VARISEED 7.0

K012017 · Varian Medical Systems · MUJ · Jul 12, 2001 · Radiology

Device Facts

• Record ID: K012017
• Device Name: VARISEED 7.0
• Applicant: Varian Medical Systems
• Product Code: MUJ · Radiology
• Decision Date: Jul 12, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures.

Device Story

VariSeed 7.0 is a software application for permanent implant brachytherapy treatment planning. It assists clinicians in prostate cancer procedures by facilitating pre-operative and intra-operative planning and evaluation. The system models dose distributions based on AAPM TG-43 guidelines. It is intended for use by healthcare professionals in a clinical setting to optimize implant placement, thereby supporting clinical decision-making for radiation delivery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Software-based brachytherapy treatment planning system. Implements AAPM TG-43 dose calculation algorithms. Operates as a standalone software application for clinical planning and evaluation.

Indications for Use

Indicated for planning and evaluating permanent implant brachytherapy procedures for prostate cancer, including pre-operative planning and intra-operative planning and evaluation, in accordance with AAPM TG-43.

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

• MMS TherapacPLUS B3DTUI (K982821)
• Brachyvision (K992762)

Submission Summary (Full Text)

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JUL 1 2 2001

KO12017
VARI
medical sy

Oncology Systems 100 Hansen Way alo Alto, CA 94304-1038 tel [phone] ww.varian.com

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

#### Date Summary was prepared:

June 7, 2001

#### Submitter's Name:

Varian Medical Systems 3140 Hansen Way F-055 Palo Alto, CA 94304

#### Contact Person:

Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance [phone] Phone [phone] FAX E-Mail linda.nash(@os.varian.com

#### Device Name:

VariSeed 7.0

#### Classification Name:

Source, Brachytherapy, Radionuclide

#### Predicate Device:

MMS TherapacPLUS B3DTUI, K982821 and Brachyvision, K992762

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### Product Description:

See the Software Description of the Device, Tab E

#### Intended Use:

VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures.

## Technological Characteristics:

See the "Substantial Equivalence Comparison Chart", Tab F.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

JUL 1 2 2001

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012017

VARISEED 7.0 (Brachytherapy Treatment Planning System) Dated: June 25, 2001 Received: June 28, 2001 Regulatory Class: II 21 CFR 892.5730/Procode: 90 MUJ

#### Dear Ms. Nash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have is substantially equivalent (for the intications 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). 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 (Premarket Approval), it may be subject th your device is classimos (so aco regulations affecting your device can be found in the Code of Federal Regulations, to such additional controls. Internally equivalent determination assumes compliance with the Current Good Manufacturing Fride 21, 1 at 5 00 to 099. 11 backed to 1941. System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 1 rache requirements, is set tour in the Quand Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply war the Federal Register. Please note: this response to your premarket notification submission does not offect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his lotter while no 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 and additionally 809.10 for in vitro If you distic devices), please contact the Office of Compliance at [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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Brogdon

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

Enclosure (s)

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Page | of |

510(k) Number (if known): K012017

Device Name: Vari Seed 7.0_

Indications For Use:

VariSeed 7.0 is a software application for planning and evaluating permanent implant Vanoood 7.0 lo a connate application of prostate cancer with permanent implants braonythorapy procount of to AAPM TG-43. It facilitates pre-operative planning and that our be models a socialing in the 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)

| (Division Sign-Off) | |
|----------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices, | |
| 510(k) Number | K012017 |

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter Use |
|----------------------|--------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |