(297 days)
GammaTile is indicated as a treatments with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms
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.
The provided text is a 510(k) summary for the GammaTile™ device. It outlines the regulatory clearance process for an expanded indication for use. However, it explicitly states:
"No additional testing was completed. The data obtained from the case studies suggest that GammaTile therapy adds no additional risk to the proposed patient population."
This means that a new study demonstrating the device meets acceptance criteria for the expanded indication was not performed. Instead, the submission relies on the technological equivalence to a previously cleared device (K190296) and an assessment of existing dosimetry data.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such new study was conducted for this specific 510(k) submission (K190839).
The document clarifies that the "technological characteristics of the proposed device, GammaTile, are identical to those of the predicate, GammaTile as described in 510(k) K190296." The submission is for an expanded indication for use, not for a change in the device or its fundamental performance.
The only "assessment" mentioned for the expanded indication is: "An assessment of dosimetry to organs at risk using GammaTile in recurrent intracranial neoplasms has been completed. The assessment resulted in a determination the cumulative radiation dose delivered to the OARs was within ranges acceptable in clinical practice." This is an assessment, not a new clinical study with defined acceptance criteria for device performance as an AI/software device would undergo.
In summary, none of the requested information regarding a study proving the device meets acceptance criteria can be extracted from the provided text because no new study of this nature was conducted or submitted for this cleared 510(k). The clearance was based on substantial equivalence and a dosimetric assessment, not a performance study against specific acceptance criteria for the expanded indication.
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January 23, 2020
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GT Medical Technologies % Ms. Jessica Newhard Regulatory Affairs Specialist 1809 S Holbrook Lane, Suite 107 TEMPE AZ 85281
Re: K190839
Trade/Device Name: GammaTile™ Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: KXK Dated: December 20, 2019 Received: December 23, 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/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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K190839
Device Name GammaTile™
Indications for Use (Describe)
GammaTile is indicated as a treatments 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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510(k) Summary III.
| Submitter | GT Medical Corporation |
|---|---|
| Address | 1809 S Holbrook DriveSuite 107Tempe, AZ 85281 |
| Telephone Number | 480-276-8609 |
| Contact Person | Jessica NewhardRegulatory Affairs Specialistjnewhard@gtmedtech.com |
| Date of Preparation | December 20, 2019 |
| 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: GammaTile that is the subject ofthis submission is substantially equivalent toGammaTile as described in 510(k) K190296. |
| Predicate Product Code | KXK |
| Predicate Regulation Number | 892.5730 |
| Product Description | GammaTile is a device intended for thetreatment of intracranial neoplasms which usescesium-131 radioactive sources embedded in acollagen matrix. GammaTile™ is designed toprovide "adjuvant" radiation therapy - therapyto eliminate any remaining neoplastic cells - topatients who require surgical resection of brainneoplasms.GammaTile is positioned within the resectioncavity immediately after surgical excision ofthe brain neoplasm to deliver radiation therapyto any neoplastic cells that remain in proximityof the resection cavity. |
| Indication for Use statement compared tocurrently marketed predicate device | The Indication for Use is being revised toinclude initial treatment of intracranialneoplasms.The currently marketed indication for use is:"GammaTile is intended to deliver radiationtherapy (brachytherapy) in patients withrecurrent intracranial neoplasms”The proposed indication for use statement is:"GammaTile is indicated as a treatment for |
| patients with newly diagnosed malignantintracranial neoplasms and patients withrecurrent intracranial neoplasms” | |
| Patient Population | This premarket submission expands the patientpopulation from patients requiring radiationtherapy after excision for recurrent intracranialneoplasms to include patients requiringradiation therapy afterexcision of newly diagnosed malignantintracranial neoplasms. |
| Statement of Technological Characteristics | The technological characteristics of theproposed device, GammaTile, are identical tothose of the predicate, GammaTile asdescribed in 510(k) K190296 |
| Assessment of Non-clinical Performance Data | No changes have been made to thetechnological characteristics of the proposeddevice since clearance of the primary predicatedevice (K190296). The indication expansionproposed does not change the anatomical siteof the indication but expands the targetpopulation to include newly diagnosed patientswith malignant intracranial neoplasms. Anassessment of dosimetry to organs at risk usingGammaTile in recurrent intracranialneoplasms has been completed. Theassessment resulted in a determination thecumulative radiation dose delivered to theOARs was within ranges acceptable in clinicalpractice. |
| Conclusion Drawn from Testing | No additional testing was completed. The dataobtained from the case studies suggest thatGammaTile therapy adds no additional risk tothe proposed patient population. |
| 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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§ 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.