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.

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 of an unknown length channel prior to the afterloader performing definitive length verification.

Device Description

BRAVOS Afterloader System: The BRAVOS Afterloader System is a computer controlled remote electro/mechanical system used for brachytherapy. The system automatically moves a stainless-steel cable incorporating a small, high activity Iridium-192 pellet in a steel capsule (sealed source) into applicator(s) or catheter(s) inserted into the patient close by a malignant tumor or tumor bed.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the BRAVOS Afterloader Family, specifically focusing on an updated BRAVOS Afterloader System. This submission claims substantial equivalence to a previously cleared predicate device (K191580).

Here's an analysis of the acceptance criteria and supporting study information based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table with reported device performance. Instead, it focuses on demonstrating that the updated device is "substantially equivalent" to its predicate and that verification and validation testing confirms it meets "initial design input requirements."

Acceptance Criteria Category	Reported Device Performance Summary (from text)
Overall Equivalence	"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 and validation demonstrate that the subject device should perform as intended in the specified use conditions."
Software Performance	"Software verification and validation was conducted according to QSR §820.30 and ISO 13485;2016 design control requirements." "The software for BRAVOS Afterloader System was determined to be a 'major' level of concern." "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."
Design Integrity	"Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements."
Technological Characteristics	"At a high level, the subject and predicate devices are based on the following similar technological elements: Same Intended Use and Indications for Use as Predicate device, Similar Design and Technology as Predicate device, Similar Jaguar Console Software (subject device updated to version 2.1)."
Safety and Effectiveness	"Varian considers the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family to be as safe and effective as the predicate device and substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific details on the sample size used for any test set or the data provenance. It mentions "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." However, the number of "changes" or "production equivalent devices" is not specified, nor is the origin of the data (e.g., country).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify any experts used to establish ground truth. The testing described appears to be technical verification and validation, rather than clinical evaluation against expert-defined ground truth. It states "Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel," but does not detail the nature or qualifications of these "qualified personnel" beyond their role in conducting validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This device is a remote-controlled radionuclide applicator system, and the submission focuses on demonstrating substantial equivalence through non-clinical performance and software verification/validation, not a human-in-the-loop study with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of the algorithm itself (e.g., specific accuracy metrics for an AI component) is not explicitly described. The "BRAVOS Control Software" is mentioned as having "new and modified risks plus risk control measures" and being updated to version 2.1. The software is deemed a "major" level of concern. Performance data is mentioned as "Software verification and validation was conducted..." and "Verification testing was performed to demonstrate that the performance and functionality of the updated BRAVOS Afterloader System meets the initial design input requirements." This suggests functional testing of the software within the system context, rather than a standalone performance evaluation of a specific algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly describe the type of "ground truth" in a clinical sense. The "ground truth" for the verification and validation appears to be the initial design input requirements and the expected functionality as part of the system's operation. No clinical ground truth (e.g., pathology, outcomes) is referenced for performance evaluation.

8. The sample size for the training set

The document does not mention any 'training set' or provide a sample size for it. This typically pertains to machine learning or AI models, which are not the primary focus of this submission (which emphasizes electromechanical system updates and software verification/validation for an existing device type).

9. How the ground truth for the training set was established

Since no training set is mentioned, information on how its ground truth was established is not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Varian Medical Systems Inc. % Peter Coronado Senior Director 3100 Hansen Way, M/S/E-110 PALO ALTO CA 94304

Re: K221797

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 16, 2022 Received: June 21, 2022

Dear Peter 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

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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/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

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221797

Device Name

BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device

Indications for Use (Describe)

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.

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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Image /page/3/Picture/0 description: The image shows the word "varian" in a simple, sans-serif font. The letters are all lowercase and evenly spaced. The word is in black and the background is white.

Varian Medical Systems

3100 Hansen Way Palo Alto, CA 94304

650.493.4000 800.544.4636

varian.com

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 14, 2022

Trade/ProprietaryNames:	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:Remote controlled radionuclideapplicator system, 21 CFR §892.5700Common/Usual Name:Afterloader SystemSource Guide TubesBrachytherapy AccessoryRegulatory Class:Class IIProduct Code:	Predicate Device:BRAVOS Afterloader Family (K191580)BRAVOS Afterloader System Transfer Guide Tubes (TGT) Length Assessment Device (LAD)
	JAQ
DeviceDescription:	BRAVOS Afterloader SystemThe BRAVOS Afterloader System is a computer controlled remote electro/mechanical system used for brachytherapy. The system automatically moves a stainless-steel cable incorporating a small, high activity Iridium-192 pellet in a steel capsule (sealed source) into applicator(s) or catheter(s) inserted into the patient close by a malignant tumor or tumor bed.
	Transfer Guide Tubes (TGT)Transfer Guide Tubes (TGT) are Brachytherapy applicator accessories. They are designedto provide a path for the dummy and source cable from the BRAVOS Afterloader System tothe Applicator. The applicator end of a Transfer Guide Tube can vary in design toaccommodate a range of Applicators.

	Length Assessment Device (LAD)
	The Length Assessment Device (LAD) is a Brachytherapy applicator accessory and is usedto determine the approximate length of the inner lumen of the Transfer Guide Tubes (TGT)and applicator assembly.
Intended/IndicationsFor UseStatement:	The subject device's indications for use and the intended use have not changed since the predicate submission.
	BRAVOS Afterloader System
	Intended Use	Indications for Use
	The BRAVOS Afterloader System is intended foruse in the treatment of both benign and malignantdisease or other conditions, for both curative andpalliative intent, in the delivery of remote-controlledHigh Dose Rate (HDR) brachytherapy.	The Bravos Afterloader System is indicated foruse in the treatment of both benign and malignantdisease or other conditions, for both curative andpalliative 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 connectbetween the BRAVOS Remote Afterloader systemand its range of Applicators. This connectioncreates a conduit for the source cable to travelthrough and allows the radioactive isotopes to bepositioned within the patient's tumor site.	The Transfer Guide Tubes are intended toconnect between the Bravos Remote Afterloadersystem and its range of applicators. Thisconnection creates a conduit for the source cableto travel through and allows the radioactiveisotopes to be positioned within the patient'stumor site.
	Length Assessment Device (LAD)
	Intended Use	Indications for Use
	The Length Assessment Device is intended toallow the user to establish an approximate length ofan unknown length channel prior to the afterloaderperforming definitive length verification.	The Length Assessment Device is intended toallow the user to establish an approximate lengthof an unknown length channel prior to theafterloader performing definitive lengthverification.

K221797

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The purpose of this submission is to provide details on the updated BRAVOS Afterloader System which is a part of the Varian's BRAVOS Afterloader Family (K191580) 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 (K191580).

The subject device Indications for Use and Intended Use are identical to the predicate device.

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varian

Comparison of Technological Characteristics 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 as Predicate device
Similar Design and Technology as Predicate device ●
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 introduced new and modified risks plus risk control measures
Warning statement added to the labeling ●

In addition to the changes listed above, other cumulative non-significant changes since the predicate device include the following:

Firmware, Control Software & Service Software: .
- Minor enhancements and bug fixes O
. Afterloader:
- O Minor feature enhancements

Performance Data

Software verification and validation was conducted according to QSR §820.30 and ISO 13485;2016 design control requirements. Submission 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 determined to be 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 (K191580). 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.

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.

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varian

Standards Conformance

The subject device conforms in whole or in part with the following standards:

IEC 60601-1-2: 2014 Edition 4.0
IEC 60601-1-6: Edition 3.2 2020
IEC 60601-1-8:2006 + A1:2012 ●
IEC 60601-2-17:2013
IEC 62304: 2006 + A1:2015 ●
UL 2900-1:2017
UL 2900-2-1:2017
IEC 80001-1:2010
IEC/TR 80001-2-2:2012
ANSI / AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) + A1 2012 ●
IEC 62366-1:2015+A1:2020
EN ISO 14971:2019
ISO 15223-1:2021
EN ISO 17664:2017
AAMI TIR-12:2010
AAMI TIR-30: 2011

The subject device also complies with the following non-FDA recognized standards:

IEC 60825-1: 2014 ●
. 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 and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers the updated BRAVOS Afterloader System from the BRAVOS Afterloader Family to be as safe and effective as the predicate device and substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.