use is identical to the<br>legally marketed device: |
| | GammaTile is intended to deliver radiation<br>therapy (brachytherapy) in patients with<br>recurrent intracranial neoplasms. |
| Patient Population | Patients requiring radiation therapy after<br>excision for recurrent intracranial<br>neoplasms. |
| Statement of Technological<br>Characteristics | The technological characteristics of the<br>proposed device, GammaTile, are<br>identical to those of the predicate,<br>GammaTile as described in 510(k)<br>K180515 |
| Assessment of Non-clinical Performance<br>Data | No significant changes have been made to<br>the technological characteristics of the<br>proposed device since clearance of the<br>primary predicate device (K180515). In<br>addition, the intended use and indication<br>for use remains the same between the<br>proposed device and the predicate device<br>(K180515). A risk/change analysis has<br>been completed to assess whether the<br>changes proposed had any impact on<br>safety or effectiveness of the device. The<br>risk/change analysis resulted in a<br>determination of no new risk and validation<br>testing confirmed these changes did not<br>raise new safety concerns. |
| Conclusion Drawn from Testing | Test results confirmed that the changes<br>made have no impact to product safety or<br>efficacy and introduce no new risks. |
| Safety and Effectiveness | To ensure that the devices are safe and<br>effective, all finished products must meet<br>all acceptance criteria required by the<br>product specification before distribution.<br>The required testing is defined in<br>documented procedures that conform to<br>the product design specifications. |

Table 1. Tabular Summary of 510 (k)

{4}------------------------------------------------