(28 days)
Not Found
No
The summary describes a physical radiation therapy system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for radiation therapy to treat malignant brain tumors, which is a therapeutic intervention.
No
Explanation: The device is a radiation therapy system used for delivering intracavity radiation to treat malignant brain tumors following tumor resection surgery. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter tray, catheter, balloons, and a radiotherapy solution, indicating it is a hardware-based system.
Based on the provided information, the GliaSite RTS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery." This describes a therapeutic intervention performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device components (catheter, radiotherapy solution, access tray) are all designed for delivering radiation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GliaSite RTS is a therapeutic device used for treating a condition.
N/A
Intended Use / Indications for Use
The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following resection surgery.
The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.
Product codes
KXK
Device Description
The GliaSite® RTS is a radiation therapy system that includes the GliaSite Catheter Tray, Iotrex™ Radiotherapy Solution, and the GliaSite RTS Access Tray. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the Catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS is provided in three balloon sizes: 2 cm, 3 cm, and 4 cm.
lotrex is an 129 radiotherapy solution and is the radiation source to be used with the GliaSite RTS. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the lotrex Radiotherapy Solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
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 shows the logo for IsoRay Medical. The logo consists of an atom symbol on the left and the text "IsoRay MEDICAL" on the right. The word "MEDICAL" is smaller and located below "IsoRay".
K111931
AUG - 5 2011
3.0 Section C: 510(k) Summary Required by 21 CFR § 807.92
- 3.1 Submitter: IsoRay Medical, Inc.
- 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: Fredric Swindler fswindler@isoray.com
- 3.5 Date of preparation of this Summary: 07/08/2011
- 3.6 Device Name, Regulatory and Classification Information:
- 3.6.1 Trade Name: GliaSite® RTS
- 3.6.2 Common Name:
- Classification Name: Radionuclide Brachytherapy Source (Per 21CFR 3.7 8892.5730)
- Marketed device to which equivalence is claimed: The modified GliaSite RTS 3.8 that is the subject of this submission is substantially equivalent to the GliaSite n RTS as described in 510(k) #K003206 (SE 04/25/2001).
- Product Description: The GliaSite® RTS is a radiation therapy system that 3.9 includes the GliaSite Catheter Tray, Iotrex™ Radiotherapy Solution, and the GliaSite RTS Access Tray. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the Catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS is provided in three balloon sizes: 2 cm, 3 cm, and 4 cm.
lotrex is an 129 radiotherapy solution and is the radiation source to be used with the GliaSite RTS. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the lotrex Radiotherapy Solution.
- 3.10 Statement of intended use compared to the currently marketed predicate device: The intended use of modified device is as follows:
The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following resection surgery.
This is identical to the legally marketed predicate device, the GliaSite RTS as described in 510(k) No. K0003206 (SE 04/25/2001).
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Image /page/1/Picture/0 description: The image shows the logo for IsoRay Medical. The logo consists of an atom symbol on the left, followed by the text "IsoRay" in a bold, sans-serif font. Below "IsoRay" is the word "MEDICAL" in a smaller, sans-serif font. The atom symbol is stylized with three intersecting orbits around a central nucleus.
- Statement of Technological Characteristics: The intended use and 3.11 technological characteristics of the modified GliaSite RTS are identical to the GliaSite RTS predicate as described in 510(k) No. 003206. The comparis ถา of the modified device to the legally marketed predicate device included implan t duration, target sites, component materials and dimensions, radionuclide source and its characteristics, and clinical usage. Both proposed and predicate devices provide a means of delivering a radioisotope to a tumor or tumor cavity. Both proposed and predicate devices have identical dosimetric properties and utilize the lotrex Radiotherapy Solution with its 125((HBS) radiation sources
- 3.12 Safety and Effectiveness: To ensure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to leak testing, testing for external contamination, apparent activity, sterility, pyrogens, and labeling. The required testing is defined by written and approved procedures that conform to the product design specifications. The testing for the GliaSite RTS is detailed in the Device Master Record.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Fredric G. Swindler Vice President. Regulatory Affairs and Quality Assurance IsoRay Medical 350 Hills St., Suite 106 RICHLAND WA 99354-5411
Re: K111931
Trade/Device Name: GliaSite Radiation Therapy System (RTS) Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: July 8, 2011 Received: July 8, 2011
Dear Mr. Swindler:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification: The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
2.0 Section B
Indications for Use
510(k) Number: K11193j
Device Name: GliaSite Radiation Therapy System (RTS)
Indications for Use:
The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.
Prescription Use_ × (Per 21 CFR § 801.109) OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510K
Macy Stadil
(Division Sign-Off)
Office of In Vitro D
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