(129 days)
Not Found
No
The 510(k) summary describes a physical device delivering radiation therapy and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to deliver radiation therapy (brachytherapy) for the treatment of recurrent intracranial neoplasms, which is a therapeutic intervention.
No
The device description states its purpose is to deliver radiation therapy for treatment, not to diagnose a condition.
No
The device description clearly states that GammaTile™ is a device that uses radioactive sources embedded in a collagen matrix, indicating it is a physical medical device, not software only.
Based on the provided information, the GammaTileTM device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that GammaTileTM is for delivering radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a device that is surgically implanted to deliver radiation directly to the tumor site. This is a treatment modality, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or prognosis
IVDs are used to examine specimens obtained from the human body to provide information for clinical purposes. GammaTileTM is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
GammaTileTM is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.
Product codes
KXK
Device Description
The GammaTile™ is a device, intended for the treatment of recurrent intracranial neoplasms that uses cesium-131 radioactive sources embedded in a collagen matrix. The 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 (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
simulated clinical use testing, characterization of the radionuclide source and source spacing during bench testing.
Key Metrics
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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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.
Isoray Medical Inc. % Mr. Bill Joy Director, RA/QA 350 Hills Street, Suite 106 RICHLAND WA 99354
Re: K180515
Trade/Device Name: GammaTile"" Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: June 11, 2018 Received: June 12, 2018
Dear Mr. Joy:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
July 6th, 2018
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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 mediation-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,
Jeff Ballegoo
for Robert Ochs, 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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Indications for Use
510(k) Number (if known) K180515
Device Name GammaTile
Indications for Use (Describe)
GammaTileTM is intended to deliver radiation therapy (brachytherapy) in 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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3.0 510(k) Summary Required by 21 CFR § 807.92(c)
- 3.1 IsoRay Medical, Inc. Submitter:
- 3.2 Address: 350 Hills Street, Suite 106 Richland, WA 99354-5411
- 3.3 Telephone and Fax Numbers: 509-375-1202
(Fax) 509-375-3473
- 3.4 Contact Person: Bill Jov. Director, Quality Assurance & Regulatory Affairs bjoy@isoray.com
- 3.5 Date of preparation of this Summary: February 23, 2018
- 3.6 Device Name, Requlatory and Classification Information:
- 3.6.1 Trade Name: GammaTile™
- 3.6.2 Common Name: Radionuclide Brachytherapy Seeds
- 3.6.3 Classification Name: Radionuclide Brachytherapy Source, (Per 21 CFR §892.5730).
- 3.7 Marketed device to which equivalence is claimed: The GammaTile™ that is the subiect of this submission are substantially equivalent to the Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands as described in 510(k) K092136 (SE 08/07/2009).
- 3.8 Product Description: The GammaTile™ is a device, intended for the treatment of recurrent intracranial neoplasms that uses cesium-131 radioactive sources embedded in a collagen matrix. The 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.
- 3.9 Statement of intended use compared to the currently marketed predicate device: The intended use of the proposed device is as follows:
GammaTile™ is intended to deliver radiation therapy (brachytherapy).
This is equivalent to the intended use of the legally marketed predicate device, Proxcelan™ (Cesium-131) Implant Devices,
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Model PL-5 – Cs-131 Preloaded Braided Strands as described in 510(k) K092136 (SE 08/07/2009).
- 3.10 Patient Population: Patients requiring radiation therapy after excision for recurrent intracranial neoplasms.
- 3.11 Statement of Technological Characteristics: The technological characteristics of the proposed device, GammaTile™, are identical to those of the predicate, Model PL-5, Preloaded Braided Strands as described in 510(k) K092136.
- 3.12 Assessment of Non-Clinical Performance Data: The proposed and predicate devices are substantially equivalent based on the results of simulated clinical use testing, characterization of the radionuclide source and source spacing during bench testing.
- 3.13 Conclusion Drawn from Testing: Based on the results of the analysis and verification/validation testing performed on the proposed device it has been demonstrated that: 1) GammaTile™ can consistently be built to design specifications, 2) GammaTile™ is biocompatible and can be routinely sterilized, 3) GammaTile™ structural integrity is maintained through the duration of therapeutic life of the cesium-131 radiation sources.
- 3.14 Safety and Effectiveness: To ensure that the devices are safe and effective, all finished products are tested and must meet all acceptance criteria required by specifications before distribution. The testing required for release includes, but is not limited to testing for proper assembly and seed spacing, apparent activity, external contamination, sterility, pyrogens, and labeling. The required testing is defined in documented procedures that conform to the product design specifications.