VariSeed (v10)

K232400 · Varian Medical Systems · MUJ · Sep 8, 2023 · Radiology

Device Facts

• Record ID: K232400
• Device Name: VariSeed (v10)
• Applicant: Varian Medical Systems
• Product Code: MUJ · Radiology
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VariSeed is intended for use as a software application used by medical professionals to plan, guide, optimize, and document low dose rate brachytherapy and procedures based on template guided needle insertion.

Device Story

VariSeed v10.0 is a PC-based software application for LDR brachytherapy and template-guided needle biopsy procedures. It supports preoperative planning, intraoperative guidance/optimization, and postoperative evaluation. Input data includes medical images (now supporting PET as secondary volumes and MR images for VariPath workflows). The software assists medical professionals in planning needle placement and documenting procedures. It operates in non-sterile environments like ORs or clinics. By providing visualization and planning tools, it enables precise needle insertion and dose optimization, potentially improving treatment accuracy and patient outcomes. It does not perform automated treatment delivery but serves as a planning and tracking aid for clinicians.

Clinical Evidence

No clinical data included. Verification and validation testing performed per QSR 820.30 and ISO 13485:2016 to demonstrate that performance and functionality meet design input requirements under clinically representative conditions.

Technological Characteristics

Free-standing PC-based software. Supports PET and MR image imports. Conforms to ISO 14971:2019, IEC 62083:2009, IEC 62366-1:2015, ISO 20417:2021, ISO 15223-1:2021, IEC 62304-1:2006, and IEC 82304-1:2016.

Indications for Use

Indicated for medical professionals to plan, guide, optimize, and document low-dose-rate (LDR) brachytherapy and template-guided needle biopsy procedures. Suitable for any patient eligible for these procedures. Used outside the sterile field in OR or office settings.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• VariSeed v9.0 (K150636)

Submission Summary (Full Text)

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September 8, 2023

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Varian Medical Systems % Lynn Allman Director, Regulatory Affairs 3100 Hansen Way M/s E-110 PALO ALTO CA 94304

Re: K232400

Trade/Device Name: VariSeed (v10) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ, KXK Dated: August 8, 2023 Received: August 10, 2023

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 (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

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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 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Locon Weidner

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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K232400

Device Name Variseed 10.0

#### Indications for Use (Describe)

VariSeed is intended for use as a software application used by medical professionals to plan, guide, optimize, and document low dose rate brachytherapy and procedures based on template guided needle insertion.

VariSeed is indicated for use as a treatment planning software application used by medical professionals to plan, guide, optimize and document low-dose-rate brachytherapy procedures and for use as a biopsy procedure tracking software application used by medical professionals to plan, guide, and document biopsy procedures based on template guided needle insertion. VariSed may be used on any patient considered suitable for this type of treatment and is intended to be used outside of the sterile field in an operating room environment or in a normal office environment.

| 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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# varian

## Premarket Notification 510(k) Summary

K232400

The following information is provided according to 21 CFR 807.92.

| Submitter: | Varian Medical Systems, Inc.<br>3100 Hansen Way<br>Palo Alto, CA 94304 | Contact Name: Lynn Allman<br>E-mail: [e-mail]<br>Date Prepared: Aug 8, 2023 |
|------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

| Trade/<br>Proprietary<br>Names: | VariSeed v10.0 | |
|---------------------------------|--------------------------------------------------------------------|-------------------------|
| | Common/Usual Name: | Predicate Device: |
| | Brachytherapy treatment planning software | VariSeed v9.0 (K150636) |
| | Classification Name: | |
| | System, planning, radiation therapy treatment,<br>21 CFR §892.5050 | |
| | Product Code: | |
| | MUJ | |
| | Regulatory Class: | |
| | Class II | |

| Device Description: | VariSeed 10 is a free-standing PC based treatment planning software designed for preoperative and intraoperative planning of LDR implants, tracking of the implant procedure, and postoperative evaluation of completed implants. VariSeed also provides tools for supporting intraoperative template guided biopsy and using those results to guide future treatment. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Intended/<br>Indications<br>for Use<br>Statement: | Intended Use | Indications for Use |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| VariSeed is intended for use as<br>a software application used by<br>medical professionals to plan,<br>guide, optimize, and document<br>low dose rate brachytherapy<br>and procedures based on<br>template guided needle<br>insertion. | VariSeed is indicated for use as a treatment<br>planning software application used by medical<br>professionals to plan, guide, optimize and document<br>low-dose-rate brachytherapy procedures and for<br>use as a biopsy procedure tracking software<br>application used by medical professionals to plan,<br>guide, and document biopsy procedures based on<br>template guided needle insertion.<br>VariSeed may be used on any patient considered<br>suitable for this type of treatment and is intended to<br>be used outside of the sterile field in an operating<br>room environment or in a normal office environment. | |

The purpose of this submission is to provide details on how the modified VariSeed v10.0 is similar to Varian's VariSeed v9.0 (K150636) for which we are claiming substantial equivalence.

The subject device Indications for Use is the same as the predicate device and the Intended Use is the same as the predicate device.

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## Comparison of Technological Characteristics with the Predicate Device

At a high level, the subject and predicate devices are based on the following similar elements:

- Design, technological characteristics, operation and use as the Predicate device ●
## Significant Difference

The significant differences (based on "Deciding When to Submit a 510(k) for a Software Change to an Existing Device. (October 2017)") compared to the predicate device are:

- Provide support for PET images as secondary image volumes. ●
- . Inclusion of MR Images in existing image import-based workflow for VariPath.

## 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.

Verification testing was performed to demonstrate that the performance and functionality of the VariSeed v10 treatment planning software meets the design input requirements. Validation testing was performed on production equivalent devices, under clinically representative conditions and by qualified personnel. International standards were incorporated into the device design and development.

No clinical tests have been included in this pre-market submission.

## Standards Conformance

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

- . ISO 14971:2019
- IEC 62083:2009
- IEC 62366-1:2015 +A1:2020 ●
- . ISO 20417:2021
- . ISO 15223-1:2021
- IEC 62304-1:2006 +A1:2015 ●
- IEC 82304-1:2016 ●

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

- ISO 13485:2016
#### Conclusion

The non-clinical data for the VariSeed v10 treatment planning software supports the safety of the device compared to the predicate and the verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers the VariSeed v10 treatment planning software to be as safe and effective as the predicate, and therefore substantially equivalent to the predicate device.