K Number
K221539
Device Name
GammaTile
Date Cleared
2022-11-09

(166 days)

Product Code
Regulation Number
892.5730
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

No
The device description and performance studies focus on the physical properties and radioactive function of the device, with no mention of AI or ML.

Yes
The device is clearly indicated as a "treatment" for intracranial neoplasms using radioactive sources to eliminate remaining neoplastic cells, which is a therapeutic action.

No

The device description clearly states that GammaTile is "intended for the treatment of intracranial neoplasms" and "designed to provide 'adjuvant' radiation therapy." It is used after surgical excision to deliver radiation therapy, which is a therapeutic action, not a diagnostic one.

No

The device description explicitly states that GammaTile uses "cesium-131 radioactive sources embedded in a collagen matrix," indicating it is a physical device with hardware components (radioactive sources and collagen matrix).

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use is for the treatment of intracranial neoplasms by delivering radiation therapy. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
  • Device Description: The description clearly states that GammaTile is a device for treatment using radioactive sources embedded in a collagen matrix. It's positioned within the body to deliver radiation.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro to diagnose a condition, monitor a disease, or screen for a disease.

IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. GammaTile is a therapeutic device used directly on or in the body to treat a condition.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

KXK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial (brain)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject device has been assessed to ensure it has technological characteristics equivalent to the predicate device. Biocompatibility testing was performed and demonstrated that GammaTile manufactured with the GTMT Collagen (subject device) maintains an equivalent biocompatibility profile as the predicate device. A collagenase study was performed on the e-beam and EO sterilized GTMT Collagen and demonstrated that the bioresorption timeframe is similar between e-beam and EO sterilized predicate collagen carrier material and e-beam and EO sterilized GTMT Collagen. A simulated use study was performed and determined that, under simulated use conditions, exposure to radioactive seeds does not impact the performance characteristics of the subject device. A risk assessment has been completed to assess whether the GTMT Collagen carrier has any impact on safety or effectiveness of the device. The risk/change analysis resulted in a determination of no new risks.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K190839

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K150825

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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

1

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

2

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)

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

"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

Table 1. Tabular Summary of 510 (k)

K221539

Table 1: Tabular Summary of 510 (k)K221559
SubmitterGT Medical Corporation
Address1809 S Holbrook Drive
Suite 107
Tempe, AZ 85281
Telephone Number480-276-8609
Contact PersonJessica Newhard
Regulatory Affairs and Quality Assurance
Manager
jnewhard@gtmedtech.com
Date of PreparationNovember 4, 2022
Device Trade NameGammaTile®
Device Common NameRadionuclide Brachytherapy Seeds
Device Classification NameRadionuclide Brachytherapy Source (per
21CFR §892.5730)
Device Regulation Number892.5730
Product CodeKXK
Predicate Device(s)Predicate: K190839 GammaTile (Indications
for Use)
Reference Device: K150825 DuraMatrix
Onlay Plus
Product DescriptionGammaTile 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.
Indications for Use StatementGammaTile is indicated as a treatment for
patients with newly diagnosed malignant
intracranial neoplasms and patients with
recurrent intracranial neoplasms.
Indication for Use statement compared to
currently marketed predicate deviceNo change is being requested to the indication
for use statement within this submission.
Patient PopulationNo change is being requested to the patient
population within this submission.
GammaTile is intended for patients with
newly diagnosed malignant intracranial
neoplasms and patients with recurrent
intracranial neoplasms.
Statement of Technological CharacteristicsThe change to materials, specifically the
change in collagen carrier of the subject
device, has been assessed to ensure it has
technological characteristics equivalent to the
predicate device. Biocompatibility testing was
performed and demonstrated that GammaTile
subject device maintains an equivalent
biocompatibility profile as the predicate
device. A collagenase study was performed
on the subject device, predicate device and
reference device which demonstrated that the
bioresorption timeframe is similar between
the predicate device material and the subject
device material. A simulated use study was
performed on the subject device and
determined that, under simulated use
conditions, exposure to radioactive seeds does
not impact the performance characteristics of
the subject device. A risk assessment has
been completed to assess whether the change
to materials has any impact on safety or
effectiveness of the device. The risk/change
analysis resulted in a determination of no new
risks.
Assessment of Non-clinical Performance DataThe subject device has been assessed to
ensure it has technological characteristics
equivalent to the predicate device.
Biocompatibility testing was performed and
demonstrated that GammaTile manufactured
with the GTMT Collagen (subject device)
maintains an equivalent biocompatibility
profile as the predicate device. A collagenase
study was performed on the e-beam and EO
sterilized GTMT Collagen and demonstrated
that the bioresorption timeframe is similar
between e-beam and EO sterilized predicate
collagen carrier material and e-beam and EO
sterilized GTMT Collagen. A simulated use
study was performed and determined that,
under simulated use conditions, exposure to
radioactive seeds does not impact the
performance characteristics of the subject
device. A risk assessment has been
completed to assess whether the GTMT
Collagen carrier has any impact on safety or
effectiveness of the device. The risk/change
analysis resulted in a determination of no new
risks.
Conclusion Drawn from TestingBiocompatibility testing demonstrated that the
predicate device and subject device have
similar biocompatibility profiles. The
collagenase testing concluded that the GTMT
Collagen performed similarly to the predicate
collagen carrier material which demonstrates
that the subject device will have a similar
bioresorption profile to the predicate device.
In addition, the simulated use study showed
no difference in performance between the
predicate device and the subject device.
Therefore, based on the results from the
previous implant studies conducted on the
predicate device and the reference device
(equivalent to GTMT Collagen), the similar
bioresorption profile. an equivalent.
Safety and Effectivenessmanufacturing process of the finished
GammaTile device, and the performance
testing results, it was determined that the
subject device has equivalent technological
characteristics to the predicate.
To ensure that the devices are safe and
effective compared to the predicate, 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.
The similar performance characteristics
demonstrated through simulated use testing
and the collagenase study provide evidence
that the GTMT Collagen will continue to
function as a three-dimensional spacer
preventing the seeds from direct tissue contact
to avoid overdosing and as a multi-seed
carrier providing even spacing between
adjacent seeds. The GTMT collagen does not
impact the safety or effectiveness of the
GammaTile device in comparison to the
predicate.

4

5

6