(297 days)
Not Found
No
The description focuses on the physical device (radioactive sources in a collagen matrix) and its function (delivering radiation therapy). There is no mention of AI, ML, image processing, or any data-driven decision-making component.
Yes
The device description indicates that GammaTile is "intended for the treatment of intracranial neoplasms" and "designed to provide 'adjuvant' radiation therapy," which clearly defines it as a device used for therapeutic purposes.
No
Explanation: The device description states that GammaTile is "intended for the treatment of intracranial neoplasms," and it "delivers radiation therapy." There is no mention of it being used for diagnosis or assessment.
No
The device description clearly states that GammaTile is a physical device using radioactive sources embedded in a collagen matrix, which is a hardware component.
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. IVDs are used for diagnosis or monitoring of diseases or conditions by examining samples from the body (like blood, urine, tissue).
- Device Description: The device description clearly states it's a device for treatment using radioactive sources. It's surgically implanted to deliver radiation. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
In summary, GammaTile is a therapeutic device used for treating brain tumors, not a diagnostic device used for testing samples.
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
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)
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.
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.
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January 23, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue box, followed by the words "U.S. FOOD & DRUG" in large blue letters, and the word "ADMINISTRATION" in smaller blue letters below.
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 Drive |
| Suite 107 | |
| Tempe, AZ 85281 | |
| Telephone Number | 480-276-8609 |
| Contact Person | Jessica Newhard |
| Regulatory Affairs Specialist | |
| jnewhard@gtmedtech.com | |
| Date of Preparation | December 20, 2019 |
| Device Trade Name | GammaTile™ |
| Device Common Name | Radionuclide Brachytherapy Seeds |
| Device Classification Name | Radionuclide Brachytherapy Source (per |
| 21CFR §892.5730) | |
| Device Regulation Number | 892.5730 |
| Product Code | KXK |
| Predicate Device(s) | Predicate: GammaTile that is the subject of |
| this submission is substantially equivalent to | |
| GammaTile as described in 510(k) K190296. | |
| Predicate Product Code | KXK |
| Predicate Regulation Number | 892.5730 |
| Product 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. | |
| Indication for Use statement compared to | |
| currently marketed predicate device | The Indication for Use is being revised to |
| include initial treatment of intracranial | |
| neoplasms. | |
| The currently marketed indication for use is: | |
| "GammaTile is intended to deliver radiation | |
| therapy (brachytherapy) in patients with | |
| recurrent intracranial neoplasms” | |
| The proposed indication for use statement is: | |
| "GammaTile is indicated as a treatment for | |
| patients with newly diagnosed malignant | |
| intracranial neoplasms and patients with | |
| recurrent intracranial neoplasms” | |
| Patient Population | This premarket submission expands the patient |
| population from patients requiring radiation | |
| therapy after excision for recurrent intracranial | |
| neoplasms to include patients requiring | |
| radiation therapy after | |
| excision of newly diagnosed malignant | |
| 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) K190296 | |
| Assessment of Non-clinical Performance Data | No changes have been made to the |
| technological characteristics of the proposed | |
| device since clearance of the primary predicate | |
| device (K190296). The indication expansion | |
| proposed does not change the anatomical site | |
| of the indication but expands the target | |
| population to include newly diagnosed patients | |
| with malignant intracranial neoplasms. 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. | |
| Conclusion Drawn from Testing | 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. | |
| 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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