(245 days)
Not Found
No
The summary describes a physical applicator set for brachytherapy and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for "intraluminal brachytherapy treatments," which is a form of radiation therapy aimed at treating specific body sites for medical conditions.
No
The device is an Intraluminal Applicator Set used for HDR brachytherapy treatments, which is a therapeutic rather than a diagnostic procedure. Its function is to deliver radiation for treatment, not to diagnose a condition.
No
The device description and performance studies clearly indicate this is a physical medical device (applicator set) used in brachytherapy, not a software-only device. The testing focuses on physical properties and functionality with hardware (afterloaders).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intraluminal brachytherapy treatments," which is a therapeutic procedure involving the delivery of radiation directly to a tumor or treatment site within a body lumen. This is a treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an "Applicator Set" used with an "afterloader" for delivering radiation. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver radiation for treatment.
N/A
Intended Use / Indications for Use
The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Intraluminal Applicator Set is designed for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy. It is compatible with Varian GammaMedplus afterloaders and can be used in combination with the appropriate accessories. The devices 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
Endo-bronchial treatments, esophagus (using a guide tube), and the bile duct.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
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 afterloaders;
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . 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;
- . the device may be sterilized effectively
- the device can be used and sterilized for the specified number of times
- . the positional accuracy of the source within the applicator is adequate.
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.
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.
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" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2015
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K151022
Trade/Device Name: Intraluminal Applicator Set GM11000620 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 13, 2015 Received: November 16, 2015
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,
Robert Oals
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151022
Device Name
Intraluminal Applicator Set GM11000620
Indications for Use (Describe)
The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
PREMARKET NOTIFICATION
510(k) Summary
Intraluminal Applicator Set
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E110
Palo Alto CA94304 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650/424.6320
Fax: 650/646.9200
Date: 25 September 2015. |
| Proprietary Name: | GM11000620 Intraluminal Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | GM11000620 Intraluminal Applicator Set |
| Predicate Devices: | K983436.Gammamedplus High Dose Rate Remote Afterloading
System. |
| Device Description: | The Intraluminal Applicator Set is designed for intraluminal
brachytherapy treatments including endo-bronchial treatments
and treatments on body sites such as the esophagus and the bile
duct using HDR brachytherapy. It is compatible with Varian
GammaMedplus afterloaders and can be used in combination with
the appropriate accessories.
The devices 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 Intraluminal Applicator Set is indicated for use for intraluminal
brachytherapy treatments including endo-bronchial treatments
and treatments on body sites such as the esophagus and the bile
duct using HDR brachytherapy. |
4
Technological Characteristics:
| | GM11000620 Intraluminal Applicator
Set
(as part of GammaMed afterloader-
K983436). | GM11000620 Intraluminal Applicator
Set |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible
Afterloader | GammaMed plus | GammaMed plus |
| Intended use | Covered by intended use of complete
afterloader system in original
submission:
The intended use of the GammaMed
Plus transportable high-dose-rate
remotely controlled afterloading
brachytherapy device is for the
treatment of cancer by intracavitary,
interstitial, intraluminal and
intraoperative irradiation. | The Intraluminal Applicator Set is
intended for intraluminal
brachytherapy treatments including
endo-bronchial treatments and
treatments on body sites such as the
esophagus and the bile duct using
HDR brachytherapy. |
| Indications for Use | Covered by indication for use of
complete afterloader system in
original submission:
The intended use of the GammaMed
Plus transportable high-dose-rate
remotely controlled
afterloading brachytherapy device is
for the treatment of cancer by
intracavitary, interstitial, intraluminal
and intraoperative irradiation. | The Intraluminal Applicator Set is
indicated for use for intraluminal
brachytherapy treatments including
endo-bronchial treatments and
treatments on body sites such as the
esophagus and the bile duct using
HDR brachytherapy. |
| Design | Set Components: | Set Components: |
| | Bronchial catheter 5 Fr.(Ø 1.67mm),
PA
[MR Safe] | Bronchial catheter 5 Fr. (Ø 1.67mm),
PA
[MR Safe] |
| | Clamping adapter for 5 Fr. Catheter,
stainless steel
[MR Unsafe] | Clamping adapter for 5 Fr. Catheter,
stainless steel
[MR Unsafe] |
| | Guide tube Ø 2.8mm, L=900mm
(FEP)
[MR Safe] | Guide tube Ø 2.8mm, L=900mm
(FEP)
[MR Safe] |
| | Bite protector for intraluminal
applicators,
PBT
[MR Safe] | Bite protector for intraluminal
applicators,
PPSU
[MR Safe] |
| | Guide wire 0.0032" x 2600 mm,
sterile,
Stainless steel, PTFE coated
(K082094)
[MR Unsafe] | Guide wire 0.0032" x 2600 mm,
sterile,
Stainless steel, PTFE coated
(K082094)
[MR Unsafe] |
| | ---- | Monofil, PA
[MR Safe] |
| | Accessories: | Accessories: |
5
| | GM11000620 Intraluminal Applicator
Set
(as part of GammaMed afterloader-
K983436). | GM11000620 Intraluminal Applicator
Set |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | ---- | Tube catheter Ø 2.8mm (FEP)
[MR Safe] |
| | ---- | Guide Tube Ø 4.5mm (FEP)
[MR Safe] |
| | Length cutting gauge (stainless steel)
[MR Unsafe] | Length cutting gauge (stainless steel)
[MR Unsafe] |
| | X-ray marker
(Nickel, Titanium, Aluminium,
Tungsten, PEEK and PTFE coated)
[MR Unsafe] | X-ray marker
(Nickel, Titanium, Aluminium,
Tungsten, PEEK and PTFE coated)
[MR Unsafe] |
| | Length gauge (stainless steel)
[MR Unsafe] | Length gauge (stainless steel)
[MR Unsafe] |
| | Cleaning caps
[MR Safe] | Cleaning caps
[MR Safe] |
| | Tube Catheter, Ø 2.8mm
(GammaMed plus)
[MR Unsafe] | Tube Catheter, Ø 2.8mm
(GammaMed plus)
[MR Unsafe] |
| | Source guide tube support
[MR Unsafe] | Source guide tube support
[MR Unsafe] |
| Tube catheter | Tube catheter included as optional
accessory | Tube catheter included as optional
accessory |
| Materials | PA (Polyamide),
FEP (Fluorinated Ethylene
Propylene),
Stainless Steel | PA (Polyamide),
FEP (Fluorinated Ethylene
Propylene),
Stainless Steel
PPSU (Polyphenylsulfone) |
| Packing | individual | individual |
| Sterility
(Bronchial catheter
and Monofil) | Supplied sterile - single use only | Supplied sterile - single use only |
| Sterilization method
(Bronchial catheter
and Monofil) | Gamma sterilization | Gamma sterilization |
| Sterilization method
(Guide Tubes) | Steam sterilization - single use only | Steam sterilization - single use only |
| Sterilization method
(Tube Catheter) | Steam sterilization up to 20 times | High level disinfection up to 20 times |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Endo-bronchial treatments,
esophagus (using a guide tube), and
the bile duct. | Endo-bronchial treatments,
esophagus (using a guide tube), and
the bile duct. |
| Human factors | Controlled through Varian
afterloaders | Controlled through Varian
afterloaders |
6
| | GM11000620 Intraluminal Applicator
Set
(as part of GammaMed afterloader-
K983436). | GM11000620 Intraluminal Applicator
Set |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Compatibility with
the environment and
other devices | CT and MR compatible | CT compatible and MR Safe (When
MR Safe components as listed in
Instructions for Use are used). |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
Non Clinical Tests Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloaders;
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . 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;
- . the device may be sterilized effectively
- the device can be used and sterilized for the specified number of times
- . the positional accuracy of the source within the applicator is adequate.
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