(30 days)
Not Found
No
The 510(k) summary describes a radioactive implant for brachytherapy and does not mention any AI or ML components or functions.
Yes
GammaTile is described as delivering radiation therapy to treat recurrent intracranial neoplasms, indicating a direct therapeutic action on the patient's condition.
No
The device description clearly states it is "intended for the treatment" and "to deliver radiation therapy". Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that GammaTile is a device that 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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms." This describes a therapeutic intervention performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a device that delivers radiation using radioactive sources embedded in a matrix, which is placed within a surgical cavity. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, tissue, urine, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
In summary, GammaTile is a therapeutic device used for radiation treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
GammaTile is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.
Product codes
KXK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial
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)
No significant changes have been made to the technological characteristics of the proposed device since clearance of the primary predicate device (K180515). In addition, the intended use and indication for use remains the same between the proposed device and the predicate device (K180515). A risk/change analysis has been completed to assess whether the changes proposed had any impact on safety or effectiveness of the device. The risk/change analysis resulted in a determination of no new risk and validation testing confirmed these changes did not raise new safety concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
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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 SERVICES
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 | | |
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| | [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 | | |
| 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
information unless it displays a currently valid OMB number." | | |
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I. 510(k) Summary
| Submitter | GT Medical Technologies |
|---|---|
| Address | 1809 S Holbrook Lane |
| Suite 107 | |
| Tempe, AZ 85281 | |
| Telephone Number | 480-276-8609 |
| Contact Person | Jessica Newhard |
| Regulatory Affairs Specialist | |
| jnewhard@gtmedtech.com | |
| Date of Preparation | February 12, 2019 |
| Device Trade Name | GammaTile™ |
| Device Common Name | Radionuclide Brachytherapy Seeds |
| Device Classification Name | Radionuclide Brachytherapy Source (per |
| 21CFR §892.5730) | |
| Predicate Device(s) | Primary Predicate: GammaTile that is the |
| subject of this submission is substantially | |
| equivalent to GammaTile as described in | |
| 510(k) 180515 | |
| Product Description | 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. | |
| Statement of Intended Use compared to | |
| currently marketed predicate device | There is no change to the intended use or |
| indications for use compared to the | |
| currently marketed predicate. |
The intended use of the proposed device
is identical to the legally marketed device: |
| | GammaTile is intended to deliver radiation
therapy (brachytherapy). |
| | The indication for use is identical to the
legally marketed device: |
| | GammaTile is intended to deliver radiation
therapy (brachytherapy) in patients with
recurrent intracranial neoplasms. |
| Patient Population | Patients requiring radiation therapy after
excision for recurrent intracranial
neoplasms. |
| Statement of Technological
Characteristics | The technological characteristics of the
proposed device, GammaTile, are
identical to those of the predicate,
GammaTile as described in 510(k)
K180515 |
| Assessment of Non-clinical Performance
Data | No significant changes have been made to
the technological characteristics of the
proposed device since clearance of the
primary predicate device (K180515). In
addition, the intended use and indication
for use remains the same between the
proposed device and the predicate device
(K180515). A risk/change analysis has
been completed to assess whether the
changes proposed had any impact on
safety or effectiveness of the device. The
risk/change analysis resulted in a
determination of no new risk and validation
testing confirmed these changes did not
raise new safety concerns. |
| Conclusion Drawn from Testing | Test results confirmed that the changes
made have no impact to product safety or
efficacy and introduce no new risks. |
| Safety and Effectiveness | 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. |
Table 1. Tabular Summary of 510 (k)
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