GammaTile

K221539 · Gt Medical Technologies · KXK · Nov 9, 2022 · Radiology

Device Facts

• Record ID: K221539
• Device Name: GammaTile
• Applicant: Gt Medical Technologies
• Product Code: KXK · Radiology
• Decision Date: Nov 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms.

Device Story

GammaTile is a brachytherapy device consisting of cesium-131 radioactive seeds embedded in a collagen matrix. It is used as an adjuvant radiation therapy for patients undergoing surgical resection of brain neoplasms. The device is placed directly into the resection cavity immediately following tumor excision. The collagen matrix acts as a three-dimensional spacer, maintaining even spacing between seeds and preventing direct contact between the radioactive sources and brain tissue to avoid localized overdosing. The matrix is bioresorbable. The device is intended for use by neurosurgeons in an operating room setting. By delivering targeted radiation to the resection cavity, the device aims to eliminate residual neoplastic cells, potentially improving local control of the disease.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including biocompatibility assessments, collagenase studies comparing bioresorption timeframes, and simulated use studies to evaluate the impact of radioactive seeds on device performance.

Technological Characteristics

Radionuclide brachytherapy source (cesium-131) embedded in a bioresorbable collagen matrix. Functions as a 3D spacer and multi-seed carrier. Sterilization via e-beam or ethylene oxide (EO).

Indications for Use

Indicated for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms.

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 (K190839)

Reference Devices

• DuraMatrix Onlay Plus (K150825)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

GT Medical Technologies % Jessica Newhard Regulatory Affairs and Quality Assurance Manager 1809 S Holbrook Lane, Suite 107 TEMPE AZ 85281

November 9, 2022

Re: K221539

Trade/Device Name: GammaTile® Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: KXK Dated: October 7, 2022 Received: October 11, 2022

Dear Jessica 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/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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Julie Sullivan -S

Julie Sullivan, Ph.D. Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K221539

Device Name GammaTile®

Indications for Use (Describe)

GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### I. 510(k) Summary

| | Table 1. Tabular Summary of 510 (k) | |
|--|-------------------------------------|--|

K221539

| Table 1: Tabular Summary of 510 (k) | K221559 |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | GT Medical Corporation |
| Address | 1809 S Holbrook Drive<br>Suite 107<br>Tempe, AZ 85281 |
| Telephone Number | 480-276-8609 |
| Contact Person | Jessica Newhard<br>Regulatory Affairs and Quality Assurance<br>Manager<br>[e-mail] |
| Date of Preparation | November 4, 2022 |
| Device Trade Name | GammaTile® |
| Device Common Name | Radionuclide Brachytherapy Seeds |
| Device Classification Name | Radionuclide Brachytherapy Source (per<br>21CFR §892.5730) |
| Device Regulation Number | 892.5730 |
| Product Code | KXK |
| Predicate Device(s) | Predicate: K190839 GammaTile (Indications<br>for Use)<br>Reference Device: K150825 DuraMatrix<br>Onlay Plus |
| Product Description | GammaTile is a device intended for<br>the treatment of intracranial neoplasms which<br>uses cesium-131 radioactive sources<br>embedded in a collagen matrix. GammaTile<br>is designed to provide “adjuvant” radiation<br>therapy – therapy to eliminate any remaining<br>neoplastic cells – to patients who require<br>surgical resection of brain neoplasms.<br>GammaTile is positioned within the resection<br>cavity immediately after surgical excision of<br>the brain neoplasm to deliver radiation<br>therapy to any neoplastic cells that remain in<br>proximity of the resection cavity. |
| Indications for Use Statement | GammaTile is indicated as a treatment for<br>patients with newly diagnosed malignant<br>intracranial neoplasms and patients with<br>recurrent intracranial neoplasms. |
| Indication for Use statement compared to<br>currently marketed predicate device | No change is being requested to the indication<br>for use statement within this submission. |
| Patient Population | No change is being requested to the patient<br>population within this submission.<br>GammaTile is intended for patients with<br>newly diagnosed malignant intracranial<br>neoplasms and patients with recurrent<br>intracranial neoplasms. |
| Statement of Technological Characteristics | The change to materials, specifically the<br>change in collagen carrier of the subject<br>device, has been assessed to ensure it has<br>technological characteristics equivalent to the<br>predicate device. Biocompatibility testing was<br>performed and demonstrated that GammaTile<br>subject device maintains an equivalent<br>biocompatibility profile as the predicate<br>device. A collagenase study was performed<br>on the subject device, predicate device and<br>reference device which demonstrated that the<br>bioresorption timeframe is similar between<br>the predicate device material and the subject<br>device material. A simulated use study was<br>performed on the subject device and<br>determined that, under simulated use<br>conditions, exposure to radioactive seeds does<br>not impact the performance characteristics of<br>the subject device. A risk assessment has<br>been completed to assess whether the change<br>to materials has any impact on safety or<br>effectiveness of the device. The risk/change<br>analysis resulted in a determination of no new<br>risks. |
| Assessment of Non-clinical Performance Data | The subject device has been assessed to<br>ensure it has technological characteristics<br>equivalent to the predicate device.<br>Biocompatibility testing was performed and<br>demonstrated that GammaTile manufactured<br>with the GTMT Collagen (subject device)<br>maintains an equivalent biocompatibility<br>profile as the predicate device. A collagenase<br>study was performed on the e-beam and EO<br>sterilized GTMT Collagen and demonstrated<br>that the bioresorption timeframe is similar<br>between e-beam and EO sterilized predicate<br>collagen carrier material and e-beam and EO<br>sterilized GTMT Collagen. A simulated use<br>study was performed and determined that,<br>under simulated use conditions, exposure to<br>radioactive seeds does not impact the<br>performance characteristics of the subject<br>device. A risk assessment has been<br>completed to assess whether the GTMT<br>Collagen carrier has any impact on safety or<br>effectiveness of the device. The risk/change<br>analysis resulted in a determination of no new<br>risks. |
| Conclusion Drawn from Testing | Biocompatibility testing demonstrated that the<br>predicate device and subject device have<br>similar biocompatibility profiles. The<br>collagenase testing concluded that the GTMT<br>Collagen performed similarly to the predicate<br>collagen carrier material which demonstrates<br>that the subject device will have a similar<br>bioresorption profile to the predicate device.<br>In addition, the simulated use study showed<br>no difference in performance between the<br>predicate device and the subject device.<br>Therefore, based on the results from the<br>previous implant studies conducted on the<br>predicate device and the reference device<br>(equivalent to GTMT Collagen), the similar<br>bioresorption profile. an equivalent. |
| Safety and Effectiveness | manufacturing process of the finished<br>GammaTile device, and the performance<br>testing results, it was determined that the<br>subject device has equivalent technological<br>characteristics to the predicate. |
| | To ensure that the devices are safe and<br>effective compared to the predicate, all<br>finished products must meet all acceptance<br>criteria required by the product specification<br>before distribution. The required testing is<br>defined in documented procedures that<br>conform to the product design specifications.<br>The similar performance characteristics<br>demonstrated through simulated use testing<br>and the collagenase study provide evidence<br>that the GTMT Collagen will continue to<br>function as a three-dimensional spacer<br>preventing the seeds from direct tissue contact<br>to avoid overdosing and as a multi-seed<br>carrier providing even spacing between<br>adjacent seeds. The GTMT collagen does not<br>impact the safety or effectiveness of the<br>GammaTile device in comparison to the<br>predicate. |

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