GammaTile by GT Medical Technologies

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.

AI/ML Overview

This document is a 510(k) premarket notification for the GammaTile brachytherapy device. It focuses on demonstrating substantial equivalence to a previously cleared GammaTile device (K180515), rather than presenting a new clinical study to establish acceptance criteria and device performance from scratch.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as would be found in a clinical study report, is not present in this 510(k) summary.

The document primarily states:

Acceptance Criteria (Implied): "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." This indicates that internal product specifications define the acceptance criteria for manufacturing and release, but these specific criteria and their values are not detailed in this public FDA letter.
Study That Proves Device Meets Acceptance Criteria: The study described here is a "risk/change analysis" and "validation testing" to confirm that changes made to the device since the clearance of the predicate (K180515) do not impact safety or efficacy and introduce no new risks.
- Conclusion: "Test results confirmed that the changes made have no impact to product safety or efficacy and introduce no new risks." This refers to the assessment of changes, not an initial validation of the device's clinical performance.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with specific metrics or values (e.g., success rates, P-values). The document generally refers to "all acceptance criteria required by the product specification."
- Reported Device Performance: Not reported in clinical metrics for performance in patients. Instead, the document discusses that "test results confirmed that the changes made have no impact to product safety or efficacy and introduce no new risks," relative to the predicate device.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or stated, as this is a substantial equivalence submission based on engineering and risk assessment of device changes, not a clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or stated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or stated.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a brachytherapy source, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable or stated for clinical performance. The "ground truth" for this submission revolves around the unchanged technological characteristics and safety/efficacy profile compared to the predicate.
The sample size for the training set: Not applicable or stated.
How the ground truth for the training set was established: Not applicable or stated.

In summary: This 510(k) submission confirms that minor modifications to an already cleared device (GammaTile K180515) were assessed through a risk/change analysis and validation testing, concluding that these changes did not negatively impact safety or efficacy. It does not contain the kind of detailed clinical study data typically associated with establishing initial device performance and acceptance criteria.

Summary

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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

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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

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood 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)
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I. 510(k) Summary

K190296

Submitter	GT Medical Technologies
Address	1809 S Holbrook LaneSuite 107Tempe, AZ 85281
Telephone Number	480-276-8609
Contact Person	Jessica NewhardRegulatory Affairs Specialistjnewhard@gtmedtech.com
Date of Preparation	February 12, 2019
Device Trade Name	GammaTile™
Device Common Name	Radionuclide Brachytherapy Seeds
Device Classification Name	Radionuclide Brachytherapy Source (per21CFR §892.5730)
Predicate Device(s)	Primary Predicate: GammaTile that is thesubject of this submission is substantiallyequivalent to GammaTile as described in510(k) 180515
Product Description	GammaTile is a device intended forthe treatment of recurrent intracranialneoplasms which uses cesium-131radioactive sources embedded in acollagen matrix. GammaTile™ isdesigned to provide “adjuvant" radiationtherapy – therapy to eliminate anyremaining neoplastic cells – to patientswho require surgical resection of recurrentbrain neoplasms.GammaTile is positioned within theresection cavity immediately after surgicalexcision of the brain neoplasm to deliverradiation therapy to any neoplastic cellsthat remain in proximity of the resectioncavity.
Statement of Intended Use compared tocurrently marketed predicate device	There is no change to the intended use orindications for use compared to thecurrently marketed predicate.The intended use of the proposed deviceis identical to the legally marketed device:
	GammaTile is intended to deliver radiationtherapy (brachytherapy).
	The indication for use is identical to thelegally marketed device:
	GammaTile is intended to deliver radiationtherapy (brachytherapy) in patients withrecurrent intracranial neoplasms.
Patient Population	Patients requiring radiation therapy afterexcision for recurrent intracranialneoplasms.
Statement of TechnologicalCharacteristics	The technological characteristics of theproposed device, GammaTile, areidentical to those of the predicate,GammaTile as described in 510(k)K180515
Assessment of Non-clinical PerformanceData	No significant changes have been made tothe technological characteristics of theproposed device since clearance of theprimary predicate device (K180515). Inaddition, the intended use and indicationfor use remains the same between theproposed device and the predicate device(K180515). A risk/change analysis hasbeen completed to assess whether thechanges proposed had any impact onsafety or effectiveness of the device. Therisk/change analysis resulted in adetermination of no new risk and validationtesting confirmed these changes did notraise new safety concerns.
Conclusion Drawn from Testing	Test results confirmed that the changesmade have no impact to product safety orefficacy and introduce no new risks.
Safety and Effectiveness	To ensure that the devices are safe andeffective, all finished products must meetall acceptance criteria required by theproduct specification before distribution.The required testing is defined indocumented procedures that conform tothe product design specifications.

Table 1. Tabular Summary of 510 (k)

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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.