(89 days)
Not Found
No
The summary describes a physical brachytherapy applicator and does not mention any software or algorithms that would incorporate AI or ML.
Yes
The device is indicated for the "treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy," which fits the definition of a therapeutic device.
No
The device is described as a brachytherapy applicator set used for treating small skin tumors, not for diagnosing them.
No
The device description explicitly states it is a "Brachytherapy applicator set" and describes its function as guiding a radioactive source, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for treating small skin tumors or superficial diseases with HDR brachytherapy. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a brachytherapy applicator set used to guide a radioactive source for treatment. This is a medical device used directly on or in the patient for therapeutic purposes.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.) or any diagnostic purpose.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely therapeutic.
N/A
Intended Use / Indications for Use
The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR brachytherapy.
Product codes
JAQ
Device Description
The Surface Applicator Set with Leipzig-style Cone is a Brachytherapy applicator set. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumour to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.. 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
skin
Indicated Patient Age Range
No specific population
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.
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)
Non Clinical Tests Berich Testing has been performed to demonstrate . that the device functions correctly with the specified afterloaders; . that the device can withstand the number of cycles of use that it will experience in its lifetime; that the device enables the radioactive source to be ● located to the accuracy required, . that 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; . that 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 the devices to be safe and effective and to perform as well or better than the predicate
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
§ 892.5700 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/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '123815'. The numbers are written in a cursive style, and there is a line above the number '5'.
PREMARKET NOTIFICATION
510(k) Summary
Surface Applicator Set with Leipzig-style Cone
As required by 21 CFR 807.92
MAR 1 1 2013
| Submitter's Name: | Varian Medical Systems
911 Hansen Way, M/S C-260
Palo Alto CA94304 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650/424.6320
Fax:650/842.5051
Date: 30 November 2012 |
| Proprietary Name: | GM11010080 Surface Applicator Set with Leipzig-style Cone |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | Surface Applicator Set(s), Surface Applicator |
| Predicate Devices: | Surface Applicator as part of GammaMedplus HDR remote
afterloader system. K983436. |
| Device Description: | The Surface Applicator Set with Leipzig-style Cone is a
Brachytherapy applicator set. Brachytherapy is a form of
radiotherapy using Gamma rays from a radioactive source placed
at locations close to or within a tumour to a predefined treatment
plan. The treatment plan defines the positions and times for the
source to ensure the correct dose for the treatment area. The
applicator acts to guide the radioactive source to the correct
location or locations for treatment..
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 Surface Applicator Set with Leipzig-style cone-GM11010080 is
indicated for treatment of small skin tumours or other superficial
disease (such as keloid formations) with HDR brachytherapy. |
1
Technological Characteristics of the device compared with the predicate device:
| | Surface Applicator | GM11010080 Surface
Applicator Set with Leipzig-
style Cone |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
Device
Clearance
Number: | GammaMedplus Afterloader system
with applicators and accessories
K983436 | N/A |
| Compatible
Afterloader | GammaMedplus
GammaMed 12i(t) | GammaMedplus series
VariSource Series |
| Intended use | 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 Surface Applicator Set with
Leipzig-style Cone is intended for
the treatment of small skin tumours
or other superficial disease (such as
keloid formations) with HDR
brachytherapy. |
| Indications for
Use | 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 Surface Applicator Set with
Leipzig-style Cone is intended for
the treatment of small skin tumours
or other superficial disease (such as
keloid formations) with HDR
brachytherapy. |
| Target
population | No specific population | No specific population |
| Design | Shielding for tubus with a vertical
source entrance: | Leipzig-style Cone with a horizontal
source entrance: |
| | Ø 10-25 mm and Ø 30-45 mm with
fixation | Ø 30-45 mm, with holder and guide |
| | Surface tubus inset set:
Ø10-25 mm, round
Ø30-45 mm, round
Ø30-45 mm, oval | Surface cone inset:
Ø 30 mm, 35 mm, 40 mm, 45 mm,
round |
| Materials | Shielding: Tungsten / Stainless Steel
Surface tubus insets:
Tungsten / PVC | Leipzig-style Cone:
Tungsten / Stainless Steel
Surface cone insets:
Tungsten / PVC |
| Packing | individual | individual |
| Sterility | Non sterile | Non sterile |
| Sterilization
method | Devices are not sterilized. | Devices are not sterilized. |
| Biocompatibility | N/A. The use of a sterile plastic
envelope or surgical foil is required to
prevent any parts of the applicator
from having body contact. | N/A. The use of a sterile plastic
envelope or surgical foil is required
to prevent any parts of the applicator
from having body contact. |
| Anatomical sites | skin | skin |
| Where used | Brachytherapy Treatment Room | Brachytherapy Treatment Room |
:
2
Non Clinical Tests Berich Testing has been performed to demonstrate . that the device functions correctly with the specified afterloaders; . that the device can withstand the number of cycles of use that it will experience in its lifetime; that the device enables the radioactive source to be ● located to the accuracy required, . that 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; . that 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 the devices to be safe and effective and to perform as well or better than the predicate
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2013
Peter J Coronado Director, Regulatory Affairs Varian Medical Systems, Inc 911 Hansen Way PALO ALTO CA 94304
Re: K123815
Trade/Device Name: Surface Applicator Set with Leipzing-style Cone Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 30, 2012 Received: December 12, 2012
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 vour 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Mr. Coronado
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm
Sincerely yours.
Michael D'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
5
Indications for Use Form
510(k) Number (if known): K123815
Device Name: Surface Applicator Set with Leipzig-style Cone.
Indications for Use:
GM110010080 Surface Applicator Set with Leipzig-style Cone.
The Surface Applicator Set with Leipzig-style cone-GM11010080 is indicated for treatment of small short of the superficial disease (such as keloid formations) with HDR brachnerapy.
skin tumours or other superficial disease (such as keloid formations) with HDR brachytherap
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED. NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Offision Sign-Off ffice of In Vitro Diagnostic Device Safety 510/k)
Page 1 of _ 1