VARISEED 7.1

• K Number: K030534
• Device Name: VARISEED 7.1
• Manufacturer: VARIAN MEDICAL SYSTEMS
• Date Cleared: 2003-05-21 ( 90 days)
• Product Code: KXK
• Regulation Number: 892.5730

Intended Use

VariSeed 7.1 is a software application for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation as well as intra-operative planning and evaluation.

Device Description

VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures. The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems. The application interfaces with video sources, printers, network sources, as well as DICOM and other image and data sources.

Predicate Devices

K982821, K992762

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a software application for brachytherapy planning and evaluation, but there is no mention of AI, ML, or related terms in the provided text. The focus is on standard software functionalities for planning and evaluation based on established models.

Therapeutic

No
The device is a software application for planning and evaluating brachytherapy procedures, not for directly treating a condition.

Diagnostic

No
The device is a planning and evaluation tool for brachytherapy procedures, not a diagnostic device that identifies diseases or conditions.

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "software application" that runs on standard PCs and interfaces with various data sources, without mentioning any proprietary or dedicated hardware components included as part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that VariSeed 7.1 is for "planning and evaluating brachytherapy procedures for the treatment of prostate cancer." This involves using imaging data and software calculations to guide a medical procedure performed directly on the patient.
• Device Description: The description reinforces that it's a "computer based software application for planning and evaluating prostate brachytherapy procedures."
• Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. VariSeed 7.1 does not perform any such analysis on biological samples. It processes imaging data and performs calculations related to radiation dosage and placement within the body.

Therefore, VariSeed 7.1 falls under the category of medical device software used for treatment planning and evaluation, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

VariSeed 7.1 is a software application for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation as well as intra-operative planning and evaluation.

Product codes

90 KXK

Device Description

VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures. The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems. It interfaces with video sources, printers, network sources, as well as DICOM and other image and data sources.

Software Features:

1. Image Acquisition/Import: The ability to acquire patient data from which a plan or evaluation is constructed.
2. Structure Contouring: The ability to define patient structures within the image space.
3. Source Placement & Dosimetry: The ability to plan source placement within the image space and to calculate the resulting dosimetry.
4. 2D and 3D visualization: The ability to visualize the resulting dose profile and structure in 2D and 3D.
5. Reporting: The ability to produce hard and soft copy reports to facilitate the delivery of the plan, to document the plan and to document the post-procedure evaluation.
6. Brachy Source Specification: The ability for the expert user to modify the profile of seed source specifications and device specifications.
7. Database functions: The ability to manage the patient data in the application database including archiving, deleting and restoring data.
8. Licensing: The ability to license the system by application function and interface.
9. Interface: The ability to interface with other planning systems.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Prostate

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

VariSeed 7.0 (K982821), BrachyVision 6.0 (K992762)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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Premarket Notification [510K] Summary as required by 21 CFR 807.92

Date Summary was prepared:

February 14, 2003

Submitter's Name:

Varian Medical Systems 3100 Hansen Way E-110 Palo Alto, CA 94304

Contact Person:

Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Phone [phone] FAX [phone] E-mail [e-mail]

Device Name:

VariSeed 7.1

Classification Name:

Source, Brachytherapy, Radionuclide

Predicate Device:

VariSeed 7.0 (K982821), BrachyVision 6.0 (K992762)

Product Description:

VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.

Hardware Platform and Operating System

The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems.

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Peripherals and Accessories

The application interfaces with video sources, printers, network sources, as well as DICOM and other image and data sources.

Software Features

• 1. Image Acquisition/Import: The ability to acquire patient data from which a plan or evaluation is constructed
• 2. Structure Contouring: The ability to define patient structures within the image space.
• 3. Source Placement & Dosimetry: The ability to plan source placement within the image space and to calculate the resulting dosimetry.
• 4. 2D and 3D visualization: The ability to visualize the resulting dose profile and structure in 2D and 3D.
• 5. Reporting: The ability to produce hard and soft copy reports to facilitate the delivery of the plan, to document the plan and to document the post-procedure evaluation.
• 6. Brachy Source Specification: The ability for the expert user to modify the profile of seed source specifications and device specifications.
• 7. Database functions: The ability to manage the patient data in the application database including archiving, deleting and restoring data.
• 8. Licensing: The ability to license the system by application function and interface.
• 9. Interface: The ability to interface with other planning systems.

Application Development

The application was developed for 32-bit Microsoft Windows® operating system using Microsoft Visual C++.

Intended Use:

VariSeed 7.1 is a software application used for planning and evaluation of brachytherapy procedures.

Technological Characteristics:

The VariSeed 7.1 treatment planning system is substantially equivalent to the brachytherapy functions of the Varian Medical Systems, Inc. VariSeed 7.0 (K982821) and Varian Medical System, Inc. Brachy Vision 6.0 (K992762) treatment planning systems.

The table below compares the feature sets of the three devices. The new software features for VariSeed 7.1 are in bold, all other VariSeed features are supported in a currently approved product.

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The intended use and indications for use of VariSeed 7.1 have been broadened to account for HDR image acquisition functionality. The intent of this functionality is more clearly stated below.

VariSeed 7.1 is substantially equivalent to the two predicate devices offering functionality for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43.

Significant functionality improvements to VariSeed 7.1 include anisotropy function and a utility for acquiring images and inputting pre-plan artifacts for high dose rate (HDR) brachytherapy planning. Each is available in the predicate BrachyVision device. With the addition of anisotropy function as a dose calculation method clinicians can have the option of representing dose distributions according to another model supported by the TG-43 standard. The HDR capture utility uses existing capabilities in the VariSeed 7.0 device to provide a simplified interface for acquiring ultrasound images and inputting pre-plan artifacts that can be exported according to the DICOM RT standard. The level of concern for VariSeed 7.1 is moderate. VariSeed 7.1 is not intended for diagnostic purposes nor will it control the delivery of the plan. Plan implementation will continue to be performed manually.

| VariSeed 7.0
(Predicate) | BrachyVision
(Predicate) | VariSeed 7.1
(New) |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Work Flows | |
| Off-line planning with or without
ultrasound images | Off-line planning with or without
ultrasound images | Off-line planning with or without
ultrasound images |
| Real-time planning using images
acquired from ultrasound | Real-time planning using images
acquired from ultrasound | Real-time planning using images
acquired from ultrasound |
| Nomogram planning | Nomogram planning | Nomogram planning |
| | HDR Image Acquisition utility | HDR Image Acquisition utility-
The HDR capture utility uses
existing capabilities in the VariSeed
7.0 device to provide a simplified
interface for acquiring ultrasound
images and inputting pre-plan
artifacts that can be exported
according to the DICOM RT
standard. |
| | Calculation | |
| AAPM TG-43 Support for Anisotropy
Constant | AAPM TG-43 Support for Anisotropy
Constant | AAPM TG-43 Support for Anisotropy
Constant |
| AAPM TG-43 Support for Anistropy
Factor | AAPM TG-43 Support for Anistropy
Factor | AAPM TG-43 Support for Anistropy
Factor |
| | AAPM TG-43 Support for Anisotropy
Function | AAPM TG-43 Support for
Anisotropy Function-
With the addition of anisotropy
function as a dose calculation
method clinicians can have the
option of representing dose
distributions according to another |
| | | model supported by the TG-43
standard. |
| Real-time calculation of isodoses and
display over patient anatomy as
isodose lines. | Real-time calculation of isodoses and
display over patient anatomy as
isodose lines. | Real-time calculation of isodoses and
display over patient anatomy as
isodose lines. |
| Automatic source decay | Automatic source decay | Automatic source decay |
| Industry Conformance | | |
| Conforms to AAPM TG-43 - Dosimetry
of interstitial brachytherapy sources | Conforms to AAPM TG-43 - Dosimetry
of interstitial brachytherapy sources | Conforms to AAPM TG-43 - Dosimetry
of interstitial brachytherapy sources |
| General | | |
| Independent of the radiation delivery
system | Independent of the radiation delivery
system | Independent of the radiation delivery
system |
| Hardcopy reports of all views | Hardcopy reports of all views | Hardcopy reports of all views |
| Planning support for all solid source
delivery systems - line, seed, and
seed train | Planning support for all solid source
delivery systems - line, seed, and
seed train | Planning support for all solid source
delivery systems - line, seed, and
seed train |
| User defined dose points | User defined dose points | User defined dose points |
| Manual structuring | Manual structuring | Manual structuring |
| Manual source localization | Manual source localization | Manual source localization |
| Window level tools | Window level tools | Window level tools |
| Multiple plan variations | Multiple plan variations | Multiple plan variations |
| Ultrasound import from DICOM | Ultrasound import from DICOM | Ultrasound import from DICOM |
| Included source management utilities | Included source management utilities | Included source management utilities |
| Included patient management utilities | Included patient management utilities | Included patient management utilities |
| Automated prostate contouring. | Automated prostate contouring. | Automated prostate contouring. |
| Contour editing | Contour editing | Contour editing |
| Contour interpolation | Contour interpolation | Contour interpolation |
| Contour margining | Contour margining | Contour margining |
| Point and line landmarks. | Reference points and lines | Point and line landmarks. |
| Source location export | Plan export | Source location export |
| Volume editing | Volume editing | Volume editing |
| Image and structure data export to
DICOM | Image and structure data export to
DICOM | Image, structure, and plan data export
to DICOM |
| Dosimetric quality alerts | Unacceptable dose values are flagged
in the Plan Organizer. | Dosimetric quality alerts |
| Image set co-registration | Image set co-registration | Image set co-registration |

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes and a flowing tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Ouality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K030534

Trade/Device Name: VariSeed 7.1 Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: February 14, 2003 Received: February 20, 2003

Dear Ms. Nash:

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. 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.

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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

(if known): K$\phi$3$\phi$534

510(k) Number (if known):

Device Name: VariSeed 7.1

Indications for use:

VariSeed 7.1 is a software application for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation as well as intra-operative planning and evaluation.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Usef OR (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030534