(229 days)
Not Found
No
The description focuses on the mechanical function of the applicator for guiding a radioactive source based on a predefined treatment plan, with no mention of AI or ML for planning, image analysis, or other functions.
Yes
The device is used for "treatment of small skin tumours or other superficial disease," directly indicating its therapeutic purpose of delivering radiation for medical treatment.
No.
The device's description and intended use clearly state it is for treatment (HDR Brachytherapy) by guiding a radioactive source, not for diagnosing conditions.
No
The device description clearly states it is an "applicator for Brachytherapy" and acts to "guide the radioactive source," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of skin tumors and superficial diseases using HDR Brachytherapy. This is a therapeutic procedure, not a diagnostic one.
- Device Description: The device is described as an applicator for Brachytherapy, which guides a radioactive source for treatment. This is a treatment delivery device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide 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 does not fit that description.
N/A
Intended Use / Indications for Use
The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR Brachytherapy.
Product codes
JAO
Device Description
The Surface Applicator Set is an applicator for Brachytherapy. 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. 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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 was performed to evaluate the suitability of the applicator sets repeated use for up to 500 times and 100 cleaning cycles. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating that the device performs as intended.
No clinical tests have been included in this pre-market submission.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a wave or ribbon.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K162018
Trade/Device Name: Surface Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 9, 2017 Received: February 10, 2017
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.
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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 O'Hara
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) K162018
Device Name Surface Applicator Set
Indications for Use (Describe)
The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR Brachytherapy.
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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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Premarket Notification [510(k)] Summary
Surface Applicator Set
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado |
| | Phone: 650.424.6320 |
| | Fax: 650.646.9200 |
| | Date: February 9, 2017 |
| Proprietary Name: | Surface Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system
21 CFR 892.5700, Class II
Product Code: JAQ |
| Common/Usual
Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | Surface Applicator Set with Leipzig-style Cone (K123815) |
| Device Description: | The Surface Applicator Set is an applicator for Brachytherapy. 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. 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. |
| Intended Use
Statement | The Surface Applicator Set is intended for treatment of small skin tumours or other
superficial disease (such as keloid formations) with HDR Brachytherapy. |
| Indications for Use
Statement | The Surface Applicator Set is intended for treatment of small skin tumours or other
superficial disease (such as keloid formations) with HDR Brachytherapy. |
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Technological Characteristics:
| FEATURE AND/OR
SPECIFICATION OF
NEW/MODIFIED DEVICE | SURFACE APPLICATOR SET WITH LEIPZIG-
STYLE CONE
(K123815) | MODIFIED DEVICE –
SURFACE APPLICATOR SET |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible Afterloader | GammaMedplus Series | GammaMedplus Series |
| Intended 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. | The Surface Applicator Set
is intended for treatment of small skin
tumours or other superficial disease
(such as keloid formations) with HDR
Brachytherapy. |
| 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. | The Surface Applicator Set
is intended for treatment of small skin
tumours or other superficial disease
(such as keloid formations) with HDR
Brachytherapy. |
| Design/Component list | Shielding for tubus with a vertical source
entrance:
• Ø 10-25 mm and Ø 30-45 mm
with fixation
Surface cone inset set:
• Ø30, 35, 40 mm round
Sterilization Plug GM11009960 and
Leak Stop Button GM11003810 | Shielding for the cone with a
vertical source entrance:
• Ø 10-25 mm and Ø 30-45 mm
with fixation
Surface cone inset set:
• Ø15, 20, 25, 30, 35, 40 mm
round
• Ø 30 x 20 mm and Ø 45 x 25
mm oval
Cleaning Caps (K152018) |
| Materials | • Surface cone inset:
Tungsten/hard PVC
• Leipzig Style Cone: Tungsten/
Stainless Steel | • Surface cone inset: Tungsten/hard
PVC
• Shielding for cones with fixation:
Tungsten/Stainless steel |
| Packing | Individual | Individual |
| Sterility | Delivered in non-sterile condition. | Delivered in non-sterile condition. |
| Sterilization method | Device is not sterilized. | Device is not sterilized. |
| Repeated Use | 500 times | 500 times |
| Cleaning cycles | 100 | 100 |
| 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 |
| Compatible with CT or
MR | No | No |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
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Performance Data:
Bench testing was performed to evaluate the suitability of the applicator sets repeated use for up to 500 times and 100 cleaning cycles. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating that the device performs as intended.
Clinical Tests No clinical tests have been included in this pre-market submission
Conclusions
The non-clinical data support the safety of the device and the bench testing demonstrates that the Surface Applicator Set performs as intended. Varian therefore considers Surface Applicator Set to be safe and effective and to perform at least as well as the predicate device.