The Aarhus Applicator Set is indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy within a hospital CT or MRI environment.

Device Description

The Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy. The Applicator is inserted into the patient and connected to an afterloader. The applicator acts to guide the radioactive source from the afterloader to the correct location or locations for treatment. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue.

AI/ML Overview

Device Acceptance Criteria and Performance Study Analysis for Aarhus Applicator Set (K222775)

Based on the provided FDA 510(k) summary for the Aarhus Applicator Set (K222775), this device is a medical accessory for brachytherapy treatment and not an AI/ML-enabled software device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML software (e.g., performance metrics like sensitivity, specificity, AUC) is not directly applicable in the same manner.

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (K150839 - 3D Interstitial Ring Applicator Set). Substantial equivalence means the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The "acceptance criteria" in this context are primarily related to safety, performance, and technological similarity to the predicate, verified through non-clinical testing.

Here's a breakdown of the information requested, interpreted in the context of this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (an applicator set) for brachytherapy, the acceptance criteria are not typically presented as quantitative diagnostic performance metrics like those for AI/ML software. Instead, they relate to:

Functionality: Does the device perform its intended physical role (guiding radioactive sources)?
Safety: Does the device pose undue risks to patients or users? This includes material biocompatibility, sterility, mechanical integrity, and compatibility with other medical equipment.
Performance: Does it meet design inputs for its specified use (e.g., accurate source positioning, durability)?
Compatibility: Is it compatible with relevant afterloaders (VariSource iX, 200, BRAVOS models) and imaging environments (CT, MRI)?

Table: Acceptance Criteria (Implied) and Reported Device Performance (as per 510(k))

Acceptance Criterion (Implied)	Reported Device Performance (Summary from 510(k))
Functional Equivalence	"Similar Design and Technology as Predicate device." "The applicator acts to guide the radioactive source from the afterloader to the correct location or locations for treatment."
Material Biocompatibility	"The device material has been changed to PEEK-only." (Implies PEEK is a known biocompatible material for such applications; conformance to ISO 10993 standards supports this.)
Mechanical Integrity/Durability	Verified through "Verification testing... to demonstrate that the performance and functionality... meets the design input requirements."
Compatibility with Afterloaders	"The compatible afterloaders have been expanded to include the VariSource iX, 200 and BRAVOS models."
Compatibility with Imaging Environment	"The subject device Intended Use now includes a CT or MRI environment." ("Verification testing... under clinically representative conditions" would confirm this.)
Sterilization & Cleanability	Conformance to standards like ANSI AAMI ST79, ISO 17664-1, ISO 17665-1 indicates validated processes for sterilization and cleaning.
Labeling and Instructions for Use	Subject to general controls, including clear labeling requirements (21 CFR Part 801).

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the typical sense of an AI/ML test set with patient data. The "tests" performed are non-clinical verification and validation activities on the device itself.

Sample Size: Not specified as a number of "cases" or "patients." These would be engineering tests, potentially involving multiple units of the applicator set to ensure reproducibility and reliability. The document states "Validation testing was performed on production equivalent devices."
Data Provenance: Not applicable. This is not clinical data but rather data generated from engineering and performance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. "Ground truth" in the context of an AI/ML study refers to a definitive diagnosis or outcome. For a physical device like this, "ground truth" is adherence to engineering specifications, safety standards, and functional requirements. These are established through:

Design Input Requirements: Defined by Varian's internal design control processes.
Industry Standards: Conformance to relevant ISO and AAMI standards (e.g., ISO 14971, IEC 62366-1, ISO 10993 series, ANSI AAMI ST79, IEC 60601-2-17, etc.).
Qualified Personnel: The document states "Validation testing was performed... by qualified personnel," but specific numbers or qualifications (e.g., "radiologist with 10 years experience") are not required or provided for this type of device submission as there are no "diagnoses" being made.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements in expert annotations of clinical data for AI/ML ground truth. For this device, verification and validation are systematic engineering processes against predefined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is a clinical study comparing the diagnostic performance of multiple readers on multiple cases, typically used for AI/ML in imaging. The 510(k) explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This confirms that no MRMC study was performed or required for this type of device.

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

This concept is irrelevant as the device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

As discussed, "ground truth" for this physical device is defined by:

Engineering Specifications: The device's design inputs and performance requirements.
International and National Standards: Compliance with a comprehensive list of standards related to medical devices, quality management, risk management, usability, biocompatibility, sterilization, and electrical safety (e.g., ISO 14971, IEC 62366-1, ISO 10993 series, ANSI AAMI ST79, IEC 60601-2-17, ISO 13485).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this physical device.

Summary Conclusion from the 510(k):

The FDA's review and Varian's submission conclude that the Aarhus Applicator Set is substantially equivalent to its predicate device based on:

Similar intended use and indications for use.
Similar basic operation and technological characteristics.
Non-clinical verification and validation testing demonstrating that the device meets design input requirements and performs as intended.
Conformance to a comprehensive set of recognized and non-recognized standards (e.g., ISO 14971, IEC 62366-1, ISO 10993 series) addressing risk management, usability, biocompatibility, sterilization, and electrical safety.

The key differences (CT/MRI environment compatibility, expanded afterloader compatibility, PEEK-only material) were assessed through these non-clinical tests to ensure they did not raise new questions of safety or effectiveness.

Summary

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

March 13, 2023

Re: K222775

Trade/Device Name: Aarhus Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: February 6, 2023 Received: February 8, 2023

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 medical devices and radiation-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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner -S. The date of the signature is 2023.03.13, and the time is 14:47:17 -04'00'.

Lora D. Weidner, 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) K222775

Device Name Aarhus Applicator Set

Indications for Use (Describe)

The Aarhus Applicator Set is indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy within a hospital CT or MRI environment.

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

3100 Hansen Way Palo Alto, CA 94304

650.493.4000 800.544.4636

varian.com

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Premarket Notification 510(k) Summary K222775

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. CoronadoPhone: 650.424.6320Fax: 650.646.9200E-mail: submissions.support@varian.com
	Date Prepared: September 8, 2022

Trade/ProprietaryNames:	Aarhus Applicator Set
	Aarhus Applicator Set
	Classification Name:
	Remote controlled radionuclideapplicator system, 21 CFR §892.5700	Predicate Device:
	Common/Usual Name:	3D Interstitial Ring Applicator Set 60 & Set 90;Ring Applicator Set 45, Set 60, Set 90(K150839)
	Afterloader SystemSource Guide TubesBrachytherapy Accessory
	Regulatory Class:Class II
	Product Code:JAQ
DeviceDescription:	Aarhus Applicator SetThe Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy.The Applicator is inserted into the patient and connected to an afterloader. Theapplicator acts to guide the radioactive source from the afterloader to the correctlocation or locations for treatment. This combination places the remote-controlledradioisotope treatment source (brachytherapy source) nearby the target tissue.

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Intended/IndicationsFor UseStatement:	Aarhus Applicator Set
Intended Use	Indications for Use
The Aarhus Applicator Set is intended for usewhen performing HDR or PDR brachytherapywithin a CT and MRI environment.	The Aarhus Applicator Set is indicated forcancer treatment of the vagina, cervix, anduterus using HDR or PDR brachytherapywithin a hospital CT or MRI environment.

The purpose of this Traditional 510(k) submission is to provide details on how the new Aarhus Applicator Set is similar to Varian's 3D Interstitial Ring Applicator Set 60 & Set 90; Ring Applicator Set 45, Set 60, Set 90 (K150839) for which we are claiming substantial equivalence.

The subject device Indications for Use is similar to the predicate device and Intended Use is similar to the predicate device.

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:

Aarhus Applicator Set:

. Similar Design and Technology as Predicate device

Significant Difference

Aarhus Applicator Set: The significant differences compared to the predicate device are

The subject device Intended Use now includes a CT or MRI environment. ●
The compatible afterloaders have been expanded to include the VariSource iX, 200 and BRAVOS models.
The device material has been changed to PEEK-only. .

Performance Data

Verification and validation were 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, Format for Traditional and Abbreviated 510(k)s.

Varian Medical's Aarhus Applicator Set is substantially equivalent to the predicate device (K150839). Compared to the predicate device, the basic operation and technological characteristics are substantially the same.

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 Aarhus Applicator Set meets the design input requirements. Validation testing was performed on production equivalent devices, under clinically representative conditions and by qualified personnel.

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varian

Standards Conformance

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

ISO 14971:2019
IEC 62366-1:2015 +A1:2020
ISO 10993-1:2018 .
ISO 10993-2:2006 ●
. ISO 10993-5:2009
ISO 10993-6:2016
ISO 10993-10:2010 ●
ISO 10993-11:2017 ●
ISO 10993-12:2021
ISO 10993-17:2002
ISO 10993-18:2020
ANSI AAMI ST79:2017 & 2020 ● Amendments A1, A2, A3, A4 (Consolidated Text)
IEC 60601-2-17:2013 ●
AAMI TIR-12:2010
AAMI TIR-30: 2011 .
. ISO 15223-1:2021
ISO 11607-1:2020 ●
ISO 11737-2:2019 .
ISO 17664-1:2021 ●
ISO 17665-1:2006/(R)2013 ●
ISO/TS 17665-2:2009 .
ASTM F2503-20 ●
ASTM F2052-15 .
ASTM F2213-17 ●
ASTM F2182-19e2
ASTM F2119-07
. ANSI / AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) + A1 2012
. ASTM D4332-13
ASTM D4332-14 ●
. ISTA 3A 2018

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

ISO 13485:2016
. ISO 11138-3:2017
ASTM D4332-13
. BS EN 1041:2008 +A1:2013

Conclusion

The non-clinical data for the new Aarhus Applicator Set supports the safety of the device and the verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers the new Aarhus Applicator Set to be as safe and effective, and substantially equivalent to the predicate device.

Regulation Number and Section

N/A