(77 days)
K113766 VariSource Transfer Guide Tube sets
Not Found
No
The device description and intended use clearly define the device as a physical accessory (guide tubes) for a brachytherapy system, with no mention of software, algorithms, or data processing that would involve AI/ML.
Yes
The device facilitates brachytherapy, which is a form of radiotherapy using gamma rays from a radioactive source placed to treat a tumor. This direct involvement in delivering therapeutic radiation makes it a therapeutic device.
No
The device description indicates that the Source Guide Tubes are used in brachytherapy to deliver radioactive isotopes to a tumor site for treatment. There is no mention of the device being used to diagnose a medical condition.
No
The device is described as "Source Guide Tubes" which are physical accessories used in brachytherapy to provide a path for a source wire. The description focuses on their physical function and material properties, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The GammaMedplus Source Guide Tubes are used in vivo (within the body) to guide a radioactive source directly to a tumor site for therapeutic purposes (radiotherapy). They are part of a system that delivers radiation treatment, not a system that analyzes biological samples for diagnosis or monitoring.
- Intended Use: The intended use clearly states that the device "allows the radioactive isotopes to be positioned within the patient´s tumor site." This is a therapeutic application, not a diagnostic one.
- Device Description: The description reinforces that it's a "Brachytherapy applicator accessory" used in a form of radiotherapy.
The device is a component of a radiotherapy system used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The GammaMedplus Source Guide Tubes are intended to connect between the GammaMedplus Remote Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
Source Guide Tubes are Brachytherapy applicator accessories. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. They are designed to provide a path for the dummy and source wire from the Afterloader to the Applicator. The applicator end of a Source Guide Tube can vary in design to accommodate a range of Applicators. They are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
NA
Indicated Patient Age Range
There is no limitation to patient population.
Intended User / Care Setting
Trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurse / MTRA / Radiology Technician / Radiographer.
Brachytherapy treatment room.
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)
Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloader and applicators
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications.
No clinical tests have been included in this pre-market submission.
All the tests that were performed met the applied pass criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113766 VariSource Transfer Guide Tube sets
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2014
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K141336
Trade/Device Name: GammaMedplus Source Guide Tubes Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: April 11, 2014 Received: May 23, 2014
Dear Mr. Coronado:
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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Janine M. Morris 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)
Device Name GammaMedplus Source Guide Tubes
Indications for Use (Describe)
The GammaMedplus Source Guide Tubes are intended to connect between the GammaMedplus Remote Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D'Hara
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PREMARKET NOTIFICATION
510(k) Summary
GammaMedplus Source Guide Tubes
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E-110
Palo Alto CA94304 | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact Name: Peter J. Coronado | |
| | Phone: 650/424.6230
Fax: 650/ 646.9200 | |
| | e-mail: submissions.support@varian.com | |
| | Date: 15th May 2014 | |
| | | |
| Proprietary Name: | GammaMedplus Source Guide Tubes and PDR Quick Connectors | |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700 | |
| | Class II | |
| Common/Usual Name: | Source Guide Tubes | |
| Product code: | JAQ | |
| Predicate Devices: | K113766 VariSource Transfer Guide Tube sets | |
| Device Description: | Source Guide Tubes are Brachytherapy applicator accessories. | |
| | Brachytherapy is a form of radiotherapy using Gamma rays from a | |
| | radioactive source placed at locations close to or within a tumor
or other treatment area to a predefined treatment plan. | |
| | They are designed to provide a path for the dummy and source | |
| | wire from the Afterloader to the Applicator. The applicator end of | |
| | a Source Guide Tube can vary in design to accommodate a range | |
| | of Applicators. | |
| | They are intended to be used by trained and qualified personnel | |
| | such as Radiation Oncologists, Physicians, Radiologists,
Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology | |
| | Technicians/Radiographers in a hospital environment. | |
| Indications for Use: | The GammaMedplus Source Guide Tubes are intended to connect | |
| | between the GammaMedplus Remote Afterloader system and its | |
| | range of applicators. This connection creates a conduit for the | |
4
source wire to travel through and allows the radioactive isotopes to be positioned within the patient´s tumor site.
Technological Characteristics:
| Predicate Device
| Clearance Number: | K113766 | N/A |
|---|---|---|
| Compatible | ||
| Afterloader | VariSource Remote HDR Afterloader | |
| system | GammaMed afterloaders | |
| Compatible | ||
| Applicators | All applicators and needles that are | |
| compatible with VariSource series | ||
| afterloaders | All applicators and needles that are | |
| compatible with GammaMed series | ||
| afterloaders | ||
| Intended use | The VariSource Reusable transfer | |
| Guide Tubes are intended to connect | ||
| between the VariSource Remote | ||
| HDR Afterloader system and its | ||
| range of applicators. This connection | ||
| creates a conduit for the source wire | ||
| to travel through and allows | ||
| radioisotopes to be positioned within | ||
| the patient's tumour site. | The GammaMedplus Source Guide | |
| Tubes are intended to connect | ||
| between the GammaMedplus | ||
| Remote Afterloader system and its | ||
| range of applicators. This connection | ||
| creates a conduit for the source wire | ||
| to travel through and allows the | ||
| radioactive isotopes to be | ||
| positioned within the patient's | ||
| tumour site. | ||
| Indications for Use | Same as above | Same as above |
| Target population | There is no limitation to patient | |
| population. Limitations are on the | ||
| maximal radiation dose applicable to | ||
| the individual organs. The equipment | ||
| is designed to be used by a trained | ||
| and qualified Radiation Oncologist, | ||
| Physician, Radiologist, Dosimetrist, | ||
| Medical Physicist, and Nurse / MTRA | ||
| / Radiology Technician / | ||
| Radiographer | There is no limitation to patient | |
| population. Limitations are on the | ||
| maximal radiation dose applicable to | ||
| the individual organs. The | ||
| equipment is designed to be used by | ||
| a trained and qualified Radiation | ||
| Oncologist, Physician, Radiologist, | ||
| Dosimetrist, Medical Physicist, and | ||
| Nurse / MTRA / Radiology | ||
| Technician / Radiographer. | ||
| Design | Transfer Guide Tubes are designed to | |
| provide a secure connection | ||
| between the VariSource afterloader | ||
| and applicators, needles or catheters | ||
| along which the source wire travels | ||
| during Brachytherapy. | The Source Guide Tubes and PDR | |
| Quick Connectors were developed | ||
| to connect between the | ||
| GammaMed Afterloader systems to | ||
| applicators with an internal length | ||
| of: | ||
| 113 mm, 180 mm, 200 mm, 250 mm | ||
| 257 mm, 320 mm, 500 mm, | ||
| 285 mm (Third party applicators), | ||
| 187 mm (Adjustable Luer) | ||
| Materials | ABS, FEP, PEEK, Titanium, stainless | |
| steel, ABS/PP. | ||
| Not in direct contact with body | ||
| tissue. | FEP, Stainless Steel, PEEK, Titanium | |
| and ABS/PP. | ||
| Not in direct contact with body | ||
| tissue. | ||
| Packing | Individual | Individual |
| Sterility | Non sterile | Non sterile |
| Sterilization method | N/A | N/A |
| Biocompatibility | No body contact | No body contact |
| Mechanical safety | Protection caps | Protection caps |
| Anatomical sites | NA | NA |
| Compatibility with | ||
| the environment and | ||
| other devices | Compatible with a range of | |
| applicators, e.g. probes, needles, | ||
| interstitial tubes | Compatible with a range of | |
| applicators, e.g. probes, needles, | ||
| interstitial tubes | ||
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
5
Non Clinical Tests
Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloader and applicators
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications
Clinical Tests No clinical tests have been included in this pre-market submission.
Conclusions All the tests that were performed met the applied pass criteria. Varian considers to be safe and effective and to perform as well or better than the predicate.