The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary 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 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. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Heyman Packing Applicator Set (GM11004580)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a separate study with specific performance metrics (like accuracy, sensitivity, specificity, etc.) that would typically apply to AI-driven or diagnostic devices.

Instead, the "acceptance criteria" here refer to the device's conformance to established engineering standards, biocompatibility, and safety, as well as its functional characteristics. The "study that proves the device meets the acceptance criteria" is primarily a series of non-clinical performance tests and adherence to consensus standards.

Here's a breakdown of the information requested, based on the provided text:

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

Since this is a physical medical device and not an AI or diagnostic software, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they relate to functional and safety attributes. The "reported device performance" refers to the confirmed characteristics after testing.

Acceptance Criteria Category	Reported Device Performance
Intended Use	Intended for use when performing HDR or PDR brachytherapy.
Indications for Use	Indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
Biocompatibility	Meets biocompatibility requirements in compliance with ISO 10993-1 and applicable parts.
Magnetic Resonance (MR) Safety	MR Safe (without mandrins inserted), complies with ASTM F2503-23. (Previously MR Conditional).
Cleaning, Disinfection, & Sterilization	Device components can be effectively sterilized (steam sterilization with common parameters using pre-vacuum sterilization) and reused for the specified number of times. Labelling emphasizes proper sterilization.
Human Factors / Usability	Performs well as intended for the intended users, uses, and use environments (validated per IEC 62366).
Mechanical Integrity	Undergone formal design verification and design validation testing, demonstrating it performs as intended.
Material Composition	Heyman capsules: PEEK; Mandrin: Stainless Steel. Change from previous model (Titanium eliminated from capsules) shown to have no new or increased biocompatibility or safety concerns, and no impact on performance specifications.
Features	Simulates classic Heyman packing technique; 4mm, 6mm, 8mm capsules; mandrins stabilize during insertion; CT Compatible; Leak stop channel markers; Reusable; Steam sterilizable; Compatible with all Varian afterloader systems (including BRAVOS); Suitable for patient contact <30 days.

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 details on specific sample sizes for tests like biocompatibility, MR testing, or cleaning/sterilization. These types of tests typically involve a defined number of device units or material samples rather than "test sets" in the clinical data sense. The data provenance (country, retrospective/prospective) is not mentioned, but it's implied to be internal testing conducted by the manufacturer, Varian Medical Systems, Inc.

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)

This information is not applicable and therefore not provided. The "ground truth" concept is relevant for diagnostic or AI-driven devices where a reference standard is needed to compare against the device's output. For a physical applicator set, the "truth" is established by direct measurement, material science, and engineering validation against specifications and safety standards.

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

Not applicable. Adjudication methods are typically used in clinical studies or expert reviews of diagnostic interpretations, which are not relevant for this device's type of testing.

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

Not applicable. This device is a physical brachytherapy applicator set, not an AI or diagnostic tool that would involve "human readers" or AI assistance.

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

Not applicable. This device does not have an algorithm or "standalone" performance in the context of AI or diagnostic software. Its performance is evaluated through physical and material testing.

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

Not applicable. As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for the type of device being described. The validation relies on established engineering principles, material science, and consensus standards for safety and performance (e.g., ISO 10993 for biocompatibility, ASTM F2503 for MR safety).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

{0}------------------------------------------------

August 30, 2024

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Varian Medical Systems, Inc. Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304

Re: K241386

Trade/Device Name: Heyman Packing Applicator Set (GM11004580) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: July 29, 2024 Received: July 30, 2024

Dear Lynn Allman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

{1}------------------------------------------------

product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Lora Werner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K241386

Device Name

Heyman Packing Applicator Set (GM11004580)

Indications for Use (Describe)

The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is in black and white.

Premarket Notification - 510(k) Summary

Traditional 510(k) Submission for Heyman Packing Applicator Set (GM11004580)

l. Submitter's Name

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

Contact Name: Lynn, Allman, PhD., Senior Director Regulatory Affairs Phone: (650) 424-5369 E-mail: submissions.support@varian.com Date Prepared: May 15th, 2024

II. Device Information

Proprietary Name: Heyman Packing Applicator Set (GM11004580) Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ

III. Predicate Device

Heyman Packing Applicator Set (K160045)

IV. Device Description

The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes.

The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets).

The Heyman Packing Applicator Set is an applicator for intracavitary 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 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.

The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Varian logo, with the word "Varian" in bold, sans-serif font. Below the logo, in a smaller font size, is the text "A Siemens Healthineers Company". The logo is simple and modern, with a focus on the company name and its affiliation with Siemens Healthineers.

The key performance characteristics of this applicator set are as follows:

Simulates the classic Heyman packing technique ●
4 mm, 6 mm, and 8 mm diameter capsules for optimal packing of the uterine cavity
. Mandrins stabilize the applicators during insertion
CT Compatible
. MR Safe-without mandrins inserted
Material is biocompatible for intracavitary use
. Leak stop channel markers allow for channel number coding
Reusable and steam sterilizable
Compatibility with all Varian afterloader systems
Suitable for patient contact for a period of less than 30 days

V. Intended Use

The Heyman Packing Applicator Set is intended for use when performing HDR or PDR brachytherapy.

VI. Indications for Use

The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.

VII. Comparison of Technological Characteristics with the Predicate Device

Table 1: Comparison of Subject Device to Predicate Device

FEATURE AND/ORSPECIFICATION OFNEW/MODIFIED DEVICE	CLEARED DEVICEFEATURE/SPECIFICATION510(k) ID # K160045HEYMAN PACKING APPLICATOR SET	NEW / MODIFIED DEVICE NAMEHEYMAN PACKING APPLICATORSET (GM11004580)	COMPARISON
CompatibleAfterloader	GammaMedplus AfterloaderseriesVariSource Afterloader series	GammaMedplusAfterloader seriesVariSource AfterloaderSeriesBRAVOS Afterloader System	Device is compatible withthe BRAVOS AfterloaderSystem, it is just now beingincluded in the labelling forcompleteness.
Intended use	The Heyman PackingApplicator Set is intended forcancer treatment of theendometrium.	The Heyman PackingApplicator Set is intendedfor use when performingHDR or PDR brachytherapy.	The intended use wasamended to accuratelyreflect the use of thepacking applicator set forgeneral HDR or PDRbrachytherapy procedures.The indications for useremain the same whichensures that the device isbeing used appropriatelyfor the therapeuticindication for which it isintended The indication for
			use statement has notchanged and limits theclinical use of the set toendometrial cancer usingHDR or PDR brachytherapy.Furthermore, the riskreview for the HeymanPacking Applicator Set didnot identify any new risks asa result of this change;
Indications for Use	The Heyman PackingApplicator Set is indicated foruse for treating endometrialcancer using HDR or PDRbrachytherapy.	No change	Same
Design	Heyman capsules:- 320 mm length- various capsule- diameters of 4mm,6mm and 8mm andlength of 17.5 mmMandrin:- 320 mm length	No change	Same
Materials	Heyman capsules: PEEK,TitaniumMandrin: Stainless Steel	Heyman capsules: PEEKMandrin: Stainless Steel	This change has notidentified any new orincreased biocompatibilityor safety concerns and doesnot impact the performancespecifications of the subjectdevice.
Packing	Individual	No change	Same
Sterility	Provided non-sterile	No change	Same
Sterilizationmethod	Manual and MachineCleaning, Disinfection, andSteam Sterilization	Manual or machine cleaningand disinfection.Steam sterilization withcommon parameters usingPre-vacuum sterilization.	These changes werecumulatively made as partof a process improvementinitiative and is used toemphasize propersterilization of the subjectdevice. This does notimpact the risk profile ofthe subject device.
Biocompatibility	Fully biocompatible	No change	Same
Anatomical sites	Endometrium	No change	Same
Compatibility withthe environmentand other devices	CT compatibleMR-Conditional	CT compatibleMR-Safe	This change was made toenhance the usability andflexibility of use in theintended population
Where used	Brachytherapy treatmentroom	No change	Same

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the logo is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern, and the text clearly identifies Varian as part of the Siemens Healthineers group.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.

VIII. Summary of Performance Testing (Non-Clinical Testing)

The following performance data was provided in support of the substantial equivalence determination.

Biocompatibility Testing:

The compatibility of the skin-contact component material in the finished product meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process".

Magnetic Resonance Testing (MR):

MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Heyman Packing Applicator Set is MR Safe and comply with the following MR standard:

ASTM F2503-23 (2023 ED): Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Cleaning, Disinfection and Sterilization Testing:

Cleaning, disinfection and sterilization testing was conducted to demonstrate the device components may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.

A human factors validation study was conducted according to the standard IEC 62366 to verify that the device performs well as intended for the intended users, uses, and use environments.

Mechanical and Acoustic Testing:

The Heyman Packing Applicator Set has undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the device performs as intended.

Design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.

Use of Consensus Standards:

The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy.

510(k) Summary

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.

Standard / CS	Standard / CS Title
EN ISO 13485:2016	Quality management systems. Requirements for regulatory purposes
EN ISO14971:2019+A11:2021	Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN ISO 15223-1:2021	Medical devices - Symbols to be used with medical device labels, labelling andinformation to be supplied - Part 1: General requirements
EN ISO 20417:2021	Information supplied by the manufacturer of medical devices
EN 62366-1:2015+A1:2020	Application of Usability Engineering to Medical Devices
EN ISO 17664-1:2021	Processing of health care products-Information to be provided by the medical devicemanufacturer for the processing of medical devices
EN ISO 17665-1:2006	Sterilization of health care products - Moist heat - Part 1: Requirements for thedevelopment, validation and routine control of a sterilization process for medical devices
EN ISO 10993-1:2020	Biological evaluation of medical devices -- Part 1: Evaluation and testing within a riskmanagement process.
EN ISO 10993-2:2022	Biological evaluation of medical devices. - Part 2: Animal welfare requirements
EN ISO 10993-3:2014	Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicityand reproductive toxicity
EN ISO 10993-5:2009	Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity
EN ISO 10993-10:2023	Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization
EN ISO 10993-11:2018	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-12:2021	Biological evaluation of medical devices - Part 12: Sample preparation and referencematerials
EN ISO 10993-17:2009	Biological evaluation of medical devices - Part 17: Establishment of allowable limits forleachable substances
EN ISO 10993-18:2020+A1:2023	Biological evaluation of medical devices - Part 18: Chemical characterization of medicaldevice materials within a risk management process
EN ISO 10993-23:2021	Biological evaluation of medical devices - Part 23: Tests for irritation
EN 60601-1:2006/A1:2013	Medical Electrical Equipment Part 1- General Requirements For Safety and essentialperformance
EN 60601-2-17:2015	Medical electrical equipment - Part 2-17: Particular requirements for the basic safety andessential performance of automatically-controlled brachytherapy after loadingequipment

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.

IX. Determination of Substantial Equivalence to the Predicate

The Heyman Packing Applicator Set was originally marketed as MR Conditional, but has now completed the testing to be classified as MR Safe.

The intended use was amended to accurately reflect the use of the packing applicator set for general HDR or PDR brachytherapy procedures. The indications for use remain the same which ensures that the device is being used appropriately for the therapeutic indication for which it is intended. The indication for use statement has not changed and limits the clinical use of the set to endometrial cancer using HDR or PDR brachytherapy. Furthermore, the risk review for the Heyman Packing Applicator Set did not identify any new risks as a result of this change.

There are no changes in the design or principle of operation of the devices.

Varian believes the major technological characteristics are substantially equivalent to the predicate device.

The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers the Heyman Packing Applicator Set to be 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.