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

Device Description

GammaTile is a device intended for the treatment of 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 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.

AI/ML Overview

The provided text concerns the FDA 510(k) premarket notification for the GammaTile device, specifically a submission (K221539) related to a change in the collagen carrier material. The document details the regulatory classification, product description, and the rationale for claiming substantial equivalence to a predicate device (K190839 GammaTile).

However, the document does not contain information about:

Acceptance criteria for a clinical study on device performance against specific metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to manufacturing and product specification conformance ("all finished products must meet all acceptance criteria required by the product specification before distribution").
A study that proves the device meets specific clinical performance acceptance criteria. The "studies" described (biocompatibility, collagenase, simulated use) are non-clinical and focused on demonstrating that the change in material does not negatively impact the device's technological characteristics, safety, or effectiveness compared to the predicate. They are not clinical performance studies.
Sample sizes used for a test set (clinical data).
Data provenance (country of origin, retrospective/prospective).
Number of experts and their qualifications for ground truth establishment.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Effect size of human readers improving with AI assistance.
Standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a training set (implying an AI/ML device, which this is not).
How ground truth for a training set was established.

The GammaTile is a Radionuclide Brachytherapy Source, which is a physical medical device that delivers radiation. It is not an AI/ML device, nor is it a diagnostic imaging device that would typically have performance metrics like sensitivity or specificity. Therefore, the questions posed regarding AI/ML device performance validation (e.g., MRMC, standalone performance, training/test sets, ground truth methodology) are not applicable to the information provided in this regulatory submission for a brachytherapy source.

The document focuses on demonstrating substantial equivalence for a material change through non-clinical testing, ensuring the modified device maintains the same safety and effectiveness profile as its predicate.

In summary, the provided text does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested, because the device is not an AI/ML or diagnostic performance device, and the submission focuses on non-clinical testing for a material change.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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 DriveSuite 107Tempe, AZ 85281
Telephone Number	480-276-8609
Contact Person	Jessica NewhardRegulatory Affairs and Quality AssuranceManagerjnewhard@gtmedtech.com
Date of Preparation	November 4, 2022
Device Trade Name	GammaTile®
Device Common Name	Radionuclide Brachytherapy Seeds
Device Classification Name	Radionuclide Brachytherapy Source (per21CFR §892.5730)
Device Regulation Number	892.5730
Product Code	KXK
Predicate Device(s)	Predicate: K190839 GammaTile (Indicationsfor Use)Reference Device: K150825 DuraMatrixOnlay Plus
Product Description	GammaTile is a device intended forthe treatment of intracranial neoplasms whichuses cesium-131 radioactive sourcesembedded in a collagen matrix. GammaTileis designed to provide “adjuvant” radiationtherapy – therapy to eliminate any remainingneoplastic cells – to patients who requiresurgical resection of brain neoplasms.GammaTile is positioned within the resectioncavity immediately after surgical excision ofthe brain neoplasm to deliver radiationtherapy to any neoplastic cells that remain inproximity of the resection cavity.
Indications for Use Statement	GammaTile is indicated as a treatment forpatients with newly diagnosed malignantintracranial neoplasms and patients withrecurrent intracranial neoplasms.
Indication for Use statement compared tocurrently marketed predicate device	No change is being requested to the indicationfor use statement within this submission.
Patient Population	No change is being requested to the patientpopulation within this submission.GammaTile is intended for patients withnewly diagnosed malignant intracranialneoplasms and patients with recurrentintracranial neoplasms.
Statement of Technological Characteristics	The change to materials, specifically thechange in collagen carrier of the subjectdevice, has been assessed to ensure it hastechnological characteristics equivalent to thepredicate device. Biocompatibility testing wasperformed and demonstrated that GammaTilesubject device maintains an equivalentbiocompatibility profile as the predicatedevice. A collagenase study was performedon the subject device, predicate device andreference device which demonstrated that thebioresorption timeframe is similar betweenthe predicate device material and the subjectdevice material. A simulated use study wasperformed on the subject device anddetermined that, under simulated useconditions, exposure to radioactive seeds doesnot impact the performance characteristics ofthe subject device. A risk assessment hasbeen completed to assess whether the changeto materials has any impact on safety oreffectiveness of the device. The risk/changeanalysis resulted in a determination of no newrisks.
Assessment of Non-clinical Performance Data	The subject device has been assessed toensure it has technological characteristicsequivalent to the predicate device.Biocompatibility testing was performed anddemonstrated that GammaTile manufacturedwith the GTMT Collagen (subject device)maintains an equivalent biocompatibilityprofile as the predicate device. A collagenasestudy was performed on the e-beam and EOsterilized GTMT Collagen and demonstratedthat the bioresorption timeframe is similarbetween e-beam and EO sterilized predicatecollagen carrier material and e-beam and EOsterilized GTMT Collagen. A simulated usestudy was performed and determined that,under simulated use conditions, exposure toradioactive seeds does not impact theperformance characteristics of the subjectdevice. A risk assessment has beencompleted to assess whether the GTMTCollagen carrier has any impact on safety oreffectiveness of the device. The risk/changeanalysis resulted in a determination of no newrisks.
Conclusion Drawn from Testing	Biocompatibility testing demonstrated that thepredicate device and subject device havesimilar biocompatibility profiles. Thecollagenase testing concluded that the GTMTCollagen performed similarly to the predicatecollagen carrier material which demonstratesthat the subject device will have a similarbioresorption profile to the predicate device.In addition, the simulated use study showedno difference in performance between thepredicate device and the subject device.Therefore, based on the results from theprevious implant studies conducted on thepredicate device and the reference device(equivalent to GTMT Collagen), the similarbioresorption profile. an equivalent.
Safety and Effectiveness	manufacturing process of the finishedGammaTile device, and the performancetesting results, it was determined that thesubject device has equivalent technologicalcharacteristics to the predicate.
	To ensure that the devices are safe andeffective compared to the predicate, allfinished products must meet all acceptancecriteria required by the product specificationbefore distribution. The required testing isdefined in documented procedures thatconform to the product design specifications.The similar performance characteristicsdemonstrated through simulated use testingand the collagenase study provide evidencethat the GTMT Collagen will continue tofunction as a three-dimensional spacerpreventing the seeds from direct tissue contactto avoid overdosing and as a multi-seedcarrier providing even spacing betweenadjacent seeds. The GTMT collagen does notimpact the safety or effectiveness of theGammaTile device in comparison to thepredicate.

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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.