(24 days)
Not Found
No
The document describes a computer-controlled electro/mechanical system for brachytherapy, but there is no mention of AI or ML in the intended use, device description, or performance studies. The software is described as "computer controlled" and subject to standard software verification and validation, not AI/ML specific validation.
Yes
The device is intended for the treatment of diseases (benign and malignant) using remote-controlled HDR brachytherapy, which directly signifies a therapeutic purpose.
No
Explanation: The device is a brachytherapy system for delivering radiation treatment, not for diagnosing conditions. Its purpose is to place radioactive sources for therapeutic intent.
No
The device description explicitly states it is a "computer controlled remote electro/mechanical system" and includes physical components like Transfer Guide Tubes and a Length Assessment Device, which are hardware accessories. While it has software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the delivery of remote-controlled High Dose Rate (HDR) brachytherapy for treating diseases and conditions. This involves placing a radioactive source directly within or near a tumor.
- Device Description: The description details a system for automatically placing a radioactive source (iridium pellet) internally or close to a tumor. It also describes accessories (Transfer Guide Tubes and Length Assessment Device) that facilitate this process.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological specimens. The device is used for direct treatment delivery.
Therefore, the BRAVOS Afterloader System and its accessories are therapeutic devices used for delivering radiation treatment, not diagnostic devices used for analyzing biological samples.
N/A
Intended Use / Indications for Use
The BRAVOS Afterloader System is intended for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.
The Transfer Guide Tubes are intended to connect between the BRAVOS Remote Afterloader system and its range of Applicators. This connection creates a conduit for the source cable to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
The Length Assessment Device is intended to allow the user to establish an approximate length channel prior to the afterloader performing definitive length verification.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The BRAVOS Afterloader System is a computer controlled remote electro/mechanical system used for automatically placing a cable incorporating an irradiated iridium pellet (sealed source) internally or close by a malignant tumor or tumor bed in a practice known as Brachytherapy.
Transfer Guide Tubes (TGT) are Brachytherapy applicator accessories. They are designed to provide a path for the dummy and source cable from the BRAVOS Afterloader System to the Applicator. The applicator end of a Transfer Guide Tube can vary in design to accommodate a range of Applicators.
The Length Assessment Device (LAD) is a Brachytherapy applicator accessory and is used to determine the approximate length of the inner lumen of the Transfer Guide Tubes (TGT) and applicator assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for BRAVOS Afterloader System was considered as a "major" level of concern.
No animal studies or clinical tests have been included in this pre-market submission.
Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements. Verification testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel.
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
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July 8, 2019
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Senior Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K191580
Trade/Device Name: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAQ Dated: June 12, 2019 Received: June 14, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191580
Device Name
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
Indications for Use (Describe)
The BRAVOS Afterloader System is intended for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.
The Transfer Guide Tubes are intended to connect between the BRAVOS Remote Afterloader system and its range of Applicators. This connection creates a conduit for the source cable to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
The Length Assessment Device is intended to allow the user to establish an approximate length channel prior to the afterloader performing definitive length verification.
| 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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3
Image /page/3/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. The letters are all lowercase and evenly spaced. The word is likely a logo or brand name. The color of the text is black.
Varian Medical Systems
3100 Hansen Way Palo Alto, CA 94304
650.493.4000 800.544.4636
varian.com
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Premarket Notification 510(K) Summary
The following information is provided according to 21 CFR 807.92.
| Submitter: | Varian Medical Systems, Inc.
3100 Hansen Way Palo Alto, CA 94304 |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
E-mail: submissions.support@varian.com
Date Prepared: June 12, 2019 |
| Trade/
Proprietary
Names: | BRAVOS Afterloader Family (K191580)
BRAVOS Afterloader System Transfer Guide Tubes (TGT) Length Assessment Device (LAD) | | | | | | | | | | | | | | | | | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | BRAVOS Afterloader System, Transfer Guide Tubes (TGT), Length Assessment Device (LAD) | | | | | | | | | | | | | | | | | | | | |
| | Classification Name: Predicate Device: Remote controlled radionuclide
applicator system, 21 CFR §892.5700 BRAVOS Afterloader Family (K181903) BRAVOS Afterloader System Transfer Guide Tubes (TGT) Length Assessment Device (LAD) Common/Usual Name: Afterloader System Source Guide Tubes Brachytherapy Accessory Regulatory Class: Class II Product Code: JAQ | | | | | | | | | | | | | | | | | | | | |
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| Device | BRAVOS Afterloader System | |
|---|---|---|
| Description: | The BRAVOS Afterloader System is a computer controlled remote electro/mechanical | |
| system used for automatically placing a cable incorporating an irradiated iridium pellet (sealed | ||
| source) internally or close by a malignant tumor or tumor bed in a practice known as | ||
| Brachytherapy. | ||
| Transfer Guide Tubes (TGT) | ||
| Transfer Guide Tubes (TGT) are Brachytherapy applicator accessories. They are designed to | ||
| provide a path for the dummy and source cable from the BRAVOS Afterloader System to the | ||
| Applicator. The applicator end of a Transfer Guide Tube can vary in design to accommodate a | ||
| range of Applicators. | ||
| Length Assessment Device (LAD) | ||
| The Length Assessment Device (LAD) is a Brachytherapy applicator accessory and is used | ||
| to determine the approximate length of the inner lumen of the Transfer Guide Tubes (TGT) | ||
| and applicator assembly. | ||
| Intended/ | ||
| Indications | The subject device's indications for use and the intended use have not changed since the predicate submission. | |
| For Use | ||
| Statement: | BRAVOS Afterloader System | |
| Intended Use | Indications for Use | |
| The BRAVOS Afterloader System is intended for | ||
| use in the treatment of both benign and malignant | ||
| disease or other conditions, for both curative and | ||
| palliative intent, in the delivery of remote-controlled | ||
| High Dose Rate (HDR) brachytherapy. | The Bravos Afterloader System is indicated for use | |
| in the treatment of both benign and malignant | ||
| disease or other conditions, for both curative and | ||
| palliative intent, in the delivery of remote-controlled | ||
| High Dose Rate (HDR) brachytherapy. | ||
| Transfer Guide Tubes (TGT) | ||
| Intended Use | Indications for Use | |
| The Transfer Guide Tubes are intended to connect | ||
| between the BRAVOS Remote Afterloader system | ||
| and its range of Applicators. This connection | ||
| creates a conduit for the source cable to travel | ||
| through and allows the radioactive isotopes to be | ||
| positioned within the patient's tumor site. | The Transfer Guide Tubes are intended to connect | |
| between the Bravos Remote Afterloader system | ||
| and its range of applicators. This connection | ||
| creates a conduit for the source cable to travel | ||
| through and allows the radioactive isotopes to be | ||
| positioned within the patient's tumor site. | ||
| Length Assessment Device (LAD) | ||
| Intended Use | Indications for Use | |
| The Length Assessment Device is intended to | ||
| allow the user to establish an approximate length | ||
| of an unknown length channel prior to the | ||
| afterloader performing definitive length verification. | The Length Assessment Device is intended to | |
| allow the user to establish an approximate length of | ||
| an unknown length channel prior to the afterloader | ||
| performing definitive length verification. |
The purpose of this Special 510(k) submission is to provide details on the updated BRAVOS Afterloader System which is a part of the Varian's BRAVOS Afterloader Family (K181903) for which we are claiming substantial equivalence. There have been no updates to the accessories Transfer Guide Tubes (TGT) and Length Assessment Device (LAD) since the previous submission (K181903). The indications for use and the intended use are identical in the subject device as for the predicate.
Note: Varian's updated BRAVOS Afterloader System was developed under the project name "G3" and "MR1" and the control software under the project name "Jaguar" which will be referenced in the design documentation as such.
5
Comparison of Technological Characteristscs with the Predicate Device
At a high level, the subject and predicate devices are based on the following similar technological elements:
BRAVOS Afterloader System
- Same Intended Use and Indications for Use .
- Similar Design and Technology ●
- o Similar Jaguar Console Software (subject device updated to version 2.1)
Transfer Guide Tubes (TGT) and Length Assessment Device (LAD):
- Same as Predicate device (no changes in the subject device) .
Significant Difference
BRAVOS Afterloader System: The significant differences compared to the predicate device are
- BRAVOS Control Software (Jaguar version 2.1) to accommodate Multi-Part Plans
- Modified Emergency Drive Behavior ●
The BRAVOS Afterloader System is remote-controlled afterloading device for brachytherapy. The system utilizes a small, high activity Iridium-192 source that is encapsulated in a steel capsule, which is fixed to a stainless-steel cable and moves into applicator(s) inserted into the patient.
In addition to the changes listed above, other cumulative non-significant changes since the predicate device include the following:
- Firmware:
- Minor enhancements and bug fixes for the connection to Service PC and loading Source o Cable (Product Service Engineer-use only)
- Jaguar:
- Minor enhancements and bug fixes to improve loading large plans and dwell time values C
- Show patient picture on treatment reports o
- Service: 0
- Minor enhancements and bug fixes to reduce parameters that are reset during source o exchange and clarify names on sensor labels (Product Service Engineer-use only)
Performance Data
Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for BRAVOS Afterloader System was considered as a "major" level of concern.
Varian's BRAVOS Afterloader Family which consists of the updated BRAVOS Afterloader System is substantially equivalent to the predicate device (K181903). Compared to the predicate device, the basic operation and technological characteristics are substantially the same. The above changes do not affect the intended use or indications for use of the BRAVOS Afterloader System.
No animal studies or clinical tests have been included in this pre-market submission.
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variar
Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements. Verification testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel.
Standards Conformance
The subject device conforms in whole or in part with the following standards:
- AAMI/ ANSI 60601-1: 2005
- · IEC 60601-1-2: 2014
- IEC 60601-1-8:2006 + A1:2012
- IEC 60601-2-17:2013
- IEC 62304: 2006
- IEC 60601-1-6: 2013-10
- · IEC 60825-1: 2007
- · EN ISO 10993-1:2009
- EN ISO 10993-5:2009
- · EN ISO 10993-10: 2010
- EN ISO 10993-18:2009
- AAMI TIR-12:2010
- AAMI TIR-30: 2011
- EN ISO 17664:2004
- · IEC 62366:2007/(R)2014
- · EN ISO 14971:2012
The subject device also complies with the following non-FDA recognized standard:
• EN ISO 13485:2016
Conclusion
The non-clinical data for the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family supports the safety of the device and the software verification demonstrates that the subject device should perform as intended in the specified use conditions. Varian therefore considers the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family to be safe and effective and are substantially equivalent to the predicate.