(79 days)
Not Found
No
The summary describes a computer-controlled electro/mechanical system for brachytherapy and its accessories. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML. The performance studies focus on software verification and validation, not the training or testing of AI/ML models.
Yes
The device is intended for "treatment of both benign and malignant disease or other conditions" using High Dose Rate (HDR) brachytherapy, which is a therapeutic intervention.
No
The device is intended for the delivery of remote-controlled High Dose Rate (HDR) brachytherapy, which is a treatment modality, not a diagnostic one. Its components (Afterloader System, Transfer Guide Tubes, Length Assessment Device) all support the delivery of radiation for treatment.
No
The device description clearly outlines hardware components like a "computer controlled remote electro/mechanical system," "Transfer Guide Tubes," and a "Length Assessment Device," which are physical parts of the medical device system. While software is mentioned and its verification/validation is discussed, the device is not solely software.
Based on the provided text, 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. This is a therapeutic procedure performed directly on or within the patient.
- Device Description: The device description details a system for placing a radioactive source internally or close to a tumor. This is a treatment delivery system, not a system for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting markers, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for delivering radiation treatment.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
BRAVOS Afterloader System
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.
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 new BRAVOS Afterloader Family met 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
January 7, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K181903
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
Dear Mr. Coronado:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 10/03/2018. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Sullivan, OHT7: Office of In Vitro Diagnostics and Radiological Health, (240) 402-4973, Julie.Sullivan@fda.hhs.gov.
Sincerely.
Michael D. O'Hara
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
1
Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right of that is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Varian Medical Systems, Inc. c/o Peter J. Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO, CA 94304
October 3, 2018
Re: K181903
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: August 20, 2018 Received: August 21, 2018
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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
K181903
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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4
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Varian Medical Systems
3100 Hansen Way Palo Alto, CA 94304
650.493.4000 800.544.4636
varian.com
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K181903 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: October 2, 2018 |
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Trade/
Proprietary
| Names: | BRAVOS Afterloader Family BRAVOS Afterloader System Transfer Guide Tubes (TGT) Length Assessment Device (LAD) | ||
|---|---|---|---|
| BRAVOS Afterloader System, Transfer Guide Tubes (TGT), Length Assessment Device (LAD) | |||
| Classification Name: | |||
| Remote controlled radionuclide | |||
| applicator system, 21 CFR §892.5700 | |||
| Common/Usual Name: | |||
| Afterloader System | |||
| Source Guide Tubes | |||
| Brachytherapy Accessory | |||
| Regulatory Class: | |||
| Class II | |||
| Product Code: | |||
| JAQ | Predicate Devices: | ||
| (K120993) | |||
| GammaMedplus iX Series | |||
| (K141336) | |||
| GammaMedplus Source Guide Tubes | |||
| (K952913) | |||
| Applicators for Varian VariSource Remote HDR | |||
| Afterloader | |||
| ➤ Accessory: Measurement Ruler, Marker Wire | |||
| & Clip Set | |||
| Device | |||
| Description: | BRAVOS Afterloader System | ||
| 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
For Use
Statement: | The indications for use and the intended use are substantially the same in the subject devices as for the predicate. | | |
| | 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. | |
| Source
Activity | Subject Device: BRAVOS Afterloader System
Maximum shielding activity: 555 GBq / 15 Ci
Maximum treatment activity: 555 GBq / 15 Ci | Predicate Device: GammaMedplus iX Series
Maximum shielding activity: 555 GBq / 15 Ci
Maximum treatment activity: 555 GBq / 15 Ci | |
5
The three devices are used together during a diagnostic procedure and are bundled in this Traditional 510(k) submission so they can be addressed during one review; BRAVOS Afterloader System, Transfer Guide Tubes (TGT), and Length Assessment Device (LAD). The indications for use and the intended use are similar in the subject devices as for the predicate. The source activity was not changed since the predicate.
6
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:
- Similar Design and Technology ●
- o Similar Console Software (subject device updated to version 2.0)
Transfer Guide Tubes (TGT):
- Similar Design
- Composed of same materials ●
- Non-patient contacting (N/A Biocompatible) o
- Provided Non-sterile
Length Assessment Device (LAD):
- Similar Compatibility with its respective Afterloader System ●
- Non-patient contacting (N/A Biocompatible)
- Provided Non-sterile
Significant Difference
BRAVOS Afterloader System: The significant difference compared to the predicate devices are
- The intended and indications for use changed to exclude Pulsed Dose Rate (PDR) mode ●
- Updated Design and Technology of Remote-controlled Afterloader .
- BRAVOS Control Software (version 2.0) ●
- BRAVOS CamScale Device ●
- BRAVOS Source Cable
The BRAVOS Afterloader System and its predicate are remote-controlled afterloading devices for brachytherapy. The systems both utilize 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.
Transfer Guide Tubes (TGT):
- . Updated Intended and Indications for Use statements
- New Guide Tubes and lengths
| Transfer Guide Tubes (TGT) for APPLICATORS | ||
|---|---|---|
| Product Number | Description | |
| GM11010800 | Transfer Guide Tube for 320 mm applicators | |
| GM11010810 | Coded Transfer Guide Tube Channel 1, for 320 mm applicators | |
| GM11010820 | Coded Transfer Guide Tube Channel 2, for 320 mm applicators | |
| GM11010830 | Coded Transfer Guide Tube Channel 3, for 320 mm applicators | |
| GM11010840 | Transfer Guide Tube for 113 mm applicators | |
| GM11010850 | Transfer Guide Tube for 200 mm applicators | |
| GM11010860 | Transfer Guide Tube for 250 mm applicators | |
| GM11010870 | Transfer Guide Tube, 1000 mm length for applicators |
7
| Transfer Guide Tubes (TGT) for CATHETERS | |
|---|---|
| Product Number | Description |
| GM11011860 | Transfer Guide Tube for 113 mm catheters |
| GM11011870 | Transfer Guide Tube for 200 mm catheters |
| GM11011880 | Transfer Guide Tube for 250 mm catheters |
| GM11011890 | Transfer Guide Tube for 320 mm catheters |
| GM11011910 | Transfer Guide Tube, 1000 mm length for catheters |
| LUER Transfer Guide Tube (TGT) | |
| Product Number | Description |
| GM11010880 | Luer Transfer Guide Tube for MammoSite (1500 mm treatment length) |
| Optional Accessory | |
| Product Number | Description |
| GM11001430 | Wall holder for source and transfer guide tubes |
| GM11001390 | Source and transfer guide tube support |
Length Assessment Device (LAD):
- Updated Intended and Indications for Use statements ●
- New design ●
- New materials ●
| Length Assessment Device (LAD) | |
|---|---|
| Product Number | Description |
| GM11011800 | Length assessment device |
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 BRAVOS Afterloader System and two accessories; Transfer Guide Tubes (TGT) and Length Assessment Device (LAD) are substantially equivalent to the predicate devices K120993, K141336, and K952913 respectively. Compared with the predicate device, the basic operation and technological characteristics are substantially the same. The indications for use and the intended use for each device are substantially the same as the predicate.
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 new BRAVOS Afterloader Family met 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.
8
varie
Standards Conformance
The subject devices conform 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 devices also comply with the following non-FDA recognized standard:
- EN ISO 13485:2016 .
Conclusion
The non-clinical data for BRAVOS Afterloader Family supports the safety of the devices and the software verification and validation demonstrate that the subject devices should perform as intended in the specified use conditions. Varian therefore considers the BRAVOS Afterloader Family which consists of BRAVOS Afterloader System and two accessories; Transfer Guide Tubes (TGT) and Length Assessment Device (LAD) to be safe and effective and are substantially equivalent to the predicate.