(139 days)
Not Found
No
The device description explicitly states that the device does not contain or consist of software/firmware, and there are no mentions of AI, DNN, or ML in the summary. The device is a physical applicator for guiding a radioactive source.
Yes.
The device is used for cancer treatment of the breast or chest wall using HDR Brachytherapy, which is a form of radiotherapy to treat health conditions.
No
The device is an applicator used for targeted radiation treatment (Brachytherapy) for cancer, not for diagnosing a condition.
No
The device description explicitly states, "The device does not contain or consist of software/firmware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cancer treatment using brachytherapy, which is a therapeutic procedure. IVDs are used for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is described as an applicator for guiding a radioactive source for treatment. It does not perform any analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological specimens (like blood, urine, tissue, etc.).
Therefore, the Advanced Breast Template System is a therapeutic device used in the treatment of cancer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Advanced Breast Template System is intended for use for cancer treatment of the breast wall using high dose rate HDR Brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Advanced Breast Template System is an applicator for interstitial 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.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. This device is used on male and female patients.
The Advanced Breast Template System is compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast or chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is 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.
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:
- Biocompatibility Testing: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Included tests for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subacute Toxicity, and Implantation. Components are categorized as surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d).
- Sterilization Testing: Performed to assess effectiveness of cleaning, disinfection, and sterilization procedures. Components were subjected to sterilization cycles up to stated use life and evaluated for performance and damage. Included Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles.
- Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable to the device.
- Software Verification and Validation Testing: Not applicable to the device as it does not contain software/firmware.
- Mechanical and Acoustic Testing: Included CT Compatibility Tests and Analysis.
Declaration of Conformity to ISO 10993-1, ISO 10993-5, ISO 10993-10, AAMI ANSI ST-79, AAMI ANSI ST-81, AAMI TIR-12, AAMI TIR-30, IEC 62366, EN ISO 17664.
No Animal Study / Clinical Tests were included.
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2016
Varian Medical Systems, Inc. % Mr. Peter Coronado Director Global Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304
Re: K161540
Trade/Device Name: Advanced Breast Template System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 12, 2016 Received: September 13, 2016
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.'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) K161540
Device Name Advanced Breast Template System
Indications for Use (Describe)
The Advanced Breast Template System is intended for use for cancer treatment of the breast wall using high dose rate 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. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
510k Summary
510(k) Submission for Advanced Breast Template System
A partner for life
As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014).
l. SUBMITTER
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E-110
Palo Alto CA 94304-1038 |
|-------------------|---------------------------------------------------------------------------------|
| Contact Name: | Peter J. Coronado |
| Position: | Director, Regulatory Affairs |
| Phone: | 1.650.424.6230 |
| Fax: | 1.650.646.9200 |
| Email: | submissions.support@varian.com |
| Date Prepared: | June 1, 2016 |
II. DEVICE
| Name of Device: | Advanced Breast Template System |
|---|---|
| Common/Usual Name: | System, Applicator, Radionuclide, Remote-Controlled |
| Regulation Name: | Remote controlled radionuclide applicator system (21 CFR 892.5700) |
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Regulatory Class: Class II Product Code: JAQ
PREDICATE DEVICE lll.
Name of Predicate: VariSource Breast Template System
510k Number: K023220
DEVICE DESCRIPTION IV.
The Advanced Breast Template System is an applicator for interstitial 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.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. This device is used on male and female patients.
The Advanced Breast Template System is compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.
5
The Advanced Breast Template System is CT compatible.
The device is 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.
V. INDICATIONS FOR USE
Indications for Use Statement: The Advanced Breast Template System is intended for use for cancer treatment of the breast or chest wall using high dose rate HDR Brachytherapy.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject and predicate devices are intended for use in the treatment of cancer through interstitial brachytherapy.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Ratchet assembly and other device components are fully biocompatible .
- Application in interstitial brachytherapy treatments .
- . Same anatomical treatment site/application
- . Sterilized by user prior to use (and reuses)
6
The following main differences exist between the subject and predicate devices:
- Reworded indications for use
- . Material change in the ratchet assembly
- Validation of machine cleaning and sterilization parameters .
- Added CT compatibility ●
- Added GammaMed Afterloader compatibility
PERFORMANCE DATA VI.
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Tests:
Biocompatibility Testing:
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included the following tests:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity ●
- Subacute Toxicity ●
- Implantation ●
7
According to ISO 10993-1 the components of the Advanced Breast Template System are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d). (B).
Sterilization Testing:
Sterilization testing was performed for the subject device was conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect safety or effectiveness.
- . Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles
Electrical Safety and Electromagnetic Compatibility (EMC):
This item is not applicable to the subject device. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence determination.
Software Verification and Validation Testing:
This item is not applicable to the subject device; the device does not contain or consist of software/firmware. No software verification and validation testing has been included in this submission in support of the substantial equivalence determination.
Mechanical and Acoustic Testing:
- . CT Compatibility Tests and Analysis
Declaration of Conformity:
The following list are standards to which the subject device declares conformity:
- . ISO 10993-1
- ISO 10993-5
- ISO 10993-10 ●
8
- AAMI ANSI ST-79 ●
- AAMI ANSI ST-81
- AAMI TIR-12
- . AAMI TIR-30
- IEC 62366 ●
- EN ISO 17664 ●
Animal Study / Clinical Tests:
No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.
CONCLUSIONS VII.
The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject device performs comparably to the predicate device, meeting the intended use.